(RTTNews) -  Pfizer Inc. (PFE: News ) announced that the U.S. Food and Drug Administration has approved Revatio (sildenafil) Injection, an intravenous formulation of Revatio. The company said that Revatio is the only FDA-approved phosphodiesterase-5 or PDE5 inhibitor available in both tablet and intravenous formulations.

Revatio is indicated for the treatment of adult patients with pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Revatio was added to background epoprostenol therapy. The efficacy of Revatio has not been adequately evaluated in patients taking bosentan concurrently. Revatio Injection is for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed Revatio Tablets but who are temporarily unable to take oral medication, the company said.
Pfizer noted that the most common side effects of Revatio are nosebleeds, headache, upset stomach, flushing, and trouble sleeping. At doses more than the approved 20 milligrams 3 times a day, some side effects increased. These included flushing, loose stools, muscle pain, and visual disturbances.

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by RTT Staff Writer

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