Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)
Med-Health Pharma, LLC
METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE 500 mg
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride tablets are contraindicated in patients with: - Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS). - Known hypersensitivity to metformin hydrochloride tablets, USP. - Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration
Store at controlled room temperature 15°-30° C (59°-86°F). Dispense in tight, light resistant container as defined in the USP.
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET MED-HEALTH PHARMA, LLC ---------- WARNINGS LACTIC ACIDOSIS: LACTIC ACIDOSIS IS A RARE, BUT SERIOUS, METABOLIC COMPLICATION THAT CAN OCCUR DUE TO METFORMIN ACCUMULATION DURING TREATMENT WITH METFORMIN; WHEN IT OCCURS, IT IS FATAL IN APPROXIMATELY 50% OF CASES. LACTIC ACIDOSIS MAY ALSO OCCUR IN ASSOCIATION WITH A NUMBER OF PATHOPHYSIOLOGIC CONDITIONS, INCLUDING DIABETES MELLITUS, AND WHENEVER THERE IS SIGNIFICANT TISSUE HYPOPERFUSION AND HYPOXEMIA. LACTIC ACIDOSIS IS CHARACTERIZED BY ELEVATED BLOOD LACTATE LEVELS (>5 MMOL/L), DECREASED BLOOD PH, ELECTROLYTE DISTURBANCES WITH AN INCREASED ANION GAP, AND AN INCREASED LACTATE/PYRUVATE RATIO. WHEN METFORMIN IS IMPLICATED AS THE CAUSE OF LACTIC ACIDOSIS, METFORMIN PLASMA LEVELS > 5 ΜG/ML ARE GENERALLY FOUND. THE REPORTED INCIDENCE OF LACTIC ACIDOSIS IN PATIENTS RECEIVING METFORMIN HYDROCHLORIDE TABLETS, USP IS VERY LOW (APPROXIMATELY 0.03 CASES/1000 PATIENT-YEARS, WITH APPROXIMATELY 0.015 FATAL CASES/1000 PATIENT-YEARS). IN MORE THAN 20,000 PATIENT-YEARS EXPOSURE TO METFORMIN IN CLINICAL TRIALS, THERE WERE NO REPORTS OF LACTIC ACIDOSIS. REPORTED CASES HAVE OCCURRED PRIMARILY IN DIABETIC PATIENTS WITH SIGNIFICANT RENAL INSUFFICIENCY, INCLUDING BOTH INTRINSIC RENAL DISEASE AND RENAL HYPOPERFUSION, OFTEN IN THE SETTING OF MULTIPLE CONCOMITANT MEDICAL/SURGICAL PROBLEMS AND MULTIPLE CONCOMITANT MEDICATIONS. PATIENTS WITH CONGESTIVE HEART FAILURE REQUIRING PHARMACOLOGIC MANAGEMENT, IN PARTICULAR THOSE WITH UNSTABLE OR ACUTE CONGESTIVE HEART FAILURE WHO ARE AT RISK OF HYPOPERFUSION AND HYPOXEMIA ARE AT INCREASED RISK OF LACTIC ACIDOSIS. THE RISK OF LACTIC ACIDOSIS INCREASES WITH THE DEGREE OF RENAL DYSFUNCTION AND THE PATIENT'S AGE. THE RISK OF LACTIC ACIDOSIS MAY, THEREFORE, BE SIGNIFICANTLY DECREASED BY REGULAR MONITORING OF RENAL FUNCTION IN PATIENTS TAKING METFORMIN AND BY USE OF THE MINIMUM EFFECTIVE DOSE OF METFORMIN. IN PARTICULAR, TREATMENT OF THE ELDERLY SHOULD BE ACCOMPANIED BY CAREFUL MONITORING OF RENAL FUNCT Läs hela dokumentet