METFORMIN HYDROCHLORIDE EXTENDED RELEASE- metformin hydrochloride tablet, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Major Pharmaceuticals

INN (Tarptautinis Pavadinimas):

METFORMIN HYDROCHLORIDE

Sudėtis:

METFORMIN HYDROCHLORIDE 500 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Metformin Hydrochloride Tablets, USP 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, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride and Metformin hydrochloride extended-release tablets are contraindicated in patients with: Metformin hydrochloride and 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 alteration of renal function (see also PRECAUTIONS ).

Produkto santrauka:

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg are available for oral administration as white to off-white, capsule shaped, unscored tablets, imprinted “APO” on one side and “XR500” on the other side. They are supplied as follows: Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-5794-61 Bottles of 500, NDC 0904-5794-40 Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers [see USP]. APOTEX INC. METFORMIN HYDROCHLORIDE TABLETS, USP 500 mg, 850 mg and 1000 mg METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP  500 mg and 750 mg Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 USA 33326 Revised: January 2014 Rev. 7 Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

METFORMIN HYDROCHLORIDE EXTENDED RELEASE- METFORMIN HYDROCHLORIDE
TABLET,
EXTENDED RELEASE
MAJOR PHARMACEUTICALS
----------
METFORMIN HYDROCHLORIDE TABLETS, USP
500 MG, 850 MG AND 1000 MG
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
500 MG AND 750 MG
RX ONLY
DESCRIPTION
Metformin Hydrochloride Tablets, USP and 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 is a white to off-white crystalline compound
with a molecular formula of
C H N •HCI 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.
Each Metformin Hydrochloride Tablet, USP for oral administration,
contains 500 mg, 850 mg or 1000
mg of metformin hydrochloride. In addition, each film-coated tablet
also contains the following inactive
ingredients: methylcellulose, microcrystalline cellulose, polyethylene
glycol, colloidal silicon
dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose and
titanium dioxide.
Each 500 mg Metformin Hydrochloride Extended-Release Tablet, USP for
oral administration, contains
500 mg of metformin hydrochloride. In addition, each 500 mg tablet
contains the following inactive
ingredients: colloidal silicon dioxide, hypromellose, magnesium
stearate and methylcellulose.
Each 750 mg Metformin Hydrochloride Extended-Release Tablet, USP for
oral administration, contains
750 mg of metformin hydrochloride. In addition, each 750 mg tablet
contains the following inactive
ingredients: colloidal silicon dioxide, hypromellose and magnesium
stearate.
Metformin Extended-Release Tablets, USP meet USP Dissolution Test