WarningLactic Acidosis.Lactic acidosis rare but potentially fatal. Increased risk of lactic acidosis in patients with renal impairment and advanced age.Generally has occurred in diabetic patients with severe renal insufficiency who frequently had concomitant medical and/or surgical problems and were receiving multiple drugs; metformin plasma concentrations 5 mcg/mL often found in patients with lactic acidosis.Periodically monitor renal function and use the minimum effective dosage.

• Metformin Hydrochloride Tablets Side Ef…

In a multiple-dose crossover study, 23 patients with type 2 diabetes mellitus were administered either Metformin Hydrochloride Extended-Release Tablets 2000 mg once a day (after dinner) or immediate-release (IR) metformin hydrochloride 1000 mg twice a day (after breakfast and after dinner). Bioequivalence based on (90% CI): Metformin. Waiver request of in-vivo testing: 500 mg and 850 mg based on (i) acceptable bioequivalence studies on the 1000 mg strength, (ii) acceptable dissolution testing across all strengths, and (iii) proportional similarity in the formulations across all strengths. Metformin hydrochloride tablets USP, for oral administration, contains 500 mg, 850 mg, or 1000 mg of metformin hydrochloride USP. Each tablet contains the inactive ingredients microcrystalline cellulose, magnesium stearate and povidone. In addition, the coating for the 500 mg, 850 mg and 1000 mg tablets contains Opadry YS-1R-7006 Clear. The components of Opadry YS-1R-7006 Clear are hydroxypropyl methylcellulose, polyethylene glycol 400 and polyethylene glycol 6000. USP Dissolution test 1 is.

Metformin Hydrochloride Tablets Side Ef…

Withhold metformin promptly in patients with any condition associated with hypoxemia, sepsis, or dehydration. Avoid use in patients with clinical or laboratory evidence of hepatic impairment. Temporarily discontinue metformin therapy before or at the time of an iodinated contrast imaging procedure in patients with an estimated glomerular filtration rate (eGFR) of 30–60 mL/minute per 1.73 m 2 and in patients with a history of liver disease, alcoholism, or heart failure. Withhold metformin temporarily in patients undergoing surgery or receiving intra-arterial iodinated contrast agents. Drugs that may affect renal function or alter metformin elimination should be used with caution.However, the American College of Radiology states that in patients with no evidence of acute kidney injury and an eGFR ≥30 mL/minute per 1.73 m 2, there is no need to discontinue metformin either before or following the administration of iodinated contrast media, nor is there a need to reassess the patient's renal function after the test or procedure.Advise patients not to consume excessive amounts of alcohol.If lactic acidosis occurs, discontinue metformin.

Treat as medical emergency; immediate hospitalization and treatment required; hemodialysis recommended.Introduction. See also:Antidiabetic agent; a biguanide, chemically and pharmacologically unrelated to sulfonylurea antidiabetic agents. Uses for Metformin Hydrochloride Diabetes MellitusUsed as an adjunct to diet and exercise for the management of type 2 diabetes mellitus.May be used in combination with a sulfonylurea, repaglinide, or thiazolidinedione antidiabetic agent for the management of type 2 diabetes mellitus in patients who do not achieve adequate glycemic control on monotherapy with metformin or any of these drugs. Also used concomitantly with nateglinide.May be used with insulin to improve glycemic control and/or decrease the required dosage of insulin.Commercially available in fixed combination with glyburide or glipizide for use as an adjunct to diet and exercise in adults with type 2 diabetes mellitus.