BOXED WARNING Contraindicated in patients with heart failure of any severity — PDE III inhibitors have decreased survival in class III–IV heart failure.
FDA dosing
Population
Start
Target
Max
Intermittent claudication
Adults
100 mg BID
100 mg BID
100 mg BID
Intermittent claudication — with CYP3A4 or CYP2C19 inhibitors
Adults
50 mg BID
50 mg BID
50 mg BID
Renal Undefined
Hepatic Undefined
Reduce to 50 mg BID with strong/moderate CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, diltiazem) or CYP2C19 inhibitors (ticlopidine, fluconazole, omeprazole)
Instructions
Take at least 30 min before or 2 hours after breakfast and dinner
Beneficial effect may take up to 12 weeks; discontinue if no improvement after 3 months
Contraindications
Heart failure of any severity
Cautions
Tachycardia, palpitation, tachyarrhythmia, hypotension; may exacerbate angina/MI in ischemic heart disease
Left ventricular outflow tract obstruction in patients with sigmoid interventricular septum
Thrombocytopenia/leukopenia progressing to agranulocytosis — monitor platelets and WBC
Avoid in hemostatic disorders or active pathologic bleeding
Adverse reactions
Headache
Diarrhea, abnormal stools
Palpitation
Pregnancy Category C; teratogenic/fetotoxic in animals — no adequate human studies
Lactation Transferred into milk in animals — discontinue nursing or the drug