Revatio Oral Suspension

— THERAPEUTIC DISORDERS TREATED —
  • Pulmonary hypertension

Revatio Oral Suspension Generic Name & Formulations

General Description

Sildenafil 10mg/mL; pwd for oral susp after reconstitution; grape flavor; contains sorbitol.

Pharmacological Class

Phosphodiesterase type 5 inhibitor (cGMP-specific).

How Supplied

Tabs—90; Susp—112mL (w. bottle adapter, oral syringe); Single-use vial (12.5mL)—1

Manufacturer

Generic Availability

Tabs (YES); Susp, inj (NO)

Revatio Oral Suspension Indications

Indications

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.

Revatio Oral Suspension Dosage and Administration

Adult

5mg or 20mg three times daily; separate dosing by 4–6hrs. Max: 20mg three times daily.

Children

Not recommended.

Revatio Oral Suspension Contraindications

Contraindications

Concomitant organic nitrates, riociguat.

Revatio Oral Suspension Boxed Warnings

Not Applicable

Revatio Oral Suspension Warnings/Precautions

Warnings/Precautions

Pulmonary veno-occlusive disease: not recommended. PAH secondary to sickle cell anemia (risk of vaso-occlusive crisis). 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.

Revatio Oral Suspension Pharmacokinetics

See Literature

Revatio Oral Suspension Interactions

Interactions

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). Increased epistaxis with Vit. K antagonists. Avoid concomitant Viagra or other PDE5 inhibitors.

Revatio Oral Suspension Adverse Reactions

Adverse Reactions

Epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, rhinitis; hypotension, vision or hearing loss, priapism.

Revatio Oral Suspension Clinical Trials

See Literature

Revatio Oral Suspension Note

Not Applicable

Revatio Oral Suspension Patient Counseling

See Literature