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Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablet for Once Daily Use Study 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 tablets /finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<0.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<0.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0; p<0.001). The efficacy and safety of tadalafil tablet 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 tablet 2.5 mg, 5 mg, for once daily use or placebo. Table 22: Mean SEP Question 3 Changes in the Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPH Tadalafil tablet 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). 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedTadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side.NDC Number Size62332-177-30 bottle of 30 Tablets with child-resistant closure62332-177-71 bottle of 500 Tablets62332-177-91 bottle of 1000 Tablets62332-177-15 30 Tablets (2 blisters of 15 tablets)Tadalafil tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side.NDC Number Size62332-178-30 bottle of 30 Tablets with child-resistant closure62332-178-71 bottle of 500 Tablets62332-178-91 bottle of 1000 Tablets62332-178-15 30 Tablets (2 blisters of 15 tablets)Tadalafil tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side.NDC Number Size62332-179-30 bottle of 30 Tablets with child-resistant closure62332-179-71 bottle of 500 Tablets62332-179-91 bottle of 1000 TabletsTadalafil tablets USP 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side.NDC Number Size62332-180-30 bottle of 30 Tablets with child-resistant closure62332-180-71 bottle of 500 Tablets62332-180-91 bottle of 1000 Tablets Tadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side.

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62332-177-30 bottle of 30 Tablets with child-resistant closure Tadalafil tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side. 62332-178-30 bottle of 30 Tablets with child-resistant closure Tadalafil tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side. 62332-179-30 bottle of 30 Tablets with child-resistant closure Tadalafil tablets USP 20 mg are yellow to viagra daily light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side. 62332-180-30 bottle of 30 Tablets with child-resistant closure 17 PATIENT COUNSELING INFORMATION “See FDA-approved patient labeling (Patient Information)”17.1 NitratesPhysicians 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 Study J, the effect of tadalafil tablet 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint.

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In Study K, the effect of tadalafil tablet 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 tablet 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 Tablets and Finasteride – Tadalafil tablet 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.

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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)].17.2 Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of tadalafil tablets 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 tablets 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 Tablet for Once Daily UsePhysicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablet 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. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.17.7 Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including tadalafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including possible permanent loss of vision that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors.

Patient resources

Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including tadalafil tablets, for this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].17.8 Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including tadalafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.1, 6.2)].17.9 AlcoholPatients should be made aware that both alcohol and tadalafil tablets, a PDE5 inhibitor, act as mild vasodilators. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].17.10 Sexually Transmitted DiseaseThe use of tadalafil tablets offers no protection against sexually transmitted diseases. Patients with multiple co-morbid conditions such as erectile dysfunction, diabetes mellitus, hypertension, and other cardiovascular disease were included. Tadalafil tablets with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS viagra sildenafil price at 12 weeks, the primary study endpoint (see Table 20).

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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 tablet 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 tablet 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo. Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks. In Study J, the effect of tadalafil tablet 5 mg once daily on maximum urinary flow rate (Qmax) was evaluated as a secondary efficacy endpoint. In Study K, the effect of tadalafil tablet 5 mg once daily on Qmax was evaluated as a safety endpoint.

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Mean Qmax increased from baseline in both the treatment and placebo groups (tadalafil tablet 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 Tablets and Finasteride – Tadalafil tablet 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. Patients with multiple co-morbid conditions such as erectile dysfunction, diabetes mellitus, hypertension, and other cardiovascular disease were included. Tadalafil tablets with finasteride demonstrated statistically significant improvement in the signs and symptoms of BPH compared to placebo with finasteride, as measured by the total IPSS viagra sildenafil price at 12 weeks, the primary study endpoint (see Table 20). The incremental benefit of tadalafil tablets beyond 26 weeks is unknown. The incremental benefit of tadalafil tablets beyond 26 weeks is unknown. Table 20: Mean Total IPSS Changes in BPH Patients in a Tadalafil Tablet for Once Daily Use Study 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 tablets /finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (tadalafil tablets/finasteride 3.7, placebo/finasteride -1.1; p<0.001), week 12 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0.6; p<0.001), and week 26 (tadalafil tablets/finasteride 4.7, placebo/finasteride 0; p<0.001). The efficacy and safety of tadalafil tablet 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 tablet 2.5 mg, 5 mg, for once daily use or placebo.

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Table 22: Mean SEP Question 3 Changes in the Tadalafil Tablet 5 mg for Once Daily Use Study in Patients with ED and BPH Tadalafil tablet 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). 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedTadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side.NDC Number Size62332-177-30 bottle of 30 Tablets with child-resistant closure62332-177-71 bottle of 500 Tablets62332-177-91 bottle of 1000 Tablets62332-177-15 30 Tablets (2 blisters of 15 tablets)Tadalafil tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side.NDC Number Size62332-178-30 bottle of 30 Tablets with child-resistant closure62332-178-71 bottle of 500 Tablets62332-178-91 bottle of 1000 Tablets62332-178-15 30 Tablets (2 blisters of 15 tablets)Tadalafil tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side.NDC Number Size62332-179-30 bottle of 30 Tablets with child-resistant closure62332-179-71 bottle of 500 Tablets62332-179-91 bottle of 1000 TabletsTadalafil tablets USP 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side.NDC Number Size62332-180-30 bottle of 30 Tablets with child-resistant closure62332-180-71 bottle of 500 Tablets62332-180-91 bottle of 1000 Tablets Tadalafil tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side.

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62332-180-30 bottle of 30 Tablets with child-resistant closure 17 PATIENT COUNSELING INFORMATION “See FDA-approved patient labeling (Patient Information)”17.1 NitratesPhysicians 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.

5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH

Side Effects

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Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including possible permanent loss of vision that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including tadalafil tablets, for this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].17.8 Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including tadalafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.1, 6.2)].17.9 AlcoholPatients should be made aware that both alcohol and tadalafil tablets, a PDE5 inhibitor, act as mild vasodilators. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache [see Warnings and Precautions (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].17.10 Sexually Transmitted DiseaseThe use of tadalafil tablets offers no protection against sexually transmitted diseases.

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