Drug Catalog - Product Detail
ISOSORBIDE MONONITRATE ER 30MG TB 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50742-0175-01 | INGENUS PHARMACEUTICALS | 100 | 30MG | TABLET |
PACKAGE FILES
Generic Name
ISOSORBIDE MONONITRATE
Substance Name
ISOSORBIDE MONONITRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA210918
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. Isosorbide mononitrate tablets contain either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. 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 +140° to 146° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, acetic acid, alcohol, acetone and ethyl acetate; soluble in ether and chloroform, slightly soluble in toluene; practically insoluble in aliphatic hydrocarbons. Isosorbide mononitrate extended-release tablets, USP meets USP Dissolution Test 8. structure
How Supplied
HOW SUPPLIED Isosorbide Mononitrate Extended-Release Tablets USP, 30 mg are white to off-white, uncoated, oval shaped tablets debossed with 'ING 175' one side and scored on the other side. They are supplied as follows: Bottles of 100 NDC 50742-175-01 Bottles of 500 NDC 50742-175-05 Isosorbide Mononitrate Extended-Release Tablets USP, 60 mg are white to off-white, uncoated, capsule shaped tablets debossed with 'ING 176' one side and scored on the other side. They are supplied as follows: Bottles of 100 NDC 50742-176-01 Bottles of 500 NDC 50742-176-05 Isosorbide Mononitrate Extended-Release Tablets USP, 120 mg are white to off-white, uncoated, oval shaped tablets debossed with 'ING 177' one side and plain on the other side. They are supplied as follows: Bottles of 100 NDC 50742-177-01 Store at 20 o -30 o C (68 o -86 o F) [See USP Controlled Room Temperature]. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811-7193 Made in India DRUGS/TS/23/2007 Rev.: 09/2023 Ingenus Logo
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, USP 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, USP should be taken in the morning on arising. Isosorbide Mononitrate Extended-Release Tablets, USP should not be chewed or crushed and should be swallowed together with a half-glassful of fluid.