Drug Detail:Sildenafil (Sildenafil (oral) [ sil-den-a-fil ])
Drug Class: Agents for pulmonary hypertension Impotence agents
Usual Adult Dose for Erectile Dysfunction
Initial dose: 50 mg orally once a day, as needed, 1 hour prior to sexual activity
Maintenance: 25 to 100 mg orally once a day, as needed, 1 hour prior to sexual activity
Comments: This drug may be taken anywhere from 30 minutes to 4 hours before sexual activity.
Use: Treatment of erectile dysfunction
Usual Adult Dose for Pulmonary Hypertension
Revatio (R):
Oral:
- Initial dose: 5 or 20 mg orally three times a day, 4 to 6 hours apart
- Maximum dose: 20 mg orally three times a day
Injection:
- Initial dose: 2.5 or 10 mg IV bolus three times a day
Comments:
- No greater efficacy was achieved with oral doses higher than the maximum recommended dose.
- A 10 mg injection dose is predicted to provide pharmacological effect equivalent to the 20 mg oral dose.
Use: Treatment of PAH (WHO Group I) in adults to improve exercise ability and delay clinical worsening
Usual Geriatric Dose for Erectile Dysfunction
Initial dose: 25 mg orally once a day 1 hour prior to sexual activity
Use: Treatment of erectile dysfunction
Renal Dose Adjustments
Erectile dysfunction:
- Mild to moderate renal dysfunction (CrCl 30 to less than 80 mL/min): No adjustment recommended.
- Severe renal dysfunction (CrCl less than 30 mL/min): 25 mg orally once a day 1 hour prior to sexual activity
Pulmonary Arterial Hypertension:
Revatio (R):
- No adjustment recommended.
Liver Dose Adjustments
Erectile dysfunction:
- Initial dose: 25 mg orally should be considered in patients with any degree of hepatic impairment
Pulmonary Arterial Hypertension:
Revatio (R):
- Mild to moderate hepatic dysfunction (Child-Pugh Class A and B): No adjustment recommended.
- Severe hepatic dysfunction (Child-Pugh Class C): Has not been studied
Dose Adjustments
Concomitant administration with alpha blockers:
- Initial dose: 25 mg orally 1 hour prior to sexual activity
- Patients should be stable on alpha blocker therapy prior initiating treatment with this drug.
Concomitant administration with ritonavir:
- Initial dose: 25 mg orally 1 hour prior to sexual activity
- Maximum dose: 25 mg within a 48 hour period
Concomitant administration with CYP450 3A4 inhibitors (ketoconazole, itraconazole, saquinavir) or erythromycin:
- Initial dose: 25 mg orally 1 hour prior to sexual activity
Revatio (R) for the treatment of pulmonary arterial hypertension in elderly patients: Caution is recommended when selecting or adjusting dose in this population.
Precautions
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- This drug may be taken with or without food.
- Revatio (R) IV injection is for the continued treatment of patients with pulmonary arterial hypertension (PAH) currently taking oral Revatio (R) and temporarily unable to take oral medication.
General:
- This drug is indicated for treatment of erectile dysfunction in male adult patients, and is also marketed as Revatio (R) to treat PAH in children and adults.
- Limitation of use: Adding Revatio (R) to bosentan therapy does not result in any beneficial effect on exercise capacity.
Monitoring:
- Cardiovascular: Blood pressure
Patient advice:
- This drug offers no protection against sexually transmitted diseases. Consider protective measures against sexually transmitted diseases.
- Patients should seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking this drug.
- Patients should seek immediate medical attention in the event of sudden decrease or loss of hearing while taking this drug.
- Patients taking Revatio (R) should not take sildenafil for erectile dysfunction or other PDE-5 inhibitors.
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