METFORMIN HYDROCHLORIDE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Legacy Pharmaceutical Packaging, LLC

INN (nume internaţional):

METFORMIN HYDROCHLORIDE

Compoziție:

METFORMIN HYDROCHLORIDE 500 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 m2) [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 were observed when met

Rezumat produs:

Metformin Hydrochloride Tablets, USP 500 mg - White to off-white, round, biconvex, film coated tablets debossing “H/102” on one side and plain on the other side. Unit of Use Bottles of 60: 500mg (NDC 68645-544-59) 850 mg - White to off-white, round, biconvex, film coated tablets debossing “H/103” on one side and plain on the other side. Unit of Use Bottles of 60: 850mg (NDC 68645-547-59) 1000 mg - White to off-white, oval, biconvex, scored, film coated tablets debossing “H/104” on one side and plain on the other side. Unit of Use Bottles of 60: 1000mg (NDC 68645-545-59) Storage Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901. DRUG(3784) Made in India Iss. 07/17 Distributed by Wal-Mart Bentonville, AR 72716 Packaged by Legacy Pharmaceutical Packaging, LLC Earth City, MO 63045 Metformin Hydrochloride Tablets, USP 500 mg - White to off-white, round, biconvex, film coated tablets debossing “H/102” on one side and plain on the other side. Unit of Use Bottles of 60: 500mg (NDC 68645-544-59) 850 mg - White to off-white, round, biconvex, film coated tablets debossing “H/103” on one side and plain on the other side. Unit of Use Bottles of 60: 850mg (NDC 68645-547-59) 1000 mg - White to off-white, oval, biconvex, scored, film coated tablets debossing “H/104” on one side and plain on the other side. Unit of Use Bottles of 60: 1000mg (NDC 68645-545-59) Store at 20°–25° C (68°–77° F); excursions permitted to 15°–30° C (59°–86° F). [See USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET
LEGACY PHARMACEUTICAL PACKAGING, LLC
----------
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/M L. (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) (1)
DOSAGE AND ADMINISTRATION
Adult Dosage for Metformin Hydrochloride Tablets: (2)
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 2550 mg per
day, given in divided doses (2.1)
Doses above 2000 mg may be better t