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warnings
WARNINGS Amplification of the vasodilatory effects of Ismo 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 hemo-dynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
ADVERSE REACTIONS The table below shows the frequencies of the adverse reactions observed in more than 1% of the subjects (a) in 6 placebo-controlled domestic studies in which patients in the active-treatment arm received 20 mg of isosorbide mononitrate twice daily, and (b) in all studies in which patients received isosorbide mononitrate in a variety of regimens. In parentheses, the same table shows the frequencies with which these adverse reactions led to discontinuation of treatment. Overall, 11% of the patients who received isosorbide mononitrate in the six controlled U.S. studies discontinued treatment because of adverse reactions. Most of these discontinued because of headache. “Dizziness” and nausea were also frequently associated with withdrawal from these studies. Frequency of Adverse Reactions (Discontinuations) Some individuals discontinued for multiple reasons. 6 Controlled Studies 92 Clinical Studies Dose Placebo 20 mg (varied) Patients 204 219 3344 Headache 9% (0%) 38% (9%) 19% (4.3%) Dizziness 1% (0%) 5% (1%) 3% (0.2%) Nausea, Vomiting <1% (0%) 4% (3%) 2% (0.2%) Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were:: Cardiovascular: angina pectoris, arrhythmias, atrial fibrillation, hypotension, palpitations, postural hypotension, premature ventricular contractions, supraventricular tachycardia, syncope. Dermatologic: pruritus, rash. Gastrointestinal: abdominal pain, diarrhea, dyspepsia, tenesmus, tooth disorder, vomiting. Genitourinary: dysuria, impotence, urinary frequency. Miscellaneous: asthenia, blurred vision, cold sweat, diplopia, edema, malaise, neck stiffness, rigors. Musculoskeletal: arthralgia. Neurological: agitation, anxiey, confusion, dyscoordination, hypoesthesia, hypokinesia, increased appetite, insomnia, nervousness, nightmares. Respiratory: bronchitis, pneumonia, upper-respiratory tract infection. Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for futher discussion of its diagnosis and treatment see under OVERDOSAGE .