Flebogamma 5% solution for infusion
1. Name Of The Medicinal Product

Flebogamma® 5%.

Solution for infusion.

2. Qualitative And Quantitative Composition

Human normal immunoglobulin (IVIg)

The percentage of IgG subclasses is approximately 68.7% IgG1, 25.9% IgG2, 3.7% IgG3 and 1.78% IgG4.

Human protein content is 50 g/l of which at least 97% is IgG.

IgA content is lower than 0.05 mg/ml.

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for infusion

4. Clinical Particulars 4.1 Therapeutic Indications

Flebogamma® 5% is indicated for:

Replacement therapy in:

Primary immunodeficiency syndromes such as:

- congenital agammaglobulinaemia and hypogammaglobulinaemia

- common variable immunodeficiency

- severe combined immunodeficiency

- Wiskott Aldrich syndrome

Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Children with congenital AIDS and recurrent infections.

Immunomodulation

Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.

Guillain Barr? Syndrome.

Kawasaki disease.

Allogeneic bone marrow transplantation.

4.2 Posology And Method Of Administration

4.2.1. Posology

The dose and dosage regimen is dependent on the indication.

In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.

Replacement therapy in primary immunodeficiency syndromes

The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4-6 g/l. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4-0.8 g/kg followed by at least 0.2 g/kg every three weeks.

The dose required to achieve a trough level of 6 g/l is of the order of 0.2-0.8 g/kg/month. The dosage interval when steady state has been reached varies from 2-4 weeks.

Trough levels should be measured in order to adjust the dose and dosage interval.

Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections

The recommended dose is 0.2-0.4 g/kg every three to four weeks.

Idiopathic Thrombocytopenic Purpura

For the treatment of an acute episode, 0.8-1 g/kg on day one, which may be repeated once within 3 days, or 0.4 g/kg daily for two to five days. The treatment can be repeated if relapse occurs.

Guillain Barr? syndrome

0.4 g/kg/day for 3 to 7 days.

Experience in children is limited.

Kawasaki Disease

1.6-2.0 g/kg should be administered in divided doses over two to five days or 2.0 g/kg as a single dose.

Patients should receive concomitant treatment with acetylsalicylic acid.

Allogeneic Bone Marrow Transplantation

Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplant.

For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. The starting dose is normally 0.5 g/kg/week, starting seven days before transplantation and for up to 3 months after transplantation.

In case of persistent lack of antibody production, dosage of 0.5 g/kg/month is recommended until antibody level returns to normal.

The dosage recommendations are summarised in the following table:

Indication

Dose

Frequency

Replacement therapy in primary immunodeficiency

- starting dose:

0.4 – 0.8 g/kg

- thereafter:

0.2 – 0.8 g/kg

 

 

every 2 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/l

Replacement therapy in secondary immunodeficiency

0.2 – 0.4 g/kg

every 3 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/l

Children with AIDS

0.2 – 0.4 g/kg

every 3 – 4 weeks

Immunomodulation:

   

Idiopathic Thrombocytopenic Purpura

0.8 – 1 g/kg

or

0.4 g/kg/d

on day 1, possibly repeated once within 3 days

 

for 2 – 5 days

Guillain Barr? syndrome

0.4 g/kg/d

for 3 – 7 days

Kawasaki disease

1.6 – 2g/kg

or

2g/kg

in several doses for 2 – 5 days in association with acetylsalicylic acid

in one dose in association with acetylsalicylic acid

Allogeneic bone marrow transplantation:

   

-treatment of infections and prophylaxis of graft versus host disease

0.5 g/kg

every week from day –7 up to 3 months after transplantation

-persistent lack of antibody production

0.5 g/kg

every month until antibody levels return to normal

4.2.2. Method of administration

Flebogamma® 5% should be infused intravenously at an initial rate of 0.6-1.2 ml/kg/hour for the first thirty minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 4.2 ml/kg/hour.

4.3 Contraindications

Hypersensitivity to any of the components.

(See special warnings about excipients, section 4.4.).

Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency, when the patient has antibodies against IgA.

4.4 Special Warnings And Precautions For Use

Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under “4.2. Posology and method of administration” must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.

Certain adverse reactions may occur more frequently:

- in case of high rate of infusion,

- in patients with hypo- or agammaglobulinemia with or without IgA deficiency,

- in patients who receive human normal immunoglobulin for the first time, or in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.

True hypersensitivity reactions are rare. They can occur in the very seldom cases of IgA deficiency with anti-IgA antibodies.

Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.

Potential complications can often be avoided by ensuring:

- that patients are not sensitive to human normal immunoglobulin by first injecting the product slowly at an initial rate of 0.6-1.2 ml/kg/hour,

- that patients are carefully monitored for any symptoms throughout the infusion period. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.

There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients. Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with diseases which increase blood viscosity).

Cases of acute renal failure have been reported in patients receiving IVIg therapy. In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant nephrotoxic medicinal products or age over 65.

In case of renal impairment, IVIg discontinuation should be considered.

While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number. Flebogamma® 5% does not contain sucrose. In patients at risk, the use of IVIg products that do not contain sucrose may be considered.

In patients at risk for acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.

In all patients, IVIg administration requires:

- adequate hydration prior to the initiation of the infusion of IVIg

- monitoring of urine output

- monitoring of serum creatinine levels

- avoidance of concomitant use of loop diuretics

In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the side effect.

In case of shock, standard medical treatment for shock should be implemented.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV.

The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.

There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.

It is strongly recommended that every time that Flebogamma® 5% is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Special warnings about excipients: this medicinal product contains 5 g of sorbitol per 100 ml as excipient. In case of fructose hereditary intolerance this product should not be used.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Live attenuated virus vaccines

Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore patients receiving measles vaccine should have their antibody status checked.

Interference with serological testing

After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patients blood may result in misleading positive results in serological testing.

Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D, may interfere with some serological tests for red cell allo-antibodies (e.g. Coombs test), reticulocyte count and haptoglobin.

4.6 Pregnancy And Lactation

The safety of Flebogamma® 5% for use in human pregnancy has not been established and therefore should only be given with caution to pregnant women and breast feeding mothers. Human immunoglobulins are excreted into the milk.

Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and neonate are to be expected.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.

Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.

Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/haemolysis and rare cases of transient cutaneous reactions, have been observed with human normal immunoglobulin.

Increase in serum creatinine level and/or acute renal failure have been observed.

Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses.

For safety with respect to transmissible agents, see 4.4.

4.9 Overdose

Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.

Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donors. It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.

The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.

5.2 Pharmacokinetic Properties

Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.

Human normal immunoglobulin has a half-life of 46 days (range 33-65 days). This half-life may vary from patient to patient, in particular in primary immunodeficiency.

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

- 5% D-sorbitol

- Water for Injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products or intravenous fluids. It should be administered by a separate intravenous line.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Flebogamma® 5% should be stored below 25 °C and protected from light. The contents must not be frozen.

Do not use after expiry date.

6.5 Nature And Contents Of Container

Flebogamma® 5% is supplied in type II glass vials containing 10 ml, 50 ml, 100 ml and 200 ml of solution.

6.6 Special Precautions For Disposal And Other Handling

The product should be brought to room or body temperature before use.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vall?s

08150 Barcelona - SPAIN

8. Marketing Authorisation Number(S)

PL 12930/0007

9. Date Of First Authorisation/Renewal Of The Authorisation

08/11/2005

10. Date Of Revision Of The Text

15/02/2006

Anemia, Megaloblastic Medications

Definition of Anemia, Megaloblastic: Megaloblastic anemia is a blood disorder characterized by anemia, with red blood cells that are larger than normal, usually resulting from a deficiency of folic acid or of vitamin B-12.

Drugs associated with Anemia, Megaloblastic

The following drugs and medications are in some way related to, or used in the treatment of Anemia, Megaloblastic. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Anemia, MegaloblasticB12 Nutritional Deficiency (10 drugs) Folic Acid Deficiency (5 drugs) Folic Acid/Cyanocobalamin Deficiency (0 drugs) Pernicious Anemia (21 drugs in 2 topics) Learn more about Anemia, Megaloblastic

Medical Encyclopedia:

Megaloblastic anemia Drug List:Folacin-800Wellcovorin

Pravachol

Generic Name: Pravastatin SodiumClass: HMG-CoA Reductase InhibitorsVA Class: CV350

Pentothal
thiopental sodium Dosage Form: injection, powder, for solutionPentothal™

THIOPENTAL SODIUM FOR INJECTION

CIII

Rx only

Pentothal Description

Pentothal (Thiopental Sodium for Injection) is a thiobarbiturate, the sulfur analogue of sodium pentobarbital.

The drug is prepared as a sterile powder and after reconstitution with an appropriate diluent is administered by the intravenous route.

Pentothal is chemically designated sodium 5-ethyl-5-(1-methylbutyl)-2-thiobarbiturate and has the following structural formula:

Fluphenazine Elixir
Dosage Form: elixirFluphenazine Hydrochloride

Heparin sodium 100 IU / ml I.V. flush solution (Leo Laboratories Ltd)
1. Name Of The Medicinal Product

HEPARIN SODIUM 100 IU/ml I.V. FLUSH SOLUTION

2. Qualitative And Quantitative Composition

Heparin sodium Ph. Eur. 100 IU/ml

3. Pharmaceutical Form

Solution for Injection.

4. Clinical Particulars 4.1 Therapeutic Indications

To maintain the patency of in-dwelling intravenous lines. It is not recommended for therapeutic use.

4.2 Posology And Method Of Administration

For routine use, 2 ml containing 200 IU of heparin should be administered into the catheter/cannula every 4-8 hours or as required.

4.3 Contraindications

Known hypersensitivity to constituents.

Current or history of heparin induced thrombocytopenia.

Heparin Sodium 100 IU/ml i.v. flush solution contains 10 mg/ml of the preservative benzyl alcohol. This formulation must not be given to premature babies or neonates.

4.4 Special Warnings And Precautions For Use

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving regular and repeated use of heparin flush solutions for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

Heparin Sodium 100 IU/ml i.v. flush solution should be used with caution in patients with hypersensitivity to low molecular weight heparin.

Heparin Sodium 100 IU/ml i.v. flush solution contains the preservative benzyl alcohol 10mg/ml. This product should be administered with caution to infants and children up to 3 years old, as there is a risk that benzyl alcohol may cause toxic and allergic reactions (anaphylactoid) in this age group (see also section 4.3 for premature babies or neonates).

Heparin Sodium 100 IU/ml i.v. flush solution contains esters of parahydroxybenzoates as a preservative system. These may cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

For incompatibilities with other medicinal products see Section 6.2.

When an indwelling device is used for repeated withdrawal of blood samples for laboratory analyses and the presence of heparin or saline is likely to interfere with or alter the results of the tests, the in situ heparin flush solution should be cleared from the device by aspirating and discarding a volume of solution equivalent to that of the indwelling venipuncture device before the desired blood sample is taken.

4.6 Pregnancy And Lactation

The dose of heparin used would not be expected to constitute a hazard. However, as benzyl alcohol may cross the placenta, the use of Heparin Sodium 100 IU/ml i.v. flush solution containing benzyl alcohol should be avoided during pregnancy.

Heparin does not cross the placental barrier and is not excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Heparin has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

When used as recommended, the low dose of heparin reaching the blood is unlikely to have any systemic effects. However, heparin may cause thrombocytopenia and hypersensitivity reactions.

Local irritation may occur if inadvertently injected subcutaneously.

4.9 Overdose

An overdose is unlikely to occur. Bleeding is the main sign of overdose with heparin. As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages. In case of severe haemorrhages heparin may be neutralised with protamine sulphate injected slowly intravenously. One mg of protamine sulphate neutralises approximately 100 IU of heparin. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and the dose administered.

It is important to avoid overdosage of protamine sulphate because protamine sulphate itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50 mg. Intravenous injection of protamine sulphate may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Heparin is a naturally occurring anticoagulant which prevents the coagulation of blood in-vivo and in-vitro. It potentiates the inhibition of several activated coagulation factors, including thrombin and factor X.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl alcohol,

Methylparahydroxybenzoate,

Propylparahydroxybenzoate,

Sodium citrate,

Sodium chloride,

Water for Injections.

6.2 Incompatibilities

This product is compatible with normal saline. Heparin has been reported to be incompatible in aqueous solution with certain substances, e.g. some antibiotics, hydrocortisone, phenothiazines, narcotic analgesics and antihistamines.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25?C.

6.5 Nature And Contents Of Container

10 x 2 ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0057

9. Date Of First Authorisation/Renewal Of The Authorisation

23 October 1978/16 January 1995

10. Date Of Revision Of The Text

November 2007

LEGAL CATEGORY

POM

Cytoxan Lyophilized oral/injection

Generic Name: cyclophosphamide (oral/injection) (sye kloe FOSS fah mide) Brand Names: Cytoxan, Cytoxan Lyophilized, Neosar

What is cyclophosphamide?

Cyclophosphamide is a cancer (chemotherapeutic) medication. Cyclophosphamide interferes with the growth of cancer cells and slows their growth and spread in the body.

Cyclophosphamide is used to treat several types of cancer. Cyclophosphamide is also used to treat certain cases of nephrotic syndrome (kidney disease) in children.

Cyclophosphamide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about cyclophosphamide?

Cyclophosphamide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of cyclophosphamide including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); bladder problems; and others. Talk to your doctor about the possible side effects from treatment with cyclophosphamide.

In some cases, secondary cancers have been reported to occur during and following treatment with cyclophosphamide. Talk to your doctor about the risks and benefits of this medication.

What should I discuss with my healthcare provider before taking cyclophosphamide?

Before taking cyclophosphamide, tell your doctor if you

have an infection or have had recent vaccinations;

have a low level of white blood cells or platelets (detected by blood tests);

have bone marrow problems;

have been previously treated with x-ray therapy;

have been previously treated with other chemotherapy medicines (i.e., Alkeran, CeeNU, Leukeran, Myleran, and others);

have had your adrenal glands removed;

need to have surgery;

have any unhealed wounds;

have a history of heart disease;

have liver disease; or have kidney disease.

You may not be able to take cyclophosphamide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Cyclophosphamide is in the FDA pregnancy category D. This means that cyclophosphamide is known to be harmful to an unborn baby. Cyclophosphamide may also affect egg production in women and sperm production in men. Do not take cyclophosphamide without first talking to your doctor if you are pregnant or could become pregnant during treatment. Use of cyclophosphamide by the father prior to conception has also been associated with birth defects. Contraceptive measures are recommended during treatment with cyclophosphamide for both men and women. Cyclophosphamide passes into breast milk and may harm a nursing infant. Do not take cyclophosphamide without first talking to your doctor if you are breast feeding a baby. How should I take cyclophosphamide?

Take cyclophosphamide exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse or pharmacist to explain them to you.

Take each oral dose with a large glass of water.

To avoid urinary bladder irritation during treatment with either oral or injectable cyclophosphamide, drink plenty of fluid during treatment and for 48 hours following treatment, usually 7 to 12 cups (3 quarts) per day, and empty your bladder frequently, every 2 to 3 hours including once during the night.

Taking oral cyclophosphamide on an empty stomach is preferable. If severe stomach upset occurs, take cyclophosphamide with food. Continue to take cyclophosphamide even if nausea and vomiting occurs. Do not stop taking the medicine without first talking to your doctor. Check with your doctor if vomiting occurs shortly after taking a dose of cyclophosphamide. Your doctor may want you to take another dose, but do not do this without checking with your doctor first.

If you are taking a liquid form of cyclophosphamide by mouth, use a dose measuring spoon or cup to ensure that you get the correct dose.

Injectable cyclophosphamide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with cyclophosphamide depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with cyclophosphamide to monitor progress and side effects.

Store cyclophosphamide oral tablets at or below 77 degrees Fahrenheit (25 degrees Celsius). Brief exposures to 86 degrees Fahrenheit (30 degrees Celsius) are permitted but the tablets should be protected from temperatures above 86 degrees Fahrenheit. Your healthcare provider will store cyclophosphamide injection as directed by the manufacturer. If you are storing cyclophosphamide injection at home, follow the directions provided by your healthcare provider. Store cyclophosphamide oral liquid in a glass container in the refrigerator for up to 14 days. What happens if I miss a dose?

Take the missed oral dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication.

Contact your doctor if you miss a dose of cyclophosphamide injection.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a cyclophosphamide overdose may include decreased bone marrow function, infection, and heart problems.

What should I avoid while taking cyclophosphamide?

Cyclophosphamide can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.

Cyclophosphamide side effects If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);

blood in the urine;

black or tarry stools;

painful or difficult urination;

signs of infection such as fever; chills, or sore throat;

jaundice (yellowing of the skin or eyes);

lower back or side pain;

chest pain, difficulty breathing, or swelling;

unusual bleeding or bruising; or

changes in bone marrow function (detected by blood tests).

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience

nausea, vomiting, or decreased appetite;

mouth sores;

abdominal pain;

diarrhea;

temporary hair loss;

temporary or permanent sterility;

rash;

changes in skin color; or

changes in nails.

In some cases, secondary cancers have been reported to occur during and following treatment with cyclophosphamide. Talk to your doctor about the risks and benefits of this medication.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect cyclophosphamide?

Before taking cyclophosphamide, tell your doctor if you are taking any other medicines, especially any of the following:

phenobarbital (Luminal, Solfoton);

allopurinol (Zyloprim);

digoxin (Lanoxin);

warfarin (Coumadin);

a thiazide diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Esidrix, Microzide, Oretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others; or

another chemotherapy medicine.

You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Do not receive "live" vaccines during treatment with cyclophosphamide. Administration of a live vaccine may be dangerous during treatment with cyclophosphamide.

Other drugs may interact with cyclophosphamide. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with cyclophosphamide.

More Cytoxan Lyophilized resources Cytoxan Lyophilized Side Effects (in more detail)Cytoxan Lyophilized Use in Pregnancy & BreastfeedingCytoxan Lyophilized Drug InteractionsCytoxan Lyophilized Support Group0 Reviews for Cytoxan Lyophilized - Add your own review/rating Compare Cytoxan Lyophilized with other medications Acute Lymphocytic LeukemiaAcute Nonlymphocytic LeukemiaBladder CancerBrain TumorBreast CancerCancerCervical CancerChronic Lymphocytic LeukemiaChronic Myelogenous LeukemiaCogan's SyndromeDermatomyositisEndometrial CancerEwing's SarcomaHistiocytosisHodgkin's LymphomaIgA NephropathyMultiple MyelomaMultiple SclerosisMycosis FungoidesNephrotic SyndromeNeuroblastomaNon-Hodgkin's LymphomaNon-Small Cell Lung CancerOrgan Transplant, Rejection ProphylaxisOsteosarcomaOvarian CancerProstate CancerRheumatoid ArthritisSmall Cell Lung CancerSystemic Lupus ErythematosusSystemic SclerosisTesticular CancerWegener's GranulomatosusWilms' Tumor Where can I get more information? Your pharmacist has additional information about cyclophosphamide written for health professionals that you may read.

See also: Cytoxan Lyophilized side effects (in more detail)

Norpace CR Sustained-Release Capsules
Pronunciation: dye-soe-PEER-a-mideGeneric Name: DisopyramideBrand Name: Norpace CR

Adrenal cortical steroids

Adrenal cortical steroids or corticosteroids are hormones synthesized by the adrenal cortex. There are two types of corticosteroids, glucocorticoids and mineralocorticoids.

Glucocorticoids e.g. cortisol and cortisone, are essential for the utilization of carbohydrate, fat and protein by the body and for normal response to stress. Naturally occurring and synthetic glucocorticoids have very powerful anti-inflammatory effects and are used to treat conditions that involve inflammation. They also decrease the body

See alsocorticotropinglucocorticoidsmineralocorticoids Drug List:

Twinject

Generic Name: epinephrine (Injection route)

ep-i-NEF-rin

Commonly used brand name(s)

In the U.S.

Adrenaclick Adrenalin Adrenalin Chloride Epipen Epipen Jr Twinject

Available Dosage Forms:

Injectable Solution

Therapeutic Class: Anaphylaxis Agent

Pharmacologic Class: Adrenergic

Chemical Class: Alkylarylamine

Uses For Twinject

Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.

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

Before Using Twinject

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

No information is available on the relationship of age to the effects of epinephrine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of epinephrine injection in geriatric patients. However, elderly patients are more likely to have age-related heart disease which may require caution in patients receiving epinephrine injection.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dihydroergotamine Isocarboxazid Linezolid Phenelzine Tranylcypromine

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.

Amitriptyline Amoxapine Bucindolol Carteolol Carvedilol Clomipramine Desipramine Dilevalol Dothiepin Doxepin Entacapone Halothane Imipramine Levobunolol Lofepramine Metipranolol Nadolol Nortriptyline Opipramol Oxprenolol Penbutolol Pindolol Propranolol Protriptyline Rasagiline Sotalol Tertatolol Timolol Trimipramine

Using this medicine 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.

Labetalol 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:

Angina pectoris (severe chest pain) or Blood vessel problems or Diabetes mellitus (sugar diabetes) or Heart attack or Heart disease or Heart rhythm problems or Hypertension (high blood pressure) or Overactive thyroid or Parkinson's disease—Use with caution. May make these conditions worse. Proper Use of epinephrine

This section provides information on the proper use of a number of products that contain epinephrine. It may not be specific to Twinject. Please read with care.

Use this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you are using this medicine at home, make sure you or any of your family members understand exactly how to give them. Also, tell your doctor if you or your caregiver has severe arthritis of the hands. If you have any questions about this, check with your doctor.

This medicine is injected under your skin or into the muscle of your outer thigh only. Do not inject this medicine into a vein or into the muscle of your buttocks. To do so, may increase the chance of having serious side effects.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine comes in an auto-injector syringe and needle kit that contains the correct dose of medicine your doctor has prescribed.

You may need to use more than one injection if your allergic reaction does not get better after the first shot.

Carry this medicine with you at all times for emergency use in case you have a severe allergic reaction.

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 injection dosage form: For allergic reactions: Adults and children weighing above 30 kilograms (66 pounds)—0.3 milligram (mg) injected under the skin or into the muscle of your thigh. Adults and children weighing 15 to 30 kilograms (33 to 66 pounds)—0.15 milligram (mg) injected under the skin or into the muscle of your thigh. Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the injection kits at room temperature, away from heat, moisture, and direct light. Do not store the medicine in the refrigerator or freezer. Keep the auto-injector in its case or tube.

Check the injection kits regularly to make sure that the liquid has not changed its color. Do not use this medicine if the liquid has changed its color, or if there are solids in the liquid.

Do not reuse the remaining portion of the medicine that is left in the auto-injector. Throw away the auto-injector after you have used it.

Precautions While Using Twinject

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

Anaphylaxis is a life-threatening reaction and requires immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after using this medicine.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not inject this medicine into your hands or feet. There is already less blood flow to the hands and feet, and epinephrine could make that worse and cause damage to these tissues. If you accidentally inject epinephrine into your hands or feet, check with your doctor or go to the hospital emergency room right away.

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

Twinject 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 immediately if any of the following side effects occur:

Incidence not known Abnormal or decreased touch sensation arm, back or jaw pain 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 blurred vision chest pain or discomfort chest tightness or heaviness dizziness fainting fast, irregular, pounding, or racing heartbeat or pulse fear or nervousness headache nausea or vomiting paleness of the skin pounding in the ears restlessness shakiness in the legs, arms, hands, or feet shortness of breath slow or fast heartbeat stroke sweating trembling or shaking of the hands or feet troubled breathing unusual tiredness or weakness wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Agitation coldness of the skin coma confusion decreased urine output depression drowsiness hostility irritability lethargy lightheadedness, dizziness, or fainting muscle twitching pounding, slow heartbeat rapid weight gain rapid, deep breathing seizures stomach cramps stupor swelling of the face, ankles, or hands

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: Twinject 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 Twinject resources Twinject Side Effects (in more detail)Twinject Use in Pregnancy & BreastfeedingTwinject Drug InteractionsTwinject Support Group0 Reviews for Twinject - Add your own review/rating Compare Twinject with other medications Adams-Stokes SyndromeAllergic ReactionsAsthma, acuteAsystoleAV Heart BlockCOPD, AcuteElectromechanical DissociationShock

Ikorel Tablets
1. Name Of The Medicinal Product

Ikorel 10mg and 20mg Tablet

2. Qualitative And Quantitative Composition

Nicorandil 10mg or 20mg

3. Pharmaceutical Form

Tablet

Off-white, round, with faceted edges, scored on one side and bearing the inscription IK10 (10mg) or IK20 (20mg).

4. Clinical Particulars 4.1 Therapeutic Indications

Ikorel tablets are indicated for the following:

• The prevention and long term treatment of chronic stable angina pectoris

• A reduction in the risk of acute coronary syndromes in patients with chronic stable angina and at least one of the following risk factors:

Previous MI

Previous CABG

CHD on angiography or a positive exercise test together with one of the following: LVH on ECG, left ventricular dysfunction, Age

4.2 Posology And Method Of Administration

Route of administration: oral.

Adults: The recommended starting dose is 10mg nicorandil twice daily, although 5mg twice daily may be employed in patients particularly susceptible to headache. Subsequently the dosage should be titrated upward depending on the clinical response. The usual therapeutic dosage is in the range 10 to 20mg nicorandil twice daily, although up to 30mg twice daily may be employed if necessary.

Elderly:

For elderly patients use of the lowest effective dose is recommended.

Children:A paediatric dosage has not been established and use of nicorandil is not recommended.

4.3 Contraindications

Ikorel is contraindicated in patients with hypersensitivity to nicorandil or any of the excipients.

Nicorandil must not be used in the case of cardiogenic shock, hypotension or left ventricular failure with low filling pressure.

Concurrent use of nicorandil and phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) is contraindicated since it can lead to a serious drop in blood pressure.

4.4 Special Warnings And Precautions For Use

Gastrointestinal ulcerations, skin and mucosal ulceration have been reported with nicorandil. These are refractory to treatment and most only respond to withdrawal of nicorandil treatment. If ulcerations develop, it is recommended to discontinue the nicorandil treatment.

Gastrointestinal perforations in context of concomitant use of nicorandil and corticosteroids have been reported. Caution is advised when concomitant use is considered.

Nicorandil must be used with caution in patients who may have blood volume depletion or in those who present, low systolic blood pressure (e.g below 100 mm Hg), acute pulmonary oedema or acute myocardial infarction with acute left ventricular failure and low filling pressures.

Caution is advised if nicorandil is used in combination with other medicinal products with blood pressure lowering effect (see section 4.5).

The tablets are sensitive to moisture; hence the patients should be advised to keep the tablets in their blister until intake. Besides the nicorandil tablets, each blister contains active substance-free silica gel tablets as desiccant in a separate blister segment which is marked accordingly. The patients should be advised not to take these tablets. Although any accidental intake of this desiccant is usually harmless, it may alter the scheduled intake of the active tablets.

Paediatric patients

Ikorel is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Gastrointestinal perforations in the context of concomitant use of nicorandil and corticosteroids have been reported. Caution is advised when concomitant use is considered.

Concurrent use of nicorandil and phosphodiesterase 5 inhibitors, e.g. sildenafil, tadalfil, vardenafil, is contraindicated, since it can lead to a serious drop in blood pressure.

Therapeutic doses of nicorandil may lower the blood pressure of hypotensive patients. If nicorandil is used concomitantly with antihypertensive agents or other medicinal products with blood-pressure-lowering effect (e.g vasodilators, tricyclic antidepressants, alcohol) the blood-pressure-lowering effect may be increased.

4.6 Pregnancy And Lactation

Pregnancy: Although animal studies have not shown any teratogenic effect of nicorandil, the medicinal product has not been studied in human pregnancy; therefore, Ikorel must only be used in pregnant women if the anticipated benefit outweighs any potential risks.

Lactation: Animal studies have shown that nicorandil is excreted in small amounts into the breast milk. It is not known whether nicorandil is excreted in human milk, therefore Ikorel is not recommended during breastfeeding.

4.7 Effects On Ability To Drive And Use Machines

Blood pressure-lowering effects of nicorandil can reduce the ability to drive or to use machines. This effect can be increased in conjunction with alcohol or other products with blood-pressure-lowering effect (e.g. vasodilators, tricyclic antidepressants). (see section 4.5).

Patients should be warned not to drive or operate machinery until it is established that their performance is unimpaired by nicorandil.

4.8 Undesirable Effects

The following definitions apply to the frequency terminology used hereafter:

Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000).

SOC

FREQUENCY

ADR

     

Nervous system disorders

Very common

Headache,particularly during the first few days of treatment.

 

Common

Dizziness

Cardiac disorders

Common

Increase in heart rate, following the administration of high doses

Vascular disorders

Common

Cutaneous vasodilation with flushing

 

Uncommon

Decrease in blood pressure.

Gastrointestinal disorders

Common

Nausea and vomiting

 

Rare

Gastrointestinal ulcerations such as aphtosis, mouth ulcers, tongue ulcers, intestinal and anal ulcers. These ulcers, if advanced, may develop into perforation, fistula, or abscess formation. (see section 4.4).

     

Hepato-biliary disorders

Very rare

Liver disorders such as hepatitis, cholestasis, or jaundice.

Skin and subcutaneous tissue disorders

Rare

Different types of rash, pruritis.

 

Very rare

Angio-oedema. Skin and muscosal ulcerations (mainly peri-anal ulcerations, genital ulcerations and parastomal ulcerations (see section 4.4).

Musculoskeletal & connective tissue disorders

Rare

Myalgia

General disorders and administration site conditions

Common

Feeling of weakness

Additional Information

In addition, the following events have been reported at a different frequency in the IONA (Impact of Nicorandil in Angina) study which was conducted in subjects at high risk of cardiovascular events only.

Skin and subcutaneous tissue disorders

Uncommon – angio-oedema

Gastrointestinal disorders

Common – rectal bleeding.

Uncommon – mouth ulcers

Very rare – abdominal pain

Musculoskeletal & connective tissue disorders

Uncommon - myalgia

4.9 Overdose

Symptoms

In case of acute overdose, the likely symptomatology may be peripheral vasodilation with a fall in blood pressure and reflex tachycardia.

Management

Monitoring cardiac function and general supportive measures are recommended. If not successful, increase in circulating plasma volume by substitution of fluid is recommended. In life-threatening situations, administration of vasopressors must be considered. There is no experience of massive overdosage in humans, although the LD50 in dogs is in the range 62.5 to 125 mg/kg and in rodents it is in the order of 1200 mg/kg.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other vasodilators used in cardiac disease, ATC code: C01DX16

Nicorandil provides a dual mode of action leading to relaxation of vascular smooth muscle. A potassium channel opening action provides arterial vasodilation, thus reducing afterload, while the nitrate component promotes venous relaxation and a reduction in preload. Nicorandil has a direct effect on coronary arteries without leading to a steal phenomenon. The overall action improves blood flow to post-stenotic regions and the oxygen balance in the myocardium.

A reduction of coronary heart disease complications has been shown in patients suffering from angina pectoris who were treated with nicorandil in the IONA study.

The study was a randomised, double blind, placebo controlled, cardiovascular endpoint study carried out in 5126 patients to determine if Nicorandil could reduce the frequency of coronary events in men and women with chronic stable angina and standard anti anginal treatment at high risk of cardiovascular events defined by either: 1) previous myocardial infarction, or 2) coronary artery bypass grafting , or 3) coronary artery disease confirmed by angiography, or a positive exercise test in the previous two years, together with one of the following: left ventricular hypertrophy on the ECG, left ventricular ejection fraction

The primary endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction, or unplanned hospital admission for cardiac chest pain, occurred in 13.1% of patients treated with nicorandil compared with 15.5% of patients receiving placebo (hazard ratio 0.83, p=0.014). The rate of acute coronary syndrome (CHD death, non fatal MI or unstable angina) was 6.1% in patients treated with nicorandil compared with 7.6% in patients receiving placebo (hazard ratio 0.79, p=0.028). All cardiovascular events were significantly less in the nicorandil than placebo group 14.7% vs 17.0% (hazard ratio 0.86 p=0.027). The validity of these finding was confirmed by re-analysing the primary endpoint using all cause rather than cardiovascular mortality (nicorandil 14.9% compared with placebo 17.3%, hazard ratio 0.85, p=0.021). The study was not expressly powered to, nor did it detect any statistically significant reduction in any individual component endpoints.

5.2 Pharmacokinetic Properties

Nicorandil is well absorbed with no significant first-pass metabolism. Maximum plasma concentrations are achieved in 30 to 60 minutes and are directly related to the dosage. Metabolism is mainly by denitration of the molecule into the nicotinamide pathway with less than 20% of an administered dose being excreted in the urine. The main phase of elimination has a half-life of about 1 hour. Nicorandil is only slightly bound to plasma proteins.

No clinically relevant modifications in the pharmacokinetic profile have been seen in the elderly or in patients with liver disease or chronic renal failure.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Maize starch, croscarmellose sodium, stearic acid and mannitol.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

18 months.

Each blister strip should be used within 30 days of opening.

6.4 Special Precautions For Storage

Store in a dry place below 25°C.

6.5 Nature And Contents Of Container

Ikorel tablets 10mg and 20mg are presented in hard tempered aluminium foil/ (Polyamide/aluminium/PVC) blister strips of 10 tablets, in which each tablet is linked to a silica gel capsule dessicant.

The blister strips are packaged in cartons of 60 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

8. Marketing Authorisation Number(S)

Ikorel tablets 10mg: PL 04425/0327

Ikorel tablets 20mg: PL 04425/0328

9. Date Of First Authorisation/Renewal Of The Authorisation

24 February 2009

10. Date Of Revision Of The Text

22 February 2011

LEGAL STATUS

POM

Vesanoid

Generic Name: tretinoin (Oral route)

TRET-i-noin

Oral route(Capsule, Liquid Filled)

Patients with acute promyelocytic leukemia (APL) can have severe adverse reactions to tretinoin including retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure. High-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. Patients can also develop rapidly evolving leukocytosis during therapy which can lead to an increased risk of life-threatening complications. There is a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. Pregnancy testing is necessary prior to initiation of treatment in women of childbearing potential and the patient must be instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of tretinoin treatment .

Commonly used brand name(s)

In the U.S.

Vesanoid

Available Dosage Forms:

Capsule, Liquid Filled

Therapeutic Class: Antineoplastic Agent

Chemical Class: Retinoid

Uses For Vesanoid

Tretinoin belongs to the group of medicines known as retinoids (RET-i-noyds). It is used to treat a form of leukemia (acute promyelocytic leukemia [APL]).

Tretinoin has side effects that can be very serious. Be sure that you discuss with your doctor the good that this medicine can do as well as the risks of taking it.

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

Before Using Vesanoid

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 in a limited number of children between 1 and 16 years of age have shown that children may be especially sensitive to the effects of this medicine, and may be more likely than adults to experience severe headaches and some other side effects during treatment.

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 tretinoin in the elderly with use in other age groups.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 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.

Aminocaproic Acid Aprotinin Paclitaxel Paclitaxel Protein-Bound Tetracycline Tranexamic Acid

Using this medicine 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.

Fluconazole Ketoconazole Voriconazole 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.

Proper Use of Vesanoid

It is very important that you take tretinoin only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

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 oral dosage form (capsules): For acute promyelocytic leukemia (APL): Adults—Dose is based on body size and must be determined by your doctor. The usual dose is 45 milligrams (mg) for each square meter of body surface area a day, given in two equally divided doses. Children—The dose will 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.

If it is almost time for your next dose, check with your health care professional to find out how much medicine to take for the next dose.

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 Vesanoid

Your doctor should check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects.

Tretinoin causes fever, headache, tiredness, and weakness in most people who take it. It is very important that you continue taking the medicine even if it makes you feel ill. Your health care professional may be able to suggest ways to relieve some of these effects. However, if you develop a very severe headache or a headache that occurs together with nausea, vomiting, or vision problems, check with your doctor right away.

Tretinoin sometimes causes a severe reaction that affects the lungs at first, but can later spread to other parts of the body. Signs of this reaction include breathing problems, bone pain, chest pain, and fever. Check with your doctor right away if any of these effects occur during treatment .

Vesanoid 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 immediately if any of the following side effects occur:

More common Black, tarry stools bleeding blistering bloody stools bone pain burning coldness difficulty in moving discomfort or pain in chest enlarged heart feeling of pressure fever hives infection inflammation joint pain lumps numbness paleness of skin rash redness scaring seizures shortness of breath, troubled breathing, tightness in chest, or wheezing soreness stinging sweating increased swelling swollen joints tenderness tingling ulceration unusual tiredness or weakness vomiting of blood or material that looks like coffee grounds warmness at site weight gain (occurring together with any of the other symptoms listed before) Less common Blue lips and fingernails convulsions (seizures) difficulty in speaking, slow speech, or inability to speak faintness feeling of heaviness in chest headache (severe) inability to move arms, legs, or muscles of the face nausea and vomiting (occurring together with a headache) no blood pressure or pulse pain in back or left arm painful, red lumps under the skin, mostly on the legs prominent superficial veins over affected area stopping of heart unconsciousness vision problems (occurring together with a headache) warmth

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

More common Any change in vision (not occurring with a headache) coughing, sneezing, sore throat, and stuffy or runny nose cracked lips crusting, redness, pain, or sores in mouth or nose decreased urination earache or feeling of fullness in the ear increase or decrease in blood pressure irregular heartbeat mental depression pain in stomach, side, abdomen or back pain and swelling in leg or foot skin rash swelling of abdomen (stomach area) swelling of face, fingers, hands, feet, or lower legs Less common Bone swelling cramping or pain in stomach (severe) difficult or painful urination drowsiness (very severe and continuing) hallucinations (seeing, hearing, or feeling things that are not there) hearing loss heartburn, indigestion, or nausea (severe and continuing) mood, mental, or personality changes pain in lower back or side swollen area that feels sore and tender yellow 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:

More common Acid or sour stomach agitation anxiety belching blurred vision bloating burning, crawling, or tingling feeling in the skin chills confusion constipation darkened urine diarrhea dizziness dryness of skin, mouth, or nose fast heartbeat flushing general feeling of discomfort or illness hair loss headache (mild and not occurring together with other side effects) indigestion irritability itching of skin loss of appetite mood or mental changes muscle pain nausea and vomiting (not occurring together with a headache) shivering trouble sleeping weakness weight loss Less common Anxiety and restlessness (occurring together) clumsiness or unsteadiness when walking difficulty sleeping disorientation forgetfulness frequent urination lethargy lightheadedness low body temperature redness, soreness or itching skin sores, welting or blisters sores on genitals swelling of feet or lower legs thirst trembling, sometimes with a flapping movement weak or feeble pulse weakness in legs

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: Vesanoid 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 Vesanoid resources Vesanoid Side Effects (in more detail)Vesanoid Use in Pregnancy & BreastfeedingDrug ImagesVesanoid Drug InteractionsVesanoid Support Group1 Review for Vesanoid - Add your own review/rating Vesanoid Prescribing Information (FDA) Vesanoid MedFacts Consumer Leaflet (Wolters Kluwer) Vesanoid Concise Consumer Information (Cerner Multum) Vesanoid Monograph (AHFS DI) Tretinoin Prescribing Information (FDA) Compare Vesanoid with other medications Acute Promyelocytic Leukemia

Menorrhagia Medications

Definition of Menorrhagia: Menorrhagia is heavy or prolonged bleeding during your menstrual period.

Drugs associated with Menorrhagia

The following drugs and medications are in some way related to, or used in the treatment of Menorrhagia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:Lysteda

Novacet

Generic Name: sulfacetamide sodium and sulfur topical (SUL fa SEET a mide SOE dee um and SUL fur TOP i kal) Brand Names: Avar Cleanser, Avar Gel, Avar LS Cleanser, Avar-E, Avar-E Emollient, Avar-E Green, Avar-e LS, BP 10-Wash, Clarifoam EF, Clenia Emollient Cream, Clenia Foaming Wash, Plexion , Plexion Cleanser, Plexion Cleansing Cloths, Plexion SCT, Prascion, Prascion Cleanser, Prascion FC Cloths, Prascion RA, Rosac, Rosac Wash, Rosaderm Cleanser, Rosanil Cleanser, Rosula, SE 10-5 SS, Sulfacet-R, Sulfatol C, Sulfatol SS, SulZee Wash, Sumaxin, Sumaxin TS, Sumaxin Wash, Suphera, Topisulf, Zencia Wash, Zetacet

What is Novacet (sulfacetamide sodium and sulfur topical)?

Sulfacetamide sodium and sulfur are antibiotic that fight bacteria.

The combination of sulfacetamide sodium and sulfur topical (for the skin) is used to treat acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sulfacetamide sodium and sulfur topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Novacet (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease. Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Do not cover the treated skin area unless your doctor has told you to.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to. What should I discuss with my healthcare provider before using Novacet (sulfacetamide sodium and sulfur topical)? You should not use this medication if you are allergy to sulfa drugs or if you have kidney disease.

To make sure you can safely use this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and sulfur topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether sulfacetamide sodium and sulfur topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use Novacet (sulfacetamide sodium and sulfur topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying this medication.

Do not cover the treated skin area unless your doctor has told you to.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Novacet (sulfacetamide sodium and sulfur topical)? Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use sulfacetamide sodium and sulfur topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical unless you doctor tells you to.

Novacet (sulfacetamide sodium and sulfur topical) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

new or worsening skin rash;

joint pain;

fever; or

mouth sores.

Less serious side effects may include redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Novacet (sulfacetamide sodium and sulfur topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied sulfacetamide sodium and sulfur. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Novacet resources Novacet Use in Pregnancy & BreastfeedingNovacet Drug InteractionsNovacet Support Group0 Reviews for Novacet - Add your own review/rating Avar LS Cleanser MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Foam MedFacts Consumer Leaflet (Wolters Kluwer) Clarifoam EF Prescribing Information (FDA) Plexion Prescribing Information (FDA) Plexion Cleansing Cloths MedFacts Consumer Leaflet (Wolters Kluwer) Plexion SCT Cream MedFacts Consumer Leaflet (Wolters Kluwer) Plexion TS Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Prascion Cleanser Prescribing Information (FDA) Rosac Cream MedFacts Consumer Leaflet (Wolters Kluwer) Rosaderm Cleanser Prescribing Information (FDA) Rosanil Cleanser Prescribing Information (FDA) Rosula Foam MedFacts Consumer Leaflet (Wolters Kluwer) Rosula Prescribing Information (FDA) Rosula Cleanser Emulsion MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan MedFacts Consumer Leaflet (Wolters Kluwer) Sumadan Wash Prescribing Information (FDA) Sumaxin Wash MedFacts Consumer Leaflet (Wolters Kluwer) Sumaxin Wash Prescribing Information (FDA) Zencia Wash Prescribing Information (FDA) Compare Novacet with other medications AcneRosaceaSeborrheic Dermatitis Where can I get more information? Your pharmacist can provide more information about sulfacetamide sodium and sulfur topical.

U40 Foam
urea Dosage Form: aerosol, foamU40 Foam U40 Foam Description

U40 Foam is a keratolytic emollient in a water and lipid-based foam which is a gentle, but potent, tissue softener for skin and nails.

chlophedianol

kloe-fe-DYE-a-nol

Uses For chlophedianol

Chlophedianol is used to relieve dry, irritating coughs. chlophedianol should not be used when there is mucus or phlegm (pronounced flem) with the cough.

Chlophedianol relieves cough by acting on the cough center in the brain.

Chlophedianol is available without a doctor's prescription.

Before Using chlophedianol

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 chlophedianol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to chlophedianol 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

chlophedianol has been tested in children 2 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems in children than it does in adults.

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 chlophedianol 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 chlophedianol. Make sure you tell your doctor if you have any other medical problems, especially:

Mucus or phlegm with cough—Since chlophedianol decreases coughing, it makes it difficult to get rid of the mucus that may collect in the lungs and airways with some diseases Proper Use of chlophedianol

Do not take liquids immediately after taking chlophedianol. To do so may decrease the soothing effect of the syrup.

Take chlophedianol only as directed. Do not take more of it and do not take it more often than your doctor ordered or the label directs you to take. To do so may increase the chance of side effects.

Dosing

The dose of chlophedianol 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 chlophedianol. 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 oral dosage form (syrup): For cough: Adults and children 12 years of age and older—25 milligrams (mg) every six to eight hours as needed. Children— Up to 2 years of age: Use is not recommended. 2 to 6 years of age: 12.5 mg every six to eight hours as needed. 6 to 12 years of age: 12.5 to 25 mg every six to eight hours as needed. Missed Dose

If you miss a dose of chlophedianol, 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 chlophedianol

If your cough has not improved after 7 days, or if you have a high fever, skin rash, or continuing headache with the cough, check with your doctor. These signs may mean that you have other medical problems.

chlophedianol will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking chlophedianol.

chlophedianol may also add to the effects of CNS stimulants, such as appetite suppressants and caffeine-containing beverages like tea, coffee, cocoa, and cola drinks. Avoid drinking large amounts of these beverages while taking chlophedianol. If you have any questions about this, check with your doctor.

chlophedianol may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to chlophedianol before you drive, use machines, or do anything else that could be dangerous if you are not alert.

chlophedianol 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:

Rare Hallucinations (seeing, hearing, or feeling things that are not there) nightmares skin rash or hives unusual excitement or irritability With large doses Blurred vision drowsiness or dizziness dryness of the mouth nausea or vomiting

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: chlophedianol 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 chlophedianol resources Chlophedianol Side Effects (in more detail)Chlophedianol Drug InteractionsChlophedianol Support Group0 Reviews for Chlophedianol - Add your own review/rating Compare chlophedianol with other medications Cough

Boots Lip and Cold Sore Cream

Boots Lip and Cold Sore Cream

Relieves cracked lips and cold sores

5 g

Read all of this carton for full instructions.

What this medicine is for

An antibacterial and protective cream for cracked lips and cold sores.

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

How to use this medicine

Adults and children: Use a very small amount on the affected area every hour, when you need to.

Apply to the skin only.

Do not use more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Talk to a doctor.

Possible side effects

Cetostearyl alcohol may cause skin reactions (e.g. contact dermatitis).

If this becomes severe, or you notice any side effect, please tell your pharmacist or doctor.

How to store this medicine

Store below 25°C.

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

Use by the date on the end flap of the carton.

Active ingredients

This cream contains Cetrimide 0.5% w/w, Chlorocresol 0.1% w/w, Dimeticone 9% w/w, Urea 1% w/w.

Also contains: deionised water, liquid paraffin, cetostearyl alcohol.

PL 30306/0028

Text prepared 8/07

Manufactured for The Boots Company PLC Nottingham NG2 3AA

by

CCS Clean Chemicals Sweden AB Borl?nge SE 78173 Sweden Marketing Authorisation held by Actavis Group PTC ehf Reykjv?kurvegi 76 – 78 220 Hafnarfjorur Iceland

If you need more advice ask your pharmacist .

2787bXPil

neomycin

nee-oh-MYE-sin

Oral route(Tablet;Solution)

Systemic absorption occurs following oral administration and toxic reactions may occur. Therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity. Patients with impaired renal function, advanced age, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity. Monitor renal and auditory function during therapy. Aminoglycoside-induced ototoxicity is usually irreversible. Neuromuscular blockade and respiratory paralysis have also been reported following administration. Concurrent use of other potentially neurotoxic or nephrotoxic agents, or potent diuretics should be avoided .

Commonly used brand name(s)

In the U.S.

Neo-Fradin

Available Dosage Forms:

Tablet Solution

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Uses For neomycin

Oral neomycin is used to help lessen the symptoms of hepatic coma, a complication of liver disease. In addition, it may be used with another medicine before any surgery affecting the bowels to help prevent infection during surgery.

Neomycin is available only with your doctor's prescription.

Before Using neomycin

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 neomycin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to neomycin 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

Damage to hearing, sense of balance, and kidneys is more likely to occur in premature infants and neonates, who are more sensitive than adults to the effects of neomycin.

Geriatric

Serious side effects, such as damage to hearing, sense of balance, and kidneys may occur in elderly patients, who are usually more sensitive than younger adults to the effects of neomycin.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 taking neomycin, 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 neomycin 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.

Alcuronium Atracurium Cidofovir Cisatracurium Colistimethate Sodium Decamethonium Doxacurium Ethacrynic Acid Fazadinium Furosemide Gallamine Hexafluorenium Metocurine Mivacurium Pancuronium Pipecuronium Rapacuronium Rocuronium Sorafenib Tacrolimus Tubocurarine Vecuronium

Using neomycin 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.

Bumetanide Digoxin 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 neomycin. Make sure you tell your doctor if you have any other medical problems, especially:

Blockage of the bowel Eighth-cranial-nerve disease (loss of hearing and/or balance)—Oral neomycin may increase the chance of hearing loss and/or balance problems Kidney disease—Patients with kidney disease may have an increased chance of side effects Myasthenia gravis or Parkinson's disease—Patients with myasthenia gravis or Parkinson's disease may have an increased chance of developing muscular weakness Ulcers of the bowel—Patients with ulcers of the bowel may have an increased chance of side effects since more neomycin may be absorbed by the body Proper Use of neomycin

neomycin may be taken on a full or empty stomach.

For patients taking the oral liquid form of neomycin:

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Keep taking neomycin for the full time of treatment. Do not miss any doses.

Dosing

The dose of neomycin 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 neomycin. 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 oral dosage forms (solution, tablets): For patients in a coma from liver disease: Adults and teenagers—1 to 3 grams every six hours for five or six days. Children—Dose is based on body size (not weight) and must be determined by your doctor. That dose is given every six hours for five or six days. For cleaning the bowel before surgery: Adults and teenagers—1 gram every hour for four hours, then 1 gram every four hours for the rest of a twenty-four hour period; or 1 gram nineteen hours before surgery, 1 gram eighteen hours before surgery, and 1 gram nine hours before surgery. Children—Dose is based on body weight. The usual dose is 14.7 milligrams (mg) per kilogram (kg) (6.7 mg per pound) of body weight every four hours for three days. Missed Dose

If you miss a dose of neomycin, 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.

neomycin 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 immediately if any of the following side effects occur:

Rare Any loss of hearing clumsiness diarrhea difficulty in breathing dizziness drowsiness greatly decreased frequency of urination or amount of urine increased amount of gas increased thirst light-colored, frothy, fatty-appearing stools ringing or buzzing or a feeling of fullness in the ears skin rash unsteadiness weakness

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:

More common Irritation or soreness of the mouth or rectal area nausea or vomiting

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.

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 neomycin resources Neomycin Use in Pregnancy & BreastfeedingDrug ImagesNeomycin Drug InteractionsNeomycin Support Group0 Reviews for Neomycin - Add your own review/rating neomycin Concise Consumer Information (Cerner Multum) Neomycin MedFacts Consumer Leaflet (Wolters Kluwer) Neo-Fradin Prescribing Information (FDA) Neo-Fradin Solution MedFacts Consumer Leaflet (Wolters Kluwer) Neomycin Sulfate Monograph (AHFS DI) Compare neomycin with other medications Bowel PreparationDiarrheaHepatic ComaHepatic Encephalopathy

Allegra-D 24 Hour Extended-Release Tablets (24 Hour)
Pronunciation: FEX-oh-FEN-a-deen/SOO-doe-e-FED-rinGeneric Name: Fexofenadine/PseudoephedrineBrand Name: Allegra-D 24 Hour

Nexterone
Dosage Form: injection, solutionFULL PRESCRIBING INFORMATION Indications and Usage for Nexterone

Nexterone  is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Nexterone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with Nexterone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2)].

Use Nexterone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but Nexterone may be safely administered for longer periods if necessary.

Nexterone Dosage and Administration

Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of Nexterone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:

Table 1: Nexterone PREMIXED INJECTION DOSE RECOMMENDATIONS: FIRST 24 HOURS Loading infusions First Rapid:

150 mg over the FIRST 10 minutes (15 mg/min).

Directly infuse Nexterone Premixed Injection (150 mg/100 mL; 1.5mg/mL) at a rate of 10mL/min.

Followed by

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