Monoket
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Side Effects & Adverse Reactions
Amplification of the vasodilatory effects of monoket® 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
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.
Uses
monoket® is indicated for the prevention and treatment 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.
History
There is currently no drug history available for this drug.
Other Information
monoket®, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for monoket® is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula:
monoket® is available in 10 mg and 20 mg tablets. Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate.
Sources
Monoket Manufacturers
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Kremers Urban Pharmaceuticals Inc.
![Monoket (Isosorbide Mononitrate) Tablet [Kremers Urban Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Monoket | Kremers Urban Pharmaceuticals Inc.
The recommended regimen of monoket® tablets is 20 mg twice daily, with the doses seven hours apart. A starting dose of 5 mg (½ tablet of the 10 mg dosing strength) might be appropriate for persons of particularly small stature but should be increased to at least 10 mg by the second or third day of therapy. Dosage adjustments are not necessary for elderly patients or patients with altered hepatic or renal function.
As noted above (Clinical Pharmacology), multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The asymmetric (2 doses, 7 hours apart) dosing regimen for monoket® tablets provides a daily nitrate-free interval to minimize the development of tolerance.
As also noted under Clinical Pharmacology, well-controlled studies have shown that tolerance to monoket® tablets occurs to some extent when using the twice-daily regimen in which the two doses are given seven hours apart. This regimen has been shown to have antianginal efficacy beginning one hour after the first dose and lasting at least seven hours after the second dose. The duration (if any) of antianginal activity beyond fourteen hours has not been studied.
In clinical trials, monoket® has been administered in a variety of regimens and doses. Doses above 20 mg twice a day (with the doses seven hours apart) have not been adequately studied. Doses of 5 mg twice a day are clearly effective (effectiveness based on exercise tolerance) for only the first day of a twice-a-day (with doses 7 hours apart) regimen.
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