TAGI PHARMA # 51224-0020-60 Metformin Hydrochloride IR Tablets, USP 500mg 500 Tablets Per Bottle DICATIONS AND USAGE Metformin hydrochloride tablets are 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) DOSAGE AND ADMINISTRATION Adult Dosage for Metformin Hydrochloride Tablets: Starting dose: 500 mg orally twice a day or 850 mg once a day, with meals (2.1) Increase the dose in increments of 500 mg weekly or 850 mg every 2 weeks, up to a maximum dose of 2,550 mg per day, given in divided doses (2.1) Doses above 2,000 mg may be better tolerated given 3 times a day with meals (2.1) Pediatric Dosage for Metformin Hydrochloride Tablets: Starting dose: 500 mg orally twice a day, with meals (2.2) Increase dosage in increments of 500 mg weekly up to a maximum of 2,000 mg per day, given in divided doses twice daily (2.2) Renal Impairment: Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) (2.3) Do not use in patients with eGFR below 30 mL/minute/1.73 m2 (2.3) Initiation is not recommended in patients with eGFR between 30 mL/minute/1.73 m2 and 45 mL/minute/ 1.73 m2 (2.3) Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m2 (2.3) Discontinue if eGFR falls below 30 mL/minute/1.73 m2 (2.3) Discontinuation for Iodinated Contrast Imaging Procedures: Metformin hydrochloride tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures (2.4) DOSAGE FORMS AND STRENGTHS Metformin Hydrochloride Tablets: 500 mg, 850 mg, and 1,000 mg (3) CONTRAINDICATIONS Severe renal impairment (eGFR below 30 mL/min/1.73 m2) (4, 5.1) Hypersensitivity to metformin (4) Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. (4) WARNINGS AND PRECAUTIONS Lactic Acidosis: See BOXED WARNING. (5.1) Vitamin B12 Deficiency: Metformin may lower vitamin B12 levels. Measure hematological parameters annually and vitamin B12 at 2 to 3 year intervals and manage any abnormalities. (5.2) Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required (5.3) ADVERSE REACTIONS For metformin hydrochloride tablets, the most common adverse reactions (> 5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact TAGI Pharma, Inc. at 1-855-225-8244 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch DRUG INTERACTIONS Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring (7) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use (7) Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake (7) USE IN SPECIFIC POPULATIONS Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8.3) Geriatric Use: Assess renal function more frequently. (8.5) Hepatic Impairment: Avoid use in patients with hepatic impairment. (8.7) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 3/2019
Size: 500 mg
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