Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
NorthStar RxLLC
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride extended-release tablets, USP 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: · Severe renal impairment (eGFR below 30 mL/minute/1.73 m2 ) [see Warnings and Precautions (5.1)] . · Known hypersensitivity to metformin. · Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Risk Summary 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 w
Metformin hydrochloride extended-release tablets, USP - 500 mg are available as white to off-white, circular, biconvex, film-coated tablets imprinted with "305" in black ink on one side and plain on the other side. Metformin hydrochloride extended-release tablets, USP - 1000 mg are available as white to off-white, circular, biconvex, film-coated tablets imprinted with "306" in black ink on one side and plain on the other side. They are supplied as follows: 500 mg tablets: Bottles of 100’s with Child Resistant Cap…..................NDC 16714-938-01 1000 mg tablets: Bottles of 90’s with Child Resistant Cap…....................NDC 16714-939-01 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE - METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE NORTHSTAR RXLLC ---------- 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._ 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) INDICATIONS AND USAGE Metformin hydrochloride is 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 Starting dose: 500 mg orally once daily with the evening meal (2.1) Increase the dose in increments of 500 mg every 1 to 2 weeks, up to a maximum of 2,000 mg once daily with the evening meal. (2.1) Patients receiving metformin hydrochloride (HCl) tablets may be switched to metformin hydrochl read_full_document