From the Guidelines
The recommended dose of sildenafil (Revatio) for pulmonary hypertension is 20 mg taken orally three times daily, approximately 4-6 hours apart. This dosing regimen aims to maintain therapeutic blood levels throughout the day to effectively reduce pulmonary vascular resistance. Patients should take sildenafil consistently, with or without food, although taking it with a meal may help reduce the incidence of side effects such as headache or flushing. It's essential not to exceed the prescribed dose, as higher doses have not been shown to provide additional benefit in pulmonary hypertension but may increase the risk of side effects, as noted in the study by 1. Sildenafil works by inhibiting phosphodiesterase type 5 (PDE5), which leads to increased levels of cyclic guanosine monophosphate (cGMP) in the pulmonary vasculature, causing relaxation of smooth muscle and vasodilation. This mechanism helps reduce pulmonary arterial pressure and improve exercise capacity and symptoms in patients with pulmonary hypertension. The most recent and highest quality study, 1, also supports this dosing regimen, listing the recommended dose of sildenafil for pulmonary hypertension as 20mg three times per day orally.
Some key points to consider when prescribing sildenafil for pulmonary hypertension include:
- The importance of consistent dosing to maintain therapeutic blood levels
- The potential for side effects, such as headache, flushing, and dyspepsia, and ways to mitigate them
- The need for regular monitoring of patients to assess the effectiveness of treatment and adjust the dose as needed
- The availability of other treatment options for pulmonary hypertension, such as endothelin receptor antagonists and prostacyclin analogues, as discussed in 1.
Overall, the use of sildenafil for pulmonary hypertension is supported by strong evidence, and the recommended dose of 20 mg taken orally three times daily is the most effective and safe regimen, as confirmed by 1 and 1.
From the FDA Drug Label
The recommended dose of sildenafil tablets is 20 mg three times a day (TID). Administer sildenafil tablet doses 4-6 hours apart. The recommended dose of sildenafil (Revatio) for pulmonary hypertension is 20 mg taken three times a day [ 2 ].
- The doses should be administered 4-6 hours apart.
- Higher doses than 20 mg three times a day are not recommended as they do not provide greater efficacy.
From the Research
Recommended Dose of Sildenafil for Pulmonary Hypertension
The recommended dose of sildenafil (Revatio) for pulmonary hypertension is as follows:
- The US Food and Drug Administration has reinforced 20 mg TID as the recommended dose, and now allows dose titration up to 80 mg TID, if needed 3.
- A study published in the International Journal of Cardiology found that sildenafil at 50 mg twice daily improved symptoms, effort tolerance, and controlled refractory heart failure in patients with primary pulmonary hypertension, with no further benefit seen at 100 mg twice daily 4.
- Another study published in Cardiology in the Young found that a low-dose of oral sildenafil (0.5 milligrams per kilogram per day) was effective and safe in patients with pulmonary arterial hypertension, with improvements in functional capacity and hemodynamics 5.
- A study published in Circulation found that long-term treatment with oral sildenafil (50 mg every 8 hours) was safe and improved functional capacity and hemodynamics in patients with pulmonary arterial hypertension 6.
Key Findings
- Sildenafil at 80 mg TID was noninferior to sildenafil at 5 mg TID in terms of all-cause mortality in adults with PAH 3.
- The addition of bosentan to sildenafil therapy did not provide significant benefits in terms of morbidity and mortality in patients with PAH 7.
- Sildenafil has been shown to be a cost-effective solution for patients with pulmonary hypertension, particularly in countries with limited resources 5, 6.