METFORMIN HYDROCHLORIDE
Generic: METFORMIN HYDROCHLORIDE
Basic Information
Manufacturer
Marlex Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
3d6f397b-e909-bee9-e063-6294a90aba17
Indications & Usage
1 INDICATIONS AND 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 Tablets USP is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
(1)
Metformin Hydrochloride Extended-Release Tablets USP 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 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)] 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 Marlex Pharmaceuticals at 1-888-582-1953 or Drugsafety@marlexpharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 Tablets-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.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Marlex Pharmaceuticals at 1-888-582-1953 or Drugsafety@marlexpharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 Tablets-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.