DESCRIPTION

Isosorbide mononitrate, an organic nitrate and the major biologically active metabolite of isosorbide dinitrate, is a vasodilator with effects on both arteries and veins.

The chemical name for isosorbide mononitrate is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate.

Isosorbide mononitrate 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.

Each Ismo tablet contains 20 mg of isosorbide mononitrate. The inactive ingredients in each tablet are D&C yellow 10 aluminum lake, FD&C yellow 6 aluminum lake, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 20, povidone, silicon dioxide, sodium starch glycolate, titanium dioxide and hydroxypropyl cellulose.

Imdur tablets contain 30 mg, 60 mg, or 120 mg of isosorbide mononitrate in an extended-release formulation. The inactive ingredients are aluminum silicate, colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, paraffin wax, polyethylene glycol, titanium dioxide, and trace amounts of ethanol.

CATEGORIES, BRAND NAMES

CATEGORIES: Angina pectoris; Pregnancy Category C; FDA Class 1C ("Little or No Therapeutic Advantage"); FDA Approved 1991 Dec; Top 200 Drugs

FDA Drug Classes: Antianginals; Coronary Vasodilators

BRAND NAMES:

BRAND NAMES: Conpin; Conpin Retardkaps; Corangin; Corangin SR; Duride; Elan; Elantan; Elantan Long; Elantan Retard; Imdur; Imdur 60; Imdur Durules; Imodur; Imtrate; ISMN; Ismexin; Ismo; Ismo-20; Ismo 20; Ismox; Isomon; Isomonat; Isomonit; Isopen-20; Iturol; Medocor; Monicor; Monis; Monit 20; Mono Corax; Mono Corax Retard; Monoclair; Monocord 20; Monocord 40; Monocord 50 SR; Monodur Durules; Monoket; Monoket OD; Monoket Retard; Monolong; Monolong 40; Monolong 60; Mono-Mack; Mono Mack; Mononit; Monopront; Mono-Sanorania; Monosorbitrate; Monosordil; Monotrate; Monovas; Mononit 20; Mononit 40; Mononit Retard 50; Nitramin; Pentacard; Pentacard 20; Vasotrate
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Conpin (Germany)
Conpin Retardkaps (Germany)
Corangin (New-Zealand)
Corangin SR (Taiwan)
Duride (New-Zealand)
Elan (Italy)
Elantan (Austria; Czech-Republic; Dominican-Republic; El-Salvador; England; Germany; Guatemala; Honduras; Hong-Kong; Indonesia; Korea; Malaysia; Mexico; Panama; Peru; Philippines; Switzerland; Taiwan; Thailand)
Elantan Long (Czech-Republic; Germany; Hong-Kong; Malaysia; Peru; Philippines)
Elantan Retard (Switzerland)
Imdur 60 (Mexico; Taiwan)
Imdur Durules (Australia)
Imodur (Colombia)
Imtrate (New-Zealand)
ISMN (Austria; Germany)
Ismexin (Finland)
Ismo-20 (Benin; Burkina-Faso; Ethiopia; Gambia; Ghana; Guinea; Ivory-Coast; Kenya; Liberia; Malawi; Mali; Mauritania; Mauritius; Morocco; Niger; Nigeria; Senegal; Seychelles; Sierra-Leone; South-Africa; Sudan; Tanzania; Tunia; Uganda; Zambia; Zimbabwe)
Ismo 20 (Bahamas; Bahrain; Barbados; Belize; Bermuda; Curacao; Cyprus; Egypt; Guyana; Hong-Kong; India; Indonesia; Iran; Iraq; Israel; Jamaica; Jordan; Kuwait; Lebanon; Libya; Malaysia; Netherland-Antilles; New-Zealand; Oman; Qatar; Republic-Of-Yemen; Saudi-Arabia; South-Africa; Surinam; Syria; Taiwan; Thailand; Trinidad; United-Arab-Emirates)
Ismox (Finland)
Isomon (Greece)
Isomonat (Austria; Czech-Republic)
Isomonit (Germany)
Isopen-20 (Thailand)
Iturol (Japan)
Medocor (Ecuador)
Monicor (France)
Monis (Colombia)
Monit 20 (India)
Mono Corax (Germany)
Mono Corax Retard (Germany)
Monoclair (Germany)
Monocord 20 (Israel)
Monocord 40 (Israel)
Monocord 50 SR (Israel)
Monodur Durules (Australia)
Monoket OD (Norway; Sweden)
Monoket Retard (Austria; Italy)
Monolong (Germany)
Monolong 40 (Israel)
Monolong 60 (Israel)
Mono-Mack (Czech-Republic)
Mono Mack (Ecuador; Mexico; South-Africa)
Mononit (Bulgaria; Poland)
Monopront (Finland)
Mono-Sanorania (Germany)
Monosorbitrate (India)
Monosordil (Greece)
Monotrate (India)
Monovas (Philippines)
Mononit 20 (Israel)
Mononit 40 (Israel)
Mononit Retard 50 (Israel)
Nitramin (Greece)
Pentacard (Belgium; Indonesia)
Pentacard 20 (Hong-Kong; Thailand)
Vasotrate (India)

COST OF THERAPY: $620.50 (Angina; Ismo Tablet; 20 mg; 2/day; 365 days)