Promixin, 1 million International Units (IU), Powder for Solution for Injection
1. Name Of The Medicinal Product
Promixin, 1 million International Units (IU), Powder for Solution for Infusion.
2. Qualitative And Quantitative CompositionEach vial contains 1 million International Units (IU) which is approximately equivalent to 80 mg of colistimethate sodium.
3. Pharmaceutical FormPowder for solution for infusion
The powder is white to off white
4. Clinical Particulars 4.1 Therapeutic IndicationsPromixin is indicated for treatment of the following infections caused by susceptible aerobic Gram-negative bacteria (see section 5.1):
- Hospital acquired pneumonia (HAP)
- Complicated urinary tract infections
It is recommended that Promixin should be selected when antibacterial agents that are commonly used to treat these infections are not considered to be appropriate for the individual patient and/or the causative pathogen(s) (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology And Method Of AdministrationIt is recommended that Promixin should be administered under the supervision of physicians with appropriate experience in its use.
Method of Administration
Administration is by intravenous infusion. Each dose of Promixin can be diluted in 50 mL and administered by intravenous infusion over 30 minutes. Patients fitted with a totally implantable venous access device (TIVAD) may tolerate an injection of up to 2 million IU in 10 mL given over a minimum of 5 minutes.
Solutions should be used immediately after reconstitution. For instructions on dilution of the product before administration see section 6.6.
Posology
The dose regimen of Promixin that is selected should take into account factors such as the susceptibility of the pathogen(s), the severity and type of infection, and the ideal body weight and renal function of the patient. The duration of treatment is usually at least 5 days.
Standard dose recommendations are as follows:
Up to 60 Kg: 50,000 IU/Kg (4 mg/Kg) bodyweight, to a maximum of 75,000 IU/Kg (6 mg/Kg), in 24 hours. The total daily dose should be administered as three equal doses at 8 hourly intervals.
Over 60 Kg: 1-2 million IU every 8 hours. The maximum standard dose is 6 million IU (480 mg) in 24 hours.
Limited pharmacokinetic data from critically ill patients suggest that use of a loading dose and higher than standard doses may be appropriate (see Section 5.2). For severe infections and in critically ill patients doses up to 9 million IU per day in divided doses, have been reported in the literature. Clinical efficacy and safety data with these regimens are very limited and caution is advised (see sections 4.4 and 5.2).
Paediatric population
Dose recommendations are the same in adults and all paediatric sub groups.
Renal impairment
The suggested dose recommendations in Table 1 for patients with renal impairment are based on the standard total daily dose of 3-6 million IU/day. For patients with renal impairment in whom higher doses (e.g. up to 9 million IU/day) would be considered if their renal function was normal, corresponding proportional adjustments should be considered when calculating the dose. Caution is advised when administering Promixin to any patient with renal impairment due to the limited information available on safety and appropriate dose regimens (see section 4.4).
Table 1: Suggested modification of dosage of Promixin for adults with impaired renal function
Degree of Renal Impairment
Normal
Mild
Moderate
Severe
Creatinine Clearance
(% of normal)
76 to 100
40 to 75
25 to 40
Less than 25
Dose
Unit dose
(Million IU)
1.3 to 2
1 to 1.5
1
1 to 1.5
Frequency
(Times per day)
3
2
1 or 2
Every 36 hours
Total Daily Dose
(Million IU)
4 to 6
2 to 3
1 to 2
0.6 to 1
Hepatic impairment
It is not known whether the dose of Promixin requires adjustment in patients with hepatic impairment and therefore caution is advised.
4.3 ContraindicationsHypersensitivity to the active substance colistimethate sodium or other polymyxins.
4.4 Special Warnings And Precautions For UseUse with caution in patients with renal impairment as colistimethate sodium is renally excreted.
Nephrotoxicity or neurotoxicity may occur especially if the recommended dose is exceeded (see also Section 4.5). There are limited safety data when colistimethate sodium is used in doses exceeding 6 million IU/day.
Monitoring of renal function should be performed before initiating treatment with Promixin. Monitoring of serum creatinine must continue at regular intervals (at least daily) during therapy. Particular caution should be exercised when administering doses greater than 6 million IU/day. The dose of Promixin may have to be reduced if serum creatinine concentrations rise or exceed the upper limit of normal.
There is evidence that it is the total cumulative dose (not the daily dose) of colistimethate sodium that may be associated with risk of nephrotoxicity.
Do not use concomitantly with other medications with nephrotoxic or neurotoxic effects except with the greatest caution.
Colistimethate sodium is known to reduce the amount of acetylcholine released from the pre-synaptic neuromuscular junction and therefore should not be used in patients with myasthenia gravis, unless in life-threatening situations.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of colistimethate sodium. Discontinuation of therapy with colistimethate sodium and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Use with extreme caution in patients with porphyria.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionDue to the effects of colistimethate sodium on the release of acetylcholine, non-depolarising muscle relaxants should be used with extreme caution in patients receiving Promixin as their effects could be prolonged.
Concomitant use of colistimethate sodium with other medications that are nephrotoxic or neurotoxic (eg. cephalothin sodium, aminoglycosides, non-depolarising muscle relaxants) should only be undertaken with the greatest caution.
The potential of colistimethate sodium to affect the pharmacokinetics of other medicinal products has not been evaluated. Caution is recommended if colistimethate sodium is combined with medicinal products with a narrow therapeutic index.
4.6 Pregnancy And LactationFertility
There are no data on the effects of colistimethate sodium on human fertility. Effects on male and female fertility have not been evaluated in animal studies.
Pregnancy
Safety in human pregnancy has not been established. Animal studies are insufficient with respect to effects on reproduction. There is evidence that colistimethate sodium crosses the placenta and consequently there is potential for foetal toxicity if administered during pregnancy. Hence, Promixin should only be given during pregnancy if the benefits outweigh any potential risk.
Lactation
Colistimethate sodium is excreted in breast milk; breast feeding is not recommended during therapy.
4.7 Effects On Ability To Drive And Use MachinesNeurotoxicity, characterised by dizziness, confusion or visual disturbances have been reported following parenteral administration of colistimethate sodium. If these effects occur patients should be warned against driving or operating machinery.
4.8 Undesirable EffectsThe most commonly reported adverse reaction is renal function impairment, and more rarely renal failure, usually following use of higher than recommended doses in patients with normal renal function, or failure to reduce the dosage in patients with renal impairment or when used concomitantly with other nephrotoxic antibiotics. The effect is usually reversible on discontinuation of therapy, but rarely intervention (renal replacement therapy) may be required.
High serum concentrations of colistimethate sodium, which may be associated with overdosage or failure to reduce the dosage in patients with renal impairment, have been reported to lead to neurotoxic effects such as facial paraesthesia, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea. Concomitant use with either non-depolarising muscle relaxants or antibiotics with similar neurotoxic effects can also lead to neurotoxicity. Dose reduction of colistimethate sodium may relieve symptoms.
Hypersensitivity reactions such as skin rash and angioedema have been known to occur. In the event such reactions occur, treatment with colistimethate sodium should be withdrawn.
Adverse reactions are tabulated below by system organ class and frequency. Frequencies are defined as Very common (
Body System
Frequency
Reported adverse reaction
Immune system disorders
Not known
Hypersensitivity reactions such as skin rash and angioedema
Nervous system disorders
Very Common
Neurotoxicity such as, facial, mouth and peri-oral paraesthesia, headache, and muscle weakness
Not known
Dizziness
Ataxia
Skin and subcutaneous tissue disorders
Very Common
Pruritus
Renal and urinary disorders
Very Common
Renal impairment demonstrated by increased blood creatinine and / or urea and / or decreased creatinine renal clearance
Rare
Renal failure
General disorders and administration site conditions
Not known
Injection site reaction
4.9 OverdoseOverdosage may cause renal insufficiency, renal failure, apnoea, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion and psychosis.
No antidote is available.
Management of overdose is by means of supportive treatment and measures designed to increase clearance of colistimethate sodium such as inducing an osmotic diuresis with mannitol, peritoneal dialysis or prolonged haemodialysis.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPharmacotherapeutic group: other antibacterials, Polymyxins
ATC code: J01XB01
General properties
Mode of action
The polymyxin antibiotics are surface active agents and act by binding to and changing the permeability of bacterial cell membrane causing bacterial cell death. Polymyxins are bactericidal against Gram-negative bacteria with a hydrophobic outer membrane.
PK/PD relationship
Polymyxins have been reported to have a concentration-dependent bactericidal effect on susceptible bacteria.
EUCAST Breakpoints
Susceptible (S) Resistant (R) a
Acinetobacter
S
Enterobacteriaceae
S
Pseudomonas Spp
S
aBreakpoints apply to dosage of 2-3 million IU x 3. A loading dose (9 million IU) may be needed.
Mechanisms of resistance
Acquired resistance to Colistimethate sodium in Pseudomonas aeruginosa appears to be related to alterations in the bacterial outer membrane. In-vitro studies with Salmonella and E. coli have shown that resistance may occur due to modification of the cell wall lipopolysaccharide phosphate groups. Modification is achieved by substitution of the phosphate groups with ethanolamine or aminoarabinose. Proteus mirabilis, Burkholderia cepacia and other naturally resistant Gram-negative bacteria, show complete substitution of their lipopolysaccharide groups.
Polymyxins including colistimethate sodium differ in their mechanism of action compared with other antibiotics and there is evidence to show that Gram-negative bacteria resistant to other antibiotics may be susceptible to colistimethate sodium. There is no co- resistance between polymyxins and other groups of antibiotics.
Susceptibility
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. Expert advice should be sought when the local prevalence of resistance is such that the utility of the agent, in at least some types of infections, is questionable.
Commonly susceptible species
Acinetobacter species
Klebsiella species
Pseudomonas aeruginosa
Species for which acquired resistance may be a problem
Stenotrophomonas maltophilia
Achromobacter xylosoxidans
Inherently resistant organisms
Burkholderia cepacia and related species
Proteus spp
Providencia spp
Serratia spp
5.2 Pharmacokinetic PropertiesAbsorption
Absorption of colistimethate sodium from the gastrointestinal tract does not occur to any appreciable extent in the normal individual.
Distribution
The volume of distribution of colistin following administration of colistimethate sodium in healthy volunteers and in patients with cystic fibrosis has been reported to be 12.4L and 20.4L respectively. In comparison the volume of distribution for colistin following administration of colistimethate sodium has been shown to be between 90.6 L and 139.9 L in critically ill patients. The increase in the volume of distribution in critically ill patients, may lead to a delay in reaching effective plasma concentrations. Therefore the use of an initial loading dose of up to 9 million IU has been suggested, especially in critically ill patients.
In critically ill patients given colistimethate sodium 2 million IU and 3 million IU three times a day intravenously, peak colistin plasma concentrations of 2.21 and 2.93 mg/L, respectively, were observed.
Biotransformation
Colistimethate sodium undergoes conversion to polymyxin E1 and polymyxin E2 (colistin) in vivo. It has been estimated that approximately 30% of the colistimethate sodium is converted to colistin.
Elimination
Colistimethate sodium is primarily excreted unchanged in the urine where the hydrolysis to the active moiety continues. Following intravenous administration 62% of a dose is recovered in the urine within 8 hours.
Colistin is excreted by the non-renal route.
The half-life of colistin following administration of colistimethate sodium in healthy volunteers and in patients with cystic fibrosis has been reported to be 3 hours and 4.2 hours respectively. The half-life of colistin following administration of colistimethate sodium has been reported to increase when administered to critically ill patients compared to healthy volunteers and mean half life is estimated to range from approximately 5.9 hours to 7.4 hours following intravenous administration to critically ill patients.
In patients with renal impairment, colistimethate sodium excretion is reduced and a higher proportion may be converted to colistin, leading to increased plasma colistin concentrations.
5.3 Preclinical Safety DataAnimal studies are insufficient with respect to effects on reproduction.
Data on potential genotoxicity are limited and carcinogenicity data for colistimethate sodium are lacking. Colistimethate sodium has been shown to induce chromosomal aberrations in human lymphocytes, in vitro. This effect may be related to a reduction in mitotic index, which was also observed.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsNone
6.2 IncompatibilitiesThis medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf LifeUnopened:
Two years
After reconstitution:
Chemical and physical in-use stability has been demonstrated for up to 8 hours at room temperature.
From a microbiological point of view solutions should be used immediately. If not used immediately in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
6.4 Special Precautions For StorageNo special precautions for storage.
For storage conditions of the reconstituted/diluted product see section 6.3.
6.5 Nature And Contents Of ContainerThe product is supplied in clear type I glass vials sealed with a siliconised chlorobutyl type I rubber stopper and protected by a 20 mm aluminium tear-off cap incorporating a red flip-up central plastic top. The product is supplied in pack sizes of 10 vials.
6.6 Special Precautions For Disposal And Other HandlingFor single use only.
Promixin must be reconstituted, under aseptic conditions, with sodium chloride solution 9 mg/mL (0.9%) to produce a clear colourless to pale yellow solution. Following reconstitution, the solution should be diluted to a suitable volume for infusion over 30 minutes with sodium chloride solution 9 mg/mL (0.9%) for infusion. The solution should be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.
Solutions should be used immediately after reconstitution (see section 4.2).
Discard any unused solution. Waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation HolderProfile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere
Chichester
West Sussex
PO20 2FT
United Kingdom
8. Marketing Authorisation Number(S)PL 19419/0002
9. Date Of First Authorisation/Renewal Of The AuthorisationDate of first authorisation: 24th June 2003
Date of latest renewal: 13th March 2009
10. Date Of Revision Of The Text30th August 2011
interferon beta-1b
Generic Name: interferon beta-1b (in ter FEAR on BAY ta 1b)
Brand Names: Betaseron, Extavia
Interferon beta-1b is made from human proteins. Interferons help the body fight viral infections.
Interferon beta-1b is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.
Interferon beta-1b may also be used for other purposes other than those listed in this medication guide.
What is the most important information I should know about interferon beta-1b? This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1b if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.Before using interferon beta-1b, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, a bleeding or blood-clotting disorder, anemia (low red blood cells), or a history of depression or suicidal behavior.
Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1b if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.Interferon beta-1b is given as an injection under the skin, usually at bedtime every 48 hours (2 days). You may be given instructions on how to use your injections at home. You may be shown how to inject your medicine at home.
Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.
What should I discuss with my healthcare provider before using interferon beta-1b? Do not use this medication if you are allergic to interferons or human albumin. Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1b if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
liver disease;
a thyroid disorder;
epilepsy or other seizure disorder;
a bleeding or blood-clotting disorder, such as hemophilia;
anemia (lack of red blood cells); or
a history of depression or suicidal behavior.
FDA pregnancy category C. This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1b if you are pregnant. Tell your doctor if you become pregnant during treatment. It is not known whether interferon beta-1b passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.Interferon beta-1b is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
How should I use interferon beta-1b?Interferon beta-1b is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home.
Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.Interferon beta-1b is injected into a skin area of the thigh, stomach, buttocks, or back of the upper arm. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Interferon beta-1b is usually given as one injection at bedtime every 48 hours (2 days). Follow the directions on your prescription label. Try to use your injections at the same time each dosing day.
Interferon beta-1b is a powder that comes in a single-use vial (bottle) with a liquid (diluent) that must be mixed with the powder in the vial. Gently swirl but do not shake the vial after mixing the medicine. Allow any bubbles or foam to settle before drawing the medicine into a syringe.
If the medicine has changed colors or has any particles in it, call your doctor for a new prescription.
Do not draw your interferon beta-1b dose into a syringe until you are ready to give yourself an injection. Use a different place on your skin each time you inject this medication. Do not inject interferon beta-1b into the same skin area two times in a row.Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled visits to your doctor.
Store interferon beta-1b vials at room temperature away from moisture and heat. After mixing the medicine you should use it right away, or within 3 hours after mixing if you store it in a refrigerator. Do not freeze. What happens if I miss a dose?Use the medication as soon as you remember the missed dose. Then wait at least 48 hours before using another injection, and restart your dosing schedule at that time. Do not use more than one injection every 48 hours (2 days).
What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an interferon beta-1b overdose are not known. What should I avoid while using interferon beta-1b?Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using interferon beta-1b.
Interferons can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Interferon beta-1b side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using interferon beta-1b and call your doctor at once if you have any of these serious side effects:depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;
bruising, swelling, oozing, or skin changes where the injection was given;
weight changes, pounding heartbeats, feeling too hot or cold;
fever, chills, body aches, flu symptoms; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
weakness;
headache;
muscle pain or weakness;
sleep problems (insomnia);
stomach pain;
swelling in your hands or feet;
skin rash; or
irregular menstrual periods.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Interferon beta-1b Dosing InformationUsual Adult Dose for Multiple Sclerosis:
Initial: 0.0625 mg subcutaneously every other day, and increased (by 25% increments) every 2 weeks, over a 6 week period, to maintenance dose
Maintenance: 0.25 mg subcutaneously every other day
Usual Adult Dose for Colorectal Cancer:
Phase II trials - advanced colorectal carcinoma (n=81)
9 million international units subcutaneously on days 1, 3, and 5, thereafter 3 times a week (in combination with fluorouracil)
Usual Pediatric Dose for Chronic Inflammatory Demyelinating Polyradiculoneuropathy:
Case (n=1)
1.5 million international units subcutaneously twice a week for 1 week, then 3 million international units 3 times a week
Usual Pediatric Dose for Multiple Sclerosis:
Study (n=1)
Greater than 8.5 years: 8 million international units (0.25 mg) subcutaneously every other day
There may be other drugs that can affect interferon beta-1b. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More interferon beta-1b resources Interferon beta-1b Side Effects (in more detail) Interferon beta-1b Use in Pregnancy & Breastfeeding Interferon beta-1b Drug Interactions Interferon beta-1b Support Group 2 Reviews for Interferon beta-1b - Add your own review/rating interferon beta-1b Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information Interferon Beta-1b Professional Patient Advice (Wolters Kluwer) Interferon Beta-1b Solution MedFacts Consumer Leaflet (Wolters Kluwer) Betaseron Prescribing Information (FDA) Betaseron Consumer Overview Extavia Prescribing Information (FDA) Extavia Consumer Overview Compare interferon beta-1b with other medications Chronic Inflammatory Demyelinating Polyradiculoneuropathy Colorectal Cancer Multiple Sclerosis Where can I get more information? Your pharmacist can provide more information about interferon beta-1b.See also: interferon beta-1b side effects (in more detail)
penicillin G potassium
Generic Name: penicillin G potassium (PEN i SIL in G poe TAS ee um)
Brand Names: Pfizerpen
Penicillin G potassium is a fast-acting antibiotic that fights bacteria in your body.
Penicillin G potassium is used to treat many different types of severe infections, including strep and staph infections, diphtheria, meningitis, gonorrhea, and syphilis.
Penicillin G potassium is also used to prevent infections of the heart valves in people with certain heart conditions who need to have dental work or surgery.
Penicillin G potassium may also be used for purposes not listed in this medication guide.
What is the most important information I should know about penicillin G potassium? You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.Before using penicillin G potassium, tell your doctor if you have asthma or a history of allergies, liver disease, kidney disease, or heart disease.
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Penicillin G potassium will not treat a viral infection such as the common cold or flu.After you have finished your treatment with penicillin G potassium, your doctor may want to do tests to make sure your infection has completely cleared up.
What should I discuss with my healthcare provider before taking penicillin G potassium? You should not use this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.To make sure you can safely use penicillin G potassium, tell your doctor if you have any of these other conditions:
asthma or a history of allergies;
liver disease;
kidney disease; or
heart disease.
FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Penicillin G potassium can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take penicillin G potassium?Penicillin G potassium is injected into a muscle or into a vein through an IV. You may be shown how to use an injection at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
Penicillin G potassium may also be injected into the membrane surrounding the lungs, or into the fluid surrounding the spinal cord. The medicine must be given slowly through an IV infusion, and can take up to 24 hours to complete.
Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Penicillin G potassium will not treat a viral infection such as the common cold or flu.If you use this medication long-term, your blood may need to be tested to make sure the medicine is not causing harmful effects. Your kidney or liver function may also need to be tested. Visit your doctor regularly.
This medication can cause false results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using penicillin G potassium.
After you have finished your treatment with penicillin G potassium, your doctor may want to do tests to make sure your infection has completely cleared up.
Store the powder at room temperature away from moisture and heat. After mixing the powder with a diluent, store in the refrigerator and use it within 7 days. Do not freeze. Penicillin G potassium that is supplied as a frozen solution should be stored in a deep freezer at a temperature of 4 degrees below 0 (F).Thaw the solution either in a refrigerator or at room temperature. Do not heat the medicine to thaw it more quickly.
Penicillin G potassium that is thawed in the refrigerator should be used within 14 days. If you have thawed the medicine at room temperature, you must use it within 24 hours. Do not refreeze.Once the solution has been thawed, it should look clear. Do not use the medicine if it looks cloudy or has particles in it, or if the medicine container leaks. Call your doctor or pharmacist for a new prescription.
What happens if I miss a dose?Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.
What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.Overdose symptoms may include confusion, agitation, hallucinations, or seizure (convulsions).
What should I avoid while taking penicillin G potassium?Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking this medication and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Penicillin G potassium side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:diarrhea that is watery or bloody;
blood in your urine;
feeling like you might pass out;
fever, chills, swollen glands, body aches, flu symptoms, rash or itching, muscle or joint pain, night sweats, general ill feeling;
white patches or sores inside your mouth or on your lips;
urinating less than usual or not at all;
skin rash with bruising, severe tingling, numbness, pain, muscle weakness;
swelling in your hands or feet;
pale or yellowed skin, dark colored urine, fever, confusion or weakness;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
twitching or uncontrollable muscle movements; or
increased thirst, feeling restless, increased urination, muscle pain or weakness, irregular heart rate, weak pulse, tingly feeling, feeling light-headed, fainting, or seizure (convulsions).
Less serious side effects may include:
overactive reflexes;
nausea, vomiting;
black or hairy tongue; or
pain, swelling, bruising, or irritation around the IV needle.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Penicillin G potassium Dosing InformationUsual Adult Dose for Streptococcal Infection:
Serious infections due to susceptible strains of streptococci (including Streptococcus pneumoniae): 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Such infections include septicemia, empyema, pneumonia, pericarditis, endocarditis, and meningitis.
Usual Adult Dose for Bacterial Infection:
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Such infections include septicemia, empyema, pneumonia, pericarditis, endocarditis, and meningitis.
Pasteurella infections (including bacteremia and meningitis): 4 million to 6 million units/day IV in divided doses every 4 to 6 hours for 2 weeks
Usual Adult Dose for Pneumonia:
Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Usual Adult Dose for Septicemia:
Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Usual Adult Dose for Endocarditis:
Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Erysipelothrix rhusiopathiae: 2 million to 20 million units/day IV in divided doses every 4 to 6 hours for 4 to 6 weeks
Listeria monocytogenes: 15 million to 20 million units/day IV in divided doses every 4 to 6 hours for 4 weeks
Usual Adult Dose for Meningitis:
Serious infections due to susceptible strains of streptococci: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Serious infections due to susceptible strains of staphylococci: 5 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Listerial meningitis: 15 million to 20 million units/day IV in divided doses every 4 to 6 hours for 2 weeks
Pasteurella meningitis: 4 million to 6 million units/day IV in divided doses every 4 to 6 hours for 2 weeks
Usual Adult Dose for Meningitis -- Meningococcal:
Meningococcal meningitis and/or septicemia: 1 million to 2 million units IM every 2 hours or 20 million to 30 million units/day as a continuous IV infusion for at least 10 to 14 days
If meningococcal meningitis is suspected, immediate treatment with penicillin is required, and should be started before lumbar puncture confirmation of the diagnosis. The mortality of this disease is 50% within the first 24 hours.
Usual Adult Dose for Meningitis -- Pneumococcal:
Serious infections due to susceptible strains: 12 million to 24 million units/day IV in divided doses every 4 to 6 hours, depending on the nature and severity of the infection
Usual Adult Dose for Neurosyphilis:
Manufacturers recommendation: 2 million to 4 million units IV every 4 hours for 10 to 14 days
Centers for Disease Control and Prevention (CDC) recommendation: 3 million to 4 million units IV every 4 hours or 18 million to 24 million units/day as a continuous infusion for 10 to 14 days
Many experts recommend additional therapy with penicillin G benzathine 2.4 million units IM once a week for up to 3 weeks following completion of IV therapy.
Usual Adult Dose for Actinomycosis:
Cervicofacial disease: 1 million to 6 million units/day IV in divided doses every 4 to 6 hours
Thoracic and abdominal disease: 10 million to 20 million units/day IV in divided doses every 4 to 6 hours
Duration: Prolonged therapy (1.5 to 18 months or longer) may be necessary. Four to 6 weeks followed by oral therapy for 6 to 12 months, depending on the nature and severity of the infection, has been recommended for patients with pulmonary actinomycosis or other severe infections caused by the organism.
Usual Adult Dose for Inhalation Bacillus anthracis:
Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure: Minimum of 8 million units/day IV in divided doses every 6 hours; higher doses may be needed depending on susceptibility of organism
Dosages up to 20 million units/day IV have been used to treat anthrax septicemia and intestinal, pulmonary, and meningeal anthrax. Some clinicians recommend 8 million to 12 million units/day in divided doses every 4 to 6 hours for the treatment of anthrax due to natural or endemic anthrax exposures.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism: 4 million units IV every 4 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)
Usual Adult Dose for Cutaneous Bacillus anthracis:
Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure: Minimum of 8 million units/day IV in divided doses every 6 hours; higher doses may be needed depending on susceptibility of organism
Dosages up to 20 million units/day IV have been used to treat anthrax septicemia and intestinal, pulmonary, and meningeal anthrax. Some clinicians recommend 8 million to 12 million units/day in divided doses every 4 to 6 hours for the treatment of anthrax due to natural or endemic anthrax exposures.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism: 4 million units IV every 4 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)
Usual Adult Dose for Botulism:
Adjunctive therapy to antitoxin: 20 million units/day IV in divided doses every 4 to 6 hours
Wound botulism (as an adjunct to antitoxin, supportive care, and surgical debridement): 2 million units IV every 4 hours plus metronidazole 250 mg IV every 6 hours
Usual Adult Dose for Tetanus:
Adjunctive therapy to human tetanus immune globulin: 20 million units/day in divided doses every 4 to 6 hours
Usual Adult Dose for Clostridial Infection:
Gas gangrene (debridement and/or surgery as indicated): 20 million units/day in divided doses every 4 to 6 hours
Usual Adult Dose for Diphtheria:
As an adjunct to antitoxin and to prevent carrier state: 2 million to 3 million units/day IV in divided doses every 4 to 6 hours for 10 to 12 days
To eliminate carrier state: 300,000 to 400,000 units/day IM in divided doses for 10 to 12 days
Usual Adult Dose for Fusospirochetosis:
Severe infections of the oropharynx (Vincent's), lower respiratory tract, and genital area: 5 million to 10 million units/day IV in divided doses every 4 to 6 hours
Usual Adult Dose for Bacteremia:
Pasteurella bacteremia: 4 million to 6 million units/day IV in divided doses every 4 to 6 hours for 2 weeks
Usual Adult Dose for Rat-bite Fever:
Infections due to Streptobacillus moniliformis (rat-bite fever or Haverhill fever) or Spirillum minus (rat-bite fever): 12 million to 20 million units/day IV in divided doses every 4 to 6 hours for 3 to 4 weeks
Usual Adult Dose for Lyme Disease -- Neurologic:
Early Lyme disease with acute neurologic disease manifested by meningitis or radiculopathy: 18 million to 24 million units/day IV in divided doses every 4 hours
Late Lyme disease and associated neurologic disease affecting the CNS or peripheral nerve disease (e.g., neuropathy, encephalopathy) and documented by CSF analysis: 18 million to 24 million units/day IV in divided doses every 4 to 6 hours
Duration: 14 to 28 days
Penicillin G is recommended as an alternative to IV ceftriaxone. Ceftriaxone is considered the parenteral drug of choice.
Usual Adult Dose for Lyme Disease -- Carditis:
Third-degree atrioventricular (AV) heart block or a PR interval exceeding 0.3 seconds: 18 million to 24 million units/day IV in divided doses every 4 to 6 hours, with cardiac monitoring and a temporary pacemaker for complete heart block
Duration: 14 to 21 days
Penicillin G is recommended as an alternative to IV ceftriaxone. Ceftriaxone is considered the parenteral drug of choice.
Usual Adult Dose for Lyme Disease -- Arthritis:
Recurrent arthritis after oral treatment: 18 million to 24 million units/day IV in divided doses every 4 hours for 14 to 28 days
Penicillin G is recommended as an alternative to IV ceftriaxone for patients with late Lyme disease who have arthritis and objective proof of neurologic disease. It is also recommended as an alternative for patients with persistent or recurrent arthritis after oral treatment; IV therapy is only recommended in those patients whose arthritis showed no improvement or worsened. Ceftriaxone is considered the parenteral drug of choice.
Usual Adult Dose for Prevention of Perinatal Group B Streptococcal Disease:
5 million units IV at onset of labor or after membrane rupture followed by 2.5 million units IV every 4 hours until delivery
Usual Adult Dose for Leptospirosis:
1.5 million units IV every 6 hours for 7 days
Usual Adult Dose for Deep Neck Infection:
2 million to 4 million units IV or IM every 4 to 6 hours for 2 to 3 weeks, depending on the nature and severity of the infection
The addition of metronidazole to high-dose penicillin therapy is recommended by many experts to treat parapharyngeal infections because of the increasing frequency of penicillin-resistant anaerobes. Removal of abscessed material is also necessary for successful treatment.
Usual Adult Dose for Skin or Soft Tissue Infection:
Erysipelas: 1 million to 2 million units IV every 4 to 6 hours
Streptococcal cellulitis: 1 million to 2 million units IV every 6 hours for 7 to 10 days
Usual Adult Dose for Aspiration Pneumonia:
2 million to 3 million units IV every 4 to 6 hours plus metronidazole 500 mg IV every 8 hours for 7 to 14 days, depending on the nature and severity of the infection
Usual Adult Dose for Joint Infection:
2 million to 3 million units IV every 4 hours for 2 weeks, depending on the nature and severity of the infection
Usual Adult Dose for Gonococcal Infection -- Disseminated:
Infections (such as meningitis, endocarditis, arthritis, etc.) caused by penicillin-susceptible organisms: 10 million units/day IV in divided doses every 4 to 6 hours
Duration: Depends on the nature and severity of the infection
Due to resistance, penicillin G is not recommended by the CDC. Ceftriaxone is the drug of choice.
Usual Adult Dose for Gram Negative Infection:
Gram-negative bacillary bacteremia (Escherichia coli, Enterobacter aerogenes, Alcaligenes faecalis, Salmonella, Shigella, and Proteus mirabilis): 20 million to 80 million units per day
Penicillin G is not the drug of choice in the treatment of gram-negative bacillary infections. Other more effective anti-infectives are usually used for the treatment of these infections.
Usual Pediatric Dose for Bacterial Infection:
American Academy of Pediatrics (AAP) recommendations:
Neonates:
7 days or less:
2000 g or less: 25,000 to 50,000 units/kg IM or IV every 12 hours
Greater than 2000 g: 25,000 to 50,000 units/kg IM or IV every 8 hours
Greater than 7 days:
Less than 1200 g: 25,000 to 50,000 units/kg IM or IV every 12 hours
1200 to 2000 g: 25,000 to 50,000 units/kg IM or IV every 8 hours
Greater than 2000 g: 25,000 to 50,000 units/kg IM or IV every 6 hours
Infants and children:
Mild to moderate infections: 100,000 to 250,000 units/kg/day IM or IV in divided doses every 4 to 6 hours
Severe infections: 250,000 to 400,000 units/kg/day IM or IV in 4 to 6 divided doses
Maximum dose: 24 million units/day
Usual Pediatric Dose for Endocarditis:
Manufacturers recommendation:
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S pneumoniae) and meningococcus: 150,000 to 300,000 units/kg/day IV in divided doses every 4 to 6 hours
The duration of therapy depends on the nature and severity of the infection.
Usual Pediatric Dose for Pneumonia:
Manufacturers recommendation:
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S pneumoniae) and meningococcus: 150,000 to 300,000 units/kg/day IV in divided doses every 4 to 6 hours
The duration of therapy depends on the nature and severity of the infection.
Usual Pediatric Dose for Streptococcal Infection:
Manufacturers recommendation:
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S pneumoniae) and meningococcus: 150,000 to 300,000 units/kg/day IV in divided doses every 4 to 6 hours
The duration of therapy depends on the nature and severity of the infection.
Usual Pediatric Dose for Meningitis -- Meningococcal:
Manufacturers recommendation: 250,000 units/kg/day IV in divided doses every 4 hours for 7 to 14 days, depending on the nature and severity of the infection
Maximum dose: 12 million to 20 million units/day
Usual Pediatric Dose for Meningitis -- Pneumococcal:
Manufacturers recommendation: 250,000 units/kg/day IV in divided doses every 4 hours for 7 to 14 days, depending on the nature and severity of the infection
Maximum dose: 12 million to 20 million units/day
AAP recommendation:
1 month or older: 250,000 to 400,000 units/kg/day IV in 4 to 6 divided doses
Usual Pediatric Dose for Meningitis -- Streptococcus Group B:
AAP recommendation:
Neonates 7 days or younger: 250,000 to 450,000 units/kg/day IV in 3 divided doses
Neonates older than 7 days: 450,000 units/kg/day IV in 4 divided doses
Usual Pediatric Dose for Congenital Syphilis:
Less than 1 month (symptomatic neonates and neonates with proven or presumed congenital syphilis): 50,000 units/kg IV every 12 hours during the first 7 days of life and every 8 hours thereafter for 10 days total; if more than 1 day of therapy is missed in patients with proven or highly probable disease, the entire course should be repeated
1 month or older: 50,000 units/kg IV every 4 to 6 hours for 10 days; some clinicians recommend following this regimen with penicillin G benzathine 50,000 units/kg IM once a week for 1 to 3 weeks
Usual Pediatric Dose for Neurosyphilis:
Manufacturers recommendation:
1 month or older: 50,000 units/kg IV every 4 to 6 hours for 10 to 14 days
CDC recommendation:
Adolescents: 3 million to 4 million units IV every 4 hours or 18 million to 24 million units/day as a continuous infusion for 10 to 14 days; many experts recommend additional therapy with penicillin G benzathine 2.4 million units IM once a week for up to 3 weeks following completion of IV therapy
Usual Pediatric Dose for Inhalation Bacillus anthracis:
Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure:
Children: Some clinicians recommend 100,000 to 150,000 units/kg/day in divided doses every 4 to 6 hours.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism:
Children less than 12 years: 50,000 units/kg IV every 6 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)
Usual Pediatric Dose for Cutaneous Bacillus anthracis:
Treatment of penicillin-susceptible anthrax:
As the result of naturally occurring or endemic anthrax exposure:
Children: Some clinicians recommend 100,000 to 150,000 units/kg/day in divided doses every 4 to 6 hours.
Duration: At least 14 days after symptoms abate
As the result of exposure to B anthracis spores during biologic warfare or bioterrorism:
Children less than 12 years: 50,000 units/kg IV every 6 hours; oral therapy may be substituted once the patient's clinical condition improves
Treatment of inhalation anthrax should be started with a multiple-drug parenteral regimen that includes ciprofloxacin or doxycycline plus 1 or 2 additional antibiotics with activity against the causative organism. A multiple-drug parenteral regimen is also recommended for initial treatment of cutaneous anthrax if there are signs of systemic involvement, extensive edema, or lesions on the head or neck. Due to concerns regarding resistance, penicillin alone is not recommended for inhalation anthrax that occurs as the result of biologic warfare or bioterrorism since high concentrations of the organism are expected, but it can be included in appropriate combination therapies.
Duration: 60 days (including IV and oral therapy)
Usual Pediatric Dose for Diphtheria:
Manufacturers recommendation:
As an adjunct to antitoxin and to prevent carrier state: 150,000 to 250,000 units/kg/day IV in divided doses every 6 hours for 7 to 10 days
AAP recommendation:
As an adjunct to antitoxin: 100,000 to 150,000 units/kg/day IV in 4 divided doses for 14 days
Usual Pediatric Dose for Rat-bite Fever:
Infections due to S moniliformis (rat-bite fever or Haverhill fever [with endocarditis]) or S minus (rat-bite fever): 150,000 to 250,000 units/kg/day in divided doses every 4 hours for 4 weeks
Usual Pediatric Dose for Lyme Disease -- Neurologic:
Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 to 6 hours for 14 to 28 days
Maximum dose: 18 million to 24 million units/day
Penicillin G is recommended as an alternative to IV ceftriaxone or IV cefotaxime for patients with early Lyme disease who have acute neurologic disease manifested by meningitis or radiculopathy. It is also recommended as an alternative for patients with late Lyme disease and associated neurologic disease affecting the CNS or peripheral nerve disease (e.g., neuropathy, encephalopathy) and documented by CSF analysis. Ceftriaxone is considered the parenteral drug of choice.
Usual Pediatric Dose for Lyme Disease -- Carditis:
Third-degree AV heart block or a PR interval exceeding 0.3 seconds during early Lyme disease:
Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 to 6 hours for 14 to 21 days
Maximum dose: 18 million to 24 million units/day
Ceftriaxone is considered the parenteral drug of choice.
Usual Pediatric Dose for Lyme Disease -- Arthritis:
Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 hours for 14 to 28 days
Maximum dose: 18 million to 24 million units/day
Penicillin G is recommended as an alternative to IV ceftriaxone or IV cefotaxime for patients with late Lyme disease who have arthritis and objective proof of neurologic disease. It is also recommended as an alternative for patients with persistent or recurrent arthritis after oral treatment; IV therapy is only recommended in those patients whose arthritis showed no improvement or worsened. Ceftriaxone is considered the parenteral drug of choice.
Usual Pediatric Dose for Gonococcal Infection -- Disseminated:
Penicillin-susceptible strains:
Less than 45 kg:
Arthritis: 100,000 units/kg/day in 4 divided doses for 7 to 10 days
Meningitis: 250,000 units/kg/day in divided doses every 4 hours for 10 to 14 days
Endocarditis: 250,000 units/kg/day in divided doses every 4 hours for 4 weeks
45 kg or more:
Arthritis, meningitis, endocarditis: 10 million units/day in 4 divided doses; duration depends on the type of infection
Due to resistance, penicillin G is not recommended by the CDC. Ceftriaxone is the drug of choice.
Tell your doctor about all other medications you use, especially:
aspirin or indomethacin (Indocin);
birth control pills;
methotrexate (Rheumatrex, Trexall(;
probenecid (Benemid);
an antibiotic such as chloramphenicol (Chloromycetin) or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);
a diuretic (water pill) such as furosemide (Lasix) or ethacrynic acid (Edecrin);
sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others); or
a tetracycline antibiotic, such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).
This list is not complete and other drugs may interact with penicillin G potassium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More penicillin G potassium resources Penicillin G potassium Side Effects (in more detail) Penicillin G potassium Use in Pregnancy & Breastfeeding Drug Images Penicillin G potassium Drug Interactions Penicillin G potassium Support Group 11 Reviews for Penicillin G potassium - Add your own review/rating Penicillin G Potassium MedFacts Consumer Leaflet (Wolters Kluwer) Pfizerpen Prescribing Information (FDA) Pfizerpen Advanced Consumer (Micromedex) - Includes Dosage Information Compare penicillin G potassium with other medications Actinomycosis Anthrax Anthrax Prophylaxis Aspiration Pneumonia Bacterial Infection Clostridial Infection Congenital Syphilis Cutaneous Bacillus anthracis Deep Neck Infection Diphtheria Endocarditis Fusospirochetosis, Trench Mouth Joint Infection Leptospirosis Lyme Disease, Arthritis Lyme Disease, Carditis Lyme Disease, Erythema Chronicum Migrans Lyme Disease, Neurologic Meningitis Meningitis, Meningococcal Meningitis, Pneumococcal Neurosyphilis Otitis Media Pneumonia Prevention of Perinatal Group B Streptococcal Disease Rat-bite Fever Rheumatic Fever Prophylaxis Skin Infection Strep Throat Syphilis, Early Syphilis, Latent Tertiary Syphilis Tonsillitis/Pharyngitis Upper Respiratory Tract Infection Where can I get more information? Your pharmacist can provide more information about penicillin G potassium.See also: penicillin G potassium side effects (in more detail)
International Apex Pethidine
International Apex Pethidine may be available in the countries listed below.
Ingredient matches for International Apex Pethidine PethidinePethidine hydrochloride (a derivative of Pethidine) is reported as an ingredient of International Apex Pethidine in the following countries:
PhilippinesInternational Drug Name Search
International Apex Tetrahydrozoline
International Apex Tetrahydrozoline may be available in the countries listed below.
Ingredient matches for International Apex Tetrahydrozoline TetryzolineTetryzoline is reported as an ingredient of International Apex Tetrahydrozoline in the following countries:
PhilippinesInternational Drug Name Search
interferon gamma-1b
Generic Name: interferon gamma-1b (in ter FEER on GAM a)
Brand Names: Actimmune
Interferon gamma-1b is made from human proteins. Interferons help the body fight viral infections.
Interferon gamma-1b is a specific interferon used to prevent infections in people with a condition called chronic granulomatous disease. Interferon gamma-1b is also used to treat a congenital bone disorder called osteopetrosis.
Interferon gamma-1b may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about interferon gamma-1b? Do not use this medication if you are allergic to interferon gamma-1b, or to drug products made from E. Coli bacteria.Before using interferon gamma-1b, tell your doctor if you are allergic to any drugs, or if you have heart rhythm problems, congestive heart failure, history of heart disease or blood clots, or epilepsy or another seizure disorder.
Interferon gamma-1b is usually given three times weekly. Do not use the medication every day unless your doctor has told you to.
Store interferon gamma-1b in the refrigerator but do not allow it to freeze. Throw away any interferon gamma-1b that has been out of the refrigerator for more than 12 hours. Do not put it back into the refrigerator.To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.
What should I discuss with my healthcare provider before using interferon gamma-1b? You should not use this medication if you are allergic to interferon gamma-1b, or to drug products made from E. Coli bacteria.Before using interferon gamma-1b, tell your doctor if you are allergic to any drugs, or if you have:
heart rhythm problems;
congestive heart failure;
history of heart disease or blood clots; or
epilepsy or other seizure disorder.
If you have any of these conditions, you may need a dose adjustment or special tests to safely use interferon gamma-1b.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether interferon gamma-1b passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use interferon gamma-1b?Interferon gamma-1b is given as an injection under the skin of your upper arm or thigh. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Interferon gamma-1b is usually given 3 times weekly. Do not use the medication every day unless your doctor has told you to.
Use a different place on your arm or thigh each time you give yourself an injection. Your doctor will show you the places on your body where you can safely inject the medication. Do not inject interferon gamma-1b into the same place two times in a row.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.
A single use vial of interferon gamma-1b is for one dose only. After measuring your dose from the vial, throw the bottle away even if there is still some medication left in it.
Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your interferon gamma-1b dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. Store interferon gamma-1b in the refrigerator but do not allow it to freeze. Throw away any interferon gamma-1b that has been out of the refrigerator for more than 12 hours. Do not put it back into the refrigerator. What happens if I miss a dose?Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.
What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.Overdose symptoms may include confusion, drowsiness, dizziness, loss of balance or coordination, or flu-like symptoms.
What should I avoid while using interferon gamma-1b?Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using interferon gamma-1b.
Interferon gamma-1b side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using interferon gamma-1b and call your doctor at once if you have any of these serious side effects:fever, chills, body aches, flu symptoms;
easy bruising or bleeding, unusual weakness;
feeling light-headed, fainting;
fast or uneven heart rate; or
sudden numbness or weakness, especially on one side of the body.
Less serious side effects may include:
problems with memory or concentration;
weakness, tired feeling, lack of coordination;
pain or redness where the injection was given;
nausea, vomiting, diarrhea;
muscle or joint pain; or
headache.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Interferon gamma-1b Dosing InformationUsual Adult Dose for Osteopetrosis:
BSA: greater than 0.5 m2
50 mcg/m2 (1 million intl units/m2) subcutaneously three times weekly.
BSA: less than or equal to 0.5 m2
1.5 mcg/kg/dose subcutaneously three times weekly.
Usual Adult Dose for Chronic Granulomatous Disease:
BSA: greater than 0.5 m2
50 mcg/m2 (1 million intl units/m2) subcutaneously three times weekly.
BSA: less than or equal to 0.5 m2
1.5 mcg/kg/dose subcutaneously three times weekly.
Usual Adult Dose for Idiopathic Pulmonary Fibrosis:
Study (n = 9)
200 mcg subcutaneously three times weekly (in combination with prednisolone 7.5 mg/day) for 12 months.
Usual Adult Dose for Cutaneous T-cell Lymphoma:
Case study (Granulomatous slack skin)
2,000,000 units IV daily for 14 days.
Usual Pediatric Dose for Chronic Granulomatous Disease:
Greater than or equal to 1 year old:
BSA: greater than 0.5 m2
50 mcg/m2 (1 million intl units/m2) subcutaneously three times weekly.
BSA: less than or equal to 0.5 m2
1.5 mcg/kg/dose subcutaneously three times weekly
Less than 1 year old: no data available
There may be other drugs that can affect interferon gamma-1b. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
More interferon gamma-1b resources Interferon gamma-1b Side Effects (in more detail) Interferon gamma-1b Use in Pregnancy & Breastfeeding Interferon gamma-1b Drug Interactions Interferon gamma-1b Support Group 0 Reviews for Interferon gamma-1b - Add your own review/rating Interferon Gamma-1b Professional Patient Advice (Wolters Kluwer) Interferon Gamma-1B MedFacts Consumer Leaflet (Wolters Kluwer) Actimmune Prescribing Information (FDA) Actimmune Monograph (AHFS DI) Actimmune Advanced Consumer (Micromedex) - Includes Dosage Information Compare interferon gamma-1b with other medications Chronic Granulomatous Disease Cutaneous T-cell Lymphoma Idiopathic Pulmonary Fibrosis Osteopetrosis Rheumatoid Arthritis Where can I get more information? Your pharmacist can provide more information about interferon gamma-1b.See also: interferon gamma-1b side effects (in more detail)
Streptase 1,500,000 IU
CSL Behring
Streptase Injection 1,500,000 (1.5 M) I.U.
(Streptokinase)
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or nurse. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. In This Leaflet: 1. What Streptase Injection is and what it is used for 2. Before you are given Streptase Injection 3. How you are given Streptase Injection 4. Possible side effects 5. Storing Streptase Injection 6. Further information What Streptase Injection Is And What It Is Used ForStreptase Injection is a type of medicine called a fibrinolytic agent. It contains a substance called streptokinase, which helps to dissolve blood clots.
Streptase Injection 1.5 M IU strength is used to limit the extent of a heart attack, within 12 hours of the event occurring.
Before You Are Given Streptase Injection You should not be given Streptase Injection if any of the following apply to you: You are allergic to any of the ingredients of Streptase (see section 6 for the ingredients) You are pregnant You have recently had a stroke or a serious head injury You have a brain tumour or a tumour with a risk of bleeding You have a blood clotting disorder or you have recently had internal bleeding You are taking drugs to prevent blood clotting (anticoagulants) You have problems with your blood vessels (e.g. weakness in an artery) You have uncontrollable high blood pressure You have recently had a major operation, in particular on your head (intracranial) or spine (intraspinal) You have inflammation of the pancreas (acute pancreatitis) or inflammation in or around your heart (endocarditis or pericarditis) You have severe liver or kidney damage Special care should be taken with Streptase Injection if: you have recently had severe bleeding in your stomach (e.g. an ulcer) you have recently had a severe injury and have been resuscitated you are at risk of severe local bleeding, for example if you have recently had an invasive operation, (e.g. where you have had a tube inserted into your body) you have recently had a baby, miscarriage or abortion you have a disease of your urogenital tract (the parts of your body used for excretion and reproduction) you have blood poisoning likely to cause clotting (septic thrombotic disease) you have a disease of the arteries or a disease affecting the blood vessels of your brain (cerebrovascular disease) you have tuberculosis (TB) you have an irregular heart-beat or heart murmur you have been treated with streptokinase before or have had a recent infection with the streptococcus bacteria (usually a throat infection), you may have high levels of antibodies against the active ingredient, streptokinase. These antibodies will block the action of streptokinase in your body and so your doctor may choose to use a different type of fibrinolytic agent.Your doctor should consider the above points before you are given Streptase Injection.
Taking or using other medicinesIf you are taking or have recently been taking drugs which prevent blood clotting (anticoagulants), there will be an increased risk of bleeding (haemorrhage).
Pregnancy and breast-feedingYou should not be given Streptase Injection if you are pregnant or have recently had a baby, miscarriage or abortion, unless there is no safer alternative.
Breast milk should be discarded if you have received Streptase Injection within the last 24 hours.
How You Are Given Streptase Injection Streptase Injection will usually be given to you by infusion into a vein (drip). It may also be infused into an artery supplying blood to your heart.Your doctor may recommend that you also take a low dose of aspirin for about 4 weeks to help thin your blood.
If you are given more Streptase Injection than you should haveIf you are given too much Streptase Injection over a long period, you may be at risk of another thrombosis (blood clot). Symptoms of a thrombosis are listed in the side effects section below.
Possible Side EffectsLike all medicines, Streptase Injection can have side-effects, although not everybody gets them.
Very common side effects (affect more than 1 in 10 people) Development of antibodies (proteins in the blood which help to fight disease) against streptokinase, the active ingredient of Streptase Injection Common side effects (affect less than 1 in 10 people) Bleeding at the injection site, bruising of the skin, bleeding into the gut, reproductive and urinary systems, nosebleed Allergic reactions e.g. skin rash, flushing, itching, blistering (may also affect the tongue and throat), difficulty breathing, low blood pressure (you may feel faint) Slow or fast heart-beat Feeling or being sick, diarrhoea, stomach pain Headache, muscle pain including back pain, feeling hot or cold, weakness, generally feeling unwell Uncommon effects (affect less than 1 in 100 people) Bleeding into eyes, liver, abdomen or joints, tearing of the spleen Stroke (cerebrovascular haemorrhage) Rare side effects (affect less than 1 in 1,000 people) Dizziness, confusion, agitation Fits Paralysis on one or both sides of the body Very rare side effects (affect less than 1 in 10,000 people) Bleeding into the space around the heart, including tearing of the heart muscle Delayed allergic reactions e.g. serum sickness (shows as pain and swelling in joints and lymph nodes, rash, fall in blood pressure and shock), arthritis, inflammation of blood vessels and kidneys, numbness or pins and needles in the arms or legs Blockage of blood vessels caused by cholesterol crystals Fluid in the lungs (not caused by heart failure) Inflammation in the eyesThe following events have been reported in patients being treated with Streptase Injection, but may not have been due to the medicine:irregular heart-beat, chest pain, lack of oxygen to the heart, heart failure, heart attack, heart shock, inflammation around the heart, fluid around the heart, stopping of heart-beat, heart valve inefficiency, blockage of a blood vessel.
If you receive a lot of Streptase, you may be at risk of a thrombosis (blood clot).
Symptoms of a thrombosis include: Unusual pain or swelling in your legs Sudden sharp pain in your chest Sudden difficulty breathing An unusual, severe or long-lasting headache Dizziness or faintingIf you have any of the side-effects listed in this section, or any other unusual or unexpected side-effects, tell your doctor or nurse immediately.
Storing Streptase InjectionYou will not normally be asked to store your medicine as it will be given to you by a doctor.
Keep out of the reach and sight of children.
Do not store above 25 °C. Do not freeze.
After the injection has been prepared it may be kept in a fridge at 2 to 8 ?C for up to 24 hours.
Do not use this medicine after the expiry date shown on the carton and vial label.
Further Information What Streptase Injection containsThe active substance is:
Streptokinase (1.5 Million International Units (IU))Other ingredients are:
human albumin sodium-L-hydrogen glutamate monohydrate polygelineStreptase Injection comes as a powder in glass containers, and will be mixed with a liquid to make a solution before use as an infusion.
Each pack contains one vial with 1.5 million IU streptokinase.
Marketing Authorisation Holder CSL Behring UK Limited Hayworth House Market Place Haywards Heath West Sussex RH16 1DB UK Manufacturer CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg GermanyThis leaflet was last approved on: 04/2008
For further information contact
CSL Behring UK Limited Hayworth House Market Place Haywards Heath West Sussex RH16 1DB UK Telephone number:01444 447 405This leaflet was last approved on: 05/2009
Metalyse 8,000 units
Metalyse
8,000 units powder and solvent for solution for injection
Tenecteplase
Read all of this leaflet carefully before you start receiving this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:1. What METALYSE is and what it is used for
2. Before you receive METALYSE
3. How is METALYSE administered
4. Possible side effects
5. How to store METALYSE
6. Further information
METALYSE is a powder and solvent for solution for injection. This means that each pack contains:
one vial of 8,000 units METALYSE powder and one pre-filled syringe containing 8 ml water for injections.Before use, the solvent (water for injections) is added to the powder to form a solution that is given by injection.
METALYSE belongs to a group of medicines called thrombolytic agents. These medicines help to dissolve blood clots. Tenecteplase is a recombinant fibrin-specific plasminogen activator.
METALYSE is used to treat myocardial infarctions (heart attacks) within 6 hours after the onset of symptoms and helps to dissolve the blood clots that have formed in the blood vessels of the heart. This helps to prevent the damage caused by heart attacks and has been shown to save lives.
Before You Receive MetalyseMETALYSE will not be prescribed and given by your doctor
if you have previously had a sudden life-threatening allergic reaction (severe hypersensitivity) to the active ingredient tenecteplase, to gentamicin (a trace residue from the manufacturing process) or any of the other ingredients of METALYSE. If treatment with Metalyse is nevertheless considered to be necessary, facilities for reanimation should be immediately available in case of need; if you have, or have recently had, an illness that increases your risk of bleeding (haemorrhage), including: a bleeding disorder or tendency to bleed (haemorrhage) stroke (cerebrovascular event) very high, uncontrolled blood pressure a head injury severe liver disease a stomach ulcer (peptic ulcer) varicose veins in the gullet (oesophageal varices) abnormality of the blood vessels (e.g. an aneurysm) certain tumours inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis); if you are taking tablets/capsules used to “thin” the blood, such as warfarin or coumarin (anti-coagulants); if you have an inflamed pancreas (pancreatitis); if you have recently had major surgery including surgery to your brain or spine; if you have been given cardiopulmonary resuscitation (chest compressions) for more than 2 minutes duration, in the last two weeks. Your doctor will take special care with METALYSE if you have had any allergic reaction other than a sudden life-threatening allergic reaction (severe hypersensitive) to the active substance tenecteplase, to gentamicin (a trace residue from the manufacturing process), or to any of the other ingredients of Metalyse (see section 6: “Further information”); if you have high blood pressure; if you have problems with circulation of blood in the brain (cerebrovascular disease); if you have had gastrointestinal (gut) or genitourinary bleeding within the last ten days (this may cause blood in stools or urine); if you have a heart valve abnormality (e.g. mitral stenosis) with an abnormal heart rhythm (e.g. atrial fibrillation); if you have had an intramuscular injection in the last two days; if you are aged over 75 years; if you weigh less than 60 kg. Taking other medicinesPlease tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feedingAsk your doctor for advice before you are given METALYSE.
How Is Metalyse AdministeredThe doctor calculates your dose of METALYSE according to your bodyweight, based on the following scheme:
Bodyweight less than 60kg 6,000 units
Bodyweight 60 to 70kg 7,000 units
Bodyweight 70 to 80kg 8,000 units
Bodyweight 80 to 90kg 9,000 units
Bodyweight above 90kg 10,000 units
Your doctor will give you medication to prevent blood clotting in addition to METALYSE, as soon as possible after your chest pain starts.
METALYSE is given by a single injection into a vein by a doctor who is experienced in the use of this type of drug.
Your doctor will give METALYSE as soon as possible after your chest pain starts as a single dose.
Repetition is not recommended.
Possible Side EffectsLike all medicines, METALYSE can cause side effects, although not everybody gets them.
Evaluation of side effects is based on the following frequencies:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data
The side effects described below have been experienced by people given METALYSE:
Very Common:
bleedingCommon:
bleeding at the injection or puncture site nosebleeds genitourinary bleeding (you may notice blood in your urine) bruising gastro-intestinal bleeding (e.g. bleeding from the stomach or bowel)Uncommon:
irregular heart beat (reperfusion arrhythmias), sometimes leading to cardiac arrest internal bleeding in the abdomen (retroperitoneal bleeding) bleeding in the brain (cerebral haemorrhage). Death or permanent disability may occur following bleeding in the brain or other serious bleeding events bleeding in the eyes (eye haemorrhage)Rare:
low blood pressure (hypotension) bleeding in the lungs (pulmonary haemorrhage) hypersensitivity (anaphylactoid reactions) e.g. rash, hives (urticaria), swelling of the throat bleeding into the area surrounding the heart (haemopericardium) blood clot in the lung (pulmonary embolism) and in the vessels of other organ systems (thrombotic embolisation)Not known :
fat embolism (clots consisting of fat) nausea vomiting body temperature increased (fever) blood transfusions as consequence of bleedingsAs with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration:
Very common:
Low blood pressure (hypotension) Irregular heart beat Chest pain (angina pectoris)Common:
Further heart attack (recurrent ischaemia) Heart failure Shock due to heart failure Inflammation of the lining around the heart Fluid in the lungs (pulmonary oedema)Uncommon:
Heart arrest Problem with the heart valve or heart lining (mitral valve incompetence, pericardial effusion) Blood clot in the veins (venous thrombosis) Fluid between the heart lining and the heart (cardiac tamponade) Rupture of the heart muscle (myocardial rupture)Rare:
Blood clot in the lung (pulmonary embolism)These cardiovascular events can be life-threatening and may lead to death.
In case of bleeding in the brain events related to the nervous system have been reported e.g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).
Tell your doctor immediately if you think you are experiencing any of these side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store MetalyseKeep out of the reach and sight of children.
Do not store above 30°C.
Keep the container in the outer carton in order to protect from light.
Once METALYSE has been reconstituted it may be stored for 24 hours at 2-8°C and 8 hours at 30°C. However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately.
Do not use METALYSE after the expiry date which is stated on the label/carton.
Further Information What METALYSE contains The active substance is tenecteplase. One vial contains 8,000 units of tenecteplase. One pre-filled syringe contains 8 ml of water for injections. The other ingredients are L-arginine, phosphoric acid and polysorbate 20. The METALYSE solvent is water for injections. Gentamicin is contained as trace residue from the manufacturing process. What METALYSE looks like and contents of the packThe folding box contains one vial with a lyophilised powder, one ready for use syringe with a solvent, one vial adapter and one needle.
Marketing Authorisation Holder and ManufacturerMarketing Authorisation Holder
Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein GermanyManufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65 D-88397 Biberach/Riss GermanyFor any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom Boehringer Ingelheim Ltd. Tel:+44 1344 424 600This leaflet was last approved in 06/2010
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
74366-01
Josamicina
Josamicina may be available in the countries listed below.
Ingredient matches for Josamicina JosamycinJosamicina (DCIT) is also known as Josamycin (Rec.INN)
International Drug Name Search
Glossary
DCIT Denominazione Comune Italiana Rec.INN Recommended International Nonproprietary Name (World Health Organization)Click for further information on drug naming conventions and International Nonproprietary Names.
Interferon Gamma-1a:
Interferon Gamma-1a: may be available in the countries listed below.
Ingredient matches for Interferon Gamma-1a: Interferon gammaInterferon Gamma-1a: (BAN, JAN) is also known as Interferon gamma (Rec.INN)
International Drug Name Search
Glossary
BAN British Approved Name JAN Japanese Accepted Name Rec.INN Recommended International Nonproprietary Name (World Health Organization)Click for further information on drug naming conventions and International Nonproprietary Names.
Interferon Alfa
Interferon Alfa may be available in the countries listed below.
Ingredient matches for Interferon Alfa Interferon alfaInterferon Alfa (BAN, JAN) is also known as Interferon alfa (Rec.INN)
International Drug Name Search
Glossary
BAN British Approved Name JAN Japanese Accepted Name Rec.INN Recommended International Nonproprietary Name (World Health Organization)Click for further information on drug naming conventions and International Nonproprietary Names.
urofollitropin
Generic Name: urofollitropin (UE roe FOL i TROE pin)
Brand names: Bravelle, Metrodin, Fertinex
Urofollitropin is a purified form of a hormone called follicle-stimulating hormone (FSH). FSH is important in the development of follicles (eggs) that are produced by the ovaries in women.
Urofollitropin is used to treat infertility in women whose own natural FSH is not sufficient in stimulating follicles to mature. Urofollitropin also is used to help the ovaries produce multiple eggs for use in "in vitro" fertilization.
Urofollitropin may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about urofollitropin? Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any symptoms of OHSS: severe pelvic pain, swelling of the hands or legs, stomach pain and swelling, shortness of breath, weight gain, diarrhea, nausea or vomiting, and urinating less than usual.Using this medicine can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.
Although urofollitropin can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment. What should I discuss with my healthcare provider before using urofollitropin?Urofollitropin will not cause ovulation (production of an egg by the ovaries). You may need to receive other medications to stimulate ovulation.
You should not use this medication if you are allergic to urofollitropin medications, or if you have:infertility that is not caused by lack of ovulation;
a condition called primary ovarian failure;
unusual vaginal bleeding;
an ovarian cyst;
a tumor of your pituitary gland;
an untreated or uncontrolled disorder of your thyroid or adrenal gland; or
if you are pregnant.
Using this medicine can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.
Although urofollitropin can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment. It is not known whether urofollitropin passes into breast milk. Do not use urofollitropin without telling your doctor if you are breast-feeding a baby. How should I use urofollitropin?Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Urofollitropin is given as an injection under the skin or into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Urofollitropin comes as a powder and liquid (diluent) that must be mixed together before you draw your dose into a syringe.
Do not shake the mixture. Vigorous shaking can ruin the medicine. Do not draw your urofollitropin dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it does not clear after mixing, or if it has any particles in it. Call your doctor for a new prescription.After giving the injection, throw away any portion of the mixed medicine that is not used right away. Do not save it for later use.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure this medication is helping your condition, your doctor will need to check you on a regular basis. Do not miss any scheduled appointments.
Infertility is often treated with a combination of different drugs. For best results, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.
If you store urofollitropin at home, keep it at room temperature away from light, moisture, and heat. What happens if I miss a dose?Call your doctor if you miss a dose of urofollitropin.
What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.Symptoms of a urofollitropin overdose are not known.
What should I avoid while using urofollitropin?Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using urofollitropin.
Urofollitropin side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition. Stop using urofollitropin and call your doctor at once if you have any symptoms of OHSS:severe pelvic pain;
swelling of your hands or legs;
stomach pain and swelling;
shortness of breath;
weight gain;
nausea, vomiting, diarrhea; or
urinating less than usual.
Less serious side effects may include:
mild stomach upset, constipation;
mild pelvic pain, cramps;
breast tenderness;
skin rash;
hot flashes;
acne; or
pain, swelling, redness, itching, or irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Urofollitropin Dosing InformationUsual Adult Dose for Follicle Stimulation:
Fertinex in Assisted Reproductive Technologies:
150 international units subcutaneously per day until sufficient follicular development is obtained. In most case, therapy should not exceed 10 days.
Fertinex in polycystic Ovary Syndrome:
75 to 300 international units subcutaneously per day depending on patient response. A response in generally evident after 5 to 7 days.
Bravelle:
150 international units subcutaneously daily for first 5 days. Depending on patient response, dose may be adjusted once every 2 days by 75 to 150 international units per adjustment. The maximum daily dose should not exceed 450 international units and in most cases dosing beyond 12 days is not recommended.
There may be other drugs that can interact with urofollitropin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
More urofollitropin resources Urofollitropin Side Effects (in more detail) Urofollitropin Use in Pregnancy & Breastfeeding Urofollitropin Drug Interactions Urofollitropin Support Group 0 Reviews for Urofollitropin - Add your own review/rating urofollitropin Intramuscular, Subcutaneous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information Urofollitropin Professional Patient Advice (Wolters Kluwer) Bravelle Prescribing Information (FDA) Bravelle MedFacts Consumer Leaflet (Wolters Kluwer) Fertinex MedFacts Consumer Leaflet (Wolters Kluwer) Compare urofollitropin with other medications Female Infertility Follicle Stimulation Where can I get more information? Your pharmacist can provide more information about urofollitropin.See also: urofollitropin side effects (in more detail)
Imidapril Hydrochloride
Imidapril Hydrochloride may be available in the countries listed below.
Ingredient matches for Imidapril Hydrochloride ImidaprilImidapril Hydrochloride (BANM, JAN) is also known as Imidapril (Rec.INN)
International Drug Name Search
Glossary
BANMBritish Approved Name (Modified)JANJapanese Accepted NameRec.INNRecommended International Nonproprietary Name (World Health Organization)Click for further information on drug naming conventions and International Nonproprietary Names.
Dacarbazine 200 mg, powder for solution for injection (Hospira UK Ltd)
DACARBAZINE 200 mg POWDER FOR SOLUTION FOR INJECTION
Read all of this leaflet carefully before you start using this medicineKeep this leaflet. You may need to read it again.
If you have any further questions ask your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet: 1. What Dacarbazine Powder for Solution for Injection is and what it is used for 2. Before you use Dacarbazine Powder for Solution for Injection 3. How to use Dacarbazine Powder for Solution for Injection 4. Possible side effects 5. How to store Dacarbazine Powder for Solution for Injection 6. Further information What Dacarbazine Powder For Solution For Injection Is And What It Is Used ForDacarbazine Powder for Solution for Injection is an anti-cancer medicine, in the form of a powder for solution for injection. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.
Dacarbazine Powder for Solution for Injection may be used for the treatment of some types of cancer, for example: metastatic malignant melanoma (a type of skin cancer that has spread) and Hodgkin’s disease and some types of cancer in soft tissues.
Before You Use Dacarbazine Powder For Solution For Injection Do not use Dacarbazine Powder for Solution for Injection if you have shown signs of hypersensitivity (severe allergy) to dacarbazine on previous occasions if you have severe liver or kidney diseases in combination with yellow fever vaccine and some other types of vaccines (live attenuated) in combination with phenytoin (a medicine used to prevent convulsions). Taking/using other medicinesSpecial care should be taken if you are taking other medicinal products which could interact with Dacarbazine:
ciclosporin or tacrolimus (medicines used after having a transplant) fotemustine (a medicine used in cancer treatment) medicines which could damage your liver warfarin (a medicine used to thin the blood). Your doctor may need to do your blood test (INR) more oftenPlease tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Pregnancy and breast feedingDo not use Dacarbazine:
if you are pregnant or trying to become pregnant if you are breast feeding Driving and using machinesDacarbazine may influence the ability to drive or operate machinery because of nausea and vomiting or rare adverse reactions affecting the nervous system.
Important information about one of the ingredients of Dacarbazine Powder for Solution for InjectionThis medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free’.
How To Use Dacarbazine Powder For Solution For InjectionThis medicinal product is for intravenous use (injection into a vein).
Your treatment will usually be given to you in hospital.
You will be given Dacarbazine as an infusion (slow injection via a drip) into a vein or a slow intravenous injection(injection into a vein).
Tell your doctor or nurse at once if you notice any pain at the injection site during or shortly after treatment. Pain around the injection site could mean the needle has not been properly inserted into the vein.
The dose of dacarbazine will depend on the illness for which you are being treated. The dose is calculated according to your body surface area (expressed as mg/m2).
Depending on your illness, dosing is typically between 200 and 850 mg/m2 of dacarbazine.
As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much. However, tell your doctor or pharmacist if you have any concerns.
Possible Side EffectsLike all medicines Dacarbazine Powder for Solution for Injection can have side effects although not everybody gets them.
If any of the following happen, tell your doctor immediately: severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth and throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.This is a very serious side effect. You may need urgent medical attention. This very serious side effect is rare.
If you experience any of the following tell your doctor as soon as possible:Common (less than 1 in 10 patients but more than 1 in 100):
pallor (anaemia) loss of appetite nausea/vomitingUncommon (Less than 1 in 100 patients but more than 1 in 1000):
confusion fits (seizures) numbness of the skin or pins and needles sensation in the face (paraesthesia) headache blurred vision facial flushing hair loss (alopecia) transient rash an influenza (‘flu’) type syndrome of fever, muscle pain (myalgia) and generally feeling unwell (malaise) which may start approximately one week after treatment and may last for up to three weeks tiredness and weakness (lethargy)Rare (less than 1 in 1000 patients but more than 1 in 10,000)
diarrhoea bruising increased sensitivity of the skin to sunlight (photosensitivity)Very rare (less than 1 in 10,000)
redness of the skin/rash itchingBlood samples will be taken to check for changes in blood cells levels, which is a common side effect of Dacarbazine treatment. Blood and urine tests will be performed to check for changes in kidney function. Blood tests may be performed to check that your liver is working properly. Kidney and liver problems are uncommon.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
HOW TO STORE DACARBAZINE 200 mg POWDER FOR SOLUTION FOR INJECTIONKeep out of the reach and sight of children
The vials should be stored at 2 - 8°C with the vials kept in the outer carton (in order to protect from light).
This medicine should not be used after the expiry date printed on the vial label.
Further Information What Dacarbazine Powder for Solution for Injection containsThe medicine is presented in glass containers called vials containing 200 mg dacarbazine. Each pack contains 1 vial.
The active substance is dacarbazine The other ingredients are citric acid monohydrate, mannitol and sodium hydroxide What Dacarbazine Powder for Solution for Injection looks like and contents of the packThe powder is a white or pale yellow solid.
The vial containing the powder is a glass container with a rubber stopper.
Each single-dose vial contains 200 mg of Dacarbazine. When reconstituted each ml of solution contains 10 mg of dacarbazine.
The 200 mg presentation of Dacarabazine is sold in packs containing 1 vial of powder
Marketing Authorisation Holder and ManufacturerThe Marketing authorisation holder and company responsible for batch release in the European Union is
Mayne Pharma Plc Queensway Royal Leamington Spa Warwickshire CV31 3RW UKThe Manufacturer is
Mayne Pharma Pty Ltd Lexia Place Mulgrave Victoria 3170 AustraliaThis leaflet was last approved in
08/2006
Interferon Gamma
Class: Biologic Response Modifiers
VA Class: IM700
Chemical Name: N2-l-Methionyl-1-139-interferon? (human lymphocyte protein moiety reduced)
Molecular Formula: C734H1166N204O216S5
CAS Number: 98059-61-1
Brands: Actimmune
Biologic response modifier; biosynthetic (recombinant DNA origin) form of endogenous human interferon gamma.1 5 6 7
Uses for Interferon Gamma Chronic Granulomatous DiseaseReduction of the frequency and severity of serious infections in patients with chronic granulomatous disease (designated an orphan drug by FDA for this use).1 5 10 13 20 21 22 24
OsteopetrosisTreatment to delay the time to disease progression in patients with severe, malignant osteopetrosis (designated an orphan drug by FDA for this use).1 6 7 13
Idiopathic Pulmonary FibrosisInterferon gamma-1b was investigated in patients with idiopathic pulmonary fibrosis† (IPF) with mild-to-moderate lung function impairment in the INSPIRE study; the study was terminated early when interim data analysis indicated lack of benefit in patients receiving the drug.26 Interim analysis also indicated that 14.5% of patients receiving interferon gamma 1-b died compared with 12.7% of those receiving placebo.26
Interferon gamma-1b is not approved for use in patients with IPF.26 FDA suggests that health-care professionals should discuss the results of this trial with their patients receiving the drug for IPF and carefully consider whether they should continue to receive treatment with interferon gamma-1b.26
Interferon Gamma Dosage and Administration GeneralIf home use is prescribed, carefully instruct patients and/or their caregivers in appropriate use; provide a puncture-resistant container for proper, safe disposal of used syringes and needles.1
Administration Sub-Q AdministrationAdminister by sub-Q injection 3 times weekly (e.g., Monday, Wednesday, Friday).1
Optimum sites for sub-Q injection include right and left deltoid and anterior thigh.1
To minimize risk of flu-like syndrome, administer at bedtime and/or give acetaminophen to prevent or partially alleviate fever and headache.1 5
Vials contain no preservative; discard any residual solution remaining in the vial after administration of the single dose.1
DosageEach mg of interferon gamma-1b is approximately equivalent to 20 million international units (equivalent to the amount that formerly was expressed as 30 million units).1
Pediatric Patients Chronic Granulomatous Disease Sub-Q50 mcg/m2 (1 million international units per m2) 3 times weekly for patients with body surface area (BSA) >0.5 m2 and 1.5 mcg/kg 3 times weekly for those with body surface area ?0.5 m2.1
If a severe adverse reaction (e.g., flu-like symptoms) occurs, reduce dosage by 50% or discontinue drug until adverse reaction abates.1
Osteopetrosis Sub-Q50 mcg/m2 (1 million international units per m2) 3 times weekly for patients with body surface area >0.5 m2 and 1.5 mcg/kg 3 times weekly for those with body surface area ?0.5 m2.1
If a severe adverse reaction (e.g., flu-like symptoms) occurs, reduce dosage by 50% or discontinue drug until adverse reaction abates.1
Adults Chronic Granulomatous Disease Sub-Q50 mcg/m2 (1 million international units per m2) 3 times weekly.1
If a severe adverse reaction (e.g., flu-like symptoms) occurs, reduce dosage by 50% or discontinue drug until adverse reaction abates.1
Osteopetrosis Sub-Q50 mcg/m2 (1 million international units per m2) 3 times weekly.1
If a severe adverse reaction (e.g., flu-like symptoms) occurs, reduce dosage by 50% or discontinue drug until adverse reaction abates.1
Prescribing Limits Pediatric Patients Chronic Granulomatous Disease Sub-QSafety and efficacy of dosages >50 mcg/m2 3 times weekly not established.1
Osteopetrosis Sub-QSafety and efficacy of dosages >50 mcg/m2 3 times weekly not established.1
Adults Chronic Granulomatous Disease Sub-QSafety and efficacy of dosages >50 mcg/m2 3 times weekly not established.1
Osteopetrosis Sub-QSafety and efficacy of dosages >50 mcg/m2 3 times weekly not established.1
Cautions for Interferon Gamma ContraindicationsKnown hypersensitivity to interferon gamma-1b, products derived from Escherichia coli, or any ingredient in the formulation.1
Warnings/Precautions Warnings Cardiac EffectsAcute and transient flu-like syndrome or constitutional symptoms (e.g., chills, fever)20 24 that are associated with daily dosages ?250 mcg/m2 (>10 times the weekly recommended dosage) may exacerbate preexisting cardiac conditions.1
Use with caution in patients with preexisting cardiac disease (e.g., arrhythmia, CHF, symptoms of ischemia).1
CNS EffectsPossible seizures, decreased mental status, dizziness, and gait disturbance, particularly at daily dosages >250 mcg/m2 (>10 times the weekly recommended dosage).1
Use with caution in patients with known seizure disorders or compromised CNS function.1
Hematologic EffectsPossibly severe, reversible, dose-limiting neutropenia and thrombocytopenia reported rarely.1
Use with caution in patients with myelosuppression and in those receiving drugs that may be myelosuppressive.1
Monitor blood cell and differential counts and platelet counts prior to initiating interferon gamma-1b and at 3-month intervals during therapy.1
Renal EffectsProteinuria reported rarely.1
Perform urinalysis and monitor appropriate blood chemistry tests prior to initiating interferon gamma-1b and at 3-month intervals during therapy.1
Hepatic EffectsPossibly substantial (up to 25-fold) elevations of AST and/or ALT reported; children <1 year of age most at risk (see Pediatric Use under Cautions).1 Reversible with dosage reduction or interruption of therapy.1
Perform liver function tests prior to initiating interferon gamma-1b and at monthly (for children <1 year of age) or 3-month intervals during therapy.1 If severe hepatic enzyme elevations occur, modify dosages.1 (See Dosage under Dosage and Administration.)
Sensitivity Reactions Hypersensitivity ReactionsIf acute, serious hypersensitivity reactions occur, discontinue immediately and initiate appropriate therapy.1
Specific Populations PregnancyCategory C.1
LactationNot known whether interferon gamma-1b is distributed into milk; discontinue nursing or the drug.1
Pediatric UseIncreased risk of elevations of AST and/or ALT in children <1 year of age.1 May occur as early as 7 days after starting treatment.1 (See Hepatic Effects under Cautions.)
Possibly reversible alkaline phosphatase elevation and hypokalemia.1
Common Adverse EffectsFlu-like syndrome (e.g., headache, fever, chills, myalgia, fatigue),1 3 5 8 10 18 erythema or tenderness at injection site,1 injection site hemorrhage,1 nausea,1 vomiting,1 rash.1
Interactions for Interferon GammaNo formal drug interaction studies to date.1
Specific DrugsDrug
Interaction
Comments
Myelosuppressive agents
Possible additive myelosuppressive effects1
Use with caution1
Interferon Gamma Pharmacokinetics Absorption BioavailabilityFollowing sub-Q injection, >89% of dose is slowly absorbed; peak plasma concentrations attained 7 hours after dose.1
Elimination Half-life5.9 hours following a single sub-Q dose.1
Stability Storage Parenteral Injection2–8°C; do not freeze.1 Unentered vials may be exposed to room temperature for up to 12 hours prior to use; discard vials not returned to refrigerator or used within 12 hours.1
Avoid shaking or excessively or vigorously agitating vials.1
ActionsActionsSpecific effects of interferon gamma include the enhancement of the oxidative metabolism of macrophages, antibody dependent cellular cytotoxicity (ADCC), activation of natural killer (NK) cells, and the expression of Fc receptors and major histocompatibility antigens.1 2
The exact mechanism(s) of action of interferon gamma-1b in patients with chronic granulomatous disease have not been fully elucidated;1 3 4 5 8 9 10 the drug appears to enhance phagocyte function to allow more effective killing of catalase-positive organisms.1 8 Changes in superoxide levels during therapy with interferon gamma-1b do not predict efficacy and should not be used to assess patient response to therapy.1
Mechanisms of action in treatment of osteopetrosis not fully elucidated1 12 15 but may involve enhanced superoxide production in leukocytes and osteoclasts.1 Changes in superoxide levels during therapy with interferon gamma-1b do not predict efficacy and should not be used to assess patient response to therapy.1
Advice to PatientsImportance of advising patients not to administer the drug until their clinician has thoroughly trained them on proper administration methods (including aseptic technique) and proper disposal of used needles and syringes.1 27
Advise patients to notify their clinician if injection site reactions (e.g., persistent lumps, swelling, bruising, signs of infection or inflammation [pus, redness, pain]) occur.27
Risk of myelosuppression and adverse hepatic effects.1
Importance of taking interferon gamma-1b as prescribed.1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
PreparationsExcipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Interferon Gamma-1b (Recombinant DNA Origin)Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Parenteral
Injection, for subcutaneous use
100 mcg/0.5 mL (2 million international units)
Actimmune
InterMune
DisclaimerThis report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References1. InterMune, Inc. Actimmune (interferon gamma-1b) prescribing information. Brisbane, CA; 2009 Jan.
2. Gallin JI, Farber JM, Holland SM et al. Interferon-? in the management of infectious diseases. Ann Intern Med. 1995; 123:216-24. [IDIS 350164] [PubMed 7598304]
3. Todd PA, Goa KL. Interferon gamma-1b. A review of its pharmacology and therapeutic potential in chronic granulomatous disease. Drugs. 1992; 43:111-22. [PubMed 1372855]
4. Lekstrom-Himes JA, Gallin JI. Immunodeficiency diseases caused by defects in phagocytes. N Engl J Med. 2000; 343:1703-14. [PubMed 11106721]
5. International Chronic Granulomatous Disease Cooperative Study Group. A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease. N Engl J Med. 1991; 324:509-16. [PubMed 1846940]
6. Key LL, Rodriguiz RM, Willi SM et al. Long-term treatment of osteopetrosis with recombinant-human interferon gamma. N Engl J Med. 1995; 332:1594-9. [IDIS 347518] [PubMed 7753137]
7. Key LL, Ries WL, Rodriguiz RM et al. Recombinant human interferon gamma therapy for osteopetrosis. J Pediatr. 1992; 121:119-24. [IDIS 299963] [PubMed 1320672]
8. Ahlin A, Elinder G, Palmblad J. Dose-dependent enhancement of interferon-? on functional responses of neutrophils from chronic granulomatous disease patients. Blood. 1997; 89:3396-401. [IDIS 385789] [PubMed 9129047]
9. Ahlin A, Larfars G, Elinder G et al. Gamma interferon treatment of patients with chronic granulomatous disease is associated with augmented production of nitric oxide by polymorphonuclear neutrophils. Clin Diag Lab Immunol. 1999; 6:420-4.
10. Weening RS, Leitz GJ, Seger RA. Recombinant human interferon-gamma in patients with chronic granulomatous disease—European follow up study. Eur J Pediatr. 1995; 154:295-8. [PubMed 7607280]
11. Hayden FG. Antiviral drugs (other than antiretrovirals). In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:460-91.
12. Madyastha PR, Yang S, Ries WL et al. IFN-gamma enhances osteoclast generation in cultures of peripheral blood from osteopetrotic patients and normalizes superoxide production. J Interferon Cytokine Res. 2000; 20:645-52. [PubMed 10926207]
13. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2002 Oct 15. From FDA web site (). Accessed 2003 Apr 14.
14. Lajeunesse D, Busque L, Menard P et al. Demonstration of an osteoblast defect in two cases of human malignant osteopetrosis. Correction of the phenotype after bone marrow transplant. J Clin Invest. 1996; 98:1835-42. [PubMed 8878435]
15. Whyte MP. Chipping away at marble-bone disease. N Engl J Med. 1995; 332:1639-40. [IDIS 347523] [PubMed 7753145]
16. Janeway CA, Travers P, Walport M et al eds. Immunology. 5th ed. New York, NY: Garland Publishing; 2001. From the National Library of Medicine website ().
17. Tramont EC, Hoover DL. Innate (general or nonspecific) host defense mechanisms. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:31-8.
18. Bemiller LS, Roberts DH, Starko KM et al. Safety and effectiveness of long-term interferon gamma therapy in patients with chronic granulomatous disease. Blood Cells Mol Dis. 1995; 21:239-247. [PubMed 8673477]
19. Intermune. Brisbane, CA: Personal communication.
20. Errante PR, Fraz?o JB, Condino-Neto A. The use of interferon-gamma therapy in chronic granulomatous disease. Recent Pat Antiinfect Drug Discov. 2008; 3:225-30. [PubMed 18991804]
21. Jones LBKR, McGrogan P, Flood TJ et al. Special Article: Chronic granulomatous disease in the United Kingdom and Ireland: a comprehensive national patient-based registry Clin Exp Immunol. 2008; 152: 211–218.
22. Kobayashi S, Murayama S, Takanashi S et al. Clinical features and prognoses of 23 patients with chronic granulomatous disease followed for 21 years by a single hospital in Japan. . Eur J Pediatr. . 2008;167:1389-94.
23. Martire B, Rondelli R, Soresina A et al. Clinical features, long-term follow-up and outcome of a large cohort of patients with Chronic Granulomatous Disease: an Italian multicenter study. Clin Immunol. 2008; 126:155-64. [PubMed 18037347]
24. Marciano BE, Wesley R, De Carlo ES et al. Long-term interferon-gamma therapy for patients with chronic granulomatous disease. Clin Infect Dis. 2004; 39:692-9. [PubMed 15356785]
25. Ma HR, Mu SC, Yang YH et al. Therapeutic effect of interferon-gamma for prevention of severe infection in X-linked chronic granulomatous disease. J Formos Med Assoc. 2003; 102:189-92. [PubMed 12783137]
26. Food and Drug Administration. Information for healthcare professionals–interferon gamma–1b (marketed as Actimmune) From FDA web site http: / / www.fda.gov / Drugs / DrugSafety / PostmarketDrugSafetyInformationforPatientsandProviders / / 2007 / march09.htm.
27. InterMune, Inc. Actimmune (interferon gamma-1b) Information for the patient/caregiver.. Brisbane, CA; 2006 Nov.
More Interferon Gamma resources Interferon Gamma Side Effects (in more detail) Interferon Gamma Use in Pregnancy & Breastfeeding Interferon Gamma Drug Interactions Interferon Gamma Support Group 0 Reviews for Interferon Gamma - Add your own review/rating Compare Interferon Gamma with other medications Chronic Granulomatous Disease Cutaneous T-cell Lymphoma Idiopathic Pulmonary Fibrosis Osteopetrosis Rheumatoid ArthritisInterferon Beta
Class: Biologic Response Modifiers
VA Class: IM900
Chemical Name: Interferon ?1 (human fibroblast protein moiety)
Molecular Formula: C908H1406N246O252S7C908H1406N246O252S5
CAS Number: 145258-61-3
Brands: Avonex, Betaseron, Rebif
REMS:
FDA approved a REMS for interferon beta to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().
IntroductionBiologic response modifier; biosynthetic (recombinant DNA origin) form of endogenous human interferon beta.1 4 8 9 19 20 21 26
Uses for Interferon Beta Multiple Sclerosis (MS)Management of relapsing-remitting MS, relapsing forms of secondary progressive MS†, and of patients at high risk of developing clinically definite MS.1 19 20 21
Not curative, but appears to reduce the frequency of attacks or relapses and produces a beneficial effect on several magnetic resonance imaging (MRI) measures of disease activity.6 7 21 26 27 28 30 32 53
Efficacy in management of primary progressive MS† not demonstrated conclusively;13 18 such use not recommended.42
Interferon Beta Dosage and Administration GeneralAdminister under the supervision of qualified clinicians.1 20
Prior to initiating therapy, provide patient with the appropriate patient information (medication guide) provided by the manufacturer for interferon beta-1a (Avonex and Rebif) or interferon beta-1b (Betaseron).1 19 20
If home use is prescribed, carefully instruct patients and/or their caregivers in appropriate use; provide a puncture-resistant container for proper, safe disposal of used syringes and needles.1 19 20
Patients may feel worse or experience a temporary worsening of MS symptoms immediately following initiation of interferon beta therapy;40 these effects often abate with continued therapy and should not be interpreted as an indication of treatment failure.42
To minimize risk of flu-like syndrome, administer at bedtime40 and/or give an NSAIA (e.g., ibuprofen) or acetaminophen to prevent or partially alleviate fever and headache.20 40 42
AdministrationAdminister by IM or sub-Q injection.1 19 20
Sub-Q administration associated with higher rates of injection site reactions than IM administration.1 19 20 29
IM Administration, Interferon Beta-1a (Avonex)Administer once weekly by IM injection.19
Administer IM into thigh or upper arm using a 23-gauge, 1?-inch needle.19 Rotate injection sites; do not use sites that appear irritated prior to injection.19
Administer Avonex provided in prefilled syringes as supplied; no dilution or reconstitution is necessary.19 Warm prefilled syringes to room temperature by removing from refrigerator about 30 minutes prior to use; do not use external heat sources (e.g., hot water) to warm syringes.19
ReconstitutionReconstitute vial containing 6.6 million units (33 mcg) of interferon beta-1a (Avonex) powder by adding 1.1 mL sterile water for injection to provide a solution containing 6 million units (30 mcg) of interferon beta-1a per mL.19 60 62 Use only the diluent supplied by manufacturer.19
Swirl vial gently to ensure complete dissolution; do not shake.19
Reconstituted solutions contain no preservatives; solutions preferably should be prepared immediately before use.19 Vials are for single use only; discard any residual solution.19
Sub-Q Administration, Interferon Beta-1a (Rebif)Administer 3 times weekly by sub-Q injection, on the same 3 days (e.g., Monday, Wednesday, and Friday) at least 48 hours apart each week and at the same time (preferably in the late afternoon or evening) each day.20
Administer sub-Q into the abdomen (except waistline),61 thigh, arm, or buttocks.1
To minimize risk of serious injection site reactions (e.g., necrosis), rotate injection sites and avoid sites that appear irritated, reddened, bruised, infected, or abnormal in any way.1 20 40
To reduce incidence of injection site pain, warm Rebif prefilled syringes to room temperature by removing from refrigerator 30 minutes prior to use.60
Administer Rebif as supplied; no dilution or reconstitution is necessary.20
Rebif solutions contain no preservatives; discard any residual solution remaining in the syringe after single use.20
Sub-Q Administration, Interferon Beta-1b (Betaseron)Administer by sub-Q injection every other day.1
Administer sub-Q into the abdomen (except waistline),61 thigh, arm, or buttocks.1
To minimize risk of serious injection site reactions (e.g., necrosis), rotate injection sites and avoid sites that appear irritated, reddened, bruised, infected, or abnormal in any way.1 20 40
ReconstitutionReconstitute vial containing 9.6 million units (0.3 mg) of interferon-beta-1b (Betaseron) powder by attaching prefilled syringe containing 1.2 mL of 0.54% sodium chloride to the vial and slowly injecting entire contents of syringe to provide a solution containing 8 million units (0.25 mg) of interferon beta-1b per mL.1 Use only the diluent supplied by manufacturer.1
Swirl vial gently to ensure complete dissolution; do not shake.1
Reconstituted solutions contain no preservatives; solutions preferably should be prepared immediately before use.1 Vials are for single use only; discard any residual solution.1
DosageAvailable as interferon beta-1a or interferon beta-1b; dosage and potency expressed in terms of international units (IU, units) or mg.1
Each mg of interferon beta-1a is approximately equivalent to 200 million units (for Avonex) and 270 million units (for Rebif);19 20 each mg of interferon beta-1b is approximately equivalent to 32 million units (for Betaseron).1
Adults Relapsing-remitting MS Interferon beta-1a (Avonex) IM6 million units (30 mcg) once weekly.19 Safety and efficacy of Avonex given for >3 years not established.19
Interferon beta-1a (Rebif) Sub-QGradually titrate dosage over a 4-week period to 6 million units (22 mcg) or 12 million units (44 mcg) 3 times weekly using the schedule in Table 1.20
Table 1. Rebif Dosage Titration Schedule20Week
Recommended Titration (% of Final Target)
Rebif 22 mcg Target Dose
Rebif 44 mcg Target Dose
Weeks 1–2
20%
1.2 million units (4.4 mcg)
2.4 million units (8.8 mcg)
Weeks 3–4
50%
3 million units (11 mcg)
6 million units (22 mcg)
Weeks 5+
100%
6 million units (22 mcg)
12 million units (44 mcg)
Interferon beta-1b (Betaseron) Sub-QGradually titrate dosage over a 6-week period to 8 million units (0.25 mg) every other day using the schedule in Table 2.1 61
Table 2. Betaseron Dosage Titration Schedule161Week
Betaseron Dose
Weeks 1–2
2 million units (0.0625 mg)
Weeks 3–4
4 million units (0.125 mg)
Weeks 5–6
6 million units (0.1875 mg)
Weeks 7+
8 million units (0.25 mg)
Safety and efficacy of interferon beta-1b (Betaseron) given for >3 years not established.1 61
Prescribing Limits Adults IMSafety of interferon beta-1a (Avonex) dosages >12 million units (60 mcg) once weekly not established.19
Special Populations Hepatic ImpairmentConsider decreasing dosages if serum ALT concentrations >5 times ULN.20
Discontinue therapy if hepatic transaminase (AST, ALT) concentrations >10 times ULN (with or without jaundice or other clinical symptoms of liver dysfunction) or if the serum bilirubin >5 times ULN.1 20
When concentrations return to normal, interferon beta therapy may be restarted at a 50% dose reduction, if clinically appropriate.1
Geriatric PatientsTitrate dosage, usually initiating therapy at the low end of the dosage range due to possible age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.20
Cautions for Interferon Beta ContraindicationsKnown hypersensitivity to natural or recombinant interferon beta or any other component of the formulations.1 19 20
Administration of preparations containing albumin human in patients with known hypersensitivity to albumin.1 19 20 (See Albumin Sensitivity under Cautions.)
Warnings/Precautions Warnings Depression and SuicidePossible depression, suicidal ideation, and suicide; use with caution in patients with depression or other mood disorders, conditions that are common in individuals with MS.1 19 20
If depression or other severe psychiatric symptoms occur during therapy, monitor closely and consider discontinuing therapy.1 19 20
HepatotoxicitySerious hepatic injury including autoimmune hepatitis and possibly severe, fulminant hepatic failure requiring liver transplantation reported.19 20 60 62 64 65 66 67 68
Use with caution in patients with active liver disease, alcohol abuse, increased serum ALT concentrations (>2.5 times ULN), or history of clinically important liver disease.19 20 65
Use with caution in patients receiving concomitant therapy with other drugs associated with hepatic injury; use caution when other drugs are added to an existing interferon beta treatment regimen.19 20 65 (See Specific Drugs under Interactions.)
Perform liver function tests prior to initiation of therapy and at regular19 intervals (e.g., 1, 3, 6 months) and then periodically thereafter in the absence of clinical symptoms.1 19 20
Possible asymptomatic elevation of hepatic transaminases.19 20 65
Injection Site NecrosisPotentially severe injection site necrosis possible following sub-Q administration, sometimes requiring dermal debridement or skin grafting.1 20 Has not been reported to date following IM administration.60 62
If injection site necrosis occurs, reevaluate patient’s understanding and use of aseptic technique and proper procedures for self-administration.1 40 Whether to discontinue therapy following a single site of necrosis depends on the extent of necrosis.1
Sensitivity Reactions Hypersensitivity ReactionsPossible anaphylaxis or anaphylactoid reactions.1 19 20
If acute, serious hypersensitivity reactions occur, discontinue immediately and initiate appropriate therapy.1 19 20
Albumin SensitivitySome formulations (e.g., Avonex powder for injection, Betaseron, Rebif) contain albumin human; contraindicated in sensitive patients.1 19 20
Antibody FormationPossible development of binding or neutralizing antibodies to interferon beta following long-term therapy.21 54 55
General Precautions Cardiovascular EffectsPossible cardiomyopathy with or without CHF1 19 ; use with caution in patients with cardiac disease or history of any cardiac condition.19
Closely monitor patients with history of cardiac disease (e.g., angina, arrhythmia, CHF) for worsening of their clinical condition during initiation and continued treatment with interferon beta.19
SeizuresPossible seizures; use with caution in patients with preexisting seizure disorders.19 20
If patients with no prior history of seizures develop seizures during therapy, establish an etiologic basis and institute appropriate anticonvulsant therapy prior to considering resumption of therapy.60 62
Hematologic EffectsDecreased peripheral blood cell counts in all cell lines, including rare pancytopenia and thrombocytopenia, reported.19
Use with caution in patients with myelosuppression and in those receiving drugs that may be myelosuppressive.60 62 (See Specific Drugs under Interactions.)
Perform CBCs, platelet counts, and appropriate blood chemistry tests prior to initiation of therapy and periodically thereafter.1 19 20
Other Autoimmune DisordersPossible development of idiopathic thrombocytopenia, hyperthyroidism, hypothyroidism, or autoimmune hepatitis; monitor patients for manifestations and perform appropriate tests when necessary.19
Infectious ComplicationsSome formulations (e.g., Avonex powder for injection, Betaseron, Rebif) contain albumin human; theoretical risk for transmission of human viruses and Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).1 19 20
Specific Populations PregnancyCategory C.1 19 20
Pregnancy registry for Rebif at 877-447-3243 or 20 and for Avonex at 800-456-2255.19 65
LactationNot known whether interferon beta is distributed into milk; discontinue nursing or the drug.1 19 20
Pediatric UseSafety and efficacy not established in children <18 years of age.1 19 20
Geriatric UseInsufficient experience in patients ?65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.1 20 (See Geriatric Patients under Dosage and Administration.)
Hepatic ImpairmentUse with caution.19 20 Adjust dosage in patients with hepatic impairment.19 20 (See Hepatic Impairment under Dosage and Administration.)
Common Adverse EffectsFlu-like symptoms, local effects at the injection site.1 19 20 40
Interactions for Interferon BetaNo formal drug interaction studies to date.1 19 20
Because of the potential for hepatic injury associated with interferon beta-1a and beta-1b, use caution when another agent is added to an existing interferon beta regimen.19 20 65 (See Hepatotoxicity under Cautions.)
Has been used concomitantly with corticosteroids, corticotropin (ACTH), antidepressants, and/or oral contraceptives in clinical studies1 19 without unusual adverse effects.19
Specific DrugsDrug
Interaction
Comments
Hepatotoxic agents (e.g., alcohol)
Potential for increased risk of hepatotoxicity19 65
Use concomitantly with caution and monitor for hepatotoxicity19 20 65
Myelosuppressive agents
Possible additive myelosuppressive effects1 19 20
Use concomitantly with caution1 19 20 and monitor closely20
Vaccines
Overall effectiveness of vaccination in patients receiving interferon beta has not been determined20
Interferon beta-1a (Rebif) does not appear to interfere with the antibody response to influenza virus vaccine inactivated20
Manufacturer of Rebif states vaccinations may be given to patients receiving interferon beta-1a20
Interferon Beta Pharmacokinetics Absorption BioavailabilityBioavailability of interferon beta-1b (Betaseron) following sub-Q administration is approximately 50%.1
Elimination Half-lifeElimination half-life of interferon beta-1a (Avonex) following a single IM dose is 10 hours.19
Plasma half-life of interferon beta-1a (Rebif) following a single sub-Q dose is approximately 69 hours.20
Stability Storage Parenteral InjectionInterferon beta-1a (Avonex) prefilled syringes: 2–8°C.19 After removing from refrigerator, warm to room temperature (about 30 minutes) and use within 12 hours.19 Protect from heat and light; do not freeze.19
Interferon beta-1a (Rebif) prefilled syringes: 2–8°C (may be stored at up to 25°C for up to 30 days).20 Protect from heat and light; do not freeze.20
Powder for InjectionInterferon beta-1a (Avonex) lyophilized powder: 2–8°C (may be stored at 25°C for up to 30 days).19 Following reconstitution, store for up to 6 hours at 2–8°C.19 Protect from heat and light; do not freeze.19
Interferon beta-1b (Betaseron) lyophilized powder: 25°C (may be exposed to 15–30°C).1 Following reconstitution, store at 2–8°C and use within 3 hours.1 Do not freeze.1
ActionsHas complex antiviral, antineoplastic, and immunomodulating activities.1 2 3 4 5 19 26
Mechanisms of action in the treatment of MS have not been fully elucidated,1 19 20 26 but may involve immunomodulating effects, including anti-inflammatory effects.4 8 9 37
Advice to PatientsProvide patient a copy of the medication guide and advise patient of the importance of reading this information each time a new or refill prescription is dispensed.1 19 20
Importance of taking interferon beta exactly as prescribed.1 19 20 60 Advise patients not to change interferon beta preparations during a single regimen of therapy without consulting their clinician.1 19 20 60 62
Risk of developing depression and suicidal ideation.1 19 20 60 Importance of notifying clinician immediately if symptoms of depression occur.1 19 20 60
Potential for temporary worsening of symptoms immediately following initiation of therapy;40 advise patients that these symptoms often abate with continued therapy and should not be interpreted as an indication of treatment failure.42
If patient or caregiver is to administer interferon beta, provide careful instructions on proper administration methods (including aseptic technique) and proper disposal of used needles and syringes.1 19 20
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1 19 20
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 19 20
Importance of informing patients of other important precautionary information.1 19 20 (See Cautions.)
PreparationsExcipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Interferon Beta-1aRoutes
Dosage Forms
Strengths
Brand Names
Manufacturer
Parenteral
For injection, for IM use
6.6 million units (33 mcg)
Avonex (with albumin human and with sterile water diluent; preservative-free)
Biogen Idec
Injection, for IM use
6 million units (30 mcg) per 0.5 mL
Avonex (prefilled syringes with needles)
Biogen Idec
Injection, for subcutaneous use
2.4 million units (8.8 mcg) per 0.2 mL
Rebif (with albumin human, preservative-free; available as prefilled syringes)
Serono (also promoted by Pfizer)
6 million units (22 mcg) per 0.5 mL
Rebif (with albumin human, preservative-free; available as prefilled syringes)
Serono (also promoted by Pfizer)
12 million units (44 mcg) per 0.5 mL
Rebif (with albumin human, preservative-free; available as prefilled syringes)
Serono (also promoted by Pfizer)
Interferon Beta-1bRoutes
Dosage Forms
Strengths
Brand Names
Manufacturer
Parenteral
For injection, for subcutaneous use
9.6 million units (0.3 mg)
Betaseron (with prefilled syringe containing 0.54% sodium chloride diluent, 27-gauge needle, vial adapter, and alcohol swabs)
Berlex
Comparative PricingThis pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Avonex 30MCG/VIAL Kit (BIOGEN IDEC): 4/$3,287.12 or 12/$9,704.83
Avonex Prefilled 30MCG/0.5ML Kit (BIOGEN IDEC): 4/$3,028.99 or 12/$9,003.97
Betaseron 0.3MG Solution (BAYER HEALTHCARE PHARMA): 14/$2,989.83 or 28/$5,970.03
Extavia 0.3MG Solution (NOVARTIS): 1/$229.98 or 3/$659.94
DisclaimerThis report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References1. Berlex Laboratories. Betaseron (interferon beta-1b) prescribing information. Richmond, CA; 2003 Oct.
2. Janeway CA, Travers P, Walport M et al eds. Immunology. 5th ed. New York, NY: Garland Publishing; 2001. From the National Library of Medicine website.
3. Pestka S, Langer JA, Zoon KC. Interferons and their actions. Annu Rev Biochem. 1987; 56: 727-77. [PubMed 2441659]
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6. The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is effective in relapsing remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology. 1993; 43:655-61. [IDIS 313026] [PubMed 8469318]
7. Paty DW, Li DKB. Interferon beta-1b is effective in relapsing remitting multiple sclerosis. II. MRI analysis of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology. 1993; 43: 627-7.
8. Absher JR. Interferon-1b to reduce exacerbations in multiple sclerosis. ACP J Club. 1993; Sep-Oct:33.
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14. Bradley JD, Scott CB, Paris KJ et al. A phase III comparison of radiation therapy with or without recombinant ?-interferon for poor-risk patients with locally advanced non-small-cell lung cancer. Int J Radiation Oncol.. 2002; 52:1173-9.
15. Repetto L, Giannessi PG, Campora E et al. Tamoxifen and interferon-beta for the treatment of metastatic breast cancer. Breast Cancer Res Treat. 1996; 39:235-8. Abstract. [PubMed 8872332]
16. Kieburtz K, McDermott M. Needed in MS: evidence not EVIDENCE. Neurology. 2002; 59:1482-3. [IDIS 492413] [PubMed 12451186]
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19. Biogen Idec, Inc. Avonex (interferon beta-1a) prescribing information. Cambridge, MA; 2005 Mar.
20. Serono, Inc. Rebif (interferon beta-1b) sterile prescribing information. Randolph, MA; 2005 Sept.
21. Goodin DS, Frohman EM, Garmany GP Jr et al. Disease modifying therapies in multiple sclerosis: report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology and the MS council for clinical practice guidelines. Neurology. 2002; 58: 169-178. From the Neurology website. [IDIS 475332] [PubMed 11805241]
22. Mikaeloff Y, Moreau T, Debouverie M et al. Interferon-? treatment in patients with childhood-onset multiple sclerosis. J Pediatr. 2001; 139:443-6. [IDIS 470673] [PubMed 11562627]
23. Rask C, Unger E, Walton M. BLA STN 103780/0: comparative study of Rebif to Avonex and orphan exclusivity. From the FDA website.
24. Haffner ME. Office of orphan products development (OOPD) analysis of exclusivity issues raised in the Serono BLA for Rebif. From the FDA website.
25. Anon. Serono Rebif approval is first orphan drug challenge based on efficacy. FDC Rep. Mar 11, 2002:19.
26. Goodin DS. Interferon-? therapy in multiple sclerosis: evidence for a clinically relevant dose response. Drugs. 2001; 61:1693-1703. [PubMed 11693459]
27. Rudick RA, Goodkin DE, Jacobs LD et al for the Multiple Sclerosis Collaborative Research Group. Impact of interferon beta-1a on neurologic disability in relapsing multiple sclerosis. Neurology. 1997; 49:358-363. (IDIS 390049) [IDIS 390049] [PubMed 9270562]
28. Simon JH, Jacobs LD, Campion M et al. Magnetic resonance studies of intramuscular interferon ?-1a for relapsing multiple sclerosis. Ann Neurol. 1996; 43:79-87. (IDIS 399819)
29. Panitch H, Goodin DS, Francis G et al. Randomized, comparative study of interferon ?-1a treatment regimens in MS: the EVIDENCE trial. Neurology. 2002; 59:1496-1506. [IDIS 492414] [PubMed 12451188]
30. PRISMS (Prevention of Relapses and Disability by Interferon ?-1a Subcutaneously in Multiple Sclerosis) study group. Randomised double-blind placebo-controlled study of interferon ?-1a in relapsing/remitting multiple sclerosis. Lancet. 1998; 352:1498-504.
31. PRISMS (Prevention of Relapses and Disability by Interferon ?-1a Subcutaneously in Multiple Sclerosis) study group. PRISMS-4: Long-term efficacy of interferon ?-1a in relapsing MS. Neurology. 2001; 56:1628-36. (IDIS 466251)
32. Li DK Paty DW et al. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo-controlled study of interferon ?1a in relapsing-remitting multiple sclerosis. Ann Neurol. 1999; 46:197-206. (IDIS 433793) [IDIS 433793] [PubMed 10443885]
33. The Once Weekly Interferon for MS (OWIMS) study group. Evidence of interferon ?-1a dose response in relapsing-remitting MS: the OWIMS study. Neurology. 1999; 53:679-86. [PubMed 10489026]
34. Durelli L, Verdun E, Barbero P et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet. 2002; 359:1453-60. [IDIS 481179] [PubMed 11988242]
35. Beghi E, Chio A, Inghilleri M et al for the Italian Amyotrophic Lateral Sclerosis Study Group. A randomized controlled trial of recombinant interferon beta-1a in ALS. Neurology. 2000; 54:469-74. (IDIS 442652) [IDIS 442652] [PubMed 10668716]
36. McDonald WI, Compston A, Edan G et al. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol. 2001; 50:121-7. [PubMed 11456302]
37. Food and Drug Administration (FDA). Summary basis of approval for interferon beta-1a (Avonex). From the FDA website.
38. Jacobs LD, Beck RW, Simon JH et al., and the CHAMPS Study Group. Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. N Engl J Med. 2000; 343:898-904. [IDIS 453132] [PubMed 11006365]
39. Comi G, Filippi M, Barkhof F et al. Effect of early interferon treatment on conversion to definite multiple sclerosis: a randomised study. Lancet. 2001; 357:1576-82. [IDIS 465183] [PubMed 11377645]
40. Bayas A, Rieckmann P. Managing the adverse effects of interferon-beta therapy in multiple sclerosis. Drug Saf. 2000; 22:149-59. [PubMed 10672896]
41. Neilley LK, Goodin DS, Goodkin DE et al. Side effect profile of interferon beta-1b in MS: results of an open label trial. Neurology. 1996; 46:552-4. (IDIS 362933). [IDIS 362933] [PubMed 8614531]
42. Lublin FD, Whitaker JN, Eidelman BH et al. Management of patients receiving interferon beta-1b for multiple sclerosis: report of a consensus conference. Neurology. 1996; 46:12-8. (IDIS 362121) [IDIS 362121] [PubMed 8559358]
43. Rice GP, Ebers GC, Lublin FD et al. Ibuprofen treatment versus gradual introduction of interferon ?-1b in patients with MS. Neurology. 1999; 52:1893-5. (IDIS 430279). [IDIS 430279] [PubMed 10371541]
44. Brex PA, Ciccarelli O, O’Riodan JI et al. A longitudinal study of abnormalities on MRI and disability from multiple sclerosis. N Engl J Med. 2002; 346:158-64. [PubMed 11796849]
45. Coyle PK, Hartung HP. Use of interferon beta in multiple sclerosis: rationale for early treatment and evidence for dose- and frequency-dependent effects on clinical response. Mult Scler. 2002; 8:2-9. [PubMed 11936484]
46. St?rzebechler S, Maibauer R, Heuner A et al. Pharmacodynamic comparison of single doses of IFN-?1b in healthy individuals. J Interferon Cytokine Res. 1999; 19:1257-64.
47. Deisenhammer F, Mayringer I, Harvey J et al. A comparative study of the relative bioavailability of different interferon beta preparations. Neurology. 2000; 54:2055-60. (IDIS 447724) [IDIS 447724] [PubMed 10851362]
48. European Study Group on interferon beta-1b in secondary progressive MS. Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. Lancet. 1998; 352:1491-7. [PubMed 9820296]
49. Molyneux PD, Barker GJ, Barkhof F et al. Clinical-MRI correlations in a European trial of interferon beta-1b in secondary progressive MS. Neurology. 2001; 57:2191-7. [IDIS 474631] [PubMed 11756596]
50. Secondary Progressive Efficacy Clinical Trial of Recombinant Interferon-beta-1a in MS (SPECTRIMS) Study Group. Randomized controlled trial of interferon- beta-1a in secondary progressive MS: clinical results. Neurology. 2001; 56:1496-504. (IDIS 464823) [IDIS 464823] [PubMed 11402106]
51. Li DK, Zhao GJ, Paty DW et al. Randomized controlled trial of interferon-beta-1a in secondary progressive MS: MRI results. Neurology. 2001; 56:1505-13. (IDIS 464824) [IDIS 464824] [PubMed 11402107]
52. Bramanti P, Sessa E, Rifici C et al. Enhanced spasticity in primary progressive MS patients treated with interferon beta-1b. Neurology. 1998; 51:1720-3. (IDIS 420036) [IDIS 420036] [PubMed 9855531]
53. Anon. Beta interferons for multiple sclerosis. Med Lett Drugs Ther. 2002; 44: 88-9.
54. Khan OA, Dhib-Jalbut SS. Neutralizing antibodies to interferon beta-1a and interferon beta-1b in MS patients are cross-reactive. Neurology. 1998; 51:1698-1702. (IDIS 420034) [IDIS 420034] [PubMed 9855525]
55. Ross C, Clemmesen KM, Svenson M et al for the Danish multiple sclerosis study group. Immunogenicity of interferon-beta in multiple sclerosis patients: influence of preparation, dosage, dose frequency, and route of administration. Ann Neurol. 2000; 48:706-12. (IDIS 457072) [IDIS 457072] [PubMed 11079533]
56. The IFNB Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group. Neutralizing antibodies during treatment of multiple sclerosis with interferon beta-1b: experience during the first three years. Neurology. 1996; 47:889-94. (IDIS 374809) [IDIS 374809] [PubMed 8857714]
57. Rudick RA, Simonian NA, Alam JA et al. Incidence and significance of neutralizing antibodies to interferon beta-1a in multiple sclerosis. Neurology. 1998; 50:1266-72. (IDIS 405926) [IDIS 405926] [PubMed 9595973]
58. Cook SD, Quinless JR, Jotkowitz A et al. Serum IFN neutralizing antibodies and neopterin levels in a cross-section of MS patients. Neurology. 2001; 57:1080-4. [IDIS 470761] [PubMed 11571337]
59. Deisenhammer F, Reindl M, Harvey J et al. Bioavailability of interferon beta-1b in MS with and without neutralizing antibodies. Neurology. 1999; 52:1239-43. (IDIS 427156) [IDIS 427156] [PubMed 10214750]
60. Reviewer’s comment (personal observation).
61. Berlex Laboratories, Richmond, CA: Personal communication.
62. Biogen, Inc., Cambridge, MA: Personal communication.
63. Joint Commission on Accreditation of Healthcare Organizations. 2004 National patient safety goals—FAQs. From JCAHO website. Accessed 2003 Nov.
64. Food and Drug Administration. Avonex(interferon beta-1a) [March 15, 2005: Biogen Idec]. MedWatch drug labeling changes. Rockville, MD; March 2005. From FDA website. Accessed on Dec 30, 2005.
65. Soo W. Dear healthcare professional letter: Important drug warning regarding hepatic injury associated with Avonex (interferon beta-1a). Cambridge, MA: Biogen Idec; (2005 Mar).
66. Food and Drug Administration. Betaseron (interferon beta-1b) [April 15, 2005: Berlex]. MedWatch reminder regarding hepatic toxicity. Rockville, MD; April 2005. From FDA website. Accessed on Dec 30, 2005.
67. Rabinowicz AL. Dear healthcare professional letter: Important drug warning regarding hepatotoxicity associated with Betaseron (interferon beta-1b). Montville, NJ: Berlex; (2005 Apr 15).
68. Food and Drug Administration. Rebif (interferon beta-1a) [Dec 2004: Serono]. MedWatch drug labeling changes regarding hepatic injury. Rockville, MD; Dec 2005. From FDA website. Accessed on Dec 30, 2005.
Ibuprof?ne
Ibuprof?ne may be available in the countries listed below.
Ingredient matches for Ibuprof?ne IbuprofenIbuprof?ne (DCF) is known as Ibuprofen in the US.
International Drug Name Search
Glossary
DCF D?nomination Commune Fran?aiseClick for further information on drug naming conventions and International Nonproprietary Names.
Insulin soluble
Insulin soluble may be available in the countries listed below.
Ingredient matches for Insulin soluble Insulin Injection, SolubleInsulin Injection, Soluble porcine or bovine (a derivative of Insulin Injection, Soluble) is reported as an ingredient of Insulin soluble in the following countries:
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Valeant Pharmaceuticals International
Address
Valeant Pharmaceuticals International,
One Enterprise
Aliso Viejo, California 92656Contact DetailsPhone: (800) 548-5100
Website: http://www.valeant.com/index.jsp
Careers: http://jobs-valeant.icims.com/jobs...
Insulina Betalin
Insulina Betalin may be available in the countries listed below.
Ingredient matches for Insulina Betalin Insulin Injection, SolubleInsulin Injection, Soluble human (a derivative of Insulin Injection, Soluble) is reported as an ingredient of Insulina Betalin in the following countries:
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