Isorsorbide Mononitrate Extended-release Recall
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Questions & Answers
Side Effects & Adverse Reactions
Amplification of the vasodilatory effects of isosorbide mononitrate by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
The benefits of isosorbide mononitrate in patients with acute myocardial infarction or congestive heart failure have not been established; because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings.
If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
There is currently no drug history available for this drug.
Isosorbide mononitrate, an organic nitrate and the major biologically active metabolite of isosorbide dinitrate, is a vasodilator with effects on both arteries and veins.
Isosorbide mononitrate extended-release tablets for oral administration contain 30 mg or 60 mg of isosorbide mononitrate in an extended-release formulation. The inactive ingredients are carnauba wax, colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maltodextrin, polyethylene glycol, stearic acid, titanium dioxide, and triacetin. The 60 mg tablet also contains synthetic red iron oxide and synthetic yellow iron oxide. The chemical name for isosorbide mononitrate is 1,4:3,6-dianhydro-D-glucitol 5-nitrate; the compound has the following structural formula:
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.