Tadalafil (Page 11 of 13)

14.4 Tadalafil 5 mg for Once Daily Use for ED and BPH

The efficacy and safety of tadalafil for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.

In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took tadalafil.

The efficacy results for patients with both ED and BPH, who received either tadalafil 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.

Tadalafil 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Tadalafil 5 mg for once daily use also resulted in statistically significant improvement in SEP3. Tadalafil 2.5 mg did not result in statistically significant improvement in the total IPSS.

Table 21: Mean IPSS and IIEF EF Domain Changes in the Tadalafil 5 mg for Once Daily Use Study in Patients with ED and BPH
Placebo Tadalafil 5 mg p-value
Total Symptom Score (IPSS)
(N=193) (N=206)
Baseline 18.2 18.5
Change from Baseline to Week 12 -3.8 -6.1 <.001
EF Domain Score (IIEF EF)
(N=188) (N=202)
Baseline 15.6 16.5
Endpoint 17.6 22.9
Change from Baseline to Week 12 1.9 6.5 <.001
Table 22: Mean SEP Question 3 Changes in the Tadalafil 5 mg for Once Daily Use Study in Patients with ED and BPH
Placebo Tadalafil 5 mg
(N=187) (N=199) p-value
Maintenance of Erection (SEP3)
Baseline 36% 43%
Endpoint 48% 72%
Change from Baseline to Week 12 12% 32% <.001

Tadalafil for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment ( see Figure 8).

Figure 8
(click image for full-size original)

In this study, the effect of tadalafil 5 mg once daily on Q max was evaluated as a safety endpoint. Mean Q max increased from baseline in both the treatment and placebo groups (tadalafil 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tadalafil tablets, USP 20 mg are available for oral administration as yellow coloured, almond shaped, biconvex, film coated tablets, debossed with “FJ4” on one side and plain on other side


Bottles of 6 count comes in a child-resistant package (NDC 70934-795-06)
Bottles of 15 count comes in a child-resistant package (NDC 70934-795-15)

16.2 Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

“See FDA-approved patient labeling ( Patient Information)”

17.1 Nitrates

Physicians should discuss with patients the contraindication of tadalafil tablets with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of tadalafil tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. In such a patient, who has taken tadalafil tablets, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil tablets before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications ( 4.1) and Warnings and Precautions ( 5.1)] .

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