מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
REMEDYREPACK INC.
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 1000 mg
ORAL
PRESCRIPTION DRUG
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. Important Limitations of Use Metformin hydrochloride extended-release tablets should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. Metformin hydrochloride extended-release tablets are contraindicated in patients with:Metformin hydrochloride extended-release tablets are contraindicated in patients with: - Severe renal impairment (eGFR below 30mL/min/1.73 m 2 ) [See Warnings and Precautions ( 5.1)] . Severe renal impairment (eGFR below 30mL/min/1.73 m 2 ) [See Warnings and Precautions ( 5.1)] . - Known hypersensitivity to metformin hydrochloride. Known hypersensitivity to metformin hydrochloride. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin. Acute or chronic m
Metformin hydrochloride extended-release tablets USP, 500 mg are available as blue, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ WPI ” on the top and “ 500 ” on the bottom of one side, and plain on the other. Metformin hydrochloride extended-release tablets USP, 1,000 mg are available as white to off-white, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ WPI ” on the top and “ 1000 ” on the bottom of one side, and plain on the other. They are supplied as follows: Package Strength NDC Code Bottles of 30 500 mg 0591-2411-30 Bottles of 100 500 mg 0591-2411-01 Bottles of 1,000 500 mg 0591-2411-10 Bottles of 30 1,000 mg 0591-2412-30 Bottles of 90 1,000 mg 0591-2412-19 Bottles of 1,000 1,000 mg 0591-2412-10 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE REMEDYREPACK INC. ---------- 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) RECENT MAJOR CHANGES Boxed Warning 04/2017 Dosage and Administration ( 2) 04/2016 Contraindications ( 4) 04/2016 Warnings and Precautions ( 5.1) 04/2017 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) Important limitations of use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1) DOSAGE AND ADMINISTRATION Starting do קרא את המסמך השלם