Drug Catalog - Product Detail
METFORMIN HCL ER 1000MG TB 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47335-0306-88 | SUN PHARMACEUTICALS | 100 | 1000MG | TABLET |
PACKAGE FILES
Generic Name
METFORMIN HYDROCHLORIDE
Substance Name
METFORMIN HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202917
Description
11 DESCRIPTION Metformin hydrochloride extended-release tablets contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown: Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.62. 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 extended-release tablets, USP contain 500 mg or 1,000 mg of metformin hydrochloride, USP, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each tablet contains anhydrous citric acid, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, magnesium stearate, povidone, sodium bicarbonate and sodium lauryl sulfate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol and shellac glaze. FDA approved dissolution specifications differ from USP spl-metformin-chemical-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Metformin hydrochloride extended-release tablets, USP - 500 mg are available as white to off-white, circular, biconvex, film-coated tablets imprinted with "305" in black ink on one side and plain on the other side. Metformin hydrochloride extended-release tablets, USP - 1,000 mg are available as white to off-white, circular, biconvex, film-coated tablets imprinted with "306" in black ink on one side and plain on the other side. They are supplied as follows: 500 mg tablets: Bottles of 30 with Child Resistant Cap…....................NDC 47335-305-83 Bottles of 100 with Child Resistant Cap…..................NDC 47335-305-88 Bottles of 1000.................................................………..NDC 47335-305-18 1,000 mg tablets: Bottles of 30 with Child Resistant Cap…....................NDC 47335-306-83 Bottles of 90 with Child Resistant Cap…....................NDC 47335-306-81 Bottles of 100 with Child Resistant Cap…..................NDC 47335-306-88 Bottles of 1000.................................................………..NDC 47335-306-18 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride is 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 · Starting dose: 500 mg orally once daily with the evening meal ( 2.1 ) · Increase the dose in increments of 500 mg every 1 to 2 weeks, up to a maximum of 2,000 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 2,000 mg once daily. (2.1) · Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew. ( 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 . o Initiation is not recommended in patients with eGFR between 30 to 45 mL/minute/1.73 m 2 . o Assess risk/benefit of continuing metformin hydrochloride extended-release tablets if eGFR falls below 45 mL/minute/1.73 m 2 . o Discontinue if eGFR falls below 30 mL/minute/1.73 m 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 The recommended starting dose of metformin hydrochloride extended-release tablets are 500 mg orally once daily with the evening meal. Increase the dose in increments of 500 mg every 1 to 2 weeks on the basis of glycemic control and tolerability, up to a maximum of 2,000 mg once daily with the evening meal. Patients receiving metformin hydrochloride (HCl) may be switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2,000 mg once daily. Swallow metformin hydrochloride extended-release tablets whole and never crush, cut or chew. 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. 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/minute/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/minute/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)] .