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Drug Catalog - Product Detail

METFORMIN HCL ER TABS 500MG 100CT

NDC Mfr Size Str Form
00591-2411-01 ACTAVIS PHARMA 100 500MG TABLET
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Description
11 DESCRIPTION Metformin hydrochloride extended-release tablet is an oral antihyperglycemic medication 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 of metformin hydrochloride (metformin HCl) is as shown: Metformin HCl, USP is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.63. Metformin HCl, USP 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, USP are modified release dosage form that contain 500 mg or 1,000 mg of metformin HCl. Each 500 mg tablet contains cellulose acetate, hydroxypropyl cellulose, FD&C blue #2, hypromellose, iron oxide black, lecithin, magnesium stearate, povidone, polyethylene glycol, polyvinyl alcohol, propylene glycol, sodium lauryl sulfate, talc, titanium dioxide, xanthan gum. Each 1,000 mg tablet contains cellulose acetate, hydroxypropyl cellulose, hypromellose, iron oxide black, lecithin, magnesium stearate, povidone, polyethylene glycol, polyvinyl alcohol, propylene glycol, sodium lauryl sulfate, talc, titanium dioxide, xanthan gum. Metformin hydrochloride extended-release tablets USP, 500 mg and 1,000 mg tablets are formulated to gradually release metformin to the upper gastrointestinal (GI) tract. structural formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Metformin hydrochloride extended-release tablets USP, 500 mg are available as blue, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ WPI ” on the top and “ 500 ” on the bottom of one side, and plain on the other. Metformin hydrochloride extended-release tablets USP, 1,000 mg are available as white to off-white, round, biconvex, film-coated tablets, an orifice on both sides, imprinted with “ WPI ” on the top and “ 1000 ” on the bottom of one side, and plain on the other. They are supplied as follows: Package Strength NDC Code Bottles of 30 500 mg 0591-2411-30 Bottles of 100 500 mg 0591-2411-01 Bottles of 1,000 500 mg 0591-2411-10 Bottles of 30 1,000 mg 0591-2412-30 Bottles of 90 1,000 mg 0591-2412-19 Bottles of 1,000 1,000 mg 0591-2412-10 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
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. Important Limitations of Use Metformin hydrochloride extended-release tablets should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. 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 ) Important limitations of use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Starting dose is 500 mg daily with evening meal ( 2.1 ) Individualize dose based on effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2,000 mg. ( 2.1 ) Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.2 ) Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 . Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 Assess risk/benefit of continuing metformin hydrochloride extended-release tablets if eGFR falls below 45 mL/minute/1.73 m 2 Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 Metformin hydrochloride extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures ( 2.4 ) Swallow whole. Never split, crush or chew. ( 2.5 ) 2.1 Recommended Dosage The starting dose of metformin hydrochloride extended-release tablets in patients who are not currently taking metformin is 500 mg orally, once daily with the evening meal. Increase the dose in 500 mg increments every 1 to 2 weeks if a higher dose of metformin hydrochloride extended-release tablets is needed and there are no gastrointestinal adverse reactions. The dosage of metformin hydrochloride extended-release tablets must be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2,000 mg. 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 Switching from Immediate-Release Metformin to Metformin Hydrochloride Extended-Release Tablets If switching from immediate-release metformin to metformin hydrochloride extended-release tablets, initiate metformin hydrochloride extended-release tablets once daily at the same total dose, up to 2,000 mg once daily. 2.4 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 [See Warnings and Precautions ( 5.1 )] . 2.5 Important Administration Instructions Administer metformin hydrochloride extended-release tablets orally, once daily with the evening meal. Metformin hydrochloride extended-release tablets must be swallowed whole and never split, crushed or chewed. If a dose of metformin hydrochloride extended-release tablets is missed, instruct patients not to take two doses the same day and to resume their usual dose of metformin hydrochloride extended-release tablets with the next schedule dose [See Patient Counseling Information ( 17 )].