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:

MARKSANS PHARMA LIMITED

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin Hydrochloride Extended-Release Tablets, USP is 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 we

Product summary:

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg         Bottles of 30         NDC 25000-101-03 500 mg         Bottles of 500       NDC 25000-101-12 500 mg         Bottle of 1000       NDC 25000-101-14 750 mg         Bottles of 30         NDC 25000-102-03 750 mg         Bottles of 500       NDC 25000-102-12 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg arewhite to off-white, capsule shaped, biconvex tablets, debossed with '101' on one side and plain on other side. Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are white to off-white, capsule shaped, biconvex tablets, debossed with '102' on one side and plain on other side Storage Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] Dispense in a light-resistant container. Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No.L-82, L-83, Vema Indl. Estate, Vema, Goa-403 722, India  Rev. 06/22

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
MARKSANS PHARMA LIMITED
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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 Tabletis a biguanide
indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type 2 diabetes
mellitus. (1) (1)
DOSAGE AND ADMINISTRATION
Adult Dosage for Metformin Hydrochloride Extended-Release Tablets (2)
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 5