Drug Catalog - Product Detail
METFORMIN HCL ER TABS 750MG 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 65162-0179-10 | AMNEAL PHARMACEUTICALS | 100 | 750MG | TABLET |
PACKAGE FILES
Generic Name
METFORMIN HYDROCHLORIDE
Substance Name
METFORMIN HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078596
Description
11 DESCRIPTION Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N -dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below: Metformin hydrochloride extended-release tablets, 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 hydrochloride extended-release tablets, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride extended-release tablets, USP is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, USP as active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose. Dissolution Method: Test 10 System Components and Performance - Metformin hydrochloride extended-release tablets, comprise a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. c
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Metformin Hydrochloride Extended-release Tablets USP, 500 mg are white, capsule shaped, biconvex tablets debossed "IP 178" on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-178-03 Bottles of 90: NDC 65162-178-09 Bottles of 100: NDC 65162-178-10 Bottles of 500: NDC 65162-178-50 Bottles of 1,000: NDC 65162-178-11 Metformin Hydrochloride Extended-release Tablets USP, 750 mg are white, capsule shaped, biconvex tablets debossed "IP 179" on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-179-03 Bottles of 90: NDC 65162-179-09 Bottles of 100: NDC 65162-179-10 Bottles of 500: NDC 65162-179-50 16.2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in light-resistant containers as defined in the USP.
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 Adult Dosage for Metformin Hydrochloride Extended-Release Tablets : 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 2,000 mg once daily with the evening meal. ( 2.1 ) Patients receiving metformin hydrochloride tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2,000 mg once daily. ( 2.1 ) Renal Impairment: Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR). ( 2.3 ) Do not use in patients with eGFR below 30 mL/minute/1.73 m 2 . ( 2.3 ) Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 . ( 2.3 ) Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 m 2 . ( 2.3 ) Discontinue if eGFR falls below 30 mL/minute/1.73 m 2 . ( 2.3 ) 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. ( 2.4 ) 2.1 Adult Dosage 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 2,000 mg once daily with the evening meal. If glycemic control is not achieved with metformin hydrochloride extended-release tablets 2,000 mg once daily, consider a trial of metformin hydrochloride extended-release tablets 1,000 mg twice daily. Patients receiving metformin hydrochloride tablets may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2,000 mg once daily. 2.3 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 Warnings and Precautions (5.1) ] . 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.