Leukine

Generic Name: sargramostim (sar GRA moe stim)

Brand Names: Leukine

What is sargramostim?

Sargramostim is a man-made form of a protein that stimulates the growth of white blood cells in your body. White blood cells help your body fight against infection.

Sargramostim is used to increase white blood cells and help prevent serious infection in conditions such as leukemia, bone marrow transplant, and pre-chemotherapy blood cell collection. Sargramostim is for use in adults who are at least 55 years old.

Sargramostim may also be used for purposes not listed in this medication guide.

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

You should not use this medication if you are allergic to sargramostim or to yeast. Sargramostim should not be used within 24 hours before or after you receive chemotherapy or radiation.

Before you receive sargramostim, tell your doctor if you have fluid retention (especially around your lungs), heart disease, high blood pressure, congestive heart failure, bone marrow cancer, a seizure disorder, liver or kidney disease, or a breathing disorder such as COPD or asthma.

Tell your caregiver right away if you feel dizzy, nauseated, light-headed, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing when you inject this medication.

Call your doctor at once if you have any other serious side effects such as fever, chills, sore throat, flu symptoms, mouth sores, easy bruising or bleeding, and swelling or rapid weight gain.

Using sargramostim may increase your risk of developing other cancers. Ask your doctor about your individual risk.

What should I discuss with my healthcare provider before using sargramostim?

You should not use this medication if you are allergic to sargramostim or to yeast. Sargramostim should not be used within 24 hours before or after you receive chemotherapy or radiation.

To make sure you can safely use sargramostim, tell your doctor if you have any of these other conditions:

• 
  

  fluid retention;

  
  


• 
  

  a buildup of fluid around your lungs (also called pleural effusion);

  
  


• 
  

  bone marrow cancer;

  
  


• 
  

  heart disease, high blood pressure; congestive heart failure;

  
  


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  epilepsy or other seizure disorder;

  
  


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  liver or kidney disease; or

  
  


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  asthma, chronic obstructive pulmonary disease (COPD), or other breathing problems.

  
  

Using sargramostim may increase your risk of developing other cancers. Ask your doctor about your individual risk.

FDA pregnancy category C. It is not known whether sargramostim 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 sargramostim 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 sargramostim?

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.

Sargramostim should not be used within 24 hours before or after you receive chemotherapy or radiation.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Sargramostim is injected into a vein or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.

When injected into a vein, sargramostim must be given slowly. The IV infusion can take up to 24 hours to complete.

Use a different place on your stomach, thigh, or upper arm each time you give the injection under the skin. Just before you give the injection, apply an ice pack to the skin for one minute. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Sargramostim powder must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Do not shake the mixed medicine or it may foam. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with sargramostim. Your liver function will also need to be tested. Visit your doctor regularly.

Store the liquid medicine in the refrigerator, do not freeze. Protect from light. You may take the medicine out and allow it to reach room temperature before measuring your dose in a syringe. Then return the medicine to the refrigerator. Throw away any unused liquid after 20 days. After mixing sargramostim powder with a diluent, store in the refrigerator and use it within 6 hours. Do not freeze. Protect from light. If you have mixed the powder with bacteriostatic water, you may store this mixture in the refrigerator for up to 20 days.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of sargramostim.

What happens if I overdose?

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

Overdose symptoms may include nausea, weakness, headache, fever, chills, skin rash, fast heart rate, or trouble breathing.

What should I avoid while using sargramostim?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sargramostim side effects

Some people receiving a sargramostim injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  high fever, chills, sore throat, stuffy nose, flu symptoms;

  
  


• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  chest pain, fast or uneven heart rate;

  
  


• 
  

  weakness or fainting;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  painful or difficult urination;

  
  


• 
  

  dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  breathing problems; or

  
  


• 
  

  problems with vision, speech, balance, or memory.

  
  

Less serious side effects may include:

• 
  

  nausea, stomach pain, vomiting, diarrhea, loss of appetite;

  
  


• 
  

  tired feeling;

  
  


• 
  

  hair loss;

  
  


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  weight loss;

  
  


• 
  

  headache;

  
  


• 
  

  mild skin rash or itching;

  
  


• 
  

  bone pain;

  
  


• 
  

  joint or muscle pain; or

  
  


• 
  

  redness, swelling, or irritation where the injection was given.

  
  

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 sargramostim?

Tell your doctor about all other medicines you use, especially:

• 
  

  lithium (Eskalith, Lithobid); or

  
  


• 
  

  a steroid such as prednisone (Meticorten, Sterapred), methylprednisolone (Medrol), dexamethasone (Decadron), and others.

  
  

This list is not complete and other drugs may interact with sargramostim. 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 Leukine resources

• Leukine Side Effects (in more detail)
• Leukine Use in Pregnancy & Breastfeeding
• Leukine Drug Interactions
• Leukine Support Group
• 0 Reviews for Leukine - Add your own review/rating

• Leukine Prescribing Information (FDA)


• Leukine Monograph (AHFS DI)


• Leukine Advanced Consumer (Micromedex) - Includes Dosage Information


• Leukine Consumer Overview


• Leukine MedFacts Consumer Leaflet (Wolters Kluwer)


• Sargramostim Professional Patient Advice (Wolters Kluwer)

Compare Leukine with other medications

• Aplastic Anemia
• Bone Marrow Transplantation
• Bone Marrow Transplantation, Failure or Engraftment Delay
• Bone Marrow Transplantation, Myeloid Reconstruction
• Neutropenia Associated with Chemotherapy

Where can I get more information?

• Your doctor or pharmacist can provide more information about sargramostim.

See also: Leukine side effects (in more detail)

Phentermine Extended Release

Dosage Form: capsule, extended release
Phentermine Resin

Extended-Release Capsules

CIV

Rx Only

Phentermine Extended Release Description

Phentermine Resin Extended-Release Capsules contain 15 mg and 30 mg respectively of phentermine as the cationic exchange resin complex. Phentermine is α, α-dimethyl phenethylamine (phenyl-tertiary-butylamine).

Inactive Ingredients: Dibasic Calcium Phosphate, Talc, and Magnesium Stearate. The 15 mg capsule shell consists of D&C Yellow #10, FD&C Yellow # 6, Titanium Dioxide, Gelatin, FD&C Blue #1, FD&C Red #40, FDA /E172 Black Iron Oxide. The capsule imprinting ink consists of Shellac Glaze in Ethanol, Black Iron Oxide, N-Butyl Alcohol, Propylene Glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake, Ethanol and Methanol. The 30 mg capsule shell consists of D&C Yellow #10, FD&C Yellow # 6, Titanium Dioxide, and Gelatin. The capsule imprinting ink consists of Shellac Glaze in Ethanol, Black Iron Oxide, N-Butyl Alcohol, Propylene Glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #1 Aluminum Lake, D&C Yellow #10 Aluminum Lake, Ethanol and Methanol.

Phentermine Extended Release - Clinical Pharmacology

Phentermine Resin Extended-Release Capsules are sympathomimetic amines with pharmacologic activity similar to the prototype drug of this class used in obesity, amphetamine (d- and dl-amphetamine). Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects may be involved.

Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks' or months' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

The bioavailability of Phentermine Resin Extended-Release Capsules has been studied in humans in which blood levels of phentermine were measured by a gas chromatography method. Blood levels obtained with the 15 mg and 30 mg resin complex formulations indicated slower absorption with a reduced but prolonged peak concentration and without a significant difference in prolongation of blood levels when compared with the same doses of phentermine hydrochloride. The clinical significance of these differences is not known. In clinical trials establishing the efficacy of Phentermine Resin Extended-Release Capsules, a single daily dose produced an effect comparable to that produced by other regimens of "anorectic" drug therapy.

Indications and Usage for Phentermine Extended Release

Phentermine Resin Extended-Release Capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia).

Below is a chart of Body Mass Index (BMI) based on various heights and weights.

BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m2

Weight (pounds)	Height (feet, inches)
	5'0"	5'3"	5'6"	5'9"	6'0"	6'3"
140	27	25	23	21	19	18
150	29	27	24	22	20	19
160	31	28	26	24	22	20
170	33	30	28	25	23	21
180	35	32	29	27	25	23
190	37	34	31	28	26	24
200	39	36	32	30	27	25
210	41	37	34	31	29	26
220	43	39	36	33	30	28
230	45	41	37	34	31	29
240	47	43	39	36	33	30
250	49	44	40	37	34	31

The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.

Contraindications

Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

Warnings

Phentermine Resin Extended-Release Capsules are indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss, including selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, the coadministration of these drug products for weight loss is not recommended.

Primary Pulmonary Hypertension (PPH) – a rare, frequently fatal disease of the lungs – has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out. The initial symptom of PPH is usually dyspnea. Other initial symptoms include: angina pectoris, syncope, or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope, or lower extremity edema.

Valvular Heart Disease

Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known.

If tolerance to the "anorectic" effect develops, the recommended dose should not be exceeded in an attempt to increase the effect: rather, the drug should be discontinued.

Phentermine Resin Extended-Release Capsules may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

When using CNS active agents, consideration must always be given to the possibility of adverse interactions with alcohol.

Drug Abuse and Dependence

Phentermine Resin Extended-Release Capsules are related chemically and pharmacologically to amphetamine (d- and dl-amphetamine) and other stimulant drugs that have been extensively abused. The possibility of abuse of Phentermine Resin Extended-Release Capsules should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamine (d- and dl-amphetamine) and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of some of these drugs to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

Usage in Pregnancy

Safe use in pregnancy has not been established. Use of Phentermine Resin Extended-Release Capsules by women who are or may become pregnant requires that the potential benefit be weighed against the possible hazard to mother and infant.

Pediatric Use

Phentermine Resin Extended-Release Capsules are not recommended for use in pediatric patients under 16 years of age.

Precautions

Caution is to be exercised in prescribing Phentermine Resin Extended-Release Capsules for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of Phentermine Resin Extended-Release Capsules and the concomitant dietary regimen.

Phentermine Resin Extended-Release Capsules may decrease the hypotensive effect of adrenergic neuron blocking drugs.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Geriatric Use

Clinical studies of Phentermine Resin Extended-Release Capsules did not include sufficient numbers of subjects aged 65 or over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Cardiovascular: Primary pulmonary hypertension (see WARNINGS), palpitation, tachycardia, elevation of blood pressure, ischemic events.

Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses with some drugs in this class.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic: Urticaria.

Endocrine: Impotence, changes in libido.

Overdosage

Manifestations of acute overdosage may include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning, usually terminating in convulsions and coma.

Management of acute Phentermine Resin Extended-Release Capsules intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Intravenous phentolamine (Regitine) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.

Phentermine Extended Release Dosage and Administration

One capsule daily, before breakfast or 10-14 hours before retiring. For individuals exhibiting greater drug responsiveness, Phentermine Resin Extended-Release Capsules, 15 mg, will usually suffice. Phentermine Resin Extended-Release Capsules, 30 mg, are recommended for less responsive patients. Phentermine Resin Extended-Release Capsules are not recommended for use in pediatric patients under 16 years of age.

Phentermine Resin Extended-Release Capsules should be swallowed whole.

How is Phentermine Extended Release Supplied

Phentermine Resin Extended-Release Capsules are available in two strengths:

15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with "LCI" on the cap and "1398" on the body.

NDC 0527-1398-01 Bottle of 100's

30 mg: Size #3 maize/maize capsules, imprinted with "LCI" on the cap and "1366" on the body.

NDC 0527-1366-01 Bottle of 100's

Dispense in a tight, well-closed container as defined in the USP with a child resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured By:

Lannett Company, Inc.

Philadelphia, PA 19136

Rev. 08/09

PRINCIPAL DISPLAY PANEL — 15 mg

NDC 0527-1398-01

Lannett

PHENTERMINE RESIN  CIV

EXTENDED-RELEASE

CAPSULES

15 mg*

Rx Only

100 CAPSULES

PRINCIPAL DISPLAY PANEL — 30 mg

NDC 0527-1366-01

Lannett

PHENTERMINE RESIN  CIV

EXTENDED-RELEASE

CAPSULES

30 mg*

Rx Only

100 CAPSULES

PHENTERMINE RESIN  ER phentermine resin  capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0527-1398 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE (PHENTERMINE) PHENTERMINE 15 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE   TALC   MAGNESIUM STEARATE   D&C YELLOW NO. 10   FD&C YELLOW NO. 6   TITANIUM DIOXIDE   GELATIN   SHELLAC   ALCOHOL   FERROSOFERRIC OXIDE   BUTYL ALCOHOL   PROPYLENE GLYCOL   FD&C BLUE NO. 2   ALUMINUM OXIDE   FD&C RED NO. 40   FD&C BLUE NO. 1   METHYL ALCOHOL

Product Characteristics Color GRAY, YELLOW (gray opaque/maize opaque capsules) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code LCI;1398 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0527-1398-01 100 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040872	07/28/2011

PHENTERMINE RESIN  ER phentermine resin  capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0527-1366 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE (PHENTERMINE) PHENTERMINE 30 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE   TALC   MAGNESIUM STEARATE   D&C YELLOW NO. 10   FD&C YELLOW NO. 6   TITANIUM DIOXIDE   GELATIN   SHELLAC   ALCOHOL   FERROSOFERRIC OXIDE   BUTYL ALCOHOL   PROPYLENE GLYCOL   FD&C BLUE NO. 2   ALUMINUM OXIDE   FD&C RED NO. 40   FD&C BLUE NO. 1   METHYL ALCOHOL

Product Characteristics Color YELLOW Score no score Shape CAPSULE Size 16mm Flavor Imprint Code LCI;1366 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0527-1366-01 100 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040872	07/28/2011

Labeler - Lannett Company, Inc. (002277481)

Establishment
Name	Address	ID/FEI	Operations
Lannett Company, Inc.		002277481	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Lannett Company, Inc.		829757603	ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 07/2011Lannett Company, Inc.

More Phentermine Extended Release resources

• Phentermine Extended Release Side Effects (in more detail)
• Phentermine Extended Release Use in Pregnancy & Breastfeeding
• Drug Images
• Phentermine Extended Release Drug Interactions
• Phentermine Extended Release Support Group
• 591 Reviews for Phentermine Extended Release - Add your own review/rating

Compare Phentermine Extended Release with other medications

• Obesity
• Weight Loss

Isonex

Isonex may be available in the countries listed below.

Ingredient matches for Isonex

Isoniazid

Isoniazid is reported as an ingredient of Isonex in the following countries:

• India

International Drug Name Search

Furadantin 25mg / 5ml Oral Suspension OR Nitrofurantoin 25mg / 5ml Oral Suspension

1. Name Of The Medicinal Product

Furadantin® 25mg/5ml Oral Suspension OR Nitrofurantoin 25mg/5ml Oral Suspension

2. Qualitative And Quantitative Composition

Contains 25mg Nitrofurantoin Ph. Eur per 5ml

3. Pharmaceutical Form

An opaque yellow liquid with a lemon/apricot charateristic odour.

4. Clinical Particulars

4.1 Therapeutic Indications

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

Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible strains of Escherichia coli, Enterococci, Staphylococci, Citrobacter, Klebsiella and Enterobacter.

4.2 Posology And Method Of Administration

Dosage:

Adults

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

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

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

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

Children and Infants over three months of age

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

Suppressive: 1mg/kg, once a day.

Elderly

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

4.3 Contraindications

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

G6PD deficiency (including pregnancy at term, and breast-feeding of affected infants, Third trimester: May produce neonatal haemolysis if used at term, only small amounts are present in milk but could be enough to produce haemolysis in G6PD deficient infants), acute porphyria.

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

Patients with known hypersensitivity to nitrofurantoin or other nitrofurans.

4.4 Special Warnings And Precautions For Use

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

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

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

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

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

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

Patients should be monitored closely for signs of hepatitis (particularly in long terms use).

Urine may be coloured yellow or brown after taking Nitrofurantoin. Patients on Nitrofurantoin are susceptible to false positive urinary glucose (if tested for reducing substances).

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

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

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

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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

2. Decreased absorption with magnesium trisilicate.

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

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

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

6. Interference with some tests for glucose in urine

7. As Nitrofurantoin belongs to the group of Antibacterials it will have the following resulting interactions:

Oestrogens: Antibacterials that do not induce liver enzymes possibly reduce contraceptive effect of oestrogens (risk probably small, Interactions of combined oral contraceptives may also apply to combined contraceptive patches).

Typhoid Vaccine (oral): Antibacterials inactivate oral typhoid vaccine.

4.6 Pregnancy And Lactation

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

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

4.7 Effects On Ability To Drive And Use Machines

Nitrofurantoin may cause dizziness and drowsiness. Patients should be advised not to drive or operate machinery if affected in this way until such symptoms go away.

4.8 Undesirable Effects

Respiratory

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

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

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

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

Hepatic

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

Neurological

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

Gastrointestinal

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

Haematological

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

Hypersensitivity

Allergic skin reactions manifesting as angioneurotic oedema, maculopapular, erythematous or eczematous eruptions, urticaria, rash, and pruritis have occurred. Lupus-like syndrome associated with pulmonary reactions to Nitrofurantoin has been reported. Exfoliative dermatitis and erythema multiforme (including Stevens- Johnson Syndrome) have been reported rarely. Other hypersensitivity reactions include anaphylaxis, sialadenitis, pancreatitis, drug fever and arthralgia.

Miscellaneous

Transient alopecia and benign intracranial hypertension. As with other antimicrobial agents, superinfections by fungi or resistant organisms such as Pseudomonas may occur. However, these are limited to the genito-urinary tract because suppression of normal bacterial flora does not occur elsewhere in the body.

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

Escherichia coli

Enterococcus Faecalis

Klebsiella Species

Enterobacter Species

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

Citrobacter Species

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

5.2 Pharmacokinetic Properties

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

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

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Furadantin Suspension contains glycerol, polysorbate-20, Carbomer, Saccharin sodium, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Sodium Hydroxide, Sodium Hydroxide, flavourings (Lemon Essence F31874 and Apricot Flavour F31191) and purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Furadantin Suspension should be protected from light and freezing. It should be stored at a temperature not exceeding 25°.

6.5 Nature And Contents Of Container

Furadantin Suspension is supplied in 300ml amber glass bottles.

6.6 Special Precautions For Disposal And Other Handling

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

Furadantin suspension should be protected from light, as exposure will cause darkening of the active principle. Because of this, amber bottles should be used in dispensing.

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Limited

NLA Tower

12-16 Addiscombe Road

Croydon

CR0 0XT

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0055

9. Date Of First Authorisation/Renewal Of The Authorisation

31/03/2000

10. Date Of Revision Of The Text

06/10/2010

Antiandrogens

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

Antiandrogen is any one of a group of drugs that act as androgen receptor blockers.

There are two types of antiandrogens, pure or non-steroidal and steroidal. They block the effects of androgens (male sex hormones; testosterone and dihydrotestosterone).

Antiandrogens are used as an adjunct in prostate cancer, which is an androgen-dependent cancer. It is used to treat precocious puberty in young males, benign prostate hyperplasia, androgenetic alopecia and various other sexual disorders (such as hypersexuality) in men.

Antiandrogens are used in women to treat polycystic ovarian syndrome, masculization and acne.

See also

Medical conditions associated with antiandrogens:

• Hirsutism
• Prostate Cancer

Drug List:

Casodex

Eulexin

Nilandron

Good Neighbor Ibuprofen Cold and Sinus

Dosage Form: tablet
Amerisource Bergen Ibuprofen Cold and Sinus Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Nasal decongestant

Uses

temporarily relieves these symptoms associated with the common cold, or flu:

• headache


• fever


• sinus pressure


• nasal congestion


• minor body aches and pains

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives


• facial swelling


• asthma (wheezing)


• shock


• skin reddening


• rash


• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.

The chance is higher if you:

• are age 60 or older


• have had stomach ulcers or bleeding problems


• take a blood thinning (anticoagulant) or steroid drug


• take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others]


• have 3 or more alcoholic drinks every day while using this product


• take more or for a longer time than directed

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer


• right before or after heart surgery


• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.


• in children under 12 years of age

Ask a doctor before use if you have

• problems or serious side effects from taking pain relievers or fever reducers


• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain


• ulcers


• bleeding problems


• high blood pressure


• heart or kidney disease


• thyroid disease


• diabetes


• trouble urinating due to an enlarged prostate gland


• taken a diuretic


• reached age 60 or older


• asthma

Ask a doctor or pharmacist before use if you are

• taking any other drug containing an NSAID (prescription or nonprescription)


• taking a blood thinning (anticoagulant) or steroid drug


• under a doctor’s care for any serious condition


• taking any other product that contains pseudoephedrine, or any other nasal decongestant


• taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin


• taking any other drug

When using this product

• take with food or milk if stomach upset occurs


• long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.


• fever gets worse or lasts more than 3 days


• nasal congestion lasts for more than 7 days


• symptoms continue or get worse


• stomach pain or upset gets worse or lasts


• redness or swelling is present in the painful area


• you get nervous, dizzy, or sleepless


• any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed


• the smallest effective dose should be used


• do not take longer than 7 days, unless directed by a doctor (see Warnings)


• adults and children 12 years of age and over:


• take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.


• do not use more than 6 caplets in any 24-hour period unless directed by a doctor


• children under 12 years of age: do not use

Other information

• store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).


• read all warnings and directions before use. Keep carton.

Inactive ingredients

acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Active Ingredients in Advil® Cold & Sinus

Non Drowsy

Ibuprofen Cold & Sinus

Ibuprofen (NSAID)* 200 mg – Pain Reliever/Fever Reducer

Pseudoephedrine HCl 30 mg – Nasal Decongestant

Tablets

*nonsteroidal anti-inflammatory drug

Relieves Sinus Pressure, Nasal Congestion and Fever

See New Warning & Dosing Directions

**Oval-Shaped Tablets

Ibuprofen Cold and Sinus Carton

GOOD NEIGHBOR PHARMACY IBUPROFEN COLD AND SINUS  ibuprofen, pseudoephedrine hydrochloride  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 24385-465 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN Score no score Shape OVAL Size 15mm Flavor Imprint Code 083 Contains

Packaging # NDC Package Description Multilevel Packaging 1 24385-465-60 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (24385-465-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074567	10/15/2001

Labeler - Amerisource Bergen (007914906)

Revised: 06/2009Amerisource Bergen

More Good Neighbor Ibuprofen Cold and Sinus resources

• Good Neighbor Ibuprofen Cold and Sinus Use in Pregnancy & Breastfeeding
• Good Neighbor Ibuprofen Cold and Sinus Drug Interactions
• Good Neighbor Ibuprofen Cold and Sinus Support Group
• 3 Reviews for Good Neighbor Ibuprofen Cold and Sinus - Add your own review/rating

Compare Good Neighbor Ibuprofen Cold and Sinus with other medications

• Sinus Symptoms

Advate rAHF-PFM injection

Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)

Brand Names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto

What is antihemophilic factor (factor VIII)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.

Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?

This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.

Do not use this medication if you have:

• 
  

  a history of allergy to antihemophilic factor; or

  
  


• 
  

  a history of allergy to products made with human or animal proteins, especially mouse proteins.

  
  

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication 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.

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

How should I use antihemophilic factor (factor VIII)?

This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Store the powder medicine in the refrigerator. Do not freeze. Do not mix this medicine with the liquid diluent until you are ready to give the injection. Once the medicine has been mixed, you must use it within 3 hours. Do not refrigerate the mixed medicine. Keep it at room temperature. You may also store the powder at room temperature for up to 6 months or until the expiration date printed on the label (whichever comes first). Do not put the medicine back into the refrigerator once you have kept it at room temperature.

What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

What should I avoid while using antihemophilic factor (factor VIII)?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Antihemophilic factor (factor VIII) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;

  
  


• 
  

  fast heart rate, chest pain, trouble breathing;

  
  


• 
  

  feeling light-headed, fainting; or

  
  


• 
  

  pain, redness, swelling, or oozing where the medicine was injected.

  
  

Other, less serious side effects may be more likely to occur, such as:

• 
  

  unusual taste in your mouth;

  
  


• 
  

  cough, runny or stuffy nose;

  
  


• 
  

  mild itching;

  
  


• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  headache or dizziness;

  
  


• 
  

  mild nausea, diarrhea, stomach pain;

  
  


• 
  

  sweating;

  
  


• 
  

  joint pain; or

  
  


• 
  

  chills or flushing (warmth or tingly feeling).

  
  

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.

What other drugs will affect antihemophilic factor (factor VIII)?

Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.

There may be other drugs that can affect antihemophilic factor (factor VIII). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has additional information about antihemophilic factor (factor VIII) written for health professionals that you may read.

What does my medication look like?

Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.