Monograph Details
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Cardiovascular System
> Pulmonary hypertension
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REVATIO |
| Manufacturer |
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Pfizer Labs |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Phosphodiesterase type 5 inhibitor (cGMP-specific). |
| Generic Name |
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Sildenafil citrate 20mg; tabs. |
| Indications |
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Pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability. |
| Children |
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Not recommended. |
| Adults |
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20mg three times daily; separate dosing by 4–6 hrs (see Interactions). |
| Contraindications |
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Concomitant organic nitrates or nitric oxide donors (eg, sodium nitroprusside). |
| Precautions |
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Pulmonary veno-occlusive disease: not recommended. Cardiovascular disease (eg, MI, stroke, or life-threatening arrhythmias within 6 months; BP<90/50 or >170/110; coronary artery disease, unstable angina, LV outflow obstruction, fluid depletion, impaired autonomic regulation of BP). Retinitis pigmentosa. Anatomical penile deformation. Predisposition to priapism. Severe renal or hepatic impairment. Active peptic ulcer. Bleeding disorders. Elderly. Pregnancy (Cat.B). Nursing mothers. |
| Interactions |
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See Contraindications. Hypotension with nitrates. Concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir): not recommended. Potentiated by inhibitors of CY3A4 or CYP2C9, or cimetidine; may need dose adjustment. Antagonized by CYP3A4 inducers (eg, rifampin), bosentan; may need to adjust dose. Concomitant α-blockers (eg, doxazosin) may cause symptomatic hypotension. Potentiates bleeding risk with Vit. K antagonists. |
| Adverse Reactions |
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Epistaxis, headache, GI upset, flushing, insomnia, erythema, dyspnea worsened, rhinitis, sinusitis, myalgia, pyrexia, paresthesia, hypotension, visual changes (eg, photophobia, blurring). |
| How Supplied |
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Tabs—90 |
| Additional Resources |
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• Related Prescribing Note |
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