GLUMETZA- metformin hydrochloride tablet, film coated, extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Depomed, Inc.

INN (Internationale Bezeichnung):

METFORMIN HYDROCHLORIDE

Zusammensetzung:

METFORMIN HYDROCHLORIDE 500 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

GLUMETZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use GLUMETZA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. GLUMETZA is contraindicated in patients with: - Renal impairment (e.g., serum creatinine levels ≥ 1.5 mg/dL for men, ≥ 1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia. (See WARNINGS AND PRECAUTIONS (5) ) - Known hypersensitivity to metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin. Teratogenic Effects: Pregnancy Category B Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day, which represent 3 and 6 times the maximum recommended human daily dose of 2000

Produktbesonderheiten:

GLUMETZA tablets - 500 mg are available as blue, film coated, oval-shaped tablets debossed with "GMZ" on one side and "500" on the other side. GLUMETZA tablets 1000 mg are available as white, film coated, oval-shaped tablets with "M1000" on one side. They are supplied as follows: 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].

Berechtigungsstatus:

New Drug Application

Fachinformation

GLUMETZA- METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
DEPOMED, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLUMETZA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GLUMETZA.
GLUMETZA
(METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS), 500 MG AND 1000 MG
INITIAL U.S. APPROVAL: 1995
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
LACTIC ACIDOSIS CAN OCCUR DUE TO METFORMIN ACCUMULATION. THE RISK
INCREASES WITH CONDITIONS SUCH AS
SEPSIS, DEHYDRATION, EXCESS ALCOHOL INTAKE, HEPATIC INSUFFICIENCY,
RENAL IMPAIRMENT, AND ACUTE
CONGESTIVE HEART FAILURE. (5.1)
SYMPTOMS INCLUDE MALAISE, MYALGIAS, RESPIRATORY DISTRESS, INCREASING
SOMNOLENCE, AND NONSPECIFIC
ABDOMINAL DISTRESS. LABORATORY ABNORMALITIES INCLUDE LOW PH, INCREASED
ANION GAP AND ELEVATED BLOOD
LACTATE. (5.1)
IF ACIDOSIS IS SUSPECTED, DISCONTINUE GLUMETZA AND HOSPITALIZE THE
PATIENT IMMEDIATELY. (5.1)
RECENT MAJOR CHANGES
Dosing and Administration: Inclusion of the 1000 mg tablet (3) 12/2007
INDICATIONS AND USAGE
GLUMETZA is a biguanide indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2
diabetes mellitus. (1)
Important limitations of use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
DOSAGE AND ADMINISTRATION
Administer once daily with the evening meal. (2.1)
Individualize the dose based on effectiveness and tolerability, while
not exceeding the maximum recommended daily
dose of 2000 mg. (2.1)
If naïve to metformin treatment, initiate with 500 mg daily. (2.1)
Swallow whole. Never split, crush or chew. (2.1)
DOSAGE FORMS AND STRENGTHS
Extended Release Tablets, 500 mg and 1000 mg (3)
CONTRAINDICATIONS
Renal impairment (4)
Metabolic acidosis, including diabetic ketoacidosis (4)
Hypersensitivity to metformin hydrochloride (4)
WARNINGS AND PRECAUTIONS
Lactic acidosis: Warn against excessive alcohol intake. GLUMETZA is
not recommended in hepatic impairment and i