Drug Catalog - Product Detail
ISOSORBIDE MONONITRATE ER 30MG TB 500CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 23155-0519-05 | AVET PHARMACEUTICALS | 500 | 30MG | TABLET |
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Description
DESCRIPTION Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, ISMN 30 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate. ISMN 60 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, yellow iron oxide. ISMN 120 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypermellose, lactose monohydrate, magnesium stearate and talc. The molecular formula of ISMN is C 6 H 9 NO 6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula: ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. Isosorbide Mononitrate Extended-Release 120 mg Tablets, USP meets USP Dissolution Test 7. 5b9ebc4-281a-4a93-aba6-42317dde8520
How Supplied
HOW SUPPLIED Isosorbide Mononitrate Extended-Release Tablets, USP 30 mg are White, biconvex oval shaped tablets, scored and embossed "30" on one side. Bottles of 30 NDC 23155-519-03 Bottles of 100 NDC 23155-519-01 Bottles of 500 NDC 23155-519-05 Isosorbide Mononitrate Extended-Release Tablets, USP 60 mg are Light yellow, biconvex oval shaped tablets, scored on both sides and embossed ‘DX 31’ on one side. Bottles of 90 NDC 23155-178-09 Bottles of 100 NDC 23155-178-01 Bottles of 500 NDC 23155-178-05 Isosorbide mononitrate Extended-Release Tablets, USP 120 mg are white, biconvex, oval-shaped tablets, embossed with '120' on one side. Bottles of 100 NDC 23155-628-01 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from excessive moisture. Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816, 1.866.901.DRUG (3784) Manufactured by: Dexcel Ltd. 1 Dexcel St. Or-Akiva, 3060000, Israel. Issued: 10/2018 9434f3c-13e1-4cd6-a2ca-9b0e6241d8bf
Indications & Usage
INDICATIONS AND USAGE Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended starting dose of Isosorbide Mononitrate Extended-Release Tablets is 30 mg (given as a single 30 mg tablet or as 1/2 of a 60 mg tablet) or 60 mg (given as a single tablet) once daily. After several days, the dosage may be increased to 120 mg (given as a single 120 mg tablet or as two 60 mg tablets) once daily. Rarely, 240 mg may be required. The daily dose of Isosorbide Mononitrate Extended-Release Tablets should be taken in the morning on arising. Isosorbide Mononitrate Extended-Release Tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid. Do not break the 30 mg tablet.