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Revatio (sildenafil)

THERAPEUTIC CLASS

Phosphodiesterase 5 (PDE5) inhibitor

DEA CLASS

RX

INDICATIONS

Treatment of pulmonary arterial HTN (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

ADULT DOSAGE

Pulmonary Arterial Hypertension

Treatment of pulmonary arterial HTN (WHO Group I) to improve exercise ability and delay clinical worsening

PO:
5mg or 20mg tid, 4-6 hrs apart
Max: 20mg tid

IV:
For continued treatment in patients currently taking tabs/sus and who are temporarily unable to take oral medications

2.5mg or 10mg IV bolus tid

ADMINISTRATION

Oral/IV route

Refer to PI for reconstitution of the powder for oral sus

Incompatibilities
Do not mix w/ any other medication or additional flavoring agent

HOW SUPPLIED

Inj: 10mg [12.5mL]; Sus: 10mg/mL [112mL]; Tab: 20mg

CONTRAINDICATIONS

Concomitant use of organic nitrates in any form, either regularly/intermittently, or riociguat, a guanylate cyclase stimulator.

WARNINGS/PRECAUTIONS

Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. Not recommended in children. Vasodilatory effects may adversely affect patients w/ resting hypotension (BP <90/50), fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction. Not recommended w/ pulmonary veno-occlusive disease (PVOD); consider possibility of associated PVOD if signs of pulmonary edema occur. Epistaxis reported in patients w/ pulmonary HTN secondary to connective tissue disorder. When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION) was reported. Caution w/ previous NAION in 1 eye and w/ retinitis pigmentosa. Cases of sudden decrease or loss of hearing, possibly accompanied by tinnitus and dizziness, reported. Caution in patients w/ anatomical penile deformation (eg, angulation, cavernosal fibrosis, Peyronie's disease) or w/ predisposition to priapism (eg, sickle-cell anemia, multiple myeloma, leukemia). Penile tissue damage and permanent loss of potency may result if priapism is not immediately treated. Vaso-occlusive crises requiring hospitalization reported in patients w/ pulmonary HTN secondary to sickle-cell disease. Caution in elderly.

ADVERSE REACTIONS

Headache, dyspepsia, gastritis, epistaxis, paresthesia, flushing, diarrhea, insomnia, dyspnea exacerbation, myalgia, nausea, sinusitis, erythema, pyrexia, rhinitis.

DRUG INTERACTIONS

See Contraindications. Vasodilatory effects may adversely affect patients on antihypertensive therapy; monitor BP when given w/ antihypertensives. Reports of epistaxis w/ oral vitamin K antagonists. Avoid w/ other PDE-5 inhibitors. Not recommended w/ ritonavir and other potent CYP3A inhibitors. Symptomatic postural hypotension w/ doxazosin reported. Additional reduction of supine BP w/ oral amlodipine reported.

PREGNANCY AND LACTATION

Category B, caution in nursing.

MECHANISM OF ACTION

PDE-5 inhibitor; increases cGMP w/in pulmonary vascular smooth muscle cells, resulting in relaxation and vasodilation of pulmonary vascular bed and (to a lesser degree) systemic circulation.

PHARMACOKINETICS

Absorption: (Oral) Rapid; absolute bioavailability (41%); Tmax=60 min (median) (fasted). Distribution: Vd=105L; plasma protein binding (96%). Metabolism: CYP3A (major route) and CYP2C9 (minor route); N-desmethyl metabolite (active metabolite). Elimination: Feces (80% metabolites), urine (13% metabolites); T1/2=4 hrs.

ASSESSMENT

Assess for hypotension, fluid depletion, left ventricular outflow obstruction, autonomic dysfunction, PVOD, risk factors for developing NAION, previous NAION in 1 eye, retinitis pigmentosa, anatomical deformities of the penis, conditions predisposing to priapism, pulmonary HTN secondary to sickle-cell disease, hypersensitivity to drug, pregnancy/nursing status, and possible drug interactions. Obtain baseline BP.

MONITORING

Monitor for signs of pulmonary edema, decreased/sudden loss of vision or hearing, tinnitus, dizziness, epistaxis, priapism, vaso-occlusive crises, hypersensitivity reactions, and other adverse reactions. Monitor BP.

PATIENT COUNSELING

Counsel about risks and benefits of the drug. Inform that drug is also marketed as Viagra for male erectile dysfunction. Advise not to take Viagra or other PDE-5 inhibitors and organic nitrates during therapy. Advise to notify physician if sudden decrease/loss of vision or hearing occurs. Instruct to seek immediate medical attention if an erection persists >4 hrs.

STORAGE

(Tab/Inj) 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). (Sus) <30°C (86°F). Protect from moisture. Constituted: <30°C (86°F) or 2-8°C (36-46°F). Do not freeze. Shelf-life: 60 days.

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