Country: United States
Language: English
Source: NLM (National Library of Medicine)
Metformin Hydrochloride (UNII: 786Z46389E) (Metformin - UNII:9100L32L2N)
Proficient Rx LP
Metformin Hydrochloride
Metformin Hydrochloride 1000 mg
ORAL
PRESCRIPTION DRUG
Metformin hydrochloride tablets 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: Metformin hydrochloride tablets 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 of renal function. (See also PRECAUTIONS .)
Metformin Hydrochloride Tablets are available as follows: 1000 mg: Bottles of 30 NDC 63187-332-30 Bottles of 60 NDC 63187-332-60 Bottles of 90 NDC 63187-332-90 Bottles of 100 NDC 63187-332-00 Metformin Hydrochloride Tablets, USP 1000 mg tablets are white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect. Store at 20°to 25° C (68°to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Sciegen Pharmaceuticals Inc 20 Davids Drive Hauppauge NY 11788 Distributed by: Carlsbad Technology, Inc. 5923 Balfour Court Carlsbad, CA 92008 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev: 01/14 Rx Only
Abbreviated New Drug Application
METFORMIN HYDROCHLORIDE- METFORMIN HYDROCHLORIDE TABLET, FILM COATED PROFICIENT RX LP ---------- METFORMIN HYDROCHLORIDE TABLETS USP RX ONLY LACTIC ACIDOSIS: LACTIC ACIDOSIS IS A RARE, BUT SERIOUS, METABOLIC COMPLICATION THAT CAN OCCUR DUE TO METFORMIN ACCUMULATION DURING TREATMENT WITH METFORMIN HYDROCHLORIDE TABLETS; 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 MCG/ML ARE GENERALLY FOUND. THE REPORTED INCIDENCE OF LACTIC ACIDOSIS IN PATIENTS RECEIVING METFORMIN HYDROCHLORIDE 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 HYDROCHLORIDE TABLETS AND BY USE OF THE MINIMUM EFFECTIVE DOSE OF METFORMIN HYDROCHLORIDE TABLETS. IN Read the complete document