METFORMIN HYDROCHLORIDE- 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:

American Health Packaging

INN (International Name):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metformin HCl extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin HCl, extended-release tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 40 mL/min/1.73 m 2 ) (see WARNINGS and PRECAUTIONS ). - Known hypersensitivity to metformin HCl. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Product summary:

Metformin HCl Extended-Release Tablets, USP 500 mg are white, capsule shaped, biconvex tablets debossed "IP 178" on one side and plain on the other side. They are available as follows: Unit dose packages of 100 (10 x 10) NDC 68084-072-01 Storage 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
AMERICAN HEALTH PACKAGING
----------
METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE TABLETS, USP
8207201/0817
RX ONLY
DESCRIPTION
Metformin hydrochloride (HCl) extended-release tablets, USP are oral
antihyperglycemic drugs used in
the management of type 2 diabetes. Metformin HCl, USP ( _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 HCl, USP is a white to off-white crystalline compound with a
molecular formula of C
H
N
• HCl and a molecular weight of 165.63. Metformin HCl, USP 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 HCl, USP is 6.68.
Metformin HCl extended-release tablets, USP contain 500 mg or 750 mg
of metformin HCl, USP as the
active ingredient.
Metformin HCl extended-release tablets, USP 500 mg contain the
inactive ingredients; colloidal silicon
dioxide, hypromellose, magnesium stearate and microcrystalline
cellulose.
Metformin HCl extended-release tablets, USP 750 mg contain the
inactive ingredients; colloidal silicon
dioxide, hypromellose and magnesium stearate.
Dissolution Method: Test 10
SYSTEM COMPONENTS AND PERFORMANCE – Metformin HCl extended-release
tablets comprise a dual
hydrophilic polymer matrix system. Metformin HCl is combined with a
drug release controlling
polymer to form an "inner" phase, which is then incorporated as
discrete particles into an "external"
phase of a second polymer. 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 tr