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Buphenyl

sodium phenylbutyrate

Dosage Form: powder, tablets
Buphenyl® (sodium phenylbutyrate) Tablets

Buphenyl® (sodium phenylbutyrate) Powder

[ bu'fen-əl ]

(sodium phenylbutyrate)

Rx Only

Buphenyl Description

Buphenyl® (sodium phenylbutyrate) Tablets for oral administration and Buphenyl® (sodium phenylbutyrate) Powder for oral, nasogastric, or gastrostomy tube administration contain sodium phenylbutyrate. Sodium phenylbutyrate is an off-white crystalline substance which is soluble in water and has a strong salty taste. Sodium phenylbutyrate also is freely soluble in methanol and practically insoluble in acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186 and the molecular formula C10H11O2Na.

Chemical Structure:

Each tablet of Buphenyl contains 500 mg of sodium phenylbutyrate and the inactive ingredients microcrystalline cellulose NF, magnesium stearate NF, and colloidal silicon dioxide NF.

Each gram of Buphenyl Powder contains 0.94 grams of sodium phenylbutyrate and the inactive ingredients calcium stearate NF, and colloidal silicon dioxide NF.

Buphenyl - Clinical Pharmacology

Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to phenylacetate. Phenylacetate is a metabolically-active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine. Phenylacetylglutamine then is excreted by the kidneys. On a molar basis, it is comparable to urea (each containing two moles of nitrogen). Therefore, phenylacetylglutamine provides an alternate vehicle for waste nitrogen excretion.

PHARMACOKINETICS

General

Pharmacokinetic studies have not been conducted in the primary patient population (neonates, infants, and children), but pharmacokinetic data were obtained from normal adult subjects.

Absorption

Peak plasma levels of phenylbutyrate occur within 1 hour after a single dose of 5 grams of sodium phenylbutyrate tablet with a Cmax of 218 µg/mL under fasting conditions; peak plasma levels of phenylbutyrate occur within 1 hour after a single dose of 5 grams of sodium phenylbutyrate powder with a Cmax of 195 µg/mL under fasting conditions. The effect of food on phenylbutyrate's absorption is unknown.

Disposition

The overall disposition of sodium phenylbutyrate and its metabolites has not been characterized fully. However, the drug is known to be metabolized to phenylacetate and subsequently to phenylacetylglutamine. Following oral administration of 5 grams (tablets), measurable plasma levels of phenylbutyrate and phenylacetate were detected 15 and 30 minutes after dosing, respectively, and phenylacetylglutamine was detected shortly thereafter. The pharmacokinetic parameters for phenylbutyrate for Cmax (µg/mL), Tmax (hours), and elimination half-life (hours) were 218, 1.35, and 0.77, respectively, and for phenylacetate were 48.5, 3.74, and 1.15, respectively.

Following oral administration of 5 grams of the powder, measurable plasma levels of phenylbutyrate and phenylacetate were detected 15 and 30 minutes after dosing, respectively, and phenylacetylglutamine was detected shortly thereafter. The pharmacokinetic parameters for phenylbutyrate for Cmax (µg/mL), Tmax (hours), and elimination half-life (hours) were 195, 1.00, and 0.76, respectively, and for phenylacetate were 45.3, 3.55, and 1.29, respectively.

The major sites for metabolism of sodium phenylbutyrate are the liver and kidney.

Excretion

A majority of the administered compound (approximately 80 – 100%) was excreted by the kidneys within 24 hours as the conjugation product, phenylacetylglutamine. For each gram of sodium phenylbutyrate administered, it is estimated that between 0.12 – 0.15 grams of phenylacetylglutamine nitrogen are produced.

Pharmacodynamics

In patients with urea cycle disorders, Buphenyl® decreased elevated plasma ammonia glutamine levels. It increases waste nitrogen excretion in the form of phenylacetylglutamine.

Special Populations

Gender

Significant gender differences were found in the pharmacokinetics of phenylbutyrate and phenylacetate, but not for phenylacetylglutamine. The pharmacokinetic parameters (AUC and Cmax), for both plasma phenylbutyrate and phenylacetate were about 30 to 50 percent greater in females than in males.

Hepatic insufficiency

In patients who did not have urea cycle disorders but had impaired hepatic function, the metabolism and excretion of sodium phenylbutyrate were not affected. However, this information was obtained from unvalidated, uncontrolled case studies.

Indications and Usage for Buphenyl

Buphenyl® is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately to improve survival. Any episode of acute hyperammonemia should be treated as a life-threatening emergency.

Buphenyl must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (See Nutritional Supplementation subsection of the DOSAGE AND ADMINISTRATION section.)

Previously, neonatal-onset disease was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogs. However, with hemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate, and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth but within the first month of life is almost 80%. Most deaths have occurred during an episode of acute hyperammonemic encephalopathy. Patients with neonatal-onset disease have a high incidence of mental retardation. Those who had IQ tests administered had an incidence of mental retardation as follows: ornithine transcarbamylase deficiency, 100% (14/14 patients tested); argininosuccinic acid synthetase deficiency, 88% (15/17 patients tested); and carbamylphosphate synthetase deficiency, 57% (4/7 patients tested). Retardation was severe in the majority of the retarded patients.

In patients diagnosed during gestation and treated prior to any episode of hyperammonemic encephalopathy, survival is 100%, but even in these patients, most subsequently demonstrate cognitive impairment or other neurologic deficits.

In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recover from hyperammonemic encephalopathy and are then treated chronically with sodium phenylbutyrate and dietary protein restriction, the survival rate is 98%. The two deaths in this group of patients occurred during episodes of hyperammonemic encephalopathy. However, compliance with the therapeutic regimen has not been adequately documented to allow evaluation of the potential for Buphenyl and dietary protein restriction to prevent mental deterioration and recurrence of hyperammonemic encephalopathy if carefully adhered to. The majority of these patients tested (30/46 or 65%) have IQ's in the average to low average/borderline mentally retarded range. Reversal of pre-existing neurologic impairment is not likely to occur with treatment and neurologic deterioration may continue in some patients.

Even on therapy, acute hyperammonemic encephalopathy recurred in the majority of patients for whom the drug is indicated.

Buphenyl may be required life-long unless orthotopic liver transplantation is elected.

(See CLINICAL PHARMACOLOGY, Pharmacodynamics subsection for the biochemical effects of Buphenyl).

Contraindications

Buphenyl® should not be used to manage acute hyperammonemia, which is a medical emergency.

Warnings

Each Buphenyl® Tablet contains 62 mg of sodium (9.2% w/w) (corresponding to 124 mg of sodium per gram of sodium phenylbutyrate [12.4% w/w]) and Buphenyl Powder contains 11.7 grams of sodium per 100 grams of powder, corresponding to 125 mg of sodium per gram of sodium phenylbutyrate (12.4% w/w). Buphenyl should be used with great care, if at all, in patients with congestive heart failure or severe renal insufficiency, and in clinical states in which there is sodium retention with edema.

Because Buphenyl is metabolized in the liver and kidney, and phenylacetylglutamine is primarily excreted by the kidney, use caution when administering the drug to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. Probenecid is known to inhibit the renal transport of many organic compounds, including hippuric acid, and may affect renal excretion of the conjugated product of Buphenyl as well as its metabolite.

Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels.

Precautions

General

Buphenyl® should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation.

There have been published reports of hyperammonemia being induced by haloperidol and by valproic acid.

Neurotoxicity of phenylacetate in animals

When given subcutaneously to rat pups, 190–474 mg/kg phenylacetate caused decreased proliferation and increased loss of neurons, and it reduced CNS myelin. Cerebral synapse maturation was retarded, and the number of functioning nerve terminals in the cerebrum was reduced, which resulted in impaired brain growth. Prenatal exposure of rat pups to phenylacetate produced lesions in layer 5 of the cortical pyramidal cells; dendritic spines were longer and thinner than normal and reduced in number.

Information for Patients

The full text of the separate insert of information for patients is reprinted at the end of the labeling.

Laboratory Tests

Plasma levels of ammonia, arginine, branched-chain amino acids, and serum proteins should be maintained within normal limits, and plasma glutamine should be maintained at levels less than 1,000 µmol/L. Serum drug levels of phenylbutyrate and its metabolites, phenylacetate and phenylacetylglutamine, should be monitored periodically.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies of sodium phenylbutyrate have not been conducted.

Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been conducted with Buphenyl®. It is also not known whether Buphenyl can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Buphenyl should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Buphenyl® is administered to a nursing woman.

Pediatric Use

The use of tablets for neonates, infants and children to the weight of 20 kg is not recommended. (See Dosage and Administration.)

Adverse Reactions

The assessment of clinical adverse events came from 206 patients treated with sodium phenylbutyrate. Adverse events (both clinical and laboratory) were not collected systematically in these patients, but were obtained from patient-visit reports by the 65 co-investigators. Causality of adverse effects is sometimes difficult to determine in this patient population because they may result from either the underlying disease, the patient's restricted diet, intercurrent illness, or Buphenyl®. Furthermore, the rates may be under-estimated because they were reported primarily by parent or guardian and not the patient.

Clinical Adverse Events

In female patients, the most common clinical adverse event reported was amenorrhea/menstrual dysfunction (irregular menstrual cycles), which occurred in 23% of the menstruating patients.

Decreased appetite occurred in 4% of all patients. Body odor (probably caused by the metabolite, phenylacetate) and bad taste or taste aversion were each reported in 3% of patients.

Other adverse events reported in 2% or fewer patients were:

Gastrointestinal: abdominal pain, gastritis, nausea and vomiting; constipation, rectal bleeding, peptic ulcer disease, and pancreatitis each occurred in one patient.

Hematologic: aplastic anemia and ecchymoses each occurred in one patient.

Cardiovascular: arrhythmia and edema each occurred in one patient.

Renal: renal tubular acidosis

Psychiatric: depression

Skin: rash

Miscellaneous: headache, syncope, and weight gain

Neurotoxicity was reported in cancer patients receiving intravenous phenylacetate, 250–300 mg/kg/day for 14 days, repeated at 4-week intervals. Manifestations were predominately somnolence, fatigue, and lightheadedness; with less frequent headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of a pre-existing neuropathy. These adverse events were mainly mild in severity. The acute onset and reversibility when the phenylacetate infusion was discontinued suggest a drug effect.

Laboratory Adverse Events

In patients with urea cycle disorders, the frequency of laboratory adverse events by body system were:

Metabolic: acidosis (14%), alkalosis and hyperchloremia (each 7%), hypophosphatemia (6%), hyperuricemia and hyperphosphatemia (each 2%), and hypernatremia and hypokalemia (each 1%).

Nutritional: hypoalbuminemia (11%) and decreased total protein (3%).

Hepatic: increased alkaline phosphatase (6%), increased liver transaminases (4%), and hyperbilirubinemia (1%).

Hematologic: anemia (9%), leukopenia and leukocytosis (each 4%), thrombocytopenia (3%), and thrombocytosis (1%).

The clinician is advised to routinely perform urinalysis, blood chemistry profiles, and hematologic tests.

Overdosage

No adverse experiences have been reported involving overdoses of sodium phenylbutyrate in patients with urea cycle disorders.

In the event of an overdose, discontinue the drug and institute supportive measures.

Hemodialysis or peritoneal dialysis may be beneficial.

Buphenyl Dosage and Administration

For oral use only.

The use of Buphenyl® Tablets is indicated for children weighing more than 20 kg and for adults.

The usual total daily dose of Buphenyl Tablets and Powder for patients with urea cycle disorders is 450 – 600 mg/kg/day in patients weighing less than 20 kg, or 9.9 – 13.0 g/m2/day in larger patients. The tablets and powder are to be taken in equally divided amounts with each meal or feeding (i.e., three to six times per day).

Buphenyl® Powder is indicated for oral use (via mouth, gastrostomy, or nasogastric tube) only.   The powder is to be mixed with food (solid or liquid) for immediate use; however, when dissolved in water, Buphenyl Powder has been shown to be stable for up to one week at room temperature or refrigerated. Sodium phenylbutyrate is very soluble in water (5 grams per 10 mL). When Buphenyl Powder is added to a liquid, only sodium phenylbutyrate will dissolve, the excipients will not. The effect of food on sodium phenylbutyrate has not been determined.

Each level teaspoon (enclosed) dispenses 3.2 grams of powder and 3.0 grams of sodium phenylbutyrate. Each level tablespoon (enclosed) dispenses 9.1 grams of powder and 8.6 grams of sodium phenylbutyrate.

Shake lightly before use.

The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established.

NUTRITIONAL MANAGEMENT

To promote growth and development, plasma levels of ammonia, arginine, branched-chain amino acids, and serum protein should be maintained within normal limits while plasma glutamine is maintained at levels less than 1,000 µmol/L. Minimum daily protein intake for a patient of a particular age should be taken from, for example, "Recommended Dietary Allowances", 10th ed., Food and Nutrition Board, National Academy of Sciences, 1989. The allocation of dietary nitrogen into natural protein and essential amino acids is a function of age, residual urea-cycle enzyme activity, and the dose of sodium phenylbutyrate.

At the recommended dose of sodium phenylbutyrate, it is suggested that infants with neonatal-onset CPS and OTC deficiencies initially receive a daily dietary protein intake limited to approximately 1.6 g/kg/day for the first 4 months of life. If tolerated, the daily protein intake may be increased to 1.9 g/kg/day during this period. Protein tolerance will decrease as the growth rate decreases, requiring a reduction in dietary nitrogen intake. From 4 months to 1 year of age, it is recommended that the infant receive at least 1.4 g/kg/day, but 1.7 g/kg/day is advisable. From 1 to 3 years of age, the protein intake should not be less than 1.2 g/kg/day; 1.4 g/kg/day is advisable during this period. For neonatal-onset patients with carbamylphosphate synthetase deficiency or ornithine transcarbamylase deficiency who are at least 6 months of age, it is recommended that the daily protein intake be equally divided between natural protein and supplemental essential amino acids.

Patients with argininosuccinic acid synthetase deficiency and those with late-onset disease (partial deficiencies, including females heterozygous for ornithine transcarbamylase), initially may receive a diet containing the age-determined minimal daily natural protein allowance. The protein intake may be increased as tolerated and determined by plasma glutamine and other amino acid levels. However, many patients with partial deficiencies avoid dietary protein.

Citrulline supplementation is required and recommended for patients diagnosed with neonatal-onset deficiency of carbamylphosphate synthetase or ornithine transcarbamylase; citrulline daily intake is recommended at 0.17 g/kg/day or 3.8 g/m2/day.

The free-base form of arginine may be used instead of citrulline in patients with milder forms of carbamylphosphate synthetase and ornithine transcarbamylase deficiency (daily intake is recommended at 0.17 g/kg/day or 3.8 g/m2/day).

Arginine supplementation is needed for patients diagnosed with deficiency of argininosuccinic acid synthetase; arginine (free base) daily intake is recommended at 0.4 – 0.7 g/kg/day or 8.8 – 15.4 g/m2/day.

If caloric supplementation is indicated, a protein-free product is recommended. Caloric intake should be based upon the "Recommended Dietary Allowances", 10th ed., Food and Nutrition Board, National Research Council, National Academy of Sciences, 1989.

How is Buphenyl Supplied

Buphenyl® Tablets are available in 250 cc bottles which contain 250 sodium phenylbutyrate tablets (NDC 62592-496-03). The bottles are equipped with child-resistant caps. Each tablet is off-white, oval, and embossed with "UCY 500". Each tablet contains 500 mg of sodium phenylbutyrate. STORE AT ROOM TEMPERATURE 15°C – 30°C (59°F – 86°F). AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED.

Buphenyl® Powder is available in 500 cc bottles, which hold 266 grams of powder, containing 250 grams of sodium phenylbutyrate (NDC 62592-188-64). The bottles are equipped with child-resistant caps. Measurers are provided. Each level teaspoon (enclosed) dispenses 3.2 grams of powder and 3.0 grams of sodium phenylbutyrate. Each level tablespoon (enclosed) dispenses 9.1 grams of powder and 8.6 grams of sodium phenylbutyrate. STORE AT ROOM TEMPERATURE 15°C – 30°C (59°F – 86°F). AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED.

All marks are the property of their respective owners.

Manufactured for: Ucyclyd Pharma, Inc., Scottsdale, AZ  85256

NDC 62592-496-03 bottle contains 250 tablets of 500 mg.

NDC 62592-188-64 bottle containing 250 g of sodium phenylbutyrate powder.

Prescribing Information as of April 2009.

08170038

PATIENT PACKAGE INSERT:

Buphenyl® (sodium phenylbutyrate) Tablets

Buphenyl® (sodium phenylbutyrate) Powder

What is the most important information I should know about Buphenyl®?

Buphenyl® is prescribed along with changes in diet for long-term treatment of urea cycle disorders. Buphenyl can only be obtained with a prescription from your doctor.

Buphenyl must be taken exactly as the doctor prescribes; do not increase or decrease the dose of this medication without the doctor's approval.

What are urea cycle disorders?

Urea cycle disorders include a group of diseases, each having a specific liver enzyme deficiency. Because they are inherited, other family members may be affected. These disorders vary in severity and may be first detected at various ages, from newborn infants to adults. They lead to increased amounts of ammonia in the blood, which may cause disturbed brain function and severe brain damage. Typical signs of the disease are decreased mental awareness, vomiting, combativeness, slurred speech, unstable gait, and unconsciousness.  The diagnosis of urea cycle disorders requires special laboratory tests. These typical signs of the disease may recur after the diagnosis is made if the condition is not under control. If they do, the doctor should be notified immediately because this is a medical emergency. An infection can cause the condition to go out of control. Therefore, if a fever develops, the doctor should be seen immediately.

A patient or carrier of these disorders should wear a Medic Alert tag stating the diagnosis. In the event that the patient has a sudden, rapid accumulation of ammonia in the blood, and, therefore, in the brain, leading to unconsciousness, the doctor will be alerted to treat the disease properly.

Periodically, depending upon the severity of a particular patient's urea cycle disorder, it will be necessary to perform blood tests. These include plasma ammonia, plasma amino acid levels, and other more routine blood tests to evaluate nutritional status.

What is Buphenyl®?

Buphenyl® is a drug that helps to prevent ammonia from accumulating in the blood. Buphenyl aids the body in eliminating substances that produce ammonia. However, despite drug treatment, blood ammonia levels may become elevated periodically and there may be episodes of altered brain function in association with these ammonia elevations. Patients who have disease onset as newborns have a high incidence of mental retardation. Medical attention should be obtained as soon as signs appear (see above under "What are urea cycle disorders?"). Buphenyl may be used as life-long therapy or as a temporary measure until liver transplantation is performed.

What diet should I or my child follow?

In addition to taking Buphenyl®, it is equally important that a prescribed diet be followed. Because there is great variability in the severity of urea cycle disorders, each patient's diet should be custom designed by a physician and a nutritionist. Because the diet is so important, it is recommended that the prescribed diet be discussed with a nutritionist who is familiar with urea cycle disorders.

Who should not take Buphenyl®?

Buphenyl® is prescribed only for patients with urea cycle disorders. It is not to be used for any other reason. Keep the medication in a safe place where children cannot reach it.

What other medical conditions may also be present that could increase the risk of taking Buphenyl®?

Heart failure or decreased kidney function may lead to retention of the sodium content of Buphenyl® with potentially serious consequences such as worsening heart failure, high blood pressure, and swelling. If these medical conditions are present, the doctor will determine if your child should take Buphenyl.

How should I or my child take Buphenyl®?

The dose of Buphenyl® prescribed for adults and children is based upon the patient's weight or size. It is very important that the full amount prescribed for any 24-hour period be taken. If a dose is missed it should be administered as soon as possible that same day. The total daily dose should be administered in equally divided amounts with meals.

What medications should I or my child avoid or be cautious of taking while on Buphenyl®?

Patients with urea cycle disorders usually should not take Depakene® (valproic acid), a drug sometimes prescribed for seizure disorders, or Haldol® (haloperidol), a drug used to treat certain types of psychiatric or neurologic disorders. Both of these drugs have been reported to increase blood ammonia levels. Steroids may break down body protein, thereby increasing blood ammonia levels. The doctor should be consulted before administering medications containing steroids.

What medications may affect the way the body breaks down the drug?

Probenecid, a medication used to treat gout, may affect the way the kidneys excrete Buphenyl® (consult the doctor for details).

What are the most common side effects of Buphenyl®?

The most common side effect reported in premenopausal women taking Buphenyl® was absent or irregular menstrual periods. Decreased appetite was reported in 4% of all people treated. Body odor and bad taste were each reported in 3% of all patients treated.

A breakdown product of Buphenyl has been associated mainly with sleepiness and light-headedness. Because these symptoms may also be due to the urea cycle going out of control, a doctor should see the patient immediately if these symptoms occur, so the cause can be determined.   Blood tests should be performed periodically for adverse effects and for levels of medication and its breakdown products.

How should Buphenyl® be stored?

Buphenyl® should be stored in a tightly closed bottle at room temperature.

This leaflet provides a brief summary of the information available on Buphenyl®. The information here is incomplete and is not designed to take the place of your doctor's instructions. For more complete information, consult your physician or call or write Ucyclyd Pharma, Inc. at 7720 N. Dobson Road, Scottsdale, AZ 85256. (888) 829-2593.

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Carton

Ucyclyd

Pharma®

NDC 62592-496-03

Buphenyl®

(sodium phenylbutyrate)

500 mg

Tablets

250 Tablets

Pharmacist: Dispense in this

unit-of-use Child Resistant container

with enclosed patient leaflet.

Rx Only

PRINCIPAL DISPLAY PANEL - 250 Gram Bottle Carton

Ucyclyd

Pharma®

NDC 62592-188-64

Buphenyl®

(sodium phenylbutyrate)

Powder

250 Grams

Rx Only

Buphenyl  sodium phenylbutyrate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 62592-496 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium phenylbutyrate (phenylbutyric acid) sodium phenylbutyrate 500 mg

Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline   magnesium stearate   silicon dioxide

Product Characteristics Color WHITE (off-white) Score no score Shape OVAL Size 16mm Flavor Imprint Code UCY;500 Contains

Packaging # NDC Package Description Multilevel Packaging 1 62592-496-03 1 BOTTLE In 1 CARTON contains a BOTTLE 1 250 TABLET In 1 BOTTLE This package is contained within the CARTON (62592-496-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020572	05/13/1996

Buphenyl  sodium phenylbutyrate  powder

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 62592-188 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium phenylbutyrate (phenylbutyric acid) sodium phenylbutyrate 0.94 g  in 1 g

Inactive Ingredients Ingredient Name Strength calcium stearate   silicon dioxide

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 62592-188-64 1 BOTTLE In 1 CARTON contains a BOTTLE 1 250 g In 1 BOTTLE This package is contained within the CARTON (62592-188-64)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020573	04/30/1996

Labeler - Ucyclyd Pharma Inc. (150393221)

Establishment
Name	Address	ID/FEI	Operations
Lyne Laboratories, Inc.		053510459	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Pharmaceuticals International, Inc. (PII)		878265586	MANUFACTURE

Revised: 05/2010Ucyclyd Pharma Inc.

More Buphenyl resources

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

• Buphenyl Concise Consumer Information (Cerner Multum)


• Buphenyl Advanced Consumer (Micromedex) - Includes Dosage Information


• Buphenyl MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Buphenyl with other medications

• Urea Cycle Disorders

Vikadar

Vikadar may be available in the countries listed below.

Ingredient matches for Vikadar

Phenoxymethylpenicillin

Phenoxymethylpenicillin is reported as an ingredient of Vikadar in the following countries:

• Bahrain


• Iraq


• Jordan


• Kuwait


• Lebanon


• Libya


• Nigeria


• Qatar


• Saudi Arabia


• Somalia


• Sudan


• United Arab Emirates


• Yemen

Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Vikadar in the following countries:

• Oman

International Drug Name Search

Bactil

Bactil may be available in the countries listed below.

Ingredient matches for Bactil

Ebastine

Ebastine is reported as an ingredient of Bactil in the following countries:

• Spain

International Drug Name Search

Nortimil

Nortimil may be available in the countries listed below.

Ingredient matches for Nortimil

Desipramine

Desipramine hydrochloride (a derivative of Desipramine) is reported as an ingredient of Nortimil in the following countries:

• Italy

International Drug Name Search

Ogasto

Ogasto may be available in the countries listed below.

Ingredient matches for Ogasto

Lansoprazole

Lansoprazole is reported as an ingredient of Ogasto in the following countries:

• Portugal

International Drug Name Search

Cardzaar

Cardzaar may be available in the countries listed below.

Ingredient matches for Cardzaar

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Cardzaar in the following countries:

• Greece

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Cardzaar in the following countries:

• Greece

International Drug Name Search

Erevit

Erevit may be available in the countries listed below.

Ingredient matches for Erevit

Tocopherol, α-

Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Erevit in the following countries:

• Czech Republic


• Slovakia

International Drug Name Search

Furosémide RPG

Furosémide RPG may be available in the countries listed below.

Ingredient matches for Furosémide RPG

Furosemide

Furosemide is reported as an ingredient of Furosémide RPG in the following countries:

• France

International Drug Name Search

Taxetil

Taxetil may be available in the countries listed below.

Ingredient matches for Taxetil

Cefpodoxime

Cefpodoxime proxetil (a derivative of Cefpodoxime) is reported as an ingredient of Taxetil in the following countries:

• Bangladesh

International Drug Name Search

Trimébutine G Gam

Trimébutine G Gam may be available in the countries listed below.

Ingredient matches for Trimébutine G Gam

Trimebutine

Trimebutine maleate (a derivative of Trimebutine) is reported as an ingredient of Trimébutine G Gam in the following countries:

• France

International Drug Name Search

Interleukina II

Interleukina II may be available in the countries listed below.

Ingredient matches for Interleukina II

Aldesleukin

Aldesleukin is reported as an ingredient of Interleukina II in the following countries:

• Chile

International Drug Name Search

Adipiodone Meglumine

Adipiodone Meglumine may be available in the countries listed below.

Ingredient matches for Adipiodone Meglumine

Adipiodone

Adipiodone Meglumine (BANM) is also known as Adipiodone (Rec.INN)

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Tamsulosin 1A Pharma

Tamsulosin 1A Pharma may be available in the countries listed below.

Ingredient matches for Tamsulosin 1A Pharma

Tamsulosin

Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tamsulosin 1A Pharma in the following countries:

• Austria

International Drug Name Search

Palface

Palface may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Palface

Dextromoramide

Dextromoramide tartrate (a derivative of Dextromoramide) is reported as an ingredient of Palface in the following countries:

• Netherlands

International Drug Name Search

Carbavim

Carbavim may be available in the countries listed below.

Ingredient matches for Carbavim

Carbamazepine

Carbamazepine is reported as an ingredient of Carbavim in the following countries:

• Romania

International Drug Name Search

Newmazole

Newmazole may be available in the countries listed below.

Ingredient matches for Newmazole

Carbimazole

Carbimazole is reported as an ingredient of Newmazole in the following countries:

• Taiwan

International Drug Name Search

Naprosyn

Naprosyn is a brand name of naproxen, approved by the FDA in the following formulation(s):

NAPROSYN (naproxen - suspension; oral)

• 
  Manufacturer: ROCHE PALO
  
  Approval date: March 23, 1987
  
  Strength(s): 25MG/ML ^[RLD][AB]

NAPROSYN (naproxen - tablet; oral)

• 
  Manufacturer: ROCHE PALO
  
  Approved Prior to Jan 1, 1982
  
  Strength(s): 250MG ^[AB], 375MG ^[AB]


• 
  Manufacturer: ROCHE PALO
  
  Approval date: April 15, 1982
  
  Strength(s): 500MG ^[RLD][AB]

Has a generic version of Naprosyn been approved?

Yes. The following products are equivalent to Naprosyn:

naproxen suspension; oral

• 
  Manufacturer: ROXANE
  
  Approval date: March 30, 1994
  
  Strength(s): 25MG/ML ^[AB]

naproxen tablet; oral

• 
  Manufacturer: AMNEAL PHARMS NY
  
  Approval date: December 18, 2001
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: AUROBINDO PHARMA USA
  
  Approval date: November 8, 2011
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: DAVA PHARMS INC
  
  Approval date: April 28, 1995
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: GLENMARK GENERICS
  
  Approval date: March 28, 2007
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: INVAGEN PHARMS
  
  Approval date: August 24, 2011
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: MARKSANS PHARMA
  
  Approval date: February 14, 2011
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: MYLAN
  
  Approval date: December 21, 1993
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: PERRIGO R AND D
  
  Approval date: April 27, 2005
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: SANDOZ
  
  Approval date: December 21, 1993
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: TEVA
  
  Approval date: December 21, 1993
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: WATSON LABS
  
  Approval date: May 31, 1995
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: WESTWARD
  
  Approval date: January 14, 2004
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]


• 
  Manufacturer: ZYDUS PHARMS USA
  
  Approval date: June 7, 2007
  
  Strength(s): 250MG ^[AB], 375MG ^[AB], 500MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Naprosyn. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Naprosyn.

See also...

• Naprosyn Consumer Information (Drugs.com)
• Naprosyn Consumer Information (Wolters Kluwer)
• Naprosyn Suspension Consumer Information (Wolters Kluwer)
• Naprosyn Consumer Information (Cerner Multum)
• Naprosyn Advanced Consumer Information (Micromedex)
• Naproxen Consumer Information (Drugs.com)
• Naproxen Consumer Information (Wolters Kluwer)
• Naproxen Enteric-Coated Tablets Consumer Information (Wolters Kluwer)
• Naproxen Suspension Consumer Information (Wolters Kluwer)
• Naproxen Sustained-Release Tablets Consumer Information (Wolters Kluwer)
• Naprelan 375 Consumer Information (Cerner Multum)
• Naprelan 500 Consumer Information (Cerner Multum)
• Naprelan 750 Consumer Information (Cerner Multum)
• Naproxen Consumer Information (Cerner Multum)
• Naprelan 500 Advanced Consumer Information (Micromedex)
• Naprelan Dose Card Advanced Consumer Information (Micromedex)
• Naxen Advanced Consumer Information (Micromedex)
• Naproxen Advanced Consumer Information (Micromedex)
• Naproxen AHFS DI Monographs (ASHP)
• Naproxen Sodium AHFS DI Monographs (ASHP)

Betafusin

Betafusin may be available in the countries listed below.

Ingredient matches for Betafusin

Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Betafusin in the following countries:

• Greece

Fusidic Acid

Fusidic Acid is reported as an ingredient of Betafusin in the following countries:

• Greece

International Drug Name Search

Carbostine

Carbostine may be available in the countries listed below.

Ingredient matches for Carbostine

Carbocisteine

Carbocisteine is reported as an ingredient of Carbostine in the following countries:

• Tunisia

International Drug Name Search

Gallbladder Contraction Medications

Drugs associated with Gallbladder Contraction

The following drugs and medications are in some way related to, or used in the treatment of Gallbladder Contraction. 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:

Kinevac

Fluosmin

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Fluosmin

Flumetasone

Flumetasone 21-acetate (a derivative of Flumetasone) is reported as an ingredient of Fluosmin in the following countries:

• United States

International Drug Name Search

Hoestdrank Noscapine HCl

Hoestdrank Noscapine HCl may be available in the countries listed below.

Ingredient matches for Hoestdrank Noscapine HCl

Noscapine

Noscapine hydrochloride (a derivative of Noscapine) is reported as an ingredient of Hoestdrank Noscapine HCl in the following countries:

• Netherlands

International Drug Name Search

Flumazénil

Flumazénil may be available in the countries listed below.

Ingredient matches for Flumazénil

Flumazenil

Flumazénil (DCF) is known as Flumazenil in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Myko Cordes

Myko Cordes may be available in the countries listed below.

Ingredient matches for Myko Cordes

Clotrimazole

Clotrimazole is reported as an ingredient of Myko Cordes in the following countries:

• Germany

International Drug Name Search

Para-don

Para-don may be available in the countries listed below.

Ingredient matches for Para-don

Paracetamol

Paracetamol is reported as an ingredient of Para-don in the following countries:

• Netherlands

Propyphenazone

Propyphenazone is reported as an ingredient of Para-don in the following countries:

• Netherlands

International Drug Name Search

Felviten

Felviten may be available in the countries listed below.

Ingredient matches for Felviten

Anetholtrithion

Anetholtrithion is reported as an ingredient of Felviten in the following countries:

• Japan

International Drug Name Search

Ketoprofene EG

Ketoprofene EG may be available in the countries listed below.

Ingredient matches for Ketoprofene EG

Ketoprofen

Ketoprofen is reported as an ingredient of Ketoprofene EG in the following countries:

• Italy

International Drug Name Search

Air-X

Air-X may be available in the countries listed below.

Ingredient matches for Air-X

Dimeticone

Dimeticone is reported as an ingredient of Air-X in the following countries:

• Myanmar

Simeticone

Simeticone is reported as an ingredient of Air-X in the following countries:

• Thailand


• Vietnam

International Drug Name Search

Biclar Junior

Biclar Junior may be available in the countries listed below.

Ingredient matches for Biclar Junior

Clarithromycin

Clarithromycin is reported as an ingredient of Biclar Junior in the following countries:

• Belgium

International Drug Name Search

Rilonacept

Pronunciation: ril-ON-a-sept
Generic Name: Rilonacept
Brand Name: Arcalyst

Rilonacept is used for:

Treating certain types of genetic syndromes (cryopyrin-associated periodic syndromes [CAPS]), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). It may also be used for other conditions as determined by your doctor.

Rilonacept is an interleukin-1 (IL-1) blocker. It works by blocking the activity of interleukin-1, which reduces inflammation.

Do NOT use Rilonacept if:

• you are allergic to any ingredient in Rilonacept


• you are using an interleukin-1 blocker (eg, anakinra) or tumor necrosis factor (TNF) blockers (eg, etanercept)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rilonacept:

Some medical conditions may interact with Rilonacept. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have an infection (including an infection that will not go away) or tuberculosis (TB), have had a positive skin test for TB, or have recently been in close contact with someone who has had TB


• if you are at risk for developing an infection, have an open sore or wound, or have a history of infections that keep coming back


• if you have a history of lung or breathing problems (eg, asthma), high cholesterol or triglyceride levels, an immune system problem, HIV, hepatitis, or diabetes


• if you are scheduled for surgery, or you recently received a vaccine or are scheduled for a vaccine


• if you take warfarin

Some MEDICINES MAY INTERACT with Rilonacept. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Interleukin-1 blockers (eg, anakinra), TNF blockers (eg, etanercept), immunosuppressants (eg, cyclosporine), or corticosteroids (eg, prednisone) because the risk of serious infection may be increased


• Live vaccines because their effectiveness may be decreased by Rilonacept

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rilonacept may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rilonacept:

Use Rilonacept as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Rilonacept. Talk to your pharmacist if you have questions about this information.


• A health care provider will teach you how to use Rilonacept. Be sure you understand how to use Rilonacept. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Rilonacept if it contains particles, is discolored, or if the vial is cracked or damaged.


• Rilonacept may be injected into the abdomen, thigh, or upper arm. Rotate the injection site with each dose. Do not inject Rilonacept into a site that is bruised, red, tender, or hard.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.


• Do not use Rilonacept more often than 1 time per week.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal


• If you miss a dose of Rilonacept, use it as soon as possible, up to the day before your next scheduled dose. Take your next dose at the regularly scheduled time. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Rilonacept.

Important safety information:

• Rilonacept may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. Tell your doctor if you have an open sore or wound.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Tell your doctor or dentist that you take Rilonacept before you receive any medical or dental care, emergency care, or surgery.


• Do not receive a live vaccine (eg, measles, mumps) while you are using Rilonacept. Talk with your doctor before you receive any vaccine.


• You may need to have a TB skin test before you begin using Rilonacept. Contact your doctor with any questions you may have about whether you should receive a TB skin test before using Rilonacept.


• Treatment with medicines that suppress the immune system, including Rilonacept, may increase the risk of developing cancer. Discuss any questions or concerns with your doctor.


• Lab tests, including cholesterol and triglyceride levels, may be performed while you use Rilonacept. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Rilonacept should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• Rilonacept may affect bone development in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Rilonacept.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Rilonacept while you are pregnant. It is not known if Rilonacept is found in breast milk. If you are or will be breast-feeding while you use Rilonacept, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Rilonacept:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild pain, swelling, bruising, or redness at the injection site; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool or stomach pain; fever, chills, cough, or persistent sore throat; flu-like symptoms; increased, decreased, or painful urination; loss of sensation or unusual numbness; unusual lumps or skin growths; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Rilonacept side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.

Proper storage of Rilonacept:

Before mixing, store Rilonacept in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. After mixing, Rilonacept may be kept at room temperature and should be used within 3 hours after mixing. Protect Rilonacept from light. Throw away any medicine that is left in the vial after you use your dose. Do not use Rilonacept after the expiration date on the vial. Keep Rilonacept out of the reach of children and away from pets.

General information:

• If you have any questions about Rilonacept, please talk with your doctor, pharmacist, or other health care provider.


• Rilonacept is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Rilonacept. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Rilonacept resources

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

• Rilonacept Professional Patient Advice (Wolters Kluwer)


• Rilonacept Monograph (AHFS DI)


• rilonacept Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information


• Arcalyst Prescribing Information (FDA)


• Arcalyst Consumer Overview

Compare Rilonacept with other medications

• Cryopyrin-Associated Periodic Syndromes
• Familial Cold Autoinflammatory Syndrome
• Gout
• Muckle Wells Syndrome

Meridol Chlorhexidingluconat

Meridol Chlorhexidingluconat may be available in the countries listed below.

Ingredient matches for Meridol Chlorhexidingluconat

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Meridol Chlorhexidingluconat in the following countries:

• Austria

International Drug Name Search

Mefoxa

Mefoxa may be available in the countries listed below.

Ingredient matches for Mefoxa

Ofloxacin

Ofloxacin is reported as an ingredient of Mefoxa in the following countries:

• Indonesia

International Drug Name Search

Reboxetine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N06AX18

CAS registry number (Chemical Abstracts Service)

0098769-81-4

Chemical Formula

C19-H23-N-O3

Molecular Weight

313

Therapeutic Category

Antidepressant: Selective noradrenaline reuptake inhibitor (SNRI)

Chemical Name

(±)-(2R*)-2-[(αR*)-α-(o-Ethoxyphenoxy)benzyl]morpholine

Foreign Names

• Reboxetinum (Latin)
• Reboxetin (German)
• Reboxetine (French)
• Reboxetina (Spanish)

Generic Names

• Reboxetina (OS: DCIT)
• Reboxetine (OS: BAN)
• Reboxetine Mesilate (OS: BANM)
• Reboxetine Mesylate (OS: USAN)
• FCE 20124 (IS: FarmitaliaCarl)
• PNU 155950 E (IS: PharmaciaUpjoh)

Brand Names

• Edronax
  Pfizer, Costa Rica; Pfizer, Finland; Pfizer, Guatemala; Pfizer, Honduras; Pfizer, Croatia (Hrvatska); Pfizer, Ireland; Pfizer, Israel; Pfizer, Latvia; Pfizer, Nicaragua; Pfizer, Oman; Pfizer, Panama; Pfizer, Peru; Pfizer, Poland; Pfizer, Portugal; Pfizer, Sweden; Pfizer, Slovenia; Pfizer, El Salvador; Pfizer, South Africa; Pharmacia, Bulgaria; Pharmacia, Luxembourg



• Narebox
  Zydus Cadila, India



• Prolift
  Pfizer, Chile



• Davedax
  Marvecs, Italy



• Edronax
  Pfizer, Austria; Pfizer, Australia; Pfizer, Belgium; Pfizer, Bahrain; Pfizer, Switzerland; Pfizer, Germany; Pfizer, Denmark; Pfizer, Estonia; Pfizer, United Kingdom; Pfizer, Hungary; Pfizer, Iceland; Pfizer, Italy; Pfizer, Lithuania; Pfizer, Norway; Pfizer, New Zealand; Pfizer, Turkey; Pharmacia, Czech Republic



• Integrex
  Pfizer, Colombia



• Irenor
  Juste, Spain



• Norebox
  Pfizer, Spain



• Prolift
  Pharmacia, Brazil



• Solvex
  Merz, Germany

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Glimepiride Mylan

Glimepiride Mylan may be available in the countries listed below.

Ingredient matches for Glimepiride Mylan

Glimepiride

Glimepiride is reported as an ingredient of Glimepiride Mylan in the following countries:

• Belgium


• Italy

International Drug Name Search

Ofloxacino Ges

Ofloxacino Ges may be available in the countries listed below.

Ingredient matches for Ofloxacino Ges

Ofloxacin

Ofloxacin hydrochloride (a derivative of Ofloxacin) is reported as an ingredient of Ofloxacino Ges in the following countries:

• Spain

International Drug Name Search