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The rate and extent of absorption of tadalafil are not influenced by food; thus CIALIS may be taken with or without food. The mean apparent volume of distribution following oral administration is approximately 63 L, indicating that tadalafil is distributed into tissues.

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In dogs, an increased incidence of disseminated arteritis was observed in 1- and 6-month studies at unbound tadalafil exposure of 1- to 54-fold above the human exposure (AUC) at the MRHD of 20 mg. In a 12-month dog study, no disseminated arteritis was observed, but 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate decreases in platelets with inflammatory signs at unbound cialis tabs 20mg tadalafil exposures of approximately14- to 18-fold the human exposure at the MRHD of 20 mg. The abnormal blood-cell findings were reversible within 2 weeks after stopping treatment. The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients. CIALIS, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).

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CIALIS was studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-weeks duration. Two of these studies were conducted in the United States and 5 were conducted in centers outside the US. Additional efficacy and safety studies were performed in ED patients with diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy. In these 7 trials, CIALIS was taken as needed, at doses ranging from 2.5 to 20 mg, up to once per day. Patients were free to choose the time interval between dose administration and the time of sexual attempts.

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Food and alcohol intake were not restricted. Several assessment tools were used to evaluate the effect of CIALIS on erectile function. The 3 primary outcome measures were the Erectile Function (EF) domain of the International Index of Erectile Function(IIEF) and Questions 2 and 3 from Sexual Encounter Profile (SEP). The IIEF is a 4-week recall questionnaire that was administered at the end of a treatment-free baseline period and subsequently at follow-up visits after randomization. The IIEF EF domain has a 30-point total score, where higher scores reflect better erectile function. At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins. Less than 0.0005% of the administered dose appeared in the semen of healthy subjects. Tadalafil is predominantly metabolized by CYP3A4 to a catechol metabolite.

The catechol metabolite undergoes extensive methylation and glucuronidation to form the methyl catechol and methyl catechol glucuronide conjugate, respectively. In vitro data suggests that metabolites are not expected to be pharmacologically active at observed metabolite concentrations. The mean oral clearance for tadalafil is 2.5 L/hr and the mean terminal half-life is 17.5 hours in healthy subjects. Tadalafil is excreted predominantly as metabolites, mainly in the feces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose). Healthy male elderly subjects (65 years or over) had a lower oral clearance of tadalafil, resulting in25% higher exposure (AUC) with no effect on Cmax relative to that observed in healthy subjects 19 to 45 years of age. However, greater sensitivity to medications winsome older individuals should be considered [see Use In Specific Populations] . In male patients with diabetes mellitus after a 10 mg tadalafil dose, exposure(AUC) was reduced approximately 19% and Cmax was 5% lower than that observed in healthy subjects. In patients with BPH following single and multiple-doses of 20 mg tadalafil, no statistically significant differences in exposure (AUC and Cmax) were observed between elderly (70 to 85 years) and younger (≤60 years of age) subjects. Animal studies showed vascular inflammation in tadalafil-treated mice, rats, and dogs. In mice and rats, lymphoid necrosis and hemorrhage were seen in the spleen, thymus, and mesenteric lymph nodes at unbound tadalafil exposure of 2- to 33-fold above the human exposure (AUCs) at the MRHD of 20 mg. In dogs, an increased incidence of disseminated arteritis was observed in 1- and 6-month studies at unbound tadalafil exposure of 1- to 54-fold above the human exposure (AUC) at the MRHD of 20 mg.

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In a 12-month dog study, no disseminated arteritis was observed, but 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate decreases in platelets with inflammatory signs at unbound cialis tabs 20mg tadalafil exposures of approximately14- to 18-fold the human exposure at the MRHD of 20 mg. The abnormal blood-cell findings were reversible within 2 weeks after stopping treatment. The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients. CIALIS, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED). CIALIS was studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-weeks duration. Two of these studies were conducted in the United States and 5 were conducted in centers outside the US. Additional efficacy and safety studies were performed in ED patients with diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy. In these 7 trials, CIALIS was taken as needed, at doses ranging from 2.5 to 20 mg, up to once per day. Patients were free to choose the time interval between dose administration and the time of sexual attempts. Food and alcohol intake were not restricted. Several assessment tools were used to evaluate the effect of CIALIS on erectile function. The 3 primary outcome measures were the Erectile Function (EF) domain of the International Index of Erectile Function(IIEF) and Questions 2 and 3 from Sexual Encounter Profile (SEP).

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Therefore, in all 7 primary efficacy and safety studies, CIALIS showed statistically significant improvement inpatients' ability to achieve an erection sufficient for vaginal penetration and to maintain the erection long enough for successful intercourse, as measured by the IIEF questionnaire and by SEP diaries. CIALIS was shown to be effective in treating ED inpatients with diabetes mellitus. Patients with diabetes were included in all 7 primary efficacy studies in the general ED population (N=235) and in one study that specifically assessed CIALIS in ED patients with type 1or type 2 diabetes (N=216). In this randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial, CIALIS 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 SEPdiary ( see Table 15). Table 15: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study in EDPatients with Diabetes CIALIS was shown to be effective in treating patients who developed ED following bilateral nerve-sparing radical prostatectomy.

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In 1 randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial in this population (N=303), CIALISdemonstrated 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 16). Table 16: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study inPatients who Developed ED Following Bilateral Nerve-Sparing Radical Prostatectomy Several studies were conducted with the objective of determining the optimal use of CIALIS in the treatment of ED. In one of these studies, the percentage of patients reporting successful erections within 30 minutes of dosing was determined. In this randomized, placebo-controlled, double-blinded trial, 223 patients were randomized to placebo, CIALIS 10, or20 mg. Using a stopwatch, patients recorded the time following dosing at which a successful erection was obtained.

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A successful erection was defined as at least 1 erection in 4 attempts that led to successful intercourse.At or prior to 30 minutes, 35% (26/74), 38% (28/74), and 52% (39/75) of patients in the placebo, 10-, and 20-mg groups, respectively, reported successful erections as defined above. Two studies were conducted to assess the efficacy of CIALIS at a given timepoint after dosing, specifically at24 hours and at 36 hours after dosing. In the first of these studies, 348 patients with ED were randomized to placebo or CIALIS 20 mg. The IIEF is a 4-week recall questionnaire that was administered at the end of a treatment-free baseline period and subsequently at follow-up visits after randomization. The IIEF EF domain has a 30-point total score, where higher scores reflect better erectile function.

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SEP is a diary in which patients recorded each sexual attempt made 2 5 mg cialis daily throughout the study. SEPQuestion 2 asks, “Were you able to insert your penis into the partner's vagina?” SEP Question 3 asks, “Did your erection last long enough for you to have successful intercourse?” The overall percentage of successful attempts to insert the penis into the vagina (SEP2) and to maintain the erection for successful intercourse (SEP3) is derived for each patient. The 2 primary US efficacy and safety trials included a total of 402men with erectile dysfunction, with a mean age of 59 years (range 27 to 87 years). The population was 78%White, 14% Black, 7% Hispanic, and 1% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (>90%) patients reported ED of at least 1-yearduration.

Study A was conducted primarily in academic centers. Study B was conducted primarily in community-based urology practices. In each of these 2 trials, CIALIS 20 mg showed clinically meaningful and statistically significant improvements in all 3 primary efficacy variables ( see Table 11). The treatment effect ofCIALIS did not diminish over time.

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SEP is a diary in which patients recorded each sexual attempt made 2 5 mg cialis daily throughout the study. SEPQuestion 2 asks, “Were you able to insert your penis into the partner's vagina?” SEP Question 3 asks, “Did your erection last long enough for you to have successful intercourse?” The overall percentage of successful attempts to insert the penis into the vagina (SEP2) and to maintain the erection for successful intercourse (SEP3) is derived for each patient. The 2 primary US efficacy and safety trials included a total of 402men with erectile dysfunction, with a mean age of 59 years (range 27 to 87 years). The population was 78%White, 14% Black, 7% Hispanic, and 1% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (>90%) patients reported ED of at least 1-yearduration.

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Study A was conducted primarily in academic centers. Study B was conducted primarily in community-based urology practices. In each of these 2 trials, CIALIS 20 mg showed clinically meaningful and statistically significant improvements in all 3 primary efficacy variables ( see Table 11). The treatment effect ofCIALIS did not diminish over time. Table 11: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the TwoPrimary US Trials The 5 primary efficacy and safety studies conducted in the general ED population outside the US included 1112 patients, with a mean age of 59 years (range 21 to 82 years).

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The population was 76% White, 1% Black, 3% Hispanic, and 20% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (90%)patients reported ED of at cialis canadian meds least 1-year duration. In these 5 trials, CIALIS 5, 10, and 20 mg showed clinically meaningful and statistically significant improvements in all 3 primary efficacy variables ( see Tables 12 , 13 and 14). The treatment effect of CIALIS did not diminish over time. Table 12: Mean Endpoint and Change from Baseline for the EF Domain of the IIEF in the General EDPopulation in Five Primary Trials Outside the US Table 13: Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 2 (“Were you able to insert your penis into the partner's vagina?”) in the General ED Population in Five Pivotal TrialsOutside the US Table 14: Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 3 (“Did your erection last long enough for you to have successful intercourse?”) in the General ED Population in Five Pivotal Trials Outside the US In addition, there were improvements in EF domain scores, success rates based upon SEP Questions 2 and 3,and patient-reported improvement in erections across patients with ED of all degrees of disease severity while taking CIALIS, compared to patients on placebo. Table 11: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the TwoPrimary US Trials The 5 primary efficacy and safety studies conducted in the general ED population outside the US included 1112 patients, with a mean age of 59 years (range 21 to 82 years). The population was 76% White, 1% Black, 3% Hispanic, and 20% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Most (90%)patients reported ED of at cialis canadian meds least 1-year duration. In these 5 trials, CIALIS 5, 10, and 20 mg showed clinically meaningful and statistically significant improvements in all 3 primary efficacy variables ( see Tables 12 , 13 and 14). The treatment effect of CIALIS did not diminish over time. Table 12: Mean Endpoint and Change from Baseline for the EF Domain of the IIEF in the General EDPopulation in Five Primary Trials Outside the US Table 13: Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 2 (“Were you able to insert your penis into the partner's vagina?”) in the General ED Population in Five Pivotal TrialsOutside the US Table 14: Mean Post-Baseline Success Rate and Change from Baseline for SEP Question 3 (“Did your erection last long enough for you to have successful intercourse?”) in the General ED Population in Five Pivotal Trials Outside the US In addition, there were improvements in EF domain scores, success rates based upon SEP Questions 2 and 3,and patient-reported improvement in erections across patients with ED of all degrees of disease severity while taking CIALIS, compared to patients on placebo. Therefore, in all 7 primary efficacy and safety studies, CIALIS showed statistically significant improvement inpatients' ability to achieve an erection sufficient for vaginal penetration and to maintain the erection long enough for successful intercourse, as measured by the IIEF questionnaire and by SEP diaries.

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The rate and extent of absorption of tadalafil are not influenced by food; thus CIALIS may be taken with or without food. The mean apparent volume of distribution following oral administration is approximately 63 L, indicating that tadalafil is distributed into tissues. At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins. Less than 0.0005% of the administered dose appeared in the semen of healthy subjects. Tadalafil is predominantly metabolized by CYP3A4 to a catechol metabolite.

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The catechol metabolite undergoes extensive methylation and glucuronidation to form the methyl catechol and methyl catechol glucuronide conjugate, respectively. In vitro data suggests that metabolites are not expected to be pharmacologically active at observed metabolite concentrations. The mean oral clearance for tadalafil is 2.5 L/hr and the mean terminal half-life is 17.5 hours in healthy subjects. Tadalafil is excreted predominantly as metabolites, mainly in the feces (approximately 61% of the dose) and to a lesser extent in the urine (approximately 36% of the dose). Healthy male elderly subjects (65 years or over) had a lower oral clearance of tadalafil, resulting in25% higher exposure (AUC) with no effect on Cmax relative to that observed in healthy subjects 19 to 45 years of age.

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However, greater sensitivity to medications winsome older individuals should be considered [see Use In Specific Populations] . In male patients with diabetes mellitus after a 10 mg tadalafil dose, exposure(AUC) was reduced approximately 19% and Cmax was 5% lower than that observed in healthy subjects. In patients with BPH following single and multiple-doses of 20 mg tadalafil, no statistically significant differences in exposure (AUC and Cmax) were observed between elderly (70 to 85 years) and younger (≤60 years of age) subjects. Animal studies showed vascular inflammation in tadalafil-treated mice, rats, and dogs. In mice and rats, lymphoid necrosis and hemorrhage were seen in the spleen, thymus, and mesenteric lymph nodes at unbound tadalafil exposure of 2- to 33-fold above the human exposure (AUCs) at the MRHD of 20 mg. CIALIS was shown to be effective in treating ED inpatients with diabetes mellitus.

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Patients with diabetes were included in all 7 primary efficacy studies in the general ED population (N=235) and in one study that specifically assessed CIALIS in ED patients with type 1or type 2 diabetes (N=216). In this randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial, CIALIS 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 SEPdiary ( see Table 15). Table 15: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study in EDPatients with Diabetes CIALIS was shown to be effective in treating patients who developed ED following bilateral nerve-sparing radical prostatectomy. In 1 randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial in this population (N=303), CIALISdemonstrated 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 16). Table 16: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in a Study inPatients who Developed ED Following Bilateral Nerve-Sparing Radical Prostatectomy Several studies were conducted with the objective of determining the optimal use of CIALIS in the treatment of ED. In one of these studies, the percentage of patients reporting successful erections within 30 minutes of dosing was determined. In this randomized, placebo-controlled, double-blinded trial, 223 patients were randomized to placebo, CIALIS 10, or20 mg. Using a stopwatch, patients recorded the time following dosing at which a successful erection was obtained. A successful erection was defined as at least 1 erection in 4 attempts that led to successful intercourse.At or prior to 30 minutes, 35% (26/74), 38% (28/74), and 52% (39/75) of patients in the placebo, 10-, and 20-mg groups, respectively, reported successful erections as defined above. Two studies were conducted to assess the efficacy of CIALIS at a given timepoint after dosing, specifically at24 hours and at 36 hours after dosing. In the first of these studies, 348 patients with ED were randomized to placebo or CIALIS 20 mg.