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:

American Health Packaging

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: - Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions (5.1) ]. - Hypersensitivity to metformin. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Risk Summary 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 wer

Tuoteyhteenveto:

Metformin Hydrochloride Tablets USP, 500 mg are white to off-white, round shaped, film-coated tablets debossed with the logo of "70" on one side and "Z" on the other side and are supplied as follows.  Unit dose packages of 100 (10 x 10) NDC 60687-155-01 Metformin Hydrochloride Tablets USP, 850 mg are white to off-white, oval shaped, film-coated tablets debossed with the logo of "69" on one side and "Z" on the other side and are supplied as follows.  Unit dose packages of 100 (10 x 10) NDC 60687-143-01 Metformin Hydrochloride Tablets USP, 1,000 mg are white to off-white, oval shaped, biconvex, film-coated tablets with bisect on both the sides; one side of the bisect is debossed with "Z" and other side of the bisect is debossed with "71" and are supplied as follows.  Unit dose packages of 100 (10 x 10) NDC 60687-162-01 Store at 20° to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
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._
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
RECOMMENDED. ( 5.1)
INDICATIONS AND USAGE
Metformin hydrochloride tablets are 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:_
Starting dose: 500 mg orally twice a day or 850 mg once a day, with
meals ( 2.1)
Increase the dose in increments of 500 mg weekly or 850 mg every 2
weeks, up to a maximum dose of
2,550 mg per day, given in divided doses ( 2.1)
Doses above 2,000 mg may be bette