Metformin Hydrochloride
Generic: METFORMIN
Basic Information
Manufacturer
Mylan Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
7e41818c-60e9-4bcf-9586-7bb8d33d5e89
Indications & Usage
1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablets are 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 are 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) ] Common adverse reactions are diarrhea, nausea/vomiting, abdominal pain, constipation, abdomen distention, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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.
In placebo-controlled trials, 781 patients were administered metformin hydrochloride extended-release tablets.
Adverse reactions reported in greater than 5% of the patients treated with metformin hydrochloride extended-release tablets and that were more common than in placebo-treated patients are listed in Table 1.
Table 1: 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 Adverse Reaction Metformin Hydrochloride Extended-Release Tablets (n = 781) Placebo (n = 195) Diarrhea 10% 3% Nausea/Vomiting 7% 2% Diarrhea led to the 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 patients treated with metformin hydrochloride extended-release tablets and were more commonly reported than in placebo-treated patients: abdominal pain, constipation, abdomen distention, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.
Laboratory Tests Vitamin B 12 Concentrations In clinical trials of 29-week duration with metformin hydrochloride tablets, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients.
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 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.
In placebo-controlled trials, 781 patients were administered metformin hydrochloride extended-release tablets.
Adverse reactions reported in greater than 5% of the patients treated with metformin hydrochloride extended-release tablets and that were more common than in placebo-treated patients are listed in Table 1.
Table 1: 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 Adverse Reaction Metformin Hydrochloride Extended-Release Tablets (n = 781) Placebo (n = 195) Diarrhea 10% 3% Nausea/Vomiting 7% 2% Diarrhea led to the 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 patients treated with metformin hydrochloride extended-release tablets and were more commonly reported than in placebo-treated patients: abdominal pain, constipation, abdomen distention, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.
Laboratory Tests Vitamin B 12 Concentrations In clinical trials of 29-week duration with metformin hydrochloride tablets, a decrease to subnormal levels of previously normal serum vitamin B 12 levels was observed in approximately 7% of patients.
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.