Metformin hcl is the generic equivalent of the brand-name drug Metformin HCl. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Metformin hcl through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
INDICATIONS & USAGE 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.
Important Warnings
WARNINGS Lactic Acidosis: Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Metformin Hydrochloride Tablets USP; 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 lactat…
Adverse Reactions
ADVERSE REACTIONS In a US double-blind clinical study of Metformin Hydrochloride Tablets USP in patients with type 2 diabetes, a total of 141 patients received Metformin Hydrochloride Tablets USP therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the Metformin Hydrochloride Tablets USP patients, and that were more common in Metformin Hydrochloride Tablets USP- than placebo-treated patients, are listed in Table 9 . Table 9: Most Com…
Drug Interactions
DRUG INTERACTIONS (Clinical Evaluation of Drug Interactions Conducted with Metformin Hydrochloride Tablets USP) Glyburide —In a single-dose interaction study in type 2 diabetes patients, coadministration of metformin and glyburide did not result in any changes in either metformin pharmacokinetics or pharmacodynamics. Decreases in glyburide AUC and C max were observed, but were highly variable. The single-dose nature of this study and the lack of correlation between glyburide blood levels and pha…
Dosage & Administration
DOSAGE & ADMINISTRATION There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride or any other pharmacologic agent. Dosage of metformin hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age). Metfo…
Patient Counseling Information
INFORMATION FOR PATIENTS Patients should be informed of the potential risks and benefits of Metformin Hydrochloride Tablets USP and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters. The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the WARNINGS and PRECAUTIONS sections, should be explained to patients. Patients should be advised…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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