METFORMIN HYDROCHLORIDE- metformin tablet, film coated, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Mylan Pharmaceuticals Inc.

INN (International Nazwa):

METFORMIN HYDROCHLORIDE

Skład:

METFORMIN HYDROCHLORIDE 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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:   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 2- and 5- times, respectively, a 2550 mg clinical dose, based on body surface area [see Data ]. The estimated backg

Podsumowanie produktu:

Metformin Hydrochloride Extended-Release Tablets, USP are available containing 500 mg or 1000 mg of metformin hydrochloride, USP. The 500 mg tablets are pink, film-coated, round, unscored tablets imprinted with M over MN2 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6002-91 bottles of 60 tablets The 1000 mg tablets are pink, film-coated, round, unscored tablets imprinted with M over MN1 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6001-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Avoid excessive heat and humidity. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep tightly closed.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

METFORMIN HYDROCHLORIDE- METFORMIN TABLET, FILM COATED, EXTENDED
RELEASE
MYLAN PHARMACEUTICALS INC.
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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._
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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
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Renal Impairment:
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Discontinuation for Iodinated Contrast Imaging Procedures:
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DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets: 500 mg and 1000 mg (3)
CONTRAINDICATIONS
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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)
Swallow metformin hydrochloride extended-release tablet