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warnings
WARNINGS Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors such as sildenafil, vardenafil, or tadalafil could result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Reasonable supportive care should consist of those measures used to treat a nitrate overdose with elevation of the extremities and central volume expansion.
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact NitroMed, Inc. at 1-888-692-4345 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. BiDil BiDil has been evaluated for safety in 517 heart failure patients in A-HeFT. A total of 317 of these patients received BiDil for at least 6 months, and 220 received BiDil for at least 12 months. In A-HeFT, 21% of the patients discontinued BiDil for adverse experiences compared to 12% who discontinued placebo. Overall, adverse events were more common in BiDil-treated than in placebo-treated patients. Table 2 lists adverse events reported with an incidence of ≥ 2% in patients treated with BiDil in A-HeFT, and, after rounding to the nearest 1%, occurring more frequently than in the placebo group, regardless of causality. Headache and dizziness were the two most frequent adverse events and were more than twice as frequent in the BiDil group. The most common reasons for discontinuing BiDil in the A-HeFT trial were headache (7%) and dizziness (4%). Table 2. Adverse Events Occurring in the A-HeFT Study in ≥ 2% of Patients Treated with BiDil. BiDil (N=517) (% of patients) Placebo (N=527) (% of patients) Headache 50 21 Dizziness 32 14 Chest pain 16 15 Asthenia 14 11 Nausea 10 6 Bronchitis 8 7 Hypotension 8 4 Sinusitis 4 2 Ventricular tachycardia 4 2 Palpitations 4 3 Hyperglycemia 4 3 Rhinitis 4 3 Paresthesia 4 2 Vomiting 4 2 Amblyopia 3 1 Hyperlipidemia 3 2 Tachycardia 2 1 The following adverse events were reported in A-HeFT in at least 1% but less than 2% of patients treated with BiDil, and also occurred in at least 0.5% more patients than in placebo-treated patients; all such events are included unless they are too non-specific to be meaningful or appear to reflect underlying disease. Body as a Whole: Allergic reaction, malaise. Central nervous system: Somnolence. Gastrointestinal: Cholecystitis. Metabolic: Hypercholesteremia. Musculoskeletal: Arthralgia, myalgia, tendon disorder. Skin: Alopecia, angioedema, sweating. In the V-HeFT I and II studies, a total of 587 patients with heart failure were treated with the combination of isosorbide dinitrate and hydralazine hydrochloride. The type, pattern, frequency and severity of adverse experiences reported in these studies were similar to those reported in A-HeFT, and no unusual adverse experiences were reported. Prior experience with BiDil components The following additional adverse events have been reported with hydralazine hydrochloride or isosorbide dinitrate but not necessarily with BiDil: Digestive: paralytic ileus. Cardiovascular: paradoxical pressor response, crescendo angina. Neurologic: peripheral neuritis, numbness, tingling, muscle cramps, psychotic reactions, disorientation. Genitourinary: difficulty in urination. Hematologic: blood dyscrasias, agranulocytosis, purpura, splenomegaly. Hypersensitive Reactions: eosinophilia, hepatitis. Other: nasal congestion, flushing, lacrimation, conjunctivitis.