displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Metformin hydrochloride tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5• HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.Metformin hydrochloride tablets, for oral administration, contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients carnauba wax, crospovidone, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide, and triacetin.
INDICATIONS AND USE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Metformin hydrochloride tablets, as monotherapy, are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Metformin hydrochloride is indicated in patients 10 years of age and older.Metformin hydrochloride may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Metformin hydrochloride is contraindicated in patients with:
Metformin hydrochloride should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PRECAUTIONS.)
- Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS).
- Known hypersensitivity to metformin hydrochloride.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
In a US double-blind clinical study of metformin hydrochloride in patients with type 2 diabetes, a total of 141 patients received metformin hydrochloride therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride patients, and that were more common in metformin hydrochloride- than placebo-treated patients, are listed in Table 7.
Table 7: Most Common Adverse Reactions (>5.0 Percent) in a Placebo-Controlled Clinical Study of Metformin Hydrochloride MonotherapyReactions that were more common in metformin hydrochloride- than placebo-treated patients.
Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin hydrochloride. Additionally, the following adverse reactions were reported in ≥1.0 – ≤5.0% of metformin hydrochloride patients and were more commonly reported with metformin hydrochloride than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
||Metformin Hydrochloride Monotherapy
(n = 141)
(n = 145)
|% of Patients
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see WARNINGS). Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride or any other pharmacologic agent. Dosage of metformin hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride is 2550 mg in adults and 2000 mg in pediatric patients (10-16 years of age).Metformin hydrochloride should be given in divided doses with meals. Metformin hydrochloride should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride, either when used as monotherapy or in combination with sulfonylurea or insulin.Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.Short-term administration of metformin hydrochloride may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Metformin Hydrochloride Tablets500 mg Bottles of 100 NDC 20091-531-01
500 mg Bottles of 500 NDC 20091-531-05
500 mg Bottles of 1000 NDC 20091-531-10850 mg Bottles of 100 NDC 20091-533-01
850 mg Bottles of 500 NDC 20091-533-05
850 mg Bottles of 1000 NDC 20091-533-101000 mg Bottles of 100 NDC 20091-535-01
1000 mg Bottles of 500 NDC 20091-535-05
1000 mg Bottles of 1000 NDC 20091-535-10Metformin Hydrochloride 500 mg tablets are white colored, round shape, film coated tablets debossed with “P531” on one side and “500” on the other side.Metformin Hydrochloride 850 mg tablets are white colored, round shape, film coated tablets debossed with “P533” on one side and “850” on the other side.Metformin Hydrochloride 1000 mg tablets are white colored, oval shape, film coated tablets debossed with “P” bisect “535” on one side and “10” bisect “00” on the other side.