Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. abametapir will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. encorafenib, isosorbide mononitrate. The increases in exercise tolerance on day 14, although statistically significant compared to placebo, were about half of that seen on day 1 of the trial. Avoid or Use Alternate Drug. Use Caution/Monitor. Only after nitrates have been absent from the body for several hours has their antianginal efficacy been restored. Platelet, Bleeding and Clotting Disorders: Purpura, thrombocytopenia. Differences between the two age groups, however, were not statistically significant. Modify Therapy/Monitor Closely. mitotane decreases levels of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Risk of increased SBP, angina pectoris. FDA approved dissolution acceptance criteria for Isosorbide Mononitrate Extended-Release 30 mg and 60 mg Tablets, USP differ from that of the USP. Symptoms of ED include. Administration of Isosorbide Mononitrate Extended-Release Tablets once daily, taken early in the morning on arising, provided at least 12 hours of antianginal activity. Minor/Significance Unknown. Because many drugs are excreted in human milk, caution should be exercised when ISMN is administered to a nursing mother. In the large majority of these trials, active agents were indistinguishable from placebo after 24 hours (or less) of continuous therapy. Monitor Closely (1)isosorbide mononitrate, bupivacaine implant. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Isosorbide Mononitrate Extended-Release Tablets, USP 120 mg are white, biconvex, oval-shaped tablets, embossed with '120' on one side. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. Avoid or Use Alternate Drug. This document does not contain all possible drug interactions. Either increases effects of the other by pharmacodynamic synergism. Chartwell RX, LLC. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. The time course and dose dependence of this interaction have not been studied. . conivaptan will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Renal clearance accounts for only about 4% of total body clearance. 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. No evidence of carcinogenicity was observed in rats exposed to Isosorbide Mononitrate in their diets at doses of up to 900 mg/kg/day for the first 6 months and 500 mg/kg/day for the remaining duration of a study in which males were dosed for up to 121 weeks and females were dosed for up to 137 weeks. The mean plasma elimination half-life of ISMN is approximately 5 hours. Treatment of Isosorbide Mononitrate overdose in these patients may be subtle and difficult, and invasive monitoring may be required. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Potentially fatal hypotension. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Severe hypotension, particularly with upright posture, may occur with even small doses of Isosorbide Mononitrate. Since headache appears to be a dose-related adverse effect and tends to disappear with continued treatment, it is recommended that ISMN treatment be initiated at low doses for several days before being increased to desired levels. Monitor Closely (1)tetracaine, isosorbide mononitrate. Isosorbide Mononitrate Extended-Release Tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites. Other (see comment). If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs. When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1-2 mg/kg intravenously. Mechanism: additive vasodilation. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Neonatal survival and development and incidence of stillbirths were adversely affected when pregnant rats were administered oral doses of 750 (but not 300) mg Isosorbide Mononitrate/kg/day during late gestation and lactation. and formulary information changes. In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Use Caution/Monitor. Either increases effects of the other by additive vasodilation. Use Caution/Monitor. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). Clinical studies of Isosorbide Mononitrate extended-release tablets did not include sufficient information on patients age 65 and over to determine whether they respond differently from younger patients. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. Monitor Closely (1)rifabutin will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Properly discard this product when it is expired or no longer needed. Dizziness was rarely associated with withdrawal from these studies. Psychiatric Disorders: Anxiety, concentration impaired, confusion, decreased libido, depression, impotence, insomnia, nervousness, paroniria, somnolence. The table below shows the frequencies of the adverse events that occurred in >5% of the subjects in three placebo-controlled North American studies, in which patients in the active treatment arm received 30 mg, 60 mg, 120 mg, or 240 mg of Isosorbide Mononitrate Extended-Release Tablets once daily. Use Caution/Monitor. Because the hypotension associated with Isosorbide Mononitrate overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward an increase in central fluid volume. Avoid or Use Alternate Drug. Monitor Closely (1)elagolix decreases levels of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Either increases effects of the other by pharmacodynamic synergism. isosorbide mononitrate, tadalafil. Either increases effects of the other by pharmacodynamic synergism. Lencapavir may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates. In rats and mice, there is significant lethality at doses of 2000 mg/kg and 3000 mg/kg, respectively. Otherwise, call a poison control center right away. rifapentine will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Avoid or Use Alternate Drug. 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 . The following table summarizes key pharmacokinetic parameters of ISMN after single- and multiple-dose administration of ISMN as an oral solution or Isosorbide Mononitrate Extended-Release Tablets: The influence of food on the bioavailability of ISMN after single-dose administration of Isosorbide Mononitrate Extended-Release Tablets 60 mg was evaluated in three different studies involving either a "light" breakfast or a high-calorie, high-fat breakfast. Minor (1)acetylcysteine (Antidote) increases effects of isosorbide mononitrate by Other (see comment). Store at 20 to 25C (68 to 77F) (see USP Controlled Room Temperature). This drug is available at the lowest co-pay. Adjust dosage of CYP3A4 substrates, if clinically indicated. Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. Also, it is not intended to be taken just before physical activities (such as exercise or sexual intercourse) to prevent chest pain. maraviroc, isosorbide mononitrate. The chemical name for ISMN is: 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula: ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90C, and an optical rotation of +144 (2% in water, 20C). Contraindicated. Avoid or Use Alternate Drug. This information does not assure that this product is safe, effective, or appropriate for you. Serious - Use Alternative (1)phenobarbital will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Consult your pharmacist or local waste disposal company. You are being redirected to Treatment with Isosorbide Mononitrate may be associated with light-headedness on standing, especially just after rising from a recumbent or seated position. Observe for possible additive hypotensive effects during concomitant use. Isosorbide Mononitrate is cleared by denitration to isosorbide and glucuronidation as the mononitrate, with 96% of the administered dose excreted in the urine within 5 days and only about 1% eliminated in the feces. Protect from excessive moisture. Manage and view all your plans together even plans in different states. lofexidine, isosorbide mononitrate. Is Low-Dose Aspirin Linked to Risk for Gastric Ulcers? It works by relaxing and widening blood vessels so blood can flow more easily to the heart.This medication will not relieve chest pain once it occurs. Consider increasing CYP3A substrate dose if needed. For most patients, this can be accomplished by taking the dose on arising. The pharmacokinetics and/or bioavailability of Isosorbide Mononitrate Extended-Release Tablets have been studied in both normal volunteers and patients following single- and multiple-dose administration. Both drugs lower blood pressure. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this medication, especially dizziness and lightheadedness, which could increase the risk of falls.During pregnancy, this medication should be used only when clearly needed. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO 2. Mechanism of Action Isosorbide is a nitrate that exerts its pharmacologic effect by releasing nitric oxide (NO), an endothelium-derived relaxing factor (EDRF).NO is endogenously produced in the endothelium to dilate the blood vessels. affecting hepatic/intestinal enzyme CYP3A4 metabolism. In addition, the following spontaneous adverse event has been reported during the marketing of Isosorbide Mononitrate: syncope. At least six different compounds have been detected in urine, with about 2% of the dose excreted as the unchanged drug and at least five metabolites. fexinidazole will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Evaluate for loss of therapeutic effect if medication must be coadministered. Minor (1)anastrozole will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Methemoglobinemia has been reported in patients receiving other organic nitrates, and it probably could also occur as a side effect of Isosorbide Mononitrate. Modify Therapy/Monitor Closely. In parentheses, the same table shows the frequencies with which these adverse events were associated with the discontinuation of treatment. Serious - Use Alternative (1)fosphenytoin will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Observe for possible additive hypotensive effects during concomitant use. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate. Minor/Significance Unknown. Modify Therapy/Monitor Closely. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Minor/Significance Unknown. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events. Minor/Significance Unknown. Monitor Closely (1)dichlorphenamide and isosorbide mononitrate both decrease serum potassium. Vascular (Extracardiac) Disorders: Flushing, intermittent claudication, leg ulcer, varicose vein. lorlatinib will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. stiripentol, isosorbide mononitrate. levoketoconazole will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Make sure laboratory personnel and all your doctors know you use this drug. The benefits of ISMN 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 unavoidable, reduce CYP3A substrate dose according to product labeling. isosorbide mononitrate, sildenafil. Alcohol or marijuana (cannabis) can make you more dizzy. Either increases effects of the other by pharmacodynamic synergism. Females showed higher AUCs and C max compared to males, but these differences were accounted for by differences in body weight between the two groups. It is important to take the drug at the same times each day. Resistance Mechanism Disorders: Bacterial infection, moniliasis, viral infection. Serious - Use Alternative (1)carbamazepine will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Either increases effects of the other by pharmacodynamic synergism. Isosorbide mononitrate extended- release tablets 30 and 60 mg (only doses evaluated acutely) demonstrated a significant increase from baseline in total treadmill time relative to placebo at 4 and 12 hours after the administration of the first dose. Fexinidazole inhibits CYP3A4. In a multiple-dose study, the effect of age on the pharmacokinetic profile of Isosorbide Mononitrate Extended-Release Tablets 60 mg and 120 mg (2 x 60 mg) was evaluated in subjects 45 years. Modify Therapy/Monitor Closely. Other adverse events, each reported by 5% of exposed patients, and in many cases of uncertain relation to drug treatment, were: Autonomic Nervous System Disorders: Dry mouth, hot flushes. Other (see comment). The administration of Isosorbide Mononitrate extended-release 120 mg (2 x 60 mg tablets every 24 hours for 7 days) produced a dose-proportional increase in C max and AUC, without changes in T max or the terminal half-life. Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. encoded search term (isosorbide mononitrate (Imdur%2C Monoket)) and isosorbide mononitrate (Imdur, Monoket), ECG Challenge: Lightheadedness and Extremely Slow Pulse. We comply with the HONcode standard for trustworthy health information. These animal doses are about 100 times the maximum recommended human dose (120 mg in a 50 kg woman) when comparison is based on body weight; when comparison is based on body surface area, the rat dose is about 17 times the human dose and the rabbit dose is about 38 times the human dose. 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Exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO 2 two groups...