METFORMIN HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)

Available from:

Contract Pharmacy Services-PA

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablet is 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: - Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). - Known hypersensitivity to metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin hydrochloride tablets and metformin hydrochlorid

Product summary:

Metformin Hydrochloride Tablets Metformin Hydrochloride Tablets, 500 mg are white to off-white, round shaped, film coated tablets debossed with the logo of "70" on one side and "Z" on the other side and are supplied as follows. NDC 67046-460-30 in blisters of 30 tablets Metformin Hydrochloride Tablets USP, 850 mg are white to off-white, oval shaped, film coated tablets debossed with the logo of "69" on one side and "Z" on the other side and are supplied as follows. NDC 67046-461-30 in blisters of 30 tablets Metformin Hydrochloride Tablets USP, 1000 mg are white to off white, oval shaped, biconvex, film coated tablets with a bisect line on both the sides, one surface is debossed with "Z" and "71" on each side of bisect and are supplied as follows. NDC 67046-462-30 in blisters of 30 tablets Store at 20° - 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Dispense in light-resistant containers. All trademarks are the property of Zydus Group.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
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METFORMIN HYDROCHLORIDE TABLETS
DESCRIPTION
Metformin hydrochloride tablets and metformin hydrochloride
extended-release tablets are oral
antihyperglycemic drugs used in the management of type 2 diabetes.
Metformin hydrochloride (_N,N_-
dimethylimidodicarbonimidic diamide hydrochloride) is not chemically
or pharmacologically related to
any other classes of oral antihyperglycemic agents. The structural
formula is as shown:
Metformin hydrochloride is a white crystalline compound with a
molecular formula of C H N • HCl
and a molecular weight of 165.63. Metformin hydrochloride is freely
soluble in water, slightly soluble
in alcohol and is practically insoluble in acetone and methylene
chloride. The pK of metformin is 12.4.
The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
Metformin hydrochloride tablets contain 500 mg or 850 mg or 1000 mg of
metformin hydrochloride.
Each tablet contains the inactive ingredients hypromellose, magnesium
stearate, microcrystalline
cellulose, polyethylene glycol and povidone.
Metformin hydrochloride extended-release tablets contain 500 mg or 750
mg of metformin
hydrochloride as the active ingredient.
Metformin hydrochloride extended-release tablets 500 mg and 750 mg
contain the inactive ingredients
glyceryl behenate, hypromellose, microcrystalline cellulose and
povidone.
SYSTEM COMPONENTS AND PERFORMANCE:
Metformin hydrochloride extended-release tablets comprise a monolithic
hydrophilic polymer matrix
system. Metformin hydrochloride is combined with a drug
release-controlling polymer to form the core
of the matrix. After administration fluid from the Gastro Intestinal
tract (GI tract) enters the tablet
causing the polymers to hydrate and swell. Due to hydration and
swelling of the polymer, the size of the
tablet in the stomach increases. As a result, the dosage may remain in
the gastrointestinal tract for a
prolonged period with slow release of the drug. Drug