Generic Name and Formulations:
Sildenafil 20mg; tabs.
Indications for REVATIO:
Pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and delay clinical worsening.
Limitations Of use:
No beneficial effect on exercise capacity in adding sildenafil to bosentan therapy.
5mg or 20mg three times daily; separate dosing by 4–6hrs. Max: 20mg three times daily.
Concomitant organic nitrates, riociguat.
Pulmonary veno-occlusive disease: not recommended. PAH secondary to sickle cell anemia. Underlying conditions that could be affected by vasodilatory effects (eg, concomitant antihypertensive therapy, BP<90/50, fluid depletion, severe left ventricular outflow obstruction, autonomic dysfunction). Risk of non-arteritic anterior ischemic optic neuropathy; monitor for sudden vision loss. Retinitis pigmentosa. Anatomical penile deformation. Predisposition to priapism. Severe hepatic impairment. Active peptic ulcer. Bleeding disorders. Elderly. Pregnancy. Nursing mothers.
Phosphodiesterase type 5 inhibitor (cGMP-specific).
See Contraindications. Hypotension with nitrates. Concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir): not recommended. May be antagonized by CYP3A4 inducers. Concomitant α-blockers (eg, doxazosin) or amlodipine may cause symptomatic hypotension (monitor BP). Potentiates bleeding risk with Vit. K antagonists. Concomitant Viagra or other PDE5 inhibitors: not recommended.
Epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, rhinitis; hypotension, vision or hearing loss, priapism, vaso-occlusive crisis.
Hepatic (CYP3A, CYP2C9).
Fecal (primary), renal.
Tabs (YES); Susp, inj (NO)
Tabs—90; Susp—112mL (w. bottle adapter, oral syringe); Single-use vial (12.5mL)—1