Metformin Tablet, Extended Release
Product Images NDC 50742-634

Table 1 shows the adverse reactions experienced by patients with Type 2 Diabetes Mellitus in clinical trials of Metformin HCI Extended-Release Tablets that occurred at a frequency of over 5%, and more common than the placebo. The table displays the percentage of patients (out of 781 for Metformin HCI Extended-Release tablets and 195 for placebo) experiencing diarrhea (10% vs. 3%) and nausea/vomiting (7% vs. 2%).*

Table 2: Clinically Significant Drug Interactions with metformin hydrochloride extended-release tablets. This table lists drugs that may have an impact on the clinical effectiveness of metformin hydrochloride extended-release tablets. Carbonic anhydrase inhibitors are known to frequently cause a decrease in serum bicarbonate and induce hyperchloremic metabolic acidosis, and their concomitant use with metformin hydrochloride extended-release tablets may increase the risk of lactic acidosis. Drugs that reduce metformin hydrochloride extended-release tablet clearance may also increase the risk of lactic acidosis. Alcohol consumption is known to potentiate the effect of metformin on lactate metabolism. Coadministration of metformin hydrochloride extended-release tablets with an insulin secretagogue or insulin may increase the risk of hypoglycemia. Certain drugs, such as diuretics, corticosteroids, and oral contraceptives can lead to loss of glycemic control. Clinically evaluating patients receiving these drugs with metformin hydrochloride extended-release tablets is important.*

This text provides a comparison of the steady-state pharmacokinetic parameters of Metformin hydrochloride extended-release tablets and Metformin HCI Tablets at 4 weeks. It presents the mean and standard deviation values for parameters like AUCy 24, T e (time to reach maximum concentration), and C, (concentration of the drug in the blood plasma) for both types of tablets. The extended-release tablets were administered once daily after dinner at a dosage of 2000 mg, while the HCI tablets were administered twice daily at a dosage of 1000 mg each time.*

Table 4 shows the mean pharmacokinetic parameters of Metformin HCI tablets in different subject groups. The table includes data on renal clearance, time to peak plasma concentration, and peak plasma concentration for each group. The groups include healthy, nondiabetic adults, elderly healthy nondiabetic adults, adults with type 2 diabetes mellitus, and renal-impaired adults. Single and multiple doses of varying strengths were given to each group, and the results were recorded. The study provides useful information about Metformin HCI dosages for different populations.*

Table 5 provides information on the effect of coadministered drugs on the plasma exposure of metformin, a drug commonly used in the treatment of type 2 diabetes. The table lists various drugs and their doses that were coadministered with metformin, along with the resulting geometric mean ratios of plasma exposure with and without the coadministered drug. The table indicates whether dosing adjustments are required or not with the coadministered drug. Cationic drugs eliminated by renal tubular secretion may reduce metformin elimination while carbonic anhydrase inhibitors may cause metabolic acidosis as given in the Warnings and precautions and Drug interactions sections. Topiramate may lead to increased plasma exposure of Metformin as indicated in the table.*

This table presents the effect of Metformin on the systemic exposure of coadministered drugs. The table shows the dose of the coadministered drug, dose of Metformin, and the geometric mean ratio of both drugs. The table reports that no dosing adjustments are required for Glyburide, Furosemide, Nifedipine, Propranolol, Ibuprofen, and Cimetidine when coadministered with Metformin.*

This is a table presenting the mean changes from baseline in hemoglobin and fasting plasma glucose at week 16 for patients with type 2 diabetes mellitus. The changes are compared between Metformin HCI extended-release tablets and placebo. The table shows the dosage of Metformin HCI extended-release tablets and frequency of administration. The baseline and final visit readings for hemoglobin and fasting plasma glucose are given for both Metformin HCI extended-release tablets and placebo, and the corresponding p-values for all comparisons against placebo are presented.*

This is a table showing the mean changes from the baseline in Hemoglobin Atc and Fasting Plasma Glucose at week 24, comparing Metformin HCI Extended-release versus Metformin HCI in patients with Type 2 Diabetes Mellitus. The table presents data for two types of Metformin HCI doses: Metformin HCI 500 mg twice daily and Metformin HCI Extended-Release 1,000 mg or 1,500 mg once daily. The changes in Hemoglobin Atc and Fasting Plasma Glucose at the final visit for each dosage are reported, along with confidence intervals. There were a total of 68 patients in the study.*

Metformin HCI Extended-Release Tablets are provided in a pack of 60 film-coated tablets. Each tablet contains 500mg of Metformin Hydrochloride. The usual dosage is mentioned in the package insert for complete prescribing information. Pharmacists should be consulted before use. The tablets should be stored at a temperature between 20°C to 25°C (68°F to 77°F) with controlled room temperature according to USP permitted between 15°C to 30°C (59°F to 86°F). Patients are warned against excessive heat and humidity. The rest of the text is not clear, and hence its meaning is not available.*

This is a description of a medicine called Metformin HCI Extended-Release Tablets, USP with the NDC code 50742-634-60. It comes in a pack of 60 tablets, each containing 1000 mg of metformin. The usual dosage is not mentioned and needs to be obtained from the prescribing physician. These tablets should not be broken, crushed, or chewed. They should be stored between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F), and kept away from excessive heat and humidity. There is a warning to keep this medicine and all medications out of the reach of children. The other text appears to be identifying information such as lot number, expiration date, and GTIN, but the text is not readable by .*