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:

Rebel Distributors Corp

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

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: - 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 extended - release tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute

Product summary:

Metformin Hydrochloride Extended - Release Tablets Metformin hydrochloride extended release tablets, 500 mg are white to off-white, capsule shaped, uncoated tablet debossed with '142' on one side and plain on the other side. Store at 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F). [See USP Controlled Room Temperature.] Dispense in light-resistant containers.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
REBEL DISTRIBUTORS CORP
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METFORMIN HYDROCHLORIDE EXTENDED - RELEASE TABLETS
DESCRIPTION
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 to off-white crystalline compound
with a molecular formula of
C4H11N5•HCl and a molecular weight of 165.63. Metformin
hydrochloride is freely soluble in water
and is practically insoluble in acetone, ether, and chloroform. The pK
of metformin is 12.4. The pH of
a 1% aqueous solution of metformin hydrochloride is 6.68.
Metformin hydrochloride extended - release tablets contain 500 mg or
750 mg of metformin
hydrochloride USP as the active ingredient.
Metformin hydrochloride extended-release tablets 500 mg contain the
inactive ingredients xanthan gum,
hypromellose, sodium carbonate, povidone, talc, colloidal silicon
dioxide and magnesium stearate.
Metformin hydrochloride extended-release tablets 750 mg contain the
inactive ingredients xanthan gum,
hypromellose, sodium carbonate, povidone, talc, colloidal silicon
dioxide, magnesium stearate and
ferric oxide (red).
SYSTEM COMPONENTS AND PERFORMANCE- Metformin hydrochloride extended -
release tablets
comprises a hydrophilic polymer matrix system. Metformin hydrochloride
is combined with a drug
release controlling polymers to form a monophasic matrix system. After
administration, fluid from the
gastrointestinal (GI) tract enters the tablet, causing the polymers to
hydrate and swell. Drug is released
slowly from the dosage form by a process of diffusion through the gel
matrix that is essentially
independent of pH. The hydrated polymer system is not rigid and is
expected to be broken up by normal
peristalsis in the GI tract. T