METFORMIN HYDROCHLORIDE tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

metformin hydrochloride (UNII: 786Z46389E) (metformin - UNII:9100L32L2N)

متاح من:

Ingenus Pharmaceuticals, LLC

INN (الاسم الدولي):

metformin hydrochloride

تركيب:

metformin hydrochloride 500 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 observe

ملخص المنتج:

Store at 20º to 25º C (68º to 77º F); excursions permitted to 15º to 30º C (59º to 86º F). [see USP Controlled Room Temperature.] Dispense in tight, light-resistant containers with child-resistant closure.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED
INGENUS PHARMACEUTICALS, LLC
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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._
• 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 2550 mg per
day, given in divided doses (2.1)
Doses above 2000 mg may be b