"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.
REVATIO is contraindicated in patients with:
- Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see WARNINGS AND PRECAUTIONS].
- Concomitant use of riociguat, a guanylate cyclase stimulator. PDE5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.
- Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.
Last reviewed on RxList: 9/15/2015
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