Label: TADALAFIL tablet, film coated

Doxazosin - Three clinical pharmacology studies were

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conducted with tadalafil and

5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies

After 48 hours, the interaction was not detectable (see Figure 1). Figure 1: Mean Maximal Change in Blood Pressure (Tadalafil Minus Placebo, Point Estimate with 90% CI) in Response to Sublingual Nitroglycerin at 2 (Supine Only)Hours, 4 Hours, 8 Hours, 24 Hours, 48 Hours, 72 Hours, and 96 Hours after the Last Dose of Tadalafil 20 mg or Placebo Therefore, tadalafil tablets administration with nitrates is contraindicated. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications (4.1)]. Six randomized, double-blinded, crossover clinical pharmacology studies were conducted to investigate the potential interaction of tadalafil with alpha-blocker agents in healthy male subjects [see Dosage and Administration (2.7) and Warnings and Precautions (5.6)]. In two studies, a daily oral alpha-blocker (at least 7 days duration) was administered to healthy male subjects taking repeated daily doses of tadalafil. doxazosin, an alpha[1]-adrenergic blocker.