METFORMIN HYDROCHLORIDE tablet, film coated METFORMIN HYDROCHLORIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Metformin Hydrochloride (UNII: 786Z46389E) (Metformin - UNII:9100L32L2N)

Available from:

Apotex Corp.

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
APOTEX CORP.
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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