Cleanse and Treat Pad
Dosage Form: clothCLEANSE AND TREAT Cleanse and Treat Pad Description

Cleanse & Treat

Jopamiro

Jopamiro may be available in the countries listed below.

Ingredient matches for Jopamiro Iopamidol

Iopamidol is reported as an ingredient of Jopamiro in the following countries:

Austria

International Drug Name Search

Thioguanine Tabloid

Generic Name: ThioguanineClass: Antineoplastic AgentsVA Class: AN300

Miglitol
Pronunciation: MIG-li-tolGeneric Name: MiglitolBrand Name: Glyset

Nivemycin Tablets 500mg
1. Name Of The Medicinal Product

Nivemycin Tablets 500mg

2. Qualitative And Quantitative Composition

Neomycin sulphate Ph Eur.

an amount equivalent to 550mg of material having a potency of 700 units per mg

3. Pharmaceutical Form

Tablets

4. Clinical Particulars 4.1 Therapeutic Indications

Nivemycin (Neomycin sulphate BP) is indicated for pre-operative sterilisation of the bowel and may be useful in the treatment of impending hepatic coma, including portal systemic encephalopathy.

For oral administration.

4.2 Posology And Method Of Administration

Pre-operative sterilisation of the bowel.

Adults: 2 tablets every hour for 4 hours; then 2 tablets every 4 hours for two or three days before the operation.

Children over 12 years: 2 tablets every 4 hours for 2 or 3 days before the operation.

Children from 6 to 12 years: ? to 1 tablet every 4 hours for 2 or 3 days before the operation.

For practical reasons, use of the tablets in children under 6 years is not recommended.

In hepatic coma, the adult dose is 4-12 gm/day in divided doses for a period of 5-7 days, whilst for children, 50-100mg/kg/day in divided doses appears appropriate. Chronic hepatic insufficiency may require up to 4 gm/day over an indefinite period.

The elderly dose is the same as for adults.

4.3 Contraindications

Nivemycin should not be given when intestinal obstruction is present.

Hypersensitivity to aminoglycosides.

Infants under 1 year.

Myasthenia gravis

4.4 Special Warnings And Precautions For Use

The absorption of neomycin is poor from the alimentary tract, with about 97% of an orally administered dose being excreted unchanged in the faeces. Impaired G.I. motility however may increase absorption of the drug and it is therefore possible, as with other broad spectrum antibiotics, that prolonged therapy could result in ototoxicity and nephrotoxicity, particularly in patients with a degree of renal failure. In such patients, and in infants and the elderly, it is generally desirable to determine dosage requirements of aminoglycosides by individual monitoring. Some authorities consider that monitoring is also important in obese patients and those with cystic fibrosis.

Impaired hepatic function or auditory function, bacteraemia, fever, and possibly exposure to loud noises have been reported to increase the risk of ototoxicity, while volume depletion or hypotension, liver disease, or female sex have been reported as additional risk factors for nephrotoxicity. Regular assessment of auditory, vestibular and renal function is particularly necessary in patients with additional risk factors.

When used as an adjunct in the management of hepatic coma, care should be taken that administration is of the minimal period necessary, since prolonged exposure to the drug may result in malabsorption.

Neomycin should be used with caution in patients with neuromuscular disorders and parkinsonism.

There is almost complete cross-resistance between neomycin, kanamycin, paromomycin and framycetin. Cross-resistance with gentamicin has also been reported.

Since prolonged therapy may result in the overgrowth of non-sensitive organisms, treatment should not be continued longer than necessary to prevent superinfection due to the overgrowth of non-sensitive organisms.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Neomycin may impair absorption of other drugs including phenoxymethylpenicillin,digoxin, methotrexate and some vitamins. Aminoglycosides exhibit synergistic activity with a number of beta lactams, but aminoglycoside activity was reported to be diminished in a few patients with severe renal impairment.

Care should be taken when considering the use of neomycin concurrently with drugs with a potential to cause nephrotoxicity (including other aminoglycosides, some of the cephalosporins, amphotericin, ciclosporin, capreomycin, polymyxins, platinum compounds, teicoplanin and vancomycin) or ototoxicity (including, loop diuretics, capreomycin, teicoplanin, vancomycin and possibly platinum coumpounds).

The effect of non-depolarising muscle relaxants may be enhanced by aminoglycosides.

Care is required if other drugs with a neuromuscular blocking action, including botulinum toxin, are given concomitantly. Care is required when patients being treated with aminoglycosides are to receive a general anaesthetic or opioids in order to avoid the possible neuromuscular side-effects provoking severe respiratory depression.

The effect of the parasympathomimetic drugs neostigmine and pyridostigmine, may be antagonised by aminoglycosides.

The hypoglycaemic effect of acarbose may be enhanced by neomycin and the severity of gastrointestinal side effects increased.

Aminoglycosides may increase the risk of hypocalcaemia in patients receiving bisphosphonates.

Experience in anticoagulant clinics suggests that INR (International Normalised Ratio) may be altered by antibacterials such as neomycin given for local action on the gut, although studies have failed to demonstrate an interaction with phenindione.

The efficacy of oral contraceptives may be reduced with broad spectrum antibiotics.

Oral typhoid vaccine is inactivated by concomitant antibiotic administration.

4.6 Pregnancy And Lactation

The use of neomycin in pregnancy is not recommended unless the benefits outweigh the potential risks.

There are no reports linking the use of neomycin to congenital defects. However, small amounts of the drug are absorbed when given orally and neomycin and other aminoglycosides may have harmful effects on the foetus following oral absorption during pregnancy.

In some circumstances neomycin may enter the breast milk of lactating mothers. There is little risk of ototoxicity in the infant, but abnormal development of the gut flora may occur. The use of neomycin in lactating mothers is not recommended unless the benefits outweigh the potential risks.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Nausea, vomiting, diarrhoea, increased salivation, stomatitis, nephrotoxicity, ototoxicity, rise in serum levels of hepatic enzymes and bilirubin, blood dyscrasias, haemolytic anaemia, confusion, paraesthesia, disorientation, nystagmus, hypersensitivity reactionsincluding dermatitis, pruritus, drug fever and anaphylaxis.

Cross-sensitivity with other aminoglycosides may occur.

Malabsorption syndrome with steatorrhoea and diarrhoea, which can be severe, may be caused by prolonged oral therapy.

Superinfection may occur, especially with prolonged oral treatment.

Electrolyte disturbances (notably hypomagnesaemia but also hypocalcaemia and hypokalaemia) have occurred with other aminoglycosides.

4.9 Overdose

In overdose, exacerbation of the adverse events reported for neomycin (nausea, diarrhoea, nephrotoxicity, ototoxicity etc.) is expected.

Monitor renal and auditory function. If these are impaired, haemodialysis is indicated. Prolonged assisted ventilation may also be required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Neomycin is an aminoglycoside antibiotic.

Neomycin acts by binding to polysomes, inhibiting protein synthesis and generating errors in the transcription of the genetic code.

5.2 Pharmacokinetic Properties

The absorption of neomycin from the alimentary tract is poor: Only ~ 3% of an oral dose is absorbed, neomycin is rapidly excreted by the kidneys in the unchanged form. The plasma half-life in healthy adults is approximately 2-3 hours. Oral doses of 3 g produce peak plasma concentrations of up to 4 ?g/ml.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Plasdone K29-32

Isopropyl alcohol

Calcium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 30°C in a dry place – protect from light.

6.5 Nature And Contents Of Container

An amber glass bottle having a tin-plate screw cap with a waxed aluminium-faced pulpboard liner. The ullage is filled with cotton wool.

Pack size: 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data 7. Marketing Authorisation Holder

Waymade Plc.

Trading as Sovereign Medical

Sovereign House

Miles Gray Road

Basildon

Essex SS14 3FR

8. Marketing Authorisation Number(S)

PL 06464/0710

9. Date Of First Authorisation/Renewal Of The Authorisation

11 January 1999

10. Date Of Revision Of The Text

July 2003

Furadantin tablets 100mg
1. Name Of The Medicinal Product

Furadantin® tablets 100mg

Nitrofurantoin 100mg tablets

2. Qualitative And Quantitative Composition

Furadantin tablets contain 100mg Nitrofurantoin Ph Eur.

3. Pharmaceutical Form

Furadantin tablets are yellow and pentagonal. Each tablet has a break line on one face and the tablet strength on the opposite face.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.

Nitrofurantoin is specifically indicated for the treatment of infections, when due to susceptible strains of Escherichia co/i, Enterococci, Staphylococci, Citrobacter, Kiebsiella and Enterobacter.

4.2 Posology And Method Of Administration

Dosage:

Adults

Acute Uncomplicated Urinary Tract Infections: 50mg four times daily for seven days

Severe Chronic Recurrence: 100mg four times day for seven days

Long Term Suppression: 50mg - 100mg once a day.

Pophylaxis: 50mg four times daily for the duration of procedure and 3 days thereafter.

Children and Infants over three months of age

Acute Urinary Tract Infections: 3mg/kg/day in four divided doses for seven days.

Suppressive: 1mg/kg, once a day.

For children under 25kg body weight consideration should be given to the use of Furadantin® Suspension.

Elderly

Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy (Section 4.8).

4.3 Contraindications

Patients suffering from renal dysfunction with a creatinine clearance of less than 60ml/minute or elevated serum creatinine.

In infants under three months of age as well as pregnant patients at term (during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the new-born infant, due to immature erythrocyte enzyme systems.

Patients with known hypersensitivity to Nitrofurantoin or other nitrofurans.

4.4 Special Warnings And Precautions For Use

Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally non-functioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.

Since pre-existing conditions may mask adverse reactions, Nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic dysfunction, neurological disorders, and allergic diathesis.

Peripheral neuropathy and susceptibility to peripheral neuropathy, which may become severe or irreversible, has occurred and may be life threatening. Therefore, treatment should be stopped at the first signs of neural involvement (paraesthesiae).

Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.

Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately.

Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary condition of patients receiving long-term therapy is warranted (especially in the elderly).

Patients should be monitored closely for signs of hepatitis (particularly in long-term use). Urine may be coloured yellow or brown after taking Nitrofurantoin. Patients on Nitrofurantoin are susceptible to false positive urinary glucose (If tested for reducing substances)

Nitrofurantoin should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate dehydogenase deficiency.

Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage.

For long-term treatment, monitor patients closely for evidence of hepatitis or pulmonary symptoms or other evidence of toxicity.

Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

1. Increased absorption with food or agents delaying gastric emptying.

2. Decreased absorption with magnesium trisilicate.

3. Decreased renal excretion of Nitrofurantoin by probenecid and sulphinpyrazone.

4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and urine alkalisation.

5. Anti-bacterial antagonism by quinolone anti-infectives.

6. Interference with some tests for glucose in urine

4.6 Pregnancy And Lactation

Animal studies with Nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive use since 1952, and its suitability in human pregnancy has been well documented. However, as with all other drugs, the maternal side effects may adversely affect course of pregnancy. The drug should be used at the lowest dose as appropriate for specific indication, only after careful assessment.

Nitrofurantoin is however contraindicated in infants under three months of age and in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infants' immature red cells. Caution should be exercised while breast-feeding an infant known or suspected to have an erythrocyte enzyme deficiency, since Nitrofurantoin is detected in trace amounts in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Nitrofurantoin may cause dizziness and drowsiness and the patient should not drive or operate machinery if affected this way.

4.8 Undesirable Effects

Respiratory

If any of the following respiratory reactions occur the drug should be discontinued.

Acute pulmonary reactions usually occur within the first week of treatment and are reversible with cessation of therapy. Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x-ray, and eosinophilia. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form.

Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients. Changes in ECG have occurred, associated with pulmonary reactions.

Minor symptoms such as fever, chills, cough and dyspnoea may be significant. Collapse and cyanosis have been reported rarely. The severity of chronic pulmonary reactions and their degree of resolution appear to be related to the duration of therapy after the first clinical signs appear. It is important to recognise symptoms as early as possible. Pulmonary function may be impaired permanently, even after cessation of therapy.

Hepatic

Hepatic reactions including cholestatic jaundice and chronic active hepatitis occur rarely. Fatalities have been reported. Cholestatic jaundice is generally associated with short-term therapy (usually up to two weeks). Chronic active hepatitis, occasionally leading to hepatic necrosis is generally associated with long-term therapy (usually after six months). The onset may be insidious. Treatment should be stopped at the first sign of hepatotoxicity.

Neurological

Peripheral neuropathy (including optical neuritis) with symptoms of sensory as well as motor involvement, which may become severe or irreversible, has been reported infrequently. Less frequent reactions of unknown causal relationship are depression, euphoria, confusion, psychotic reactions, nystagmus, vertigo, dizziness, asthenia, headache and drowsiness. Treatment should be stopped at the first sign of neurological involvement.

Gastrointestinal

Nausea and anorexia have been reported. Emesis, abdominal pain and diarrhoea are less common gastrointestinal reactions.

Haematological

Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, megaloblastic anaemia, glucose-6-phosphate dehydrogenase deficiency anaemia, and eosinophilia have been reported. Aplastic anaemia has been reported rarely. Cessation of therapy has generally returned the blood picture to normal.

Hypersensitivity

Allergic skin reactions manifesting as angioneurotic oedema, maculopapular, erythematous or eczematous eruptions, urticaria, rash, and pruritis have occurred.

Lupus-like syndrome associated with pulmonary reactions to Nitrofurantoin has been reported.

Exfoliative dermatitis and erythema multiforme (including Stevens- Johnson Syndrome) have been reported rarely.

Other hypersensitivity reactions include anaphylaxis, sialadenitis, pancreatitis, drug fever and arthralgia.

Miscellaneous

Transient alopecia and benign intracranial hypertension. As with other antimicrobial agents, superinfections by fungi or resistant organisms such as Pseudomonas may occur.

However, these are limited to the genitourinary tract because suppression of normal bacterial flora does not occur elsewhere in the body.

4.9 Overdose

Symptoms and signs of overdose include gastric irritation, nausea and vomiting. There is no known specific antidote. However, Nitrofurantoin can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by gastric lavage. Monitoring of full blood count, liver function, and pulmonary function tests are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Furadantin is a broad-spectrum antibacterial agent, active against the majority of urinary pathogens. The wide range of organisms sensitive to the bactericidal activity include:

Escherichia coli

Enterococcus Faecalis

Klebsiella Species

Enterobacter Species

Staphylococcus Species, e.g. S.Aureus, S.Saprophyticus, S.Epidermidis

Citrobacter Species

Clinically most common urinary pathogens are sensitive to Nitrofurantoin. Most strains of Proteus and Serratia are resistant. All pseudomonas strains are resistant.

5.2 Pharmacokinetic Properties

Orally administered Nitrofurantoin is readily absorbed in the upper gastrointestinal tract and is rapidly excreted in the urine. Blood concentrations at therapeutic dosages are usually low with an elimination half-life of about 30 minutes.

Maximum urinary excretion usually occurs 2-4 hours after administration of Nitrofurantoin. Urinary drug dose recoveries of about 40-45% are obtained.

5.3 Preclinical Safety Data

Carcinogenic effect of Nitrofurantoin in animal studies was observed. However, human data and extensive use of Nitrofurantoin over 50 years do not support such observation.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Furadantin tablets also contain lactose, maize starch, talc, alginic acid and magnesium stearate and purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

The tablets are packaged in light-proof and moisture-resistant containers. Storage temperatures must not exceed 25°C.

6.5 Nature And Contents Of Container

Furadantin tablets are supplied in packs of 30 and 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

Used as directed by physician. A Patient Information Leaflet is provided with details of use and handling of the product.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited

NLA Tower

12-16 Addiscombe Road

Croydon

CR0 0XT

United Kingdom.

8. Marketing Authorisation Number(S)

PL 12762/0051 (100mg tablets)

9. Date Of First Authorisation/Renewal Of The Authorisation

31/03/2000.

10. Date Of Revision Of The Text

13/08/2010

Panoxyl Soap
benzoyl peroxide Dosage Form: soapDrug Facts Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use for the treatment of acne; helps prevent new acne blemishes from forming

Warnings

For external use only

Do not use if you have very sensitive skin if you are sensitive to benzoyl peroxide When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if irritation becomes severe. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions using warm water, wash the affected area for 1 to 2 minutes rinse well and pat dry with a clean towel because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor. Other information

Store at controlled room temperature 59° -86°F (15°-30°C).

Inactive ingredients

cetearyl alcohol, cocamidopropyl betaine, glycerin, hydrogenated castor oil, lactic acid, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, silica, sodium lauryl sulfate, titanium dioxide, zea mays (corn) starch

Questions?

call 1-888-784-3335 (STIEFEL). Side effects associated with use of this product may be reported to this number.

Now you can take control of your acne with Maximum Strength PanOxyl® Acne Cleansing Bar, the highest strength of Benzoyl Peroxide (BPO) available without a prescription. The Benzoyl Peroxide in the PanOxyl Acne Cleansing Bar is the same medicine prescribed by dermatologists.

The convenient bar form of PanOxyl gently removes dirt and excess oil to cleanse and unclog pores, making it an excellent choice for the management of acne on the face, chest and back.

PANOXYL is a registered trademark of Stiefel Laboratories, Inc.

www.stiefelchc.com

©2010 Stiefel Laboratories, Inc.

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

Principal Display Panel

NDC 0145-0983-05

PanOxyl®

10% Benzoyl Peroxide

Maximum Strength

ACNE CLEANSING BAR

DERMATOLOGIST Recommended Ingredients

Therapeutic acne control

FACE

CHEST

BACK

Benzoyl Peroxide effectively penetrates pores killing the bacteria that cause acne Clears existing acne blemishes and prevents new blemishes from forming

Stiefel

Net Wt 4 Oz (113 g)

cefazolin Injection

sef-A-zoe-lin

Commonly used brand name(s)

In the U.S.

Ancef

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: 1st Generation Cephalosporin

Uses For cefazolin

Cefazolin is used to treat bacterial infections in many different parts of the body. cefazolin is also given before certain types of surgery to prevent infections.

Cefazolin belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, cefazolin will not work for colds, flu, or other virus infections.

cefazolin is available only with your doctor's prescription.

Before Using cefazolin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cefazolin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cefazolin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cefazolin in children.

Because of cefazolin's toxicity, use in newborn and premature babies is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefazolin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefazolin.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving cefazolin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using cefazolin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Warfarin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of cefazolin. Make sure you tell your doctor if you have any other medical problems, especially:

Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body. Kidney disease, severe or Liver disease, severe or Undernourished condition—May be worsened by cefazolin and you may need to take Vitamin K. Stomach or bowel disease (e.g., colitis or severe diarrhea), history of or Seizures—Use with caution. May make these conditions worse. Proper Use of cefazolin

A nurse or other trained health professional will give you cefazolin. cefazolin is given as a shot into one of your muscles or through a needle placed in one of your veins.

Precautions While Using cefazolin

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Cefazolin may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using cefazolin. The results of some tests may be affected by cefazolin.

Do not take other medicines unless they have been discussed with your doctor. This includes calcium-containing solutions for injection, prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

cefazolin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare Bluish color changes in skin color pain swelling of the foot or leg tenderness Incidence not known Abdominal or stomach cramps or tenderness back, leg, or stomach pains black, tarry stools bleeding gums blistering, peeling, or loosening of the skin bloating blood in the urine or stools bloody or cloudy urine chest pain chills clay-colored stools cloudy urine cough coughing up blood dark urine decrease in urine output or decrease in urine-concentrating ability decreased frequency or amount of urine diarrhea diarrhea, watery and severe, which may also be bloody difficult or painful urination difficulty with breathing or swallowing dizziness excessive muscle tone fast heartbeat feeling of discomfort fever general body swelling general tiredness and weakness headache hives increased blood pressure increased menstrual flow or vaginal bleeding increased thirst inflammation of the joints itching itching of the vagina or genital area joint or muscle pain light-colored stools loss of appetite lower back or side pain muscle aches or stiffness muscle tension or tightness nausea or vomiting nosebleeds pain during sexual intercourse pain, warmth, or burning in the fingers, toes, and legs pale skin paralysis pinpoint red spots on the skin problems with vision or hearing prolonged bleeding from cuts puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue rash red irritated eyes red or black, tarry stools red or dark brown urine red skin lesions, often with a purple center red, irritated eyes restlessness seizures skin rash sore throat sores, ulcers, or white spots on the lips or in the mouth stomach cramps sudden decrease in the amount of urine swelling of the face, fingers, or lower legs swollen lymph glands swollen or painful glands thick, white vaginal discharge with no odor or with a mild odor tightness in the chest trouble sitting still troubled breathing unpleasant breath odor unusual bleeding or bruising unusual tiredness or weakness unusual weight loss upper right abdominal pain vomiting vomiting of blood weight gain wheezing yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site hives or welts redness of the skin sore mouth or tongue weight loss white patches in the mouth, tongue, or throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: cefazolin Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More cefazolin Injection resources Cefazolin Injection Side Effects (in more detail)Cefazolin Injection Use in Pregnancy & BreastfeedingCefazolin Injection Drug InteractionsCefazolin Injection Support Group0 Reviews for Cefazolin Injection - Add your own review/rating Compare cefazolin Injection with other medications Bacterial Endocarditis PreventionBacterial InfectionBone infectionCholecystitisEndocarditisJoint InfectionKidney InfectionsPeritonitisPneumoniaPrevention of Perinatal Group B Streptococcal DiseaseSepticemiaSkin InfectionSurgical ProphylaxisUrinary Tract Infection

Ibuflam Lichtenstein

Ibuflam Lichtenstein may be available in the countries listed below.

Ingredient matches for Ibuflam Lichtenstein Ibuprofen

Ibuprofen is reported as an ingredient of Ibuflam Lichtenstein in the following countries:

Germany

International Drug Name Search

Novolog Mix 70/30
Dosage Form: injection, suspensionFULL PRESCRIBING INFORMATION Indications and Usage for Novolog Mix 70/30

Novolog Mix 70/30 is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.

 Important Limitations of Use:

 In premix insulins, such as Novolog Mix 70/30, the proportions of rapid acting and long acting insulins are fixed and do not allow for basal versus prandial dose adjustments.

Novolog Mix 70/30 Dosage and Administration Dosing

Novolog Mix 70/30 is an insulin analog with an earlier onset and intermediate duration of action in comparison to the basal human insulin premix. The addition of protamine to the rapid-acting aspart insulin analog (NovoLog) results in insulin activity that is 30% short-acting and 70% long-acting. Novolog Mix 70/30 is typically dosed on a twice-daily basis (with each dose intended to cover 2 meals or a meal and a snack). The dosage of Novolog Mix 70/30 must be individualized. The written prescription for Novolog Mix 70/30 should include the full name, to avoid confusion with NovoLog (insulin aspart) and Novolin 70/30 (human premix).

Novolog Mix 70/30 should appear uniformly white and cloudy. Do not use it if it looks clear or if it contains solid particles. Novolog Mix 70/30 should not be used after the printed expiration date.

Novolog Mix 70/30 should be administered by subcutaneous injection in the abdominal region,  buttocks, thigh, or upper arm. Novolog Mix 70/30 has a faster onset of action than human insulin premix 70/30 and should be dosed within 15 minutes before meal initiation for patients with type 1 diabetes. For patients with type 2 diabetes, dosing should occur within 15 minutes before or after meal initiation. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy. As with all insulins, the duration of action may vary according to the dose, injection site, blood flow, temperature, and level of physical activity.

Novolog Mix 70/30 should not be administered intravenously or used in insulin infusion pumps. Dose regimens of Novolog Mix 70/30 will vary among patients and should be determined by the health care professional familiar with the patient’s recommended glucose treatment goals, metabolic needs, eating habits, and other lifestyle variables.

Resuspension

Novolog Mix 70/30 is a suspension that must be visually inspected and resuspended immediately before use. The Novolog Mix 70/30 vial should be rolled gently in your hands in a horizontal position 10 times to mix it. The rolling procedure must be repeated until the suspension appears uniformly white and cloudy. Inject immediately. Resuspension is easier when the insulin has reached room temperature.

The Novolog Mix 70/30 FlexPen should be rolled 10 times gently between your hands in a horizontal position. Thereafter, turn the Novolog Mix 70/30 FlexPen upside down so that the glass ball moves from one end of the reservoir to the other. Do this at least 10 times. The rolling and turning procedure must be repeated until the suspension appears uniformly white and cloudy. Inject immediately. Before each subsequent injection, turn the disposable Novolog Mix 70/30 FlexPen upside down so that the glass ball moves from one end of the reservoir to the other at least 10 times and until the suspension appears uniformly white and cloudy. Inject immediately.

Dosage Forms and Strengths

Novolog Mix 70/30 is available in the following package sizes: each presentation contains 100 units of insulin aspart per mL (U-100).

10 mL vials 3 mL Novolog Mix 70/30 FlexPen Contraindications

Novolog Mix 70/30 is contraindicated

during episodes of hypoglycemia in patients with hypersensitivity to NovoLog  Mix 70/30 or one of its excipients. Warnings and Precautions Administration

The short and long-acting components of insulin mixes, including Novolog Mix 70/30, cannot be titrated independently. Because Novolog Mix 70/30 has peak pharmacodynamic activity between 1-4 hours after injection, it should be administered within 15 minutes of meal initiation [see Clinical Pharmacology (12)]. The dose of insulin required to provide adequate glycemic control for one of the meals may result in hyper- or hypoglycemia for the other meal. The pharmacodynamic profile may also be inadequate for patients who require more frequent meals.

Novolog Mix 70/30 should not be mixed with any other insulin product.

Novolog Mix 70/30 should not be used intravenously.

Novolog Mix 70/30 should not be used in insulin infusion pumps.

Glucose monitoring is recommended for all patients with diabetes. Any change of insulin dose should be made cautiously and only under medical supervision. Changing from one insulin product to another or changing the insulin strength may result in the need for a change in dosage. Changes may also be necessary during illness, emotional stress, and other physiologic stress in addition to changes in meals and exercise.

The pharmacokinetic and pharmacodynamic profiles of all insulins may be altered by the site used for injection and the degree of vascularization of the site. Smoking, temperature, and exercise contribute to variations in blood flow and insulin absorption. These and other factors contribute to inter- and intra-patient variability.

Needles and Novolog Mix 70/30 FlexPen must not be shared.

Hypoglycemia

Hypoglycemia is the most common adverse effect of insulin therapy, including Novolog Mix 70/30. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. Severe hypoglycemia requiring the assistance of another person and/or parenteral glucose infusion or glucagon administration has been observed in clinical trials with insulin, including trials with Novolog Mix 70/30.

The timing of hypoglycemia may reflect the time-action profile of the insulin formulation [see Clinical Pharmacology (12)]. Other factors, such as changes in dietary intake (e.g., amount of food or timing of meals), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia [see Drug Interactions (7)]. As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g. patients who are fasting or have erratic food intake). The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating machinery.

Rapid changes in serum glucose levels may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control [see Drug Interactions (7)].

Hypokalemia

All insulin products, including Novolog Mix 70/30, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia that, if left untreated, may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g. patients using potassium-lowering medications or patients taking medications sensitive to potassium concentrations).

Renal Impairment

Clinical or pharmacology studies with Novolog Mix 70/30 in diabetic patients with various degrees of renal impairment have not been conducted. As with other insulins, the requirements for Novolog Mix 70/30 may be reduced in patients with renal impairment [see Clinical Pharmacology (12.3)].

Hepatic Impairment

Clinical or pharmacology studies with Novolog Mix 70/30 in diabetic patients with various degrees of hepatic impairment have not been conducted. As with other insulins, the requirements for Novolog Mix 70/30 may be reduced in patients with hepatic impairment [see Clinical Pharmacology (12.3)].

Hypersensitivity and Allergic Reactions

Local Reactions- As with other insulin therapy, patients may experience reactions such as erythema, edema or pruritus at the site of Novolog Mix 70/30 injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require  discontinuation of Novolog Mix 70/30. In some instances, these reactions may be related to the insulin molecule, other components in the insulin preparation including protamine and cresol, components in skin cleansing agents, or injection techniques. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.

Systemic Reactions- Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reaction, may be life threatening.

Antibody Production

Specific anti-insulin antibodies as well as cross-reacting anti-insulin antibodies were monitored in a 3-month, open-label comparator trial as well as in a long-term extension trial. Changes in cross-reactive antibodies were more common after Novolog Mix 70/30 than with Novolin 70/30 but these changes did not correlate with change in HbA1c or increase in insulin dose. The clinical significance of these antibodies has not been established. Antibodies did not increase further after long-term exposure (>6 months) to Novolog Mix 70/30.

Adverse Reactions

Clinical Trial Experience

Clinical trials are conducted under widely varying designs, therefore, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolog Mix 70/30 [see Warnings and Precautions (5.2)]. Novolog Mix 70/30 should not be used during episodes of hypoglycemia [see Contraindications (4)] and [Warnings and Precautions (5)].

Insulin initiation and glucose control intensification

Intensification or rapid improvement in glucose control has been associated with transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.

Lipodystrophy

Long-term use of insulin, including Novolog Mix 70/30, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection sites within the same region to reduce the risk of lipodystrophy.

Weight gain

Weight gain can occur with some insulin therapies, including Novolog Mix 70/30, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

Peripheral Edema

Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Frequencies of adverse drug reactions

The frequencies of adverse drug reactions during a clinical trial with Novolog Mix 70/30 in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below. The trial was a three-month, open-label trial in patients with Type 1 or Type 2 diabetes who were treated twice daily (before breakfast and before supper) with Novolog Mix 70/30.

Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 diabetes mellitus (Adverse events with frequency ? 5% are included.)

Novolog Mix 70/30

(N=55)

Novolin 70/30

(N=49) Preferred Term N % N % Hypoglycemia 38 69 37 76 Headache 19 35 6 12 Influenza-like symptoms 7 13 1 2 Dyspepsia 5 9 3 6 Back pain 4 7 2 4 Diarrhea 4 7 3 6 Pharyngitis 4 7 1 2 Rhinitis 3 5 6 12 Skeletal pain 3 5 2 4 Upper respiratory tract infection 3 5 1 2 Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 diabetes mellitus (Adverse events with frequency ? 5% are included.)

Novolog Mix 70/30

(N=85)

Novolin 70/30

(N=102) Preferred Term N % N % Hypoglycemia 40 47 51 50 Upper respiratory tract infection 10 12 6 6 Headache 8 9 8 8 Diarrhea 7 8 2 2 Neuropathy 7 8 2 2 Pharyngitis 5 6 4 4 Abdominal pain 4 5 0 0 Rhinitis 4 5 2 2

Postmarketing Data

Additional adverse reactions have been identified during post-approval use of Novolog Mix 70/30. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency. They include medication errors in which other insulins have been accidentally substituted for Novolog Mix 70/30 [see Patient Counseling Information (17)].

Drug Interactions

A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.

The following are examples of substances that may increase the blood-glucose-lowering effect and susceptibility to hypoglycemia: oral antidiabetic products, pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, salicylates, somatostatin analog (e.g. octreotide), sulfonamide antibiotics. The following are examples of substances that may reduce the blood-glucose-lowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, salbutamol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), atypical antipsychotics. Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic products such as beta-blockers, clonidine, guanethidine, and reserpine. USE IN SPECIFIC POPULATIONS Pregnancy

Pregnancy Category B.

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in such patients.

An open-label, randomized study compared the safety and efficacy of NovoLog (the rapid-acting component of Novolog Mix 70/30) versus human insulin in the treatment of pregnant women with Type 1 diabetes (322 exposed pregnancies (NovoLog: 157, human insulin: 165)). Two-thirds of the enrolled patients were already pregnant when they entered the study. Since only one-third of the patients enrolled before conception, the study was not large enough to evaluate the risk of congenital malformations. Mean HbA1c of ~ 6% was observed in both groups during pregnancy, and there was no significant difference in the incidence of maternal hypoglycemia.

Animal reproduction studies have not been conducted with Novolog Mix 70/30. However, subcutaneous reproduction and teratology studies have been performed with NovoLog (the rapid-acting component of Novolog Mix 70/30) and regular human insulin in rats and rabbits. In these studies, NovoLog was given to female rats before mating, during mating, and throughout pregnancy, and to rabbits during organogenesis. The effects of NovoLog did not differ from those observed with subcutaneous regular human insulin.

NovoLog, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 U/kg/day (approximately 32-times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area), and in rabbits at a dose of 10 U/kg/day (approximately three times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area). The effects are probably secondary to maternal hypoglycemia at high doses. No significant effects were observed in rats at a dose of 50 U/kg/day and rabbits at a dose of 3 U/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1.0 U/kg/day for rats and equal to the human subcutaneous dose of 1.0 U/kg/day for rabbits based on U/body surface area.

Female patients should be advised to discuss with their physician if they intend to, or if they become pregnant. There are no adequate and well-controlled studies of the use of Novolog Mix 70/30 in pregnant women.

Nursing Mothers

It is unknown whether insulin aspart is excreted in human milk as occurs with human insulin. There are no adequate and well-controlled studies of the use of Novolog Mix 70/30 or NovoLog in lactating women. Women with diabetes who are lactating may require adjustments of their insulin doses. 

Pediatric Use

Safety and effectiveness of Novolog Mix 70/30 have not been established in pediatric patients.

Geriatric Use

Clinical studies of Novolog Mix 70/30 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in this population.

Overdosage

Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery.

Novolog Mix 70/30 Description

Novolog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is a human insulin analog suspension containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. Novolog Mix 70/30 is a blood-glucose-lowering agent with an earlier onset and an intermediate duration of action. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker’s yeast). Insulin aspart (NovoLog) has the empirical formula C256H381N65O79S6 and a molecular weight of 5825.8 Da.

Figure 1. Structural formula of insulin aspart

Novolog Mix 70/30 is a uniform, white, sterile suspension that contains insulin aspart 100 Units/mL.

Inactive ingredients are glycerol 16.0 mg/mL, phenol 1.50 mg/mL, metacresol 1.72 mg/mL, zinc 19.6 ?g/mL, disodium hydrogen phosphate dihydrate 1.25 mg/mL, sodium chloride 0.877 mg/mL, and protamine sulfate 0.32 mg/mL. Novolog Mix 70/30 has a pH of 7.20 - 7.44. Hydrochloric acid or sodium hydroxide may be added to adjust pH.

Novolog Mix 70/30 - Clinical Pharmacology Mechanism of Action

The primary activity of Novolog Mix 70/30 is the regulation of glucose metabolism. Insulins, including Novolog Mix 70/30, bind to the insulin receptors on muscle, liver and fat cells and lower blood glucose by facilitating the cellular uptake of glucose and simultaneously inhibiting the output of glucose from the liver.

Pharmacodynamics

The two euglycemic clamp studies described below [see Clinical Pharmacology (12.3)] assessed glucose utilization after dosing of healthy volunteers. Novolog Mix 70/30 has an earlier onset of action than human premix 70/30 in studies of normal volunteers and patients with diabetes. The onset of action is between 10-20 minutes for Novolog Mix 70/30 compared to 30 minutes for Novolin 70/30. The mean ± SD time to peak activity for Novolog Mix 70/30 is 2.4 hr ± 0.8 hr compared to 4.2 hr ± 0.4 hr for Novolin 70/30. The duration of action may be as long as 24 hours (see Figure 2).

Figure 2. Pharmacodynamic Activity Profile of Novolog Mix 70/30 and Novolin 70/30 in healthy subjects.

Pharmacokinetics

The single substitution of the amino acid proline with aspartic acid at position B28 in insulin aspart (NovoLog) reduces the molecule’s tendency to form hexamers as observed with regular human insulin. The rapid absorption characteristics of NovoLog are maintained by Novolog Mix 70/30. The insulin aspart in the soluble component of Novolog Mix 70/30 is absorbed more rapidly from the subcutaneous layer than regular human insulin. The remaining 70% is in crystalline form as insulin aspart protamine which has a prolonged absorption profile after subcutaneous injection.

Bioavailability and Absorption- The relative bioavailability of Novolog Mix 70/30 compared to NovoLog and Novolin 70/30 indicates that the insulins are absorbed to similar extent. In euglycemic clamp studies in healthy volunteers (n=23) after dosing with Novolog Mix 70/30 (0.2 U/kg), a mean maximum serum concentration (Cmax) of 23.4 ± 5.3 mU/L was reached after 60 minutes. The mean half-life (t1/2) of Novolog Mix 70/30 was about 8 to 9 hours. Serum insulin levels returned to baseline 15 to 18 hours after a subcutaneous dose of Novolog Mix 70/30. Similar data were seen in a separate euglycemic clamp study in healthy volunteers (n=24) after dosing with Novolog Mix 70/30 (0.3 U/kg). A Cmax of 61.3 ± 20.1 mU/L was reached after 85 minutes. Serum insulin levels returned to baseline 12 hours after a subcutaneous dose.

The Cmax and the area under the insulin concentration-time curve (AUC) after administration of Novolog Mix 70/30 was approximately 20% greater than those after administration of Novolin 70/30, (see Fig. 3 for pharmacokinetic profiles).

Figure 3. Pharmacokinetic Profiles of NovoLog  Mix 70/30 and Novolin 70/30

Distribution and Elimination- NovoLog has a low binding to plasma proteins, 0 to 9%, similar to regular human insulin. After subcutaneous administration in normal male volunteers (n=24), NovoLog was more rapidly eliminated than regular human insulin with an average apparent half-life of 81 minutes compared to 141 minutes for regular human insulin.

The effect of sex, age, obesity, ethnic origin, renal and hepatic impairment, pregnancy, or smoking, on the pharmacodynamics and pharmacokinetics of Novolog Mix 70/30 has not been studied.

Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility

Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of Novolog Mix 70/30. In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with NovoLog, the rapid-acting component of Novolog Mix 70/30, at 10, 50, and 200 U/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0 U/kg/day, based on U/body surface area, respectively). At a dose of 200 U/kg/day, NovoLog increased the incidence of mammary gland tumors in females when compared to untreated controls. The incidence of mammary tumors found with NovoLog was not significantly different from that found with regular human insulin. The relevance of these findings to humans is not known.

NovoLog was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward gene mutation test, human peripheral blood lymphocyte chromosome aberration test, in vivo micronucleus test in mice, and in ex vivo UDS test in rat liver hepatocytes.

In fertility studies in male and female rats, NovoLog at subcutaneous doses up to 200 U/kg/day (approximately 32 times the human subcutaneous dose, based on U/body surface area) had no direct adverse effects on male and female fertility, or on general reproductive performance of animals.

Animal Toxicology and/or Pharmacology

In standard biological assays in mice and rabbits, one unit of NovoLog has the same glucose-lowering effect as one unit of regular human insulin. However, the effect of Novolog Mix 70/30 is more rapid in onset compared to Novolin (human insulin) 70/30 due to its faster absorption after subcutaneous injection.

Clinical Studies Novolog Mix 70/30 versus Novolin 70/30

In a three-month, open-label trial, patients with Type 1 (n=104) or Type 2 (n=187) diabetes were treated twice daily (before breakfast and before supper) with Novolog Mix 70/30 or Novolin 70/30. Patients had received insulin for at least 24 months before the study. Oral hypoglycemic agents were not allowed within 1 month prior to the study or during the study. The small changes in HbA1c were comparable across the treatment groups (see Table 3).

Table 3: Glycemic Parameters at the End of Treatment [Mean ± SD (N subjects)] Novolog Mix 70/30 Novolin 70/30 Type 1, N=104 Fasting Blood Glucose (mg/dL) 174 ± 64 (48) 142 ± 59 (44) 1.5 Hour Post Breakfast (mg/dL) 187 ± 82 (48) 200 ± 82 (42) 1.5 Hour Post Dinner (mg/dL) 162 ± 77 (47) 171 ± 66 (41) HbA1c (%) Baseline 8.4 ± 1.2 (51) 8.5 ± 1.1 (46) HbA1c (%) Week 12 8.4 ± 1.1 (51) 8.3 ± 1.0 (47) Type 2, N=187 Fasting Blood Glucose (mg/dL) 153 ± 40 (76) 152 ± 69 (93) 1.5 Hour Post Breakfast (mg/dL) 182 ± 65 (75) 200 ± 80 (92) 1.5 Hour Post Dinner (mg/dL) 168 ± 51 (75) 191 ± 65 (93) HbA1c (%) Baseline 8.1 ± 1.2 (82) 8.2 ± 1.3 (98) HbA1c (%) Week 12 7.9 ± 1.0 (81) 8.1 ± 1.1 (96)

The significance, with respect to the long-term clinical sequelae of diabetes, of the differences in postprandial hyperglycemia between treatment groups has not been established.

Specific anti-insulin antibodies as well as cross-reacting anti-insulin antibodies were monitored in the 3-month, open-label comparator trial as well as in a long-term extension trial.

Combination Therapy: Insulin and Oral Agents in Patients with Type 2 Diabetes

Trial 1:

In a 34-week, open-label trial, insulin-na?ve patients with type 2 diabetes currently treated with 2 oral antidiabetic agents were switched to treatment with metformin and pioglitazone. During an 8-week optimization period metformin and pioglitazone were increased to 2500 mg per day and 30 or 45 mg per day, respectively. After the optimization period, subjects were randomized to receive either Novolog Mix 70/30 twice daily added on to the metformin and pioglitazone regimen or continue the current optimized metformin and pioglitazone therapy. Novolog Mix 70/30 was started at a dose of 6 IU twice daily (before breakfast and before supper). Insulin doses were titrated to a pre-meal glucose goal of 80-110 mg/dL. The total daily insulin dose at the end of the study was 56.9 ± 30.5 IU.

Table 4: Combination Therapy with Oral Agents and Insulin in Patients with Type 2 Diabetes Mellitus [Mean (SD)] Treatment duration 24-weeks

Novolog Mix 70/30 + Metformin

+ Pioglitazone Metformin + Pioglitazone HbA1c Baseline mean ± SD (n) 8.1 ± 1.0 (102) 8.1 ± 1.0 (98) End-of-study mean ± SD (n) - LOCF 6.6 ± 1.0 (93) 7.8 ± 1.2 (87) Adjusted Mean change from baseline ± SE (n)* -1.6 ± 0.1 (93) -0.3 ± 0.1 (87) Treatment difference mean ± SE* 95% CI*

-1.3 ± 0.1

(-1.6, -1.0)

Percentage of subjects reaching HbA1c <7.0% 76% 24% Percentage of subjects reaching HbA1c ?6.5% 59% 12% Fasting Blood Glucose (mg/dL) Baseline Mean ± SD (n) 173 ± 39.8 (93) 163 ± 35.4 (88) End of Study Mean ± SD (n) - LOCF 130 ± 50.0 (90) 162 ± 40.8 (84) Adjusted Mean change from baseline ± SE (n)* -43.0 ± 5.3 (90) -3.9 ± 5.3 (84) End-of-Study Blood Glucose (Plasma) (mg/dL) 2 Hour Post Breakfast 138 ± 42.8 (86) 188 ± 57.7 (74) 2 Hour Post Lunch 150 ± 41.5 (86) 176 ± 56.5 (74) 2 Hour Post Dinner 141 ± 57.8 (86) 195 ± 60.1 (74) % of patients with severe hypoglycemia** 3 0 % of patients with minor hypoglycemia** 52 3 Weight gain at end of study (kg)** 4.6 ± 4.3 (92) 0.8 ± 3.2 (86)

 *Adjusted mean per group, treatment difference, and 95% CI were obtained based on an ANCOVA model with treatment, FPG stratum, and secretagogue stratum as fixed factors and baseline HbA1c as the covariate.

**If metabolic control is improved by intensified insulin therapy, an increased risk of hypoglycemia and weight gain may occur.

 

Trial 2:

In a 28-week, open-label trial, insulin-na?ve patients with type 2 diabetes with fasting plasma glucose above 140 mg/dL currently treated with metformin ± thiazolidinedione therapy were randomized to receive either Novolog Mix 70/30 twice daily [before breakfast and before supper] or insulin glargine once daily1 (see Table 5). Novolog Mix 70/30 was started at an average dose of 5-6 IU (0.07 ± 0.03 IU/kg) twice daily (before breakfast and before supper), and bedtime insulin glargine was started at 10-12 IU (0.13 ± 0.03 IU/kg). Insulin doses were titrated weekly by decrements or increments of -2 to +6 units per injection to a pre-meal glucose goal of 80-110 mg/dL. The metformin dose was adjusted to 2550 mg/day. Approximately one-third of the patients in each group were also treated with pioglitazone (30 mg/day). Insulin secretagogues were discontinued in order to reduce the risk of hypoglycemia. Most patients were Caucasian (53%), and the mean initial weight was 90 kg.

Table 5: Combination Therapy with Oral Agents and Two Types of Insulin in Patients with Type 2 Diabetes Mellitus [Mean (SD)] Treatment duration 28-weeks NovoLog  Mix 70/30 + Metformin ± Pioglitazone Insulin Glargine + Metformin ± Pioglitazone Number of patients 117 116 HbA1c Baseline mean (%) 9.7 ± 1.5 (117) 9.8 ± 1.4 (114) End-of-study mean (± SD) 6.9 ± 1.2 (108) 7.4 ± 1.2 (114) Mean change from baseline -2.7 ± 1.6 (108) -2.4 ± 1.5 (114) Percentage of subjects reaching HbA1c <7.0% 66% 40% Total Daily Insulin Dose at end of study (U) 78 ± 40 (117) 51 ± 27 (116) % of patients with severe hypoglycemia 0 0

Aloquin Gel
Pronunciation: eye-OH-doe-KWIN-ol/AL-ohGeneric Name: Iodoquinol/AloeBrand Name: Aloquin

Boots Soothing Eye Drops

Boots Soothing Eye Drops

(Cetrimide, Hamamelis Water)

Soothing & antiseptic

10 ml e

Read all of this carton for full instructions.

Uses: A soothing and antiseptic sterile solution for the relief of minor eye irritation. It can be used to soothe eyes irritated by smoke and dust. Before you use this medicine Do not use: If you are allergic to any of the ingredients If you wear soft contact lenses

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Check the cap seal is not broken before first use. If it is, do not use the drops.

Tilt head back and hold down lower eye lid. Squeeze the bottle to put drops into the corner (lower sac) of the eye.

For use in the eyes only.

Age: Adults and children How much: One or two drops How often: Morning and night, or when you need to

If anyone accidentally swallows some: Talk to a doctor

Possible side effects

Most people will not have problems, but some may get some of these:

Red, swollen or itchy eyes (signs of allergic reaction) – if this happens stop using the drops

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton. Throw away any unused drops 28 days after first opening.

Active ingredients

These eye drops contain Cetrimide 0.01% w/v, Hamamelis Water 5% v/v.

Also contains: purified water, boric acid, borax.

PL 00014/5237

[P]

Text prepared 11/07

Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA

by

Hamol Limited Nottingham NG90 2DB

If you need more advice ask your pharmacist.

BTC16394 vE 28/02/08

Vexol

Generic Name: rimexolone (Ophthalmic route)

ri-MEX-oh-lone

Commonly used brand name(s)

In the U.S.

Vexol

Available Dosage Forms:

Suspension

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Vexol

Rimexolone belongs to the group of medicines known as corticosteroids (cortisone-like medicines). It is used to treat inflammation of the eye, which may occur following eye surgery or with certain eye problems.

This medicine is available only with your doctor's prescription.

Before Using Vexol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of rimexolone in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of rimexolone in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Bupropion Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Certain eye diseases that cause the cornea to get thin—Use of ophthalmic rimexolone could cause a hole to form (perforation) Fungus infection of the eye or Herpes infection of the eye or Virus infection of the eye or Yeast infection of the eye or Any other eye infection—Ophthalmic rimexolone may make existing infections worse or cause new infections Proper Use of Vexol

Shake the container very well before applying the eye drops.

To use:

First, wash your hands. Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye. If you think you did not get the drop of medicine into your eye properly, use another drop. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ophthalmic dosage form (eye drops): For inflammation after surgery: Adults—Use one or two drops in the affected eye four times a day beginning twenty-four hours after surgery and continuing throughout the first two weeks after surgery. Children—Use and dose must be determined by your doctor. For anterior uveitis (inflammation in the iris of the eye): Adults—Use one or two drops in the affected eye every hour, while awake, for the first week. Then use one drop in the affected eye every two hours, while awake, for the second week. Then gradually decrease the number of times the medicine is used each day according to your physician's instructions. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Vexol

An ophthalmologist (eye doctor) should examine your eyes at regular visits while you are using this medicine.

Vexol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare Blurred vision or other change in vision eye discharge, discomfort, dryness, or tearing eye redness, irritation, or pain feeling of something in the eye itching sore throat stuffy or runny nose swelling of the lining of the eyelids

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare Browache change in taste crusting in corner of eye dizziness, lightheadedness, or faintness headache increased sensitivity of eyes to light sticky sensation of eyelids unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Vexol side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Vexol resources Vexol Side Effects (in more detail)Vexol Use in Pregnancy & BreastfeedingVexol Drug InteractionsVexol Support Group0 Reviews for Vexol - Add your own review/rating Vexol Prescribing Information (FDA) Vexol Concise Consumer Information (Cerner Multum) Vexol Monograph (AHFS DI) Vexol MedFacts Consumer Leaflet (Wolters Kluwer) Compare Vexol with other medications Postoperative Ocular InflammationUveitis

Otic anesthetics

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Otic anesthetics are agents that act locally to relieve pain in the ears. Some of these agents are available with other medicines such as analgesics, decongestants, etc. They are generally available as ear drops.

See also

Medical conditions associated with otic anesthetics:

Acute Otitis ExternaEar ConditionsEar Wax ImpactionOtitis ExternaOtitis Media Drug List:Americaine-Otic-DropsAurodexRe-Benzotic-Otic-DropsDoloticOticaineOticin-Ear-DropsOtocain-DropsPramoticRx-OticTympagesicUni-Otic-Drops

Anakinra

Class: Disease-modifying Antirheumatic AgentsChemical Name: N2-l-methionyl-interleukin 1 receptor antagonist (human isoform ? reduced)Molecular Formula: C759H1186N208O232S10

Tambocor 50mg Tablets
1. Name Of The Medicinal Product

Tambocor™ 50mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains flecainide acetate 50mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

Tambocor is a potent sodium channel blocking agent for the treatment of the conditions listed below:

The effect on the JT interval is insignificant at therapeutic levels.

4.1 Therapeutic Indications

Tambocor tablets are indicated for:

a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways.

b) Paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction (see 4.4, Special warnings and special precautions for use). Arrhythmias of recent onset will respond more readily.

c) Symptomatic sustained ventricular tachycardia.

d) Premature ventricular contractions and/or non-sustained ventricular tachycardia which are causing disabling symptoms, where these are resistant to other therapy or when other treatment has not been tolerated.

Tambocor tablets can be used for the maintenance of normal rhythm following conversion by other means.

Tambocor tablets are for oral administration.

4.2 Posology And Method Of Administration

Adults: Supraventricular arrhythmias: The recommended starting dosage is 50mg twice daily and most patients will be controlled at this dose. If required the dose may be increased to a maximum of 300mg daily.

Ventricular arrhythmias: The recommended starting dosage is 100mg twice daily. The maximum daily dose is 400mg and this is normally reserved for patients of large build or where rapid control of the arrhythmia is required.

After 3-5 days it is recommended that the dosage be progressively adjusted to the lowest level which maintains control of the arrhythmia. It may be possible to reduce dosage during long-term treatment.

Children: Tambocor is not recommended in children under 12, as there is insufficient evidence of its use in this age group.

Elderly Patients: The rate of flecainide elimination from plasma may be reduced in elderly people. This should be taken into consideration when making dose adjustments.

Plasma levels: Based on PVC suppression, it appears that plasma levels of 200-1000 ng/ml may be needed to obtain the maximum therapeutic effect. Plasma levels above 700-1000 ng/ml are associated with increased likelihood of adverse experiences.

Dosage in impaired renal function: In patients with significant renal impairment (creatinine clearance of 35ml/min/1.73 sq.m. or less) the maximum initial dosage should be 100mg daily (or 50mg twice daily).

When used in such patients, frequent plasma level monitoring is strongly recommended.

It is recommended that intravenous treatment with Tambocor should be administered in hospitals.

Treatment with oral Tambocor should be under direct hospital or specialist supervision for patients with:

a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways

b) Paroxysmal atrial fibrillation in patients with disabling symptoms.

Treatment for patients with other indications should continue to be initiated in hospital.

4.3 Contraindications

Tambocor is contra-indicated in cardiac failure and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia.

It is also contra-indicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm, and in patients with haemodynamically significant valvular heart disease.

Unless pacing rescue is available, Tambocor should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrio-ventricular block, bundle branch block or distal block.

4.4 Special Warnings And Precautions For Use

Electrolyte disturbances should be corrected before using Tambocor.

Since flecainide elimination from the plasma can be markedly slower in patients with significant hepatic impairment, flecainide should not be used in such patients unless the potential benefits clearly outweigh the risks. Plasma level monitoring is strongly recommended in these circumstances.

Tambocor is known to increase endocardial pacing thresholds - ie to decrease endocardial pacing sensitivity. This effect is reversible and is more marked on the acute pacing threshold than on the chronic. Tambocor should thus be used with caution in all patients with permanent pacemakers or temporary pacing electrodes, and should not be administered to patients with existing poor thresholds or non-programmable pacemakers unless suitable pacing rescue is available.

Generally, a doubling of either pulse width or voltage is sufficient to regain capture, but it may be difficult to obtain ventricular thresholds less than 1 Volt at initial implantation in the presence of Tambocor.

The minor negative inotropic effect of flecainide may assume importance in patients predisposed to cardiac failure. Difficulty has been experienced in defibrillating some patients. Most of the cases reported had pre-existing heart disease with cardiac enlargement, a history of myocardial infarction, arterio-sclerotic heart disease and cardiac failure.

Tambocor should be avoided in patients with structural organic heart disease or abnormal left ventricular function.

Tambocor should be used with caution in patients with acute onset of atrial fibrillation following cardiac surgery.

In a large scale, placebo-controlled clinical trial in post-myocardial infarction patients with asymptomatic ventricular arrhythmia, oral flecainide was associated with a 2.2 fold higher incidence of mortality or non-fatal cardiac arrest as compared with its matching placebo. In that same study, an even higher incidence of mortality was observed in flecainide-treated patients with more than one myocardial infarction. Comparable placebo-controlled clinical trials have not been done to determine if flecainide is associated with higher risk of mortality in other patient groups.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Flecainide is a class I anti-arrhythmic and interactions are possible with other anti-arrhythmic drugs where additive effects may occur or where drugs interfere with the metabolism of flecainide. The following known categories of drugs may intereact with flecainide:

Cardiac glycosides; Flecainide can cause the plasma digoxin level to rise by about 15%, which is unlikely to be of clinical significance for patients with plasma levels in the therapeutic range. It is recommended that the digoxin plasma level in digitalised patients should be measured not less than six hours after any digoxin dose, before or after administration of flecainide.

Class II anti-arrhythmics; the possibility of additive negative inotropic effects of beta-blockers, and other cardiac depressants such as verapamil, with flecainide should be recognised.

Class III anti-arrhythmics; when flecainide is given in the presence of amiodarone, the usual flecainide dosage should be reduced by 50% and the patient monitored closely for adverse effects. Plasma level monitoring is strongly recommended in these circumstances

Class IV anti-arrhythmics; use of flecainide with other sodium channel blockers is not recommended.

Anti-depressants; fluoxetine increases plasma flecainide concentration; increased risk of arrhythmias with tricyclics; manufacturer of reboxetine advises caution.

Anti-epileptics; limited data in patients receiving known enzyme inducers (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.

Anti-psychotics: clozapine– increased risk of arrhythmias

Anti-histamines; increased risk of ventricular arrhythmias with mizolastine and terfenadine (avoid concomitant use)

Anti-malarials: quinine increases plasma concentration of flecainide.

Antivirals: plasma concentration increased by ritonavir, lopinavar and indinavir (increased risk of ventricular arrhythmias (avoid concomitant use)

Diuretics: Class effect due to hypokalaemia giving rise to cardiac toxicity.

Ulcer healing drugs: cimetidine inhibits metabolism of flecainide. In healthy subjects receiving cimetidine (1g daily) for one week, plasma flecainide levels increased by about 30% and the half-life increased by about 10%.

Anti-smoking aids: Co-administration of bupropion with drugs that are metabolized by CYP2D6 isoenzyme including flecainide, should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medication. If bupropion is added to the treatment regimen of a patient already receiving flecainide, the need to decrease the dose of the original medication should be considered.

Treatment with Tambocor is compatible with use of oral anti-coagulants.

4.6 Pregnancy And Lactation

There is no evidence as to drug safety in human pregnancy. In New Zealand White rabbits high doses of flecainide caused some foetal abnormalities, but these effects were not seen in Dutch Belted rabbits or rats. The relevance of these findings to humans has not been established. Data have shown that flecainide crosses the placenta to the foetus in patients taking flecainide during pregnancy.

Flecainide is excreted in human milk and appears in concentrations which reflect those in maternal blood. The risk of adverse effects to the nursing infant is very small.

4.7 Effects On Ability To Drive And Use Machines

No effect.

4.8 Undesirable Effects

Body as a Whole: Asthenia, fatigue, fever,oedema.

Cardiovascular: Pro-arrhythmic effects occur but are most likely in patients with structural heart disease and/or significant left ventricular impairment.

In patients with atrial flutter the use of Tambocor has been associated with

1:1 AV conduction following initial atrial slowing with resultant ventricular acceleration. This has been seen most commonly following the use of the injection for acute conversion. This effect is usually short lived and abates quickly following cessation of therapy.

The following adverse effects have also been reported.

AV block-second-degree and third degree, bradycardia, cardiac failure/congestive cardiac failure, chest pain, hypotension, myocardial infarction, palpitation, sinus pause or arrest and tachycardia (AT or VT).

Skin and Appendages: A range of allergic skin reactions have been reported including rashes, alopecia and rare but serious reports of urticaria. There have also been isolated cases of photosensitivity and rash.

Immune System: A small number of cases of increases in anti-nuclear antibodies have been reported, with and without systemic inflammatory involvement.

Haematological: Reductions in red blood cells, white blood cells and platelets have been occasionally reported. These changes are usually mild.

Psychiatric: Rarely, hallucinations, depression, confusion, amnesia, anxiety and insomnia have been reported.

Gastrointestinal: Occasionally nausea and vomiting. The following have also been reported: abdominal pain, anorexia, constipation, diarrhoea, dyspepsia and flatulence (bloating)

Liver and Bilary System: A number of cases of elevated liver enzymes and jaundice have been reported in association with Tambocor treatment. So far this has always been reversible on stopping treatment. Hepatic dysfunction has also been reported.

Neurological: Most commonly giddiness, dizziness and lightheadedness which are usually transient. Rare instances of dyskinesia have been reported, which have improved on withdrawal of flecainide therapy. Rare instances of convulsions, and during long term therapy a few cases of peripheral neuropathy, paraesthesia and ataxia have been reported.There also have been reports of flushing, headache, hypoaesthesia, increased sweating, somnolence, syncope, tinnitus, tremor and vertigo.

Ophthalmological: Visual disturbances, such as double vision and blurring of vision may occur but these are usually transient and disappear upon continuing or reducing the dosage.

Extremely rare cases of corneal deposits have also been reported.

Respiratory: Dyspnoea and rare cases of pneumonitis have been reported.

4.9 Overdose

Overdosage with flecainide is a potentially life threatening medical emergency. No specific antidote is known. There is no known way of rapidly removing flecainide from the system, but forced acid diuresis may theoretically be helpful. Neither dialysis nor haemoperfusion is helpful and injections of anticholinergics are not recommended.

Treatment may include therapy with an inotropic agent, intravenous calcium, giving circulatory assistance (eg balloon pumping), mechanically assisting respiration, or temporarily inserting a transvenous pacemaker if there are severe conduction disturbances or the patient's left ventricular function is otherwise compromised.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Tambocor is a Class 1 anti-arrhythmic (local anaesthetic) agent.

Tambocor slows conduction through the heart, having its greatest effect on His Bundle conduction. It also acts selectively to increase anterograde and particularly retrograde accessory pathway refractoriness. Its actions may be reflected in the ECG by prolongation of the PR interval and widening of the QRS complex. The effect on the JT interval is insignificant.

5.2 Pharmacokinetic Properties

Oral administration of flecainide results in extensive absorption, with bioavailability approaching 90 to 95%. Flecainide does not appear to undergo significant hepatic first-pass metabolism. In patients, 200 to 600 mg flecainide daily produced plasma concentrations within the therapeutic range of 200-1000 µg/L. Protein binding of flecainide is within the range 32 to 58%.

Recovery of unchanged flecainide in urine of healthy subjects was approximately 42% of a 200mg oral dose, whilst the two major metabolites (Meta-O-Dealkylated and Dealkylated Lactam Metabolites) accounted for a further 14% each. The elimination half-life was 12 to 27 hours.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars 6.1 List Of Excipients

Pregelatinised Starch, USNF

Croscarmellose Sodium, USNF

Microcrystalline Cellulose, Ph Eur

Hydrogenated Vegetable Oil, USNF

Magnesium Stearate, Ph Eur

6.2 Incompatibilities

None known

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

Do not store above 30°C. Keep container in the outer carton.

6.5 Nature And Contents Of Container

UPVC/PVDC blister packs containing 60 tablets

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

United Kingdom

8. Marketing Authorisation Number(S)

PL 15142/0078

9. Date Of First Authorisation/Renewal Of The Authorisation

22 May 1997/ 16 March 2001

10. Date Of Revision Of The Text

13th July 2010

Xismox 60 XL Prolonged Release Tablets
1. Name Of The Medicinal Product

ISIB 60 XL Prolonged Release Tablets

and

CIBRAL 60 XL Prolonged Release Tablets

and

XISMOX 60 XL Prolonged Release Tablets

2. Qualitative And Quantitative Composition

Isosorbide mononitrate 60.0 mg

For excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged Release Tablets

Light yellow, biconvex, oval-shaped, prolonged release tablets, scored on both sides and marked "DX 31" on one side.

4. Clinical Particulars 4.1 Therapeutic Indications

Prophylaxis of angina pectoris

4.2 Posology And Method Of Administration

Adults: The recommended dose is one 60 mg tablet once daily to be taken in the morning. The dose may be increased to 120 mg (two tablets) daily, both to be taken once daily in the morning. The dose can be titrated, by initiating treatment with 30 mg (half tablet) for the first 2-4 days to minimize the possibility of headache.

Children: The safety and efficacy in children has not been established.

Elderly: No evidence of a need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.

There is a risk of tolerance developing when nitrate therapy is given. For this reason it is important that the tablets are taken once a day to achieve an interval with low nitrate concentration, thereby reducing the risk of tolerance development.

When necessary the product may be used in combination with beta-adrenoreceptor blockers and calcium antagonists. Dose adjustments of either class of agent may be necessary.

The tablets must not be chewed or crushed. They should be swallowed with half a glass of water.

4.3 Contraindications

Hypersensitivity to isosorbide mononitrate, or to any of the excipients.

Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contra-indicated.

Isosorbide mononitrate is contraindicated in constrictive pericarditis and pericardial tamponade.

4.4 Special Warnings And Precautions For Use

Use with extreme caution in hypotension with or without other signs of shock and in cases of cerebrovascular insufficiency.

Other special warnings and precautions with Isosorbide mononitrate:

Significant aortic or mitral valve stenosis.

Hypertrophic obstructive cardiomyopathy.

Anaemia. Hypoxaemia, Hypothyroidism.

The tablets are not indicated for relief of acute angina attacks.

Patients with rare hereditary problems of fructose or galactose intolerance, the Lapp lactase deficiency, sucrase-isomaltase insufficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Isosorbide mononitrate may act as a physiological antagonist to noradrenaline, acetylcholine, histamine and many other agents. The effect of anti-hypertensive drugs may be enhanced. Alcohol may enhance the hypotensive effects of isosorbide mononitrate.

The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil.

4.6 Pregnancy And Lactation

The tablets should not be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Patients experiencing headache or dizziness following initial treatment with the tablets should become stabilised on treatment before driving or using machines.

4.8 Undesirable Effects

Most of the adverse reactions are pharmacodynamically mediated and dose dependent. Headache may occur when treatment is initiated but usually disappears after continued treatment. Hypotension with symptoms such as dizziness and nausea has occasionally been reported. These symptoms generally disappear during long-term treatment. Less common are vomiting and diarrhoea. Uncommon is fainting.

Skin rashes (dry rash, exfoliative dermatitis) and pruritus have been reported rarely with isosorbide mononitrate. Myalgia has been reported very rarely.

4.9 Overdose

Symptoms: Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure. Very large doses may give rise to methaemoglobinaemia (Very rare).

Treatment: Induction of emesis, activated charcoal. In case of pronounced hypotension the patient should first be placed in the supine position with legs raised. If necessary, fluid should be administered intravenously. (In cases of cyanosis as a result of methaemoglobinaemia, methyl thionine (methylene blue) 1 -2mg/Kg, slow intravenous delivery). Expert advice should be sought.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Organic nitrates, ATC code: C01D A14.

Isosorbide mononitrate is an organic nitrate, the major active metabolite of isosorbide dinitrate and an active vasodilator in its own right. The mechanism of action of Isosorbide mononitrate, like other organic nitrates, is believed to involve peripheral vasodilation, both venous and arterial. Maximal venous dilatation is usually achieved with lower doses of the nitrate, while higher doses cause progressive dilatation of the arterial vasculature. Nitrates thus lead to pooling of blood in the veins and reduced left ventricular and diastolic pressure. As arterial vascular resistance is also decreased, arterial blood pressure is reduced. Isosorbide mononitrate is an effective antianginal agent because it improves exertional angina by reducing myocardial oxygen demand, secondary to reduced preload and afterload. Organic nitrates release nitric oxide (NO), which induces protein phosphorylations, finally resulting in vascular smooth muscle relaxation.

In comparison to an immediate release product taken on a multiple dose basis, this prolonged release product has the advantage of both lowering the incidence of tolerance and increasing patient compliance.

5.2 Pharmacokinetic Properties

Isosorbide mononitrate is completely absorbed after oral administration. The absorption is not affected by simultaneous food intake. Contrary to many other nitrates, Isosorbide mononitrate is not subject to first pass metabolism and its oral bioavailability is therefore close to 100%. This feature probably contributes to the relatively small intersubject variability in plasma levels that are achieved following ingestion of the drug. Peak plasma concentrations of Isosorbide mononitrate after oral ingestion of a prolonged release tablet usually occur within 3.1-4.5 hours. Isosorbide mononitrate's volume of distribution is about 0.6 litres/kg, and its plasma protein binding is negligible (about 4%). Isosorbide mononitrate is metabolised to form several inactive compounds. Elimination is primarily by denitration and conjugation in the liver. The metabolites are excreted mainly via the kidneys. About 2% of the dose is excreted intact via the kidneys. The half-life of Isosorbide mononitrate in the plasma of healthy volunteers as well as in most patients is about 6.5 hours after administration of prolonged release tablets. Neither renal nor hepatic disease influence the pharmacokinetic of isosorbide mononitrate. The tablets are a prolonged release formulation. The active substance is released independently of pH.

5.3 Preclinical Safety Data

Isosorbide mononitrate is a well-established drug for which there is adequate published safety data.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Hypromellose 2208

Lactose monohydrate

Compressible Sugar (composed of Sucrose and Maltodextrin)

Magnesium stearate

Colloidal anhydrous silica

Iron oxide yellow.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life 5 years 6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Blister pack PVDC- or ACLAR-coated-PVC/Aluminium 28, 30 or 98 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Dexcel-Pharma Ltd.

1 Cottesbrooke Park

Heartlands Business Park, Daventry

Northamptonshire NN1 1 8YL, England

8. Marketing Authorisation Number(S)

PL 14017/0096

9. Date Of First Authorisation/Renewal Of The Authorisation 27th October 2004. 10. Date Of Revision Of The Text

29 October 2009

Poly-Pred Drops
Pronunciation: NEE-oh-MYE-sin/POL-ee-MIX-in/pred-NIS-oh-loneGeneric Name: Neomycin/Polymyxin B/PrednisoloneBrand Name: Poly-Pred

Pemirolast
Pronunciation: pem-EER-oh-lastGeneric Name: PemirolastBrand Name: Alamast

Xifaxan
Pronunciation: rif-AX-i-minGeneric Name: RifaximinBrand Name: Xifaxan

← Previous 1 2 3 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 ... 248 Next →