METFORMIN HYDROCHLORIDE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Mylan Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

METFORMIN HYDROCHLORIDE

Koostumus:

METFORMIN HYDROCHLORIDE 500 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride tablets are contraindicated in patients with:   Limited data with metformin hydrochloride 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 2- and 5-times, respectively, a 2550 mg clinical dose, based on body surface area [see Data ]. The estimated backgro

Tuoteyhteenveto:

Metformin Hydrochloride Tablets, USP are available containing 500 mg, 850 mg or 1000 mg of metformin hydrochloride, USP. The 500 mg tablets are white to off-white, film-coated, round, unscored tablets with blackberry scent debossed with MF over 1 on one side of the tablet and G on the other side. They are available as follows: NDC 0378-7185-05 bottles of 500 tablets The 850 mg tablets are white to off-white, film-coated, round, unscored tablets with blackberry scent debossed with MF over 2 on one side of the tablet and G on the other side. They are available as follows: NDC 0378-7186-05 bottles of 500 tablets The 1000 mg tablets are white to off-white, film-coated, oblong, scored tablets with blackberry scent debossed with MF to the left side of the score and 3 to the right side of the score on one side of the tablet and G to the left side of the score and G to the right side of the score on the other side. They are available as follows: NDC 0378-7187-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METFORMIN HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METFORMIN
HYDROCHLORIDE TABLETS.
METFORMIN HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: LACTIC ACIDOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Metformin hydrochloride tablets are a biguanide indicated as an
adjunct to diet and exercise to improve glycemic control in
adults and pediatric patients 10 years of age and older with type 2
diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
Adult Dosage for Metformin Hydrochloride Tablets:
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Pediatric Dosage for Metformin Hydrochloride Tablets:
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Renal Impairment:
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Discontinuation for Iodinated Contrast Imaging Procedures:
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DOSAGE FORMS AND STRENGTHS
Metformin Hydrochloride Tablets: 500 mg, 850 mg, and 1000 mg (3)
CONTRAINDICATIONS
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
TABLETS AND INSTITUTE GENERAL
SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS