Nitrate Vasodilator

Isosorbide Mononitrate

Approved 30 Oct 1998OralTablet

The FDA lists this product in 44 strengths and forms.

Indications

Isosorbide mononitrate tablets, USP are 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.

Contraindications

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. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use isosorbide mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat.

Concomitant use can cause hypotension.

Warnings and precautions

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.

Interactions

Drug Interactions Concomitant use of isosorbide mononitrate with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS ). Concomitant use of isosorbide mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS ). The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Contraindications

Concomitant use can cause hypotension.

Warnings and precautions

Interactions

Adverse reactions

Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy. The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad. The same table shows the frequency of withdrawal for these adverse reactions.

In many cases the adverse reactions were of uncertain relation to drug treatment. Frequency of Adverse Reactions (Discontinuations)* 6 Placebo-Controlled Studies Dose Placebo 5 mg 10 mg 20 mg Patients 160 54 52 159 Headache 6% (0%) 17% (0%) 13% (0%) 35% (5%) Fatigue 2% (0%) 0% (0%) 4% (0%) 1% (0%) Upper Respiratory Infection <1% (0%) 0% (0%) 4% (0%) 1% (0%) Pain <1% (0%) 4% (0%) 0% (0%) <1% (0%) Dizziness 1% (0%) 0% (0%) 0% (0%) 4% (0%) Nausea <1% (0%) 0% (0%) 0% (0%) 3% (2%) Increased Cough <1% (0%) 0% (0%) 2% (0%) <1% (0%) Rash 0% (0%) 2% (2%) 0% (0%) <1% (0%) Abdominal Pain <1% (0%) 0% (0%) 2% (0%) 0% (0%) Allergic Reaction 0% (0%) 0% (0%) 2% (0%) 0% (0%) Cardiovascular Disorder 0% (0%) 2% (0%) 0% (0%) 0% (0%) Chest Pain <1% (0%) 0% (0%) 2% (0%) <1% (0%) Diarrhea 0% (0%) 0% (0%) 2% (0%) 0% (0%) Flushing 0% (0%) 0% (0%) 2% (0%) 0% (0%) Emotional Lability 0% (0%) 2% (0%) 0% (0%) 0% (0%) Pruritus 1% (0%) 2% (2%) 0% (0%) 0% (0%) *Some individuals discontinued for multiple reasons.

Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were: Cardiovascular: acute myocardial infarction, apoplexy, arrhythmias, bradycardia, edema, hypertension, hypotension, pallor, palpitations, tachycardia. Dermatologic: sweating. Gastrointestinal: anorexia, dry mouth, dyspepsia, thirst, vomiting, decreased weight. Genitourinary: prostatic disorder.

Miscellaneous: amblyopia, back pain, bitter taste, muscle cramps, neck pain, paresthesia, susurrus aurium. Neurologic: anxiety, impaired concentration, depression, insomnia, nervousness, nightmares, restlessness, tremor, vertigo. Respiratory: asthma, dyspnea, sinusitis. Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see under OVERDOSAGE .

To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Isosorbide Mononitrate

Indications

Contraindications

Warnings and precautions

Interactions

Two medicines in one question?

Isosorbide Mononitrate

Indications

Contraindications

Warnings and precautions

Interactions

Two medicines in one question?

Pregnancy and breastfeeding

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance