METFORMIN HYDROCHLORIDE tablet, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

RedPharm Drug, Inc.

DCI (Dénomination commune internationale):

METFORMIN HYDROCHLORIDE

Composition:

METFORMIN HYDROCHLORIDE 500 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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: Severe renal impairment (eGFR below 30 mL/min/1.73 m2) (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.

Descriptif du produit:

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Bottles of 100 NDC 62756-142-01 500 mg Bottles of 500 NDC 62756-142-02 750 mg Bottles of 100 NDC 62756-143-01 Metformin hydrochloride extended-release tablets, USP 500 mg are white to off-white, capsule shaped, uncoated tablets debossed with "142" on one side and plain on the other side. Metformin hydrochloride extended-release tablets, USP 750 mg are red colored, biconvex, capsule shaped, uncoated tablets debossed with "143" 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.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
REDPHARM DRUG, INC.
----------
METFORMIN ER 500MG
DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of Action
Metformin is an antihyperglycemic agent which improves glucose
tolerance in patients
with type 2 diabetes, lowering both basal and postprandial plasma
glucose. Its
pharmacologic mechanisms of action are different from other classes of
oral
antihyperglycemic agents. Metformin decreases hepatic glucose
production, decreases
intestinal absorption of glucose, and improves insulin sensitivity by
increasing peripheral
glucose uptake and utilization. Unlike sulfonylureas, metformin does
not produce
hypoglycemia in either patients with type 2 diabetes or normal
subjects (except in special
circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia.
With
metformin therapy, insulin secretion remains unchanged while fasting
insulin levels and
day-long plasma insulin response may actually decrease.
Pharmacokinetics
Absorption and Bioavailability
Following a single oral dose of metformin hydrochloride
extended-release tablet, Cmax is
achieved with a median value of 7 hours and a range of 4 hours to 8
hours.
At steady state, the AUC and Cmax are less than dose proportional for
metformin
hydrochloride extended-release tablets within the range of 500 mg to
2000 mg
administered once daily. Peak plasma levels are approximately 0.6,
1.1, 1.4, and 1.8
mcg/mL for 500 mg, 1000 mg, 1500 mg, and 2000 mg once-daily doses,
respectively.
The extent of metformin absorption (as measured by AUC) from metformin
hydrochloride extended-release tablets at a 2000 mg once-daily dose is
similar to the
same total daily dose administered as metformin hydrochloride tablets
1000 mg twice
daily. After repeated administration of metformin hydrochloride
extended-release
tablets, metformin did not accumulate in plasma.
Within-subject variability in Cmax and AUC of metformin from metformin
hydrochloride
extended-release tablets is comparable to that with metformin
hydrochlori