Sildenafil Injection is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Sildenafil Injection was added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Sildenafil Injection Dosage and Administration
Sildenafil Injection is for the continued treatment of patients with PAH who are currently prescribed oral sildenafil and who are temporarily unable to take oral medication.
The recommended dose is 10 mg administered as an intravenous bolus injection three times a day. The dose of Sildenafil Injection does not need to be adjusted for body weight.
A 10 mg dose of Sildenafil Injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose.
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Dosage Forms and Strengths
Single use vial containing 10 mg/12.5 mL of sildenafil.
Sildenafil Injection 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 (5.2)].
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 injection. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.
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