מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
Metformin Hydrochloride (UNII: 786Z46389E) (Metformin - UNII:9100L32L2N)
Apotex Corp.
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride tablets and Metformin hydrochloride extended-release tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) [see Warnings and Precautions (5.1) ]. - Hypersensitivity to metformin. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Risk Summary Limited data with metformin hydrochloride tablets / metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear asso
Metformin hydrochloride tablets, USP are available for oral administration and supplied as follow: Metformin hydrochloride tablets, USP 500 mg white to off-white, capsule shaped, unscored, biconvex, film-coated tablets, imprinted “APO 500” on one side and “MET” on the other side. Bottles of 30 (NDC 60505-0190-3) Bottles of 100 (NDC 60505-0190-0) Bottles of 500 (NDC 60505-0190-1) Bottles of 1,000 (NDC 60505-0190-8) Metformin hydrochloride tablets, USP 850 mg white to off-white, capsule shaped, unscored, biconvex, film-coated tablets, imprinted “APO 850” on one side and plain on the other side. Bottles of 30 (NDC 60505-0191-3) Bottles of 100 (NDC 60505-0191-0) Bottles of 500 (NDC 60505-0191-1) Bottles of 1,000 (NDC 60505-0191-8) Metformin hydrochloride tablets, USP 1,000 mg white to off-white, oval, scored, biconvex, film-coated tablets, imprinted “APO 1000” on one side and plain with a full bisect on the other side. Bottles of 30 (NDC 60505-0192-3) Bottles of 100 (NDC 60505-0192-0) Bottles of 500 (NDC 60505-0192-1) Bottles of 1,000 (NDC 60505-0192-8) Metformin hydrochloride extended-release tablets, USP are available for oral administration and supplied as follow: Metformin hydrochloride extended-release tablets, USP 500 mg white to off-white, capsule shaped, unscored tablets, imprinted “APO” on one side and “XR500” on the other side. Bottles of 100 (NDC 60505-0260-1) Bottles of 500 (NDC 60505-0260-2). Metformin hydrochloride extended-release tablets, USP 750 mg white to off-white, capsule shaped, unscored tablets, imprinted “APO” on one side and “XR750” on the other side. Bottles of 30 (NDC 60505-1329-3) Bottles of 100 (NDC 60505-1329-1) Bottles of 500 (NDC 60505-1329-5). Store at 20°Cto 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers [see USP].
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE APOTEX CORP. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METFORMIN HYDROCHLORIDE TABLETS AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METFORMIN HYDROCHLORIDE TABLETS AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE TABLETS, FOR ORAL USE METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 WARNING: LACTIC ACIDOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ POSTMARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE RESULTED IN DEATH, HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS INCLUDED MALAISE, MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL PAIN. LABORATORY ABNORMALITIES INCLUDED ELEVATED BLOOD LACTATE LEVELS, ANION GAP ACIDOSIS, INCREASED LACTATE/PYRUVATE RATIO; AND METFORMIN PLASMA LEVELS GENERALLY >5 MCG/ML. (5.1) RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN DRUGS, AGE >65 YEARS OLD, RADIOLOGICAL STUDIES WITH CONTRAST, SURGERY AND OTHER PROCEDURES, HYPOXIC STATES, EXCESSIVE ALCOHOL INTAKE, AND HEPATIC IMPAIRMENT. STEPS TO REDUCE THE RISK OF AND MANAGE METFORMIN-ASSOCIATED LACTIC ACIDOSIS IN THESE HIGH RISK GROUPS ARE PROVIDED IN THE FULL PRESCRIBING INFORMATION. (5.1) IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE METFORMIN HYDROCHLORIDE TABLETS / METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1) INDICATIONS AND USAGE Metformin hydrochloride tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (1) Metformin hydrochloride extended-release tablets are a big קרא את המסמך השלם