METFORMIN HYDROCHLORIDE tablet, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Blenheim Pharmacal, Inc.

INN (nume internaţional):

METFORMIN HYDROCHLORIDE

Compoziție:

METFORMIN HYDROCHLORIDE 500 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Metformin hydrochloride tablets, USP is 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 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride tablets, USP and metformin hydrochloride extended-release tablets, USP 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. Me

Rezumat produs:

Metformin hydrochloride tablets, USP are available as: Metformin hydrochloride 500 mg tablets, USP are round, white to off-white, film coated tablets debossed with “Andrx 674” on one side and “500” debossed on the other side. Metformin hydrochloride 850 mg tablets, USP are round, white to off-white, film coated tablets debossed with “Andrx 675” on one side and “850” debossed on the other side. Metformin hydrochloride 1000 mg tablets, USP are oval, white to off-white, film coated tablets with “Andrx 676” debossed on one side and bisected “1000” on the other side. Metformin hydrochloride extended-release tablets, USP are available as: Metformin hydrochloride extended-release 500 mg tablets, USP 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 750 mg tablets, USP are light yellow, capsule shaped tablets, debossed with and “577” on one side and “750” on opposite side. Store at controlled room temperature 20°-25°C (68°-77°F). [See USP.] Dispense in light-resistant containers. Metformin hydrochloride tablets, USP are manufactured by: Patheon Puerto Rico, Inc. Caguas, Puerto Rico 00725, USA Distributed by: Watson Pharma, Inc. Metformin hydrochloride extended-release tablets, USP are manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Rev. date 05/09                                                                         190733

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, EXTENDED
RELEASE
BLENHEIM PHARMACAL, INC.
----------
METFORMIN HYDROCHLORIDE, USP TABLETS
AND
METFORMIN HYDROCHLORIDE, USP EXTENDED-RELEASE TABLETS
METFORMIN HYDROCHLORIDE TABLETS, USP
AND
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP
RX ONLY
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
The absolute bioavailability of a metformin hydrochloride 500 mg
tablet, USP given under fasting
conditions is approximately 50-60%. Studies using single oral doses of
metformin hydrochloride
tablets, USP of 500 mg to 1500 mg, and 850 mg to 2550 mg, indicate
that there is a lack of dose
proportionality with increasing doses, which is due to decreased
absorption rather than an alteration in
elimination. Food decreases the extent and slightly delays the
absorption of metformin, as shown by
approximately a 40% lower mean peak plasma concentration (C
), a 25% lower area under the plasma
concentration versus time curve (AUC), and a 35 minute prolongation of
time to peak plasma
concentration (T
) following administration of a single 850 mg tablet of metformin with
food,
compared to the same tablet strength administered fasting. The
clinica