METFORMIN HYDROCHLORIDE- metformin hydrochloride tablet, film coated METFORMIN HYDROCHLORIDE- metformin hydrochloride tablet,

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Cadila Healthcare Limited

INN (International Name):

METFORMIN HYDROCHLORIDE

Sammensetning:

METFORMIN HYDROCHLORIDE 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 andPRECAUTIONS). - Known hypersensitivity to metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with orwithout coma. Diabetic ketoacidosis should be treated with insulin. Metformin hydrochloride tablets and metformin hydrochloride exten

Produkt oppsummering:

Metformin Hydrochloride Tablets, USP Metformin Hydrochloride Tablets USP, 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 68382-028-16 in bottles of 90 tablets NDC 68382-028-01 in bottles of 100 tablets NDC 68382-028-05 in bottles of 500 tablets NDC 68382-028-10 in bottles of 1000 tablets NDC 68382-028-30 in blister pack of 100 unit dose 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 68382-029-16 in bottles of 90 tablets NDC 68382-029-01 in bottles of 100 tablets NDC 68382-029-05 in bottles of 500 tablets NDC 68382-029-10 in bottles of 1000 tablets NDC 68382-029-30 in blister pack of 100 unit dose 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 68382-030-16 in bottles of 90 tablets NDC 68382-030-01 in bottles of 100 tablets NDC 68382-030-05 in bottles of 500 tablets NDC 68382-030-10 in bottles of 1000 tablets NDC 68382-030-30 in blister pack of 100 unit dose tablets Metformin Hydrochloride Extended-release Tablets Metformin Hydrochloride Extended-release Tablets, 500 mg are white to off-white, capsule shaped, uncoated tablets, debossed with "63" on one side and "Z" on the other side and are supplied as follows. NDC 68382-027-01 in bottles of 100 tablets NDC 68382-027-05 in bottles of 500 tablets Metformin Hydrochloride Extended-release Tablets, 750 mg are white to off-white, capsule shaped, uncoated tablets, debossed with "Z", "C" on one side and "20" on the other side and are supplied as follows. NDC 68382-039-01 in bottles of 100 tablets NDC 68382-039-05 in bottles of 500 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED
CADILA HEALTHCARE LIMITED
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METFORMIN HYDROCHLORIDE TABLETS, USP
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE 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, USP 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