REVATIO ORAL SUSPENSION Rx
Generic Name and Formulations:
Sildenafil 10mg/mL; pwd for oral susp after reconstitution; grape flavor; contains sorbitol.
Indications for REVATIO ORAL SUSPENSION:
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 (see Interactions).
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 (Cat.B). Nursing mothers.
See Contraindications. Hypotension with nitrates. Concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir): not recommended. Potentiated by inhibitors of CY3A4 or CYP2C9. 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.
Phosphodiesterase type 5 inhibitor (cGMP-specific).
Epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea worsened, rhinitis, sinusitis, myalgia, pyrexia, paresthesia; 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—1