METFORMIN HCL ER 750MG 100 TAB
Generic: Metformin Hydrochloride
METFORMIN HCL ER 750MG 100 TAB
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Identification
Metformin Hydrochloride
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
TIME CAP LABORATORIES, INC
HUMAN PRESCRIPTION DRUG
Administration
TABLET, EXTENDED RELEASE
ORAL
ANDA090295
Active Ingredients
| Ingredient | Strength |
|---|---|
| METFORMIN HYDROCHLORIDE | 750 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS & USAGE Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablet is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Dosage & Administration
2 DOSAGE & ADMINISTRATION 1.1 2.1 Adult Dosage Swallow Metformin Hydrochloride Extended-Release Tablets whole and never crush, cut or chew. The recommended starting dose of Metformin Hydrochloride Extended-Release Tablet is 500 mg orally once daily with the evening meal. Increase the dose in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved with Metformin Hydrochloride Extended-Release Tablet 2000 mg once daily, consider a trial of Metformin Hydrochloride Extended-Release Tablet 1000 mg twice daily. If higher doses are required, switch to Metformin Hydrochloride at total daily doses up to 2550 mg administered in divided daily doses, as described above. Patients receiving Metformin Hydrochloride Tablets may be switched to Metformin Hydrochloride Extended-Release Tablet once daily at the same total daily dose, up to 2000 mg once daily. 2.3 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of Metformin Hydrochloride Extended-Release Tablet and periodically thereafter. Metformin Hydrochloride Extended-Release Tablet is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . Initiation of Metformin Hydrochloride Extended-Release Tablet in patients with an eGFR between 30 – 45 mL/minute/1.73 m 2 is not recommended. In patients taking Metformin Hydrochloride Extended-Release Tablet whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. Discontinue Metformin Hydrochloride Extended-Release Tablet if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [see Warnings and Precautions (5.1) ] . 2.4 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue Metformin Hydrochloride Extended-Release Tablet at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intraarterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Metformin Hydrochloride Extended-Release Tablet if renal function is stable. Adult Dosage for Metformin Hydrochloride Extended-Release Tablets Swallow Metformin Hydrochloride Extended-Release Tablets whole and never crush, cut or chew (2.1) Starting dose: 500 mg orally once daily with the evening meal (2.1) Increase the dose in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal (2.1) Patients receiving Metformin Hydrochloride Tablets may be switched to Metformin Hydrochloride Extended-Release Tablets once daily at the same total daily dose, up to 2000 mg once daily (2.1) 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 m 2 (2.3) Initiation is not recommended in patients with eGFR between 30-45 mL/minute/1.73 m 2 (2.3) Assess risk/benefit of continuing if eGFR falls below 45mL/minute/1.73 m 2 (2.3) Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 (2.3) Discontinuation for Iodinated Contrast Imaging Procedures: Metformin Hydrochloride Extended-Release Tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures (2.4)
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in 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)] 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Metformin Hydrochloride Extended-Release Tablets In placebo-controlled trials, 781 patients were administered metformin hydrochloride extended-release tablets. Adverse reactions reported in greater than 5% of the metformin hydrochloride extended-release tablets patients, and that were more common in metformin hydrochloride extended-release tablet -than placebo-treated patients, are listed in Table 2. Table 2: Adverse Reactions from Clinical Trials of Metformin Hydrochloride Extended-Release Tablets Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus Metformin Hydrochloride Extended-Release Tablets (n=781) Placebo (n=195) Diarrhea 10% 3% Nausea/Vomiting 7% 2% Diarrhea led to discontinuation of metformin hydrochloride extended-release tablets in 0.6% of patients. Additionally, the following adverse reactions were reported in ≥1.0% to ≤5.0% of metformin hydrochloride extended-release tablets patients and were more commonly reported with metformin hydrochloride extended-release tablets than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of metformin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin. For metformin hydrochloride extended-release 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 Time-Cap Labs at 1-877-376-4271 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Information for Patients
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 renal function while receiving metformin hydrochloride extended-release tablets.Instruct patients to inform their doctor that they are taking metformin hydrochloride extended-release tabletsprior to any surgical or radiological procedure, as temporary discontinuation may be required [see Warnings and Precautions (5.1)]. Hypoglycemia Inform patients that hypoglycemia may occur when metformin hydrochloride extended-release tabletis coadministered with oral sulfonylureas and insulin. Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [see Warnings and Precautions (5.3)]. Vitamin B 12 Deficiency: Inform patients about importance of regular haematological parameters while receiving metformin hydrochloride extended-release tablets [see Warnings and Precautions (5.2)] . Females of Reproductive Age: Inform females that treatment with metformin hydrochloride extended-release tabletsmay result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [see Use in Specific Populations (8.3)]. Metformin Hydrochloride Extended-Release Tablets Administration Information: Inform patients that metformin hydrochloride extended-release tablets must be swallowed whole and not crushed, cut, or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet. Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No.L-82, L-83, Verna Indl. Estate, Verna, Goa-403 722, India Rev. 03/25
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.