Metformin Hydrochloride Tablets, USP

/Metformin Hydrochloride Tablets, USP
Metformin Hydrochloride Tablets, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Metformin Hydrochloride Tablets, USP

ID:

19D0917A-3468-CFD2-6570-8CEEF3DEB3F7

Code:

34391-3

DESCRIPTION


id: 1CCD0586-1339-D521-C8BF-DD1B0EEF36D2
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


id: 43D901B7-845D-061F-5A64-92D5D385C066
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).

CONTRAINDICATIONS


id: 8FE7CB05-5E28-B018-2492-1AF288BBC2C9
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Metformin hydrochloride is contraindicated in patients with: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.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.)

ADVERSE REACTIONS


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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.
Adverse Reaction Metformin Hydrochloride Monotherapy
(n = 141)
Placebo

(n = 145)

% of Patients
Diarrhea 53.2 11.7
Nausea/Vomiting 25.5 8.3
Flatulence 12.1 5.5
Asthenia 9.2 5.5
Indigestion 7.1 4.1
Abdominal Discomfort 6.4 4.8
Headache 5.7 4.8
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.

OVERDOSAGE


id: 72D27F9B-6088-4796-9C65-534FE5DBD1F5
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


id: A3D0404D-AFC7-1A63-B47E-B1FB5126506D
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.

HOW SUPPLIED


id: E998F39A-B0CF-4133-0BBD-A57F7EB042EA
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 20091-531-10
850 mg Bottles of 100           NDC 20091-533-01
850 mg Bottles of 500           NDC 20091-533-05
850 mg Bottles of 1000         NDC 20091-533-10
1000 mg Bottles of 100         NDC 20091-535-01
1000 mg Bottles of 500         NDC 20091-535-05
1000 mg Bottles of 1000       NDC 20091-535-10
Metformin 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.