METFORMIN HYDROCHLORIDE tablet, film coated, extended release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Oceanside Pharmaceuticals

INN（国际名称）:

METFORMIN HYDROCHLORIDE

组成:

METFORMIN HYDROCHLORIDE 500 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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: Risk Summary Limited data with Metformin Hydrochloride Extended-Release Tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see Data]. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations] . No adverse developmental effects were observed when metformin was administered to pregnant Sprague Dawley rats and rabbits during the period of organogenesis at doses up to 3 and 1 times, respectively, a 2,000 mg clinical dose, based on body surface area [see Data] . The estima

產品總結:

Metformin Hydrochloride Extended-Release Tablets are supplied as:

授权状态:

New Drug Application Authorized Generic

产品特点

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
OCEANSIDE PHARMACEUTICALS
REFERENCE LABEL SET ID: 8B24D45E-4AE4-43AB-BBBF-A96B2AC5C210
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR METFORMIN
HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INDICATIONS AND USAGE
Metformin Hydrochloride Extended-Release Tablets are a biguanide
indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
Renal Impairment:
•
o
o
o
o
Discontinuation for Iodinated Contrast Imaging Procedures:
•
•
•
•
POSTMARKETING CASES OF METFORMIN-ASSOCIATED LACTIC ACIDOSIS HAVE
RESULTED IN DEATH,
HYPOTHERMIA, HYPOTENSION, AND RESISTANT BRADYARRHYTHMIAS. SYMPTOMS
INCLUDED MALAISE,
MYALGIAS, RESPIRATORY DISTRESS, SOMNOLENCE, AND ABDOMINAL PAIN.
LABORATORY ABNORMALITIES
INCLUDED ELEVATED BLOOD LACTATE LEVELS, ANION GAP ACIDOSIS, INCREASED
LACTATE/PYRUVATE RATIO; AND
METFORMIN PLASMA LEVELS GENERALLY >5 MCG/ML. (5.1)
RISK FACTORS INCLUDE RENAL IMPAIRMENT, CONCOMITANT USE OF CERTAIN
DRUGS, AGE ≥65 YEARS OLD,
RADIOLOGICAL STUDIES WITH CONTRAST, SURGERY AND OTHER PROCEDURES,
HYPOXIC STATES, EXCESSIVE
ALCOHOL INTAKE, AND HEPATIC IMPAIRMENT. STEPS TO REDUCE THE RISK OF
AND MANAGE METFORMIN-
ASSOCIATED LACTIC ACIDOSIS IN THESE HIGH RISK GROUPS ARE PROVIDED IN
THE FULL PRESCRIBING
INFORMATION. (5.1)
IF LACTIC ACIDOSIS IS SUSPECTED, DISCONTINUE METFORMIN HYDROCHLORIDE
EXTENDED-RELEASE TABLETS
AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING.
PROMPT HEMODIALYSIS IS
RECOMMENDED. (5.1)
Starting dose: 500 mg orally once daily with the evening meal (2.1)
Increas