Metformin hydrochloride is the generic equivalent of the brand-name drug METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE EXTENDED RELEASE. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Metformin hydrochloride through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: · Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1)] · Vitamin B 12 Deficiency [see Warnings and Precautions (5.2)] · Hypoglycemia [see Warnings and Precautions (5.3)] Adverse reactions occurring >5% in metformin hydrochloride extended-release tablets clinical trials: hypoglycemia, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun…
Drug Interactions
7 DRUG INTERACTIONS Table 2 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets. Table 2: Clinically Significant Drug Interactions with Metformin Hydrochloride Extended-Release Tablets Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with metformin hydrochloride extended-release…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION · Starting dose: 500 mg orally once daily with the evening meal ( 2.1 ) · Increase the dose in increments of 500 mg every 1 to 2 weeks, up to a maximum of 2,000 mg once daily with the evening meal. ( 2.1 ) · Patients receiving metformin hydrochloride (HCl) tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2,000 mg once daily. (2.1) · Swallow metformin hydrochloride extended-release tablets whole…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Lactic Acidosis: Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue metformin hydrochloride extended-release tablets immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur. Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of rena…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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