T20 Pill: yellow, oval, 13mm

Most (> 96%) patients reported ED of at least 1-year duration. The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years). Ninety-three percent of patients reported ED of at least 1-year duration.

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In each of these trials, conducted without regard to the timing of dose and sexual intercourse, tadalafil demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 17).

2.3 Dosage Adjustments in Specific Situations

Most (> 96%) patients reported ED of at least 1-year duration. The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years). Ninety-three percent of patients reported ED of at least 1-year duration. In each of these trials, conducted without regard to the timing of dose and sexual intercourse, tadalafil demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 17). When taken as directed, tadalafil was effective at improving erectile function.

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In the 6 month double-blind study, the treatment effect of tadalafil did not diminish over time. Table 17: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Tadalafil for Once Daily Use Studies Efficacy Results in ED Patients with Diabetes Mellitus — Tadalafil for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. In this third trial, tadalafil demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 18). Table 18: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil for Once Daily Use Study in ED Patients with Diabetes The efficacy and safety of tadalafil for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, multinational, double-blinded, placebo-controlled, parallel-design, efficacy and safety studies of 12 weeks duration. The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization.

Erectile dysfunction

The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either tadalafil 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively. In each of these 2 trials, tadalafil 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo. Table 19: Mean IPSS Changes in BPH Patients in Two Tadalafil for Once Daily Use Studies Figure 5: Mean IPSS Changes in BPH Patients by Visit in Study J Figure 6: Mean IPSS Changes in BPH Patients by Visit in Study K In Study J, the effect of tadalafil 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. In Study K, the effect of tadalafil 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil 5 mg: 1.6 mL/sec, placebo: 1.1 mL/sec); however, these changes were not significantly different between groups. When taken as directed, tadalafil was effective at improving erectile function.

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In the 6 month double-blind study, the treatment effect of tadalafil did not diminish over time. Table 17: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Tadalafil for Once Daily Use Studies Efficacy Results in ED Patients with Diabetes Mellitus — Tadalafil for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. In this third trial, tadalafil demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 18). Table 18: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Tadalafil for Once Daily Use Study in ED Patients with Diabetes The efficacy and safety of tadalafil for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, multinational, double-blinded, placebo-controlled, parallel-design, efficacy and safety studies of 12 weeks duration. The primary efficacy endpoint in the two studies that evaluated the effect of tadalafil for the signs and symptoms of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. The results for BPH patients with moderate to severe symptoms and a mean age of 63.2 years (range 44 to 87) who received either tadalafil 5 mg for once daily use or placebo (N=748) in Studies J and K are shown in Table 19 and Figures 5 and 6, respectively. In each of these 2 trials, tadalafil 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo.

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Table 19: Mean IPSS Changes in BPH Patients in Two Tadalafil for Once Daily Use Studies Figure 5: Mean IPSS Changes in BPH Patients by Visit in Study J Figure 6: Mean IPSS Changes in BPH Patients by Visit in Study K In Study J, the effect of tadalafil 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. In Study K, the effect of tadalafil 5 mg once daily on Qmax was evaluated as a safety endpoint. Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil 5 mg: 1.6 mL/sec, placebo: 1.1 mL/sec); however, these changes were not significantly different between groups. Efficacy Results in Patients with BPH initiating Tadalafil and Finasteride – Tadalafil for once daily use initiated together with finasteride was shown to be effective in treating the signs and symptoms of BPH in men with an enlarged prostate (> 30 cc) for up to 26 weeks. Tadalafil with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS at 12 weeks, the primary study endpoint (see Table 20). The incremental benefit of tadalafil beyond 26 viagra connect form weeks is unknown. Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil for Once Daily Use Study Together with Finasteride Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Tadalafil for Once Daily Use Together With Finasteride In the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. A statistically significant improvement from baseline (tadalafil/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (tadalafil/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (tadalafil/finasteride 4.7, placebo/finasteride 0.0; p<.001). 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.

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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). 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.

12.2 Pharmacodynamics

Bottles of 30: NDC 69238-1348-3 Tadalafil Tablets USP, 20 mg are supplied as yellow colored, oval, biconvex, film-coated tablets debossed with “AA” on one side and “09” on the other. Bottles of 30: NDC 69238-1349-3 17 PATIENT COUNSELING INFORMATION “See FDA-approved patient labeling (Patient Information)”.17.1 NitratesPhysicians should discuss with patients the contraindication of tadalafil with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of tadalafil 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. Therefore, patients who experience anginal chest pain after taking tadalafil should seek immediate medical attention [see Contraindications (4.1) and Warnings and Precautions (5.1)].17.2 Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of tadalafil with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of tadalafil with GC stimulators may cause blood pressure to drop to an unsafe level.17.3 Cardiovascular ConsiderationsPhysicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease.

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Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)].17.4 Concomitant Use with Drugs Which Lower Blood PressurePhysicians should discuss with patients the potential for tadalafil to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].17.5 Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily UsePhysicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablets for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol [see Dosage and Administration (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)].17.6 PriapismThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds.

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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.

User Type	Recommended Dose	Comments
Healthy Men	50-100 mg	Based on tolerance
Sensitive Users	25 mg	Start low to assess response
Older Adults	25-50 mg	Lower doses preferred
Patients with Heart Conditions	Under medical supervision	No self-medication

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 Table 22: Mean SEP Question 3 Changes in the Tadalafil 5 mg for Once Daily Use Study in Patients with ED and BPH 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).

8.3 Females and Males of Reproductive Potential

Efficacy Results in Patients with BPH initiating Tadalafil and Finasteride – Tadalafil for once daily use initiated together with finasteride was shown to be effective in treating the signs and symptoms of BPH in men with an enlarged prostate (> 30 cc) for up to 26 weeks. Tadalafil with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS at 12 weeks, the primary study endpoint (see Table 20). The incremental benefit of tadalafil beyond 26 viagra connect form weeks is unknown. Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil for Once Daily Use Study Together with Finasteride Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking Tadalafil for Once Daily Use Together With Finasteride In the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. A statistically significant improvement from baseline (tadalafil/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (tadalafil/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (tadalafil/finasteride 4.7, placebo/finasteride 0.0; p<.001).

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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. 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). 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 2.5 mg did not result in statistically significant improvement in the total IPSS.

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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 Table 22: Mean SEP Question 3 Changes in the Tadalafil 5 mg for Once Daily Use Study in Patients with ED and BPH 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: Mean IPSS Changes in ED/BPH Patients by Visit in Study L In this study, the effect of tadalafil 5 mg once daily on Qmax was evaluated as a safety endpoint. 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedTadalafil Tablets USP, 2.5 mg are supplied as white to off-white, round, biconvex, film-coated tablets debossed with “C1” on one side and plain on the other.They are available as follows:Bottles of 30: NDC 69238-1346-3Tadalafil Tablets USP, 5 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “A13” on one side and plain on the other.They are available as follows:Bottles of 30: NDC 69238-1347-3Tadalafil Tablets USP, 10 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “AC” above “06” on one side and plain on the other.They are available as follows:Bottles of 30: NDC 69238-1348-3Tadalafil Tablets USP, 20 mg are supplied as yellow colored, oval, biconvex, film-coated tablets debossed with “AA” on one side and “09” on the other.They are available as follows:Bottles of 30: NDC 69238-1349-3 Tadalafil Tablets USP, 2.5 mg are supplied as white to off-white, round, biconvex, film-coated tablets debossed with “C1” on one side and plain on the other. Bottles of 30: NDC 69238-1346-3 Tadalafil Tablets USP, 5 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “A13” on one side and plain on the other. Bottles of 30: NDC 69238-1347-3 Tadalafil Tablets USP, 10 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “AC” above “06” on one side and plain on the other. Figure 8: Mean IPSS Changes in ED/BPH Patients by Visit in Study L In this study, the effect of tadalafil 5 mg once daily on Qmax was evaluated as a safety endpoint. 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedTadalafil Tablets USP, 2.5 mg are supplied as white to off-white, round, biconvex, film-coated tablets debossed with “C1” on one side and plain on the other.They are available as follows:Bottles of 30: NDC 69238-1346-3Tadalafil Tablets USP, 5 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “A13” on one side and plain on the other.They are available as follows:Bottles of 30: NDC 69238-1347-3Tadalafil Tablets USP, 10 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “AC” above “06” on one side and plain on the other.They are available as follows:Bottles of 30: NDC 69238-1348-3Tadalafil Tablets USP, 20 mg are supplied as yellow colored, oval, biconvex, film-coated tablets debossed with “AA” on one side and “09” on the other.They are available as follows:Bottles of 30: NDC 69238-1349-3 Tadalafil Tablets USP, 2.5 mg are supplied as white to off-white, round, biconvex, film-coated tablets debossed with “C1” on one side and plain on the other. Bottles of 30: NDC 69238-1346-3 Tadalafil Tablets USP, 5 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “A13” on one side and plain on the other.

8.6 Hepatic Impairment

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Bottles of 30: NDC 69238-1347-3 Tadalafil Tablets USP, 10 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “AC” above “06” on one side and plain on the other. Bottles of 30: NDC 69238-1348-3 Tadalafil Tablets USP, 20 mg are supplied as yellow colored, oval, biconvex, film-coated tablets debossed with “AA” on one side and “09” on the other. Bottles of 30: NDC 69238-1349-3 17 PATIENT COUNSELING INFORMATION “See FDA-approved patient labeling (Patient Information)”.17.1 NitratesPhysicians should discuss with patients the contraindication of tadalafil with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of tadalafil 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. Therefore, patients who experience anginal chest pain after taking tadalafil should seek immediate medical attention [see Contraindications (4.1) and Warnings and Precautions (5.1)].17.2 Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of tadalafil with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of tadalafil with GC stimulators may cause blood pressure to drop to an unsafe level.17.3 Cardiovascular ConsiderationsPhysicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)].17.4 Concomitant Use with Drugs Which Lower Blood PressurePhysicians should discuss with patients the potential for tadalafil to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].17.5 Potential for Drug Interactions When Taking Tadalafil Tablets for Once Daily UsePhysicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablets for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol [see Dosage and Administration (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)].17.6 PriapismThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds.