METFORMIN 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:

Ingenus Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 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 association with metformin and major birth defect or miscarriage risk [see Data] . There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations ]. No adverse developmental effects were observed when

Product summary:

Metformin hydrochloride extended-release tablets are supplied as oval biconvex-shaped, film-coated extended-release tablets containing 500 mg or 1,000 mg of metformin hydrochloride. NDC 50742-633: 500 mg extended-release, white or off-white tablets imprinted with “NL2” on one side: bottles of 60, 90 and 1,000. NDC 50742-633-60 – 500 mg oval biconvex-shaped tablets supplied in bottles containing 60 tablets. NDC 50742-633-90 – 500 mg oval biconvex-shaped tablets supplied in bottles containing 90 tablets. NDC 50742-633-10 – 500 mg oval biconvex-shaped tablets supplied in bottles containing 1,000 tablets. NDC 50742-634: 1000 mg extended-release, white or off-white tablets imprinted with “NL1” on one side: bottles of 30, 60 and 1,000. NDC 50742-634-30 – 1,000 mg oval biconvex-shaped tablets supplied in bottles containing 30 tablets. NDC 50742-634-60 – 1,000 mg oval biconvex-shaped tablets supplied in bottles containing 60 tablets. NDC 50742-634-10 – 1,000 mg oval biconvex-shaped tablets supplied in bottles containing 1,000 tablets. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)[See USP Controlled Room Temperature]. Avoid excessive heat and humidity. Keep tightly closed (protect from moisture). Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN- METFORMIN TABLET, EXTENDED RELEASE
INGENUS PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METFORMIN
HYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
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
EXTENDED-
RELEASE TABLETS AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A
HOSPITAL SETTING.
PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1)
INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablets are a biguanide
indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes
mellitus. (1)
DOSAGE AND ADMINISTRATION
Swallow metformin hydrochloride extended-release tablets whole and
never crush, cut or chew (2.1)
Starting dose: 500 mg orally once daily with the evening meal (2.1)
Increase the dose in increments of 500 mg weekly, up to a maximum of
2,000 mg once daily with the
evening meal (2.1)
Patients rece