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Drug Catalog - Product Detail

METFORM ER TAB 1000MG MYLN 60CT

NDC Mfr Size Str Form
00378-6001-91 MYLAN 60 1000MG TABLET
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Generic Name
METFORMIN
Substance Name
METFORMIN HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA200690
Description
11 DESCRIPTION Metformin hydrochloride extended-release tablets, USP contain the biguanidine antihyperglycemic agent, metformin, in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is 1,1-Dimethybiguanide monohydrochloride with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.6. Its structural formula is: Metformin hydrochloride, USP is a white crystalline powder that 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 extended-release tablets deliver 500 mg or 1000 mg of metformin hydrochloride. In addition to the active ingredient metformin hydrochloride, each tablet contains the following inactive ingredients: cellulose acetate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, red iron oxide, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate and yellow iron oxide. In addition, the black imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Meets USP Dissolution Test 5. Metformin hydrochloride structural formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Metformin Hydrochloride Extended-Release Tablets, USP are available containing 500 mg or 1000 mg of metformin hydrochloride, USP. The 500 mg tablets are pink, film-coated, round, unscored tablets imprinted with M over MN2 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6002-91 bottles of 60 tablets The 1000 mg tablets are pink, film-coated, round, unscored tablets imprinted with M over MN1 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6001-91 bottles of 60 tablets 16.2 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Avoid excessive heat and humidity. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep tightly closed.
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 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew ( 2.1 ) • Starting dose: 500 mg orally once daily with the evening meal ( 2.1 ) • Increase the dose in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal ( 2.1 ) • Patients receiving metformin hydrochloride (HCl) tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2000 mg once daily ( 2.1 ) Renal Impairment: • Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.2 ) o Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 ( 2.2 ) o Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 ( 2.2 ) o Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m 2 ( 2.2 ) o Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 ( 2.2 ) Discontinuation for Iodinated Contrast Imaging Procedures: • Metformin hydrochloride extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.3 ) 2.1 Adult Dosage and Administration • Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew. • The recommended starting dose of metformin hydrochloride extended-release tablets is 500 mg orally once daily with the evening meal. • Increase the dose in increments of 500 mg weekly on the basis of glycemic control and tolerability, up to a maximum of 2000 mg once daily with the evening meal. • If glycemic control is not achieved with metformin hydrochloride extended-release tablets 2000 mg once daily, consider a trial of metformin hydrochloride extended-release tablets 1000 mg twice daily. • Patients receiving metformin hydrochloride (HCl) may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2000 mg once daily. 2.2 Recommendations for Use in Renal Impairment • Assess renal function prior to initiation of metformin hydrochloride extended-release tablets and periodically thereafter. • Metformin hydrochloride extended-release tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 • Initiation of metformin hydrochloride extended-release tablets in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended. • In patients taking metformin hydrochloride extended-release tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. • Discontinue metformin hydrochloride extended-release tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [ see Contraindications (4) and Warnings and Precautions (5.1) ]. 2.3 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue metformin hydrochloride extended-release tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin hydrochloride extended-release tablets if renal function is stable.