PMS-SILDENAFIL R

Adverse Drug Reaction Overview Sildenafil Oral Administration:

Safety data on sildenafil citrate were obtained from a single pivotal study consisting of 68 (25%) men and 209 (75%) women, and an open-label extension study in 277 treated patients with pulmonary arterial hypertension. The 259 subjects who completed the pivotal study entered a long-term extension study.

d.. d. 9%). Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. d. doses, and more commonly on sildenafil citrate than on placebo, are shown in Table 1. d. d. ) as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, the clinically meaningful adverse drug reactions that were reported by at least 2% of patients in the sildenafil citrate arm are shown in Table 2.

The duration of treatment was 16 weeks. 7% in the placebo/epoprostenol treated patients. There were 242 subjects who completed the initial study and entered a long-term extension study. d..

Table 2:

Sildenafil-Epoprostenol All Causality Adverse Events Reported by ≥ 2% of Sildenafil-treated Patients and More Frequent Than Placebo. 4 9 Sildenafil Intravenous Administration: In a placebo-controlled study of intravenous sildenafil citrate in pulmonary hypertension, a total of 66 patients were treated with sildenafil citrate resulting in plasma concentrations up to a minimum of 8 times the predicted Cmax in healthy volunteers for the recommended intravenous dose of 10 mg.

Nineteen (19) patients received placebo. The study population consisted of patients with PAH, pulmonary venous hypertension (PVH) and pulmonary hypertension secondary to COPD. The subjects received increases in dose to achieve plasma concentrations from 10 ng/mL to 500 ng/mL.

The commonly reported treatment-related adverse reactions (> 1/100, < 1/10 and in more than 1 subject) were vasodilatation (flushing) (6%), headache (3%), hypotension (3%) and pms-SILDENAFIL R Product Monograph Page 13 of 55 nausea (3%).