Take the missed dose as soon as you remember. Consider therapy modification, Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. For availability, costs and complete details of coverage, contact a licensed agent or Cigna sales representative. slide 21 of 29, Isosorbide Mononitrate Extended Release. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. Monitor therapy, Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with ISMN, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Isosorbide mononitrate will not treat an angina attack that has already begun. Zydus Pharmaceuticals (USA) Inc. 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. Each tablet contains: Isosorbide mononitrate .60 mg, Each tablet contains: Isosorbide mononitrate .120 mg, Dispense in a tight container as defined in the. Ask your pharmacist if you have any questions about the new kind of isosorbide mononitrate you receive at the pharmacy. The importance of these observations to the routine, clinical use of oral ISMN is not known. WebMD does not provide medical advice, diagnosis or treatment. This information does not replace the advice of a doctor. Take the missed dose as soon as you remember. At day 42, the 120 mg and 240 mg dose of Isosorbide mononitrate extended-release tablets demonstrated a significant increase in total treadmill time at 4 and 12 hours post dosing, but by day 42 the 30 mg and 60 mg doses no longer were differentiable from placebo. Even in patients totally without cytochrome b5 reductase activity, however, and even assuming that the nitrate moiety of ISMN is quantitatively applied to oxidation of hemoglobin, about 2 mg/kg of ISMN should be required before any of these patients manifest clinically significant ( 10%) methemoglobinemia. When the pooled data were reviewed, headache and dizziness were the only adverse events that were reported by >5% of patients. 4, 7 Isosorbide mononitrate is an active metabolite of isosorbide dinitrate. Females showed higher AUCs and Cmax compared to males, but these differences were accounted for by differences in body weight between the two groups. Isosorbide mononitrate extended-release tablets during long-term use over 42 days dosed at 120 mg once daily continued to improve exercise performance at 4 hours and at 12 hours after dosing but their effects (although better than placebo) are less than or, at best, equal to the effects of the first dose of 60 mg. After oral administration of ISMN as a solution or immediate-release tablets, maximum plasma concentrations of ISMN are achieved in 30 to 60 minutes, with an absolute bioavailability of approximately 100%. Combinations of these agents may increase the likelihood of significant methemoglobinemia. There are no data suggesting what dose of ISMN is likely to be life threatening in humans. Follow your doctor's dosing instructions very carefully. Keep the bottle tightly closed when not in use. No evidence of carcinogenicity was observed in mice exposed to isosorbide mononitrate in their diets for up to 104 weeks at doses of up to 900 mg/kg/day. 1 interaction . Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Monitor therapy, Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. (Levitra, Staxyn). risk . Monitor therapy, Phosphodiesterase 5 Inhibitors: May enhance the vasodilatory effect of Vasodilators (Organic Nitrates). Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Tell your doctor if you are pregnant or plan to become pregnant. To make sure isosorbide mononitrate is safe for you, tell your doctor if you have: It is not known whether this medicine will harm an unborn baby. Isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites. WellSpan Imaging, About Heart failure does not mean the heart has failed completely. Isosorbide Mononitrate Extended-release Tablets should therefore be used with caution in elderly patients who may be volume depleted, on multiple medications or who, for whatever reason, are already hypotensive. The two doses should be administered 7 hours apart in order to avoid tolerance (decreased effect after several doses). Isosorbide dinitrate (Isordil) is a nitrate vasodilator, which means that it works to relax your blood vessels. The benefits of ISMN in patients with acute myocardial infarction or congestive heart failure have not been established; because the effects of ISMN are difficult to terminate rapidly, this drug is not recommended in these settings. Primarily reduces cardiac oxygen demand by decreasing preload (left ventricular end-diastolic pressure); may modestly reduce afterload; dilates coronary arteries and improves collateral flow to ischemic regions. Keep this medicine on hand at all times. In addition, each tablet contains the . Dose adjustments of either class of agents may be necessary. Overall, 8% of the patients who received 30 mg, 60 mg, 120 mg, or 240 mg of ISMN in the three placebo-controlled North American studies discontinued treatment because of adverse events. July 30, 2019. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy, particularly in the elderly. ISMN is approximately 5% bound to human plasma proteins and is distributed into blood cells and saliva. ED is often a symptom of another health problem or health-related factor. Immediate release: 20 mg twice daily with the 2 doses given 7 hours apart (eg, 8 AM and 3 PM) to decrease tolerance development; patients with small stature may initiate therapy with 5 mg twice daily and titrate to at least 10 mg twice daily in first 2 to 3 days of therapy. In addition, the following spontaneous adverse event has been reported during the marketing of Isosorbide Mononitrate (ISMN): syncope. Tolerance can only be overcome by short periods of nitrate absence from the body. Physician Directory slide 9 of 29, Isosorbide Mononitrate Extended Release. When the data were analyzed using age as a variable, the results indicated that there were no significant differences in any of the pharmacokinetic variables of ISMN between older ( 65 years) and younger individuals (45-64 years). The key is to know and recognize the warning signs as early as possible and take the right steps to prevent or treat the heart problem, Angina is chest discomfort, tightness, or pain caused by reduced blood flow through the coronary arteries to the heart muscle. Monitor therapy, Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Treatment of ISMN overdose in these patients may be subtle and difficult, and invasive monitoring may be required. **Patients were started on 60 mg and titrated to their final dose. Management: Seek alternatives to the CYP3A4 substrate when possible. As with other nitrates, daily headaches sometimes accompany treatment with ISMN. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Hypersensitivity to isosorbide mononitrate, other nitrates or nitrites, or any component of the formulation; concurrent use with phosphodiesterase-5 (PDE-5) inhibitors (sildenafil, tadalafil, or vardenafil) or riociguat. Chest pain caused by angina Isosorbide dinitrate (Isordil) dosage forms sublingual tablet 2.5mg 5mg tablet Isosorbide mononitrate extended-release 30 mg tablets are oval, reddish pink, film-coated tablets, debossed "N" bisect "30" on one side and bisect on the other side, packaged as follows: Isosorbide mononitrate extended-release 60 mg tablets are oval, yellow, film-coated tablets, debossed "N" bisect "60" on one side and bisect on the other side, packaged as follows: Isosorbide mononitrate extended-release 120 mg tablets are oval, white, film-coated tablets, debossed "N120" on one side, packaged as follows: Store at 20 to 25C (68 - 77F). Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. being unable to get an erection at any time. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Graduate Medical Education In industrial workers who have had long term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. slide 7 of 29, Isosorbide Mononitrate Extended Release. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy, Riociguat: Vasodilators (Organic Nitrates) may enhance the hypotensive effect of Riociguat. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. The vasodilating effects of ISMN may be additive with those of other vasodilators. 12 Refer to isosorbide mononitrate and isosorbide dinitrate drug entries for more isosorbide indications. Isosorbide mononitrate helps to prevent angina chest pain from developing. Isosorbide mononitrate may also be used for purposes not listed in this medication guide. The 60 mg tablet also contains D&C Yellow No. slide 26 of 29, Isosorbide Mononitrate Extended Release. PDE-5 inhibitors: Avoid concurrent use with PDE-5 inhibitors (eg, sildenafil, tadalafil, vardenafil). Overdose symptoms may include a severe throbbing headache, fever, confusion, severe dizziness, fast or pounding heartbeats, vision problems, nausea, vomiting, stomach pain, bloody diarrhea, trouble breathing, sweating, cold or clammy skin, fainting, and seizure (convulsions). Myo-, Endo-, Pericardial and Valve Disorders: Angina pectoris aggravated, heart murmur, heart sound abnormal, myocardial infarction, Q-Wave abnormality. Alcohol may increase certain side effects of isosorbide mononitrate (dizziness, drowsiness, feeling light-headed, or fainting). You should not stop using isosorbide mononitrate suddenly or you could have a severe attack of angina. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. a light-headed feeling, like you might pass out; pounding heartbeats or fluttering in your chest. Gastrointestinal System Disorders: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gastric ulcer, gastritis, glossitis, hemorrhagic gastric ulcer, hemorrhoids, loose stools, melena, nausea, vomiting. slide 15 of 29, Isosorbide Mononitrate Extended Release. Alcohol may increase certain side effects of isosorbide mononitrate (dizziness, drowsiness, feeling light-headed, or fainting). (Levitra, Staxyn). Treatment with ISMN may be associated with light-headedness on standing, especially just after rising from a recumbent or seated position. If you take too much sildenafil or take it together with these medicines, the chance for side effects will be higher Nursing at WellSpan Sildenafil ( generic Viagra ), the active ingredient in Viagra, is a PDE5 inhibitor. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. You should not stop using isosorbide mononitrate suddenly or you could have a severe attack of angina. In single- and multiple-dose studies, the pharmacokinetics of ISMN were dose proportional between 30 mg and 240 mg. slide 2 of 29, Isosorbide Mononitrate Extended Release. Predominantly urine (2% as unchanged drug); feces (1%), Immediate release: 6 hours (Thadani1987); Extended release: 12 to 24 hours (Anderson 2007). The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the doing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of the concomitant disease or other drug therapy. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. [See USP Controlled Room Temperature]. The time course and dose dependence of this interaction have not been studied. While CI/F was independent of dose in the younger group, the older group showed slightly lower CI/F following the 120 mg regimen compared to the 60 mg regimen. Alcohol, in particular, has been found to exhibit additive effects of this variety. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. How should I take isosorbide mononitrate? If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good. Taking vardenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure. 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. Cardiovascular Disorders, General: Cardiac failure, hypertension, hypotension. Volunteer, Connect With Us Do not take riociguat (Adempas), sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) while you are using this medicine. Several well-controlled clinical trials have used exercise testing to assess the antianginal efficacy of continuously delivered nitrates. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Not all possible interactions are listed in this medication guide. Isosorbide mononitrate extended-release tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. Specifically, the risk for methemoglobinemia may be increased. 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