METFORMIN HYDROCHLORIDE tablet, extended release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Inventia Healthcare Private Limited

INN (Rahvusvaheline Nimetus):

METFORMIN HYDROCHLORIDE

Koostis:

METFORMIN HYDROCHLORIDE 500 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 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 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.

Toote kokkuvõte:

Metformin hydrochloride extended release tablets USP                      500 mg                        Bottles of 100                      NDC 49252-001-13                      500 mg                        Bottles of 500                      NDC 49252-001-17                      500 mg                        Bottles of 1000                    NDC 49252-001-18 Metformin hydrochloride extended release tablets USP 500 mg are white to off-white, capsule shaped, biconvex, beveled edge tablet, with occasionally mottled appearance, debossed with "˥L 001" on one side and plain on other side. Storage 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. Manufactured By: Inventia Healthcare Private Limited Plot No. F1 & F-1/1, Additional Ambernath M.I.D.C., Ambernath (East)-421506, Dist. Thane, Maharashtra, India Marketed by: Space for address                                                                                                                                                                                          AT2118L/01

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
INVENTIA HEALTHCARE PRIVATE LIMITED
----------
METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS USP
RX ONLY
DESCRIPTION
Metformin hydrochloride extended release tablets USP is an oral
antihyperglycemic drug used in the
management of type 2 diabetes. Metformin hydrochloride
(_N,N_-dimethylimidodicar- bonimidic 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 • 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 of
metformin hydrochloride
USP as the active ingredient.
Metformin hydrochloride extended release tablets USP 500 mg contain
the inactive ingredients sodium
carboxymethyl cellulose, hypromellose and magnesium stearate.
Metformin hydrochloride extended
release tablets USP 500 mg meets USP dissolution Test 3.
SYSTEM COMPONENTS AND PERFORMANCE- Metformin hydrochloride extended
release tablets USP
comprises a swellable matrix system. In the aqueous gastrointestinal
(GI) environment, the dosage form
swells remarkably thereby increasing in size and geometry from where
drug is released slowly 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 occasionally remain
intact during GI transit and will be
eliminated in the feces as a soft, hydrated mass.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Metformin is an antihyperglycemic agent which improves glucose
tolerance in patien