Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Sun Pharmaceutical Industries, Inc.
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg in 5 mL
ORAL
PRESCRIPTION DRUG
RIOMET is 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.
Flavor Appearance Size NDC Cherry clear, colorless solution 4 ounce (118 mL) 10631-206-01 16 ounce (473 mL) 10631-206-02 Strawberry clear, colorless to light yellow solution 4 ounce (118 mL) 10631-238-01 16 ounce (473 mL) 10631-238-02
New Drug Application
RIOMET- METFORMIN HYDROCHLORIDE SOLUTION SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RIOMET SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RIOMET. RIOMET (METFORMIN HYDROCHLORIDE) SOLUTION, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 WARNING: LACTIC ACIDOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ • • • INDICATIONS AND USAGE RIOMET is a 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 RIOMET: (2) • • • Pediatric Dosage for RIOMET: (2) • • Renal Impairment: (2) • • • • • Discontinuation for Iodinated Contrast Imaging Procedures: (2) • DOSAGE FORMS AND STRENGTHS Oral Solution: 500 mg per 5 mL (100 mg/mL) in cherry and strawberry flavor (3) (3) CONTRAINDICATIONS ® 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 RIOMET AND INSTITUTE GENERAL SUPPORTIVE MEASURES IN A HOSPITAL SETTING. PROMPT HEMODIALYSIS IS RECOMMENDED. (5.1) Starting dose: 500 mg (5 mL) orally twice a day or 850 mg (8.5 mL) once a day, wit Lesen Sie das vollständige Dokument