METFORMIN HYDROCHLORIDE tablet, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Actavis Pharma, Inc.

INN (International Name):

METFORMIN HYDROCHLORIDE

Sammensætning:

METFORMIN HYDROCHLORIDE 500 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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: 1. Severe renal impairment (eGFR below 30 mL/min/1.73 m2 ) (see WARNINGS  and PRECAUTIONS ). 2. Known hypersensitivity to metformin hydrochloride. 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. 

Produkt oversigt:

Metformin hydrochloride extended-release tablets, USP are available as: 500 mg Bottles of 90 NDC 62037-571-90 500 mg Bottles of 100 NDC 62037-571-01 500 mg Bottles of 500 NDC 62037-571-05 500 mg Bottles of 1000 NDC 62037-571-10 750 mg Bottles of 100 NDC 62037-577-01 750 mg Bottles of 500 NDC 62037-577-05 750 mg Bottles of 1000 NDC 62037-577-10 Metformin hydrochloride extended-release tablets USP, 500 mg are white to off-white, capsule shaped tablets, debossed with the “ ” and “571 ”on one side and “500 ” on the other side. Metformin hydrochloride extended-release tablets USP, 750 mg are light yellow, capsule shaped tablets, debossed with “ ” and “577 ” on one side and “750 ” on opposite side. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in light-resistant containers. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ  07054 USA Revised:  June 2017                                                                    

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
ACTAVIS PHARMA, INC.
----------
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
RX ONLY
DESCRIPTION
Metformin hydrochloride extended-release tablets, USP are an oral
antihyperglycemic drug used in the
management of type 2 diabetes. Metformin hydrochloride, 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 hydrochloride, 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
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, USP contain 500 mg
or 750 mg of metformin
hydrochloride, USP as the active ingredient.
Metformin hydrochloride extended-release tablets USP, 500 mg contain
the inactive ingredients
hypromellose 2208, colloidal silicon dioxide, and magnesium stearate.
Metformin hydrochloride extended-release tablets USP, 750 mg contain
the inactive ingredients
hypromellose 2208, colloidal silicon dioxide, D&C yellow #10 aluminum
lake, and magnesium
stearate.
SYSTEM COMPONENTS AND PERFORMANCE
Metformin hydrochloride extended-release tablets comprise a
monohydrophilic polymer matrix system.
Metformin hydrochloride is combined with a drug release controlling
polymer to form the matrix. 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. The biologically
inert components of the tablet may