METFORMIN HYDROCHLORIDE tablet, extended release

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

NuCare Pharmaceuticals,Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Metformin hydrochloride tablets are 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 tablets are 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: 1. Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) (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.

Ապրանքի ամփոփագիր:

Metformin hydrochloride extended-release tablets, USP NDC 68071-4153-3 Bottles of 30 NDC 68071-4153-6 Bottles of 60 NDC 68071-4153-9 Bottles of 90 NDC 68071-4153-2 Bottles of 120 NDC 68071-4153-8 Bottles of 180 Metformin hydrochloride extended-release tablets, USP 500 mg are white to off white, capsule shaped, biconvex, film coated tablets debossed with ML 30 on one side and plain on the other side. 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]. Dispense in light-resistant containers. Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 USA Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA Revised: 04/2017 PM02416502

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS,INC.
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METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP
DESCRIPTION
Metformin hydrochloride extended-release tablets, USP 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 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 pKa 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
carbomer homopolymer type A, magnesium trisilicate, dibasic calcium
phosphate anhydrous, hydroxyl
propyl cellulose, xanthan gum, microcrystalline cellulose, magnesium
stearate, polyvinyl alcohol,
titanium dioxide, polyethylene glycol and talc.
Metformin hydrochloride extended-release tablets, USP 750 mg contain
the inactive ingredients
carbomer homopolymer type A, magnesium trisilicate, dibasic calcium
phosphate anhydrous, hydroxyl
propyl cellulose, xanthan gum, microcrystalline cellulose, magnesium
stearate, polyvinyl alcohol,
titanium dioxide, polyethylene glycol, talc and iron oxide red.
SYSTEM COMPONENTS AND PERFORMANCE - Metformin hydrochloride
extended-release tablets
comprises a dual hydrophilic polymer matrix system. Metformin
hydrochloride 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 poly