As all tests were negative the mutagenic risk in humans is considered low.Neither the long term toxicity studies in rats and dogs nor a special carcinogenicity study, performed in rats over 125 weeks (males) and 138 weeks (females), indicated neoplastic properties of isosorbide mononitrate. be increased to 10 mg twice daily after 2 to 3 days. Tablets should be taken after meals, unchewed with water.In patients taking one tablet twice daily the second dose should be taken 8 hours after the first dosage. 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.Severe hypotension, particularly with upright posture, may occur with even small doses of Isosorbide Mononitrate. Isosorbide mononitrate is used to effectively prevent chest pain or angina attacks. Both the dosage and frequency should be tapered gradually (see section 4.4)Isosorbide mononitrate tablets should not be given to patients with a known sensitivity to isosorbide mononitrate, the listed ingredients or other nitrates.Isosorbide mononitrate tablets should not be used in cases of acute myocardial infarction with low filling pressures, acute circulatory failure (shock, vascular collapse), or very low blood pressure (systolic blood pressure below 90 mmHg), hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g.
Wyeth-Ayerst Laboratories, Philadelphia, PA. 2. Thus taking into account the recommended dosage of 20 to 30 mg/d in humans, the therapeutic index can be stated as high.These studies included a fertility and breeding study over two generations in rats; teratology studies in rats and rabbits; and a rat peri-postnatal study. Peak plasma concentrations usually occur in about 30 to 60 minutes.
Dilatation of the coronary arteries also occurs. It has been found to be particularly useful in heart failure due to systolic dysfunction together with hydralazine in black people. Both the dosage and frequency should be tapered gradually (see section 4.2)In patients with decreased gastrointestinal transit time, a decrease in release of the active ingredient may occur.Patients who undergo a maintenance treatment with Isosorbide mononitrate should be informed that they must not use phosphodiesterase inhibitor-containing products (e.g.
Caution is recommended during concomitant use of sapropterine- containing medicine with all agents that cause vasodilation by affecting nitric oxide (NO) metabolism or action, including classical NO donors (e.g.
Vasotrate-60 OD(isosorbide mononitrate): Prophylaxis of angina & as adjunct in CHF. 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.Isosorbide Mononitrate tablets, USP are available as follows:Dispense in tight containers as defined in the USP.Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). The incidence and magnitude of such phenomena have appeared, in studies of other nitrates, to be highly dependent upon the schedule of nitrate administration.Isosorbide Mononitrate is rapidly and completely absorbed from the gastrointestinal tract. It cannot be excluded that an overdose of isosorbide mononitrate may cause this adverse reaction.In very high doses the intracranial pressure may be increased.
The onset of action of oral Isosorbide Mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.Isosorbide Mononitrate is contraindicated in patients who are allergic to it.Do not use Isosorbide Mononitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil.
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