The primary efficacy and safety study conducted outside the US cialis 10 or 20 included 268 patients, with a mean age of 56 years (range 21 to 78 years).
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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. 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.
What CIALIS contains
Food and alcohol intake were not restricted. Several assessment tools were used to chep cialis evaluate the effect of CIALIS on erectile function. SEP Question 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. Results in ED Population in US Trials — The 2 primary US efficacy and safety trials included a total of 402 men with erectile dysfunction, with a mean age of 59 years (range 27 to 87 years). The treatment effect of CIALIS did not diminish over time. Ninety-three percent of patients reported ED of at least 1-year duration.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Black | 80mg | 60 + 4 Pills | 150.98€ 143.79€ | |
| Cialis Generic | 20mg | 180 + 10 Pills | 254.09€ 241.99€ | |
| Cialis Generic | 10mg | 20 Pills | 48.23€ 45.93€ | |
| Cialis Professional | 40mg | 270 + 6 Pills | 898.37€ 855.59€ | |
| Cialis Professional | 20mg | 180 + 4 Pills | 423.11€ 402.96€ | |
| Cialis Generic | 5mg | 30 + 4 Pills | 53.56€ 51.01€ | |
| Cialis Generic | 40mg | 90 + 6 Pills | 171.35€ 163.19€ | |
| Cialis Original | 20mg | 76 + 4 Pills | 319.19€ 303.99€ | |
| Cialis Generic | 2.5mg | 180 + 10 Pills | 154.86€ 147.49€ | |
| Cialis Professional | 20mg | 360 + 6 Pills | 807.03€ 768.60€ | |
| Cialis Generic | 20mg | 90 + 6 Pills | 154.71€ 147.34€ | |
| Cialis Generic | 20mg | 20 Pills | 54.72€ 52.11€ | |
| Cialis Black | 80mg | 90 + 6 Pills | 207.88€ 197.98€ | |
| Cialis Generic | 10mg | 270 + 10 Pills | 308.71€ 294.01€ | |
| Cialis Super Active | 20mg | 120 + 16 Pills | 382.15€ 363.95€ |
In each of these trials, conducted without regard to the timing of dose and sexual intercourse, 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 SEP diary (see Table 16).
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Results in General ED Population in Trials Outside the US — 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). 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 in patients' 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. Efficacy Results in ED Patients with Diabetes Mellitus — CIALIS was shown to be effective in treating ED in patients with diabetes mellitus. 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 SEP diary (see Table 14).
Use in children
Efficacy Results in ED Patients following Radical Prostatectomy — 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), 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 SEP diary (see Table 15). Results in Studies to Determine the Optimal Use of CIALIS — Several studies were conducted with the objective of determining the optimal use of CIALIS in the treatment of ED. 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 10mg cialis price conducted to assess the efficacy of CIALIS at a given timepoint after dosing, specifically at 24 hours and at 36 hours after dosing. When taken as directed, CIALIS was effective at improving erectile function.
| Advice | Explanation | Additional Notes |
|---|---|---|
| Take with water | To facilitate swallowing | Avoid grapefruit juice, which can affect metabolism |
| Do not exceed prescribed dose | Overuse can increase side effects | Follow doctor’s instructions |
| Be aware of onset time | Typically 30-60 minutes before sexual activity | Effect lasts up to 36 hours |
| Avoid heavy alcohol consumption | Can reduce effectiveness and increase side effects | Moderate use recommended |
In the 6 month double blind study, the treatment effect of CIALIS did not diminish over time.
- Erectile dysfunction often has both physical and psychological components.
- Underlying health conditions contributing to ED should be addressed.
- Diabetes, hypertension, and cholesterol management improve erectile function.
- Stress reduction techniques can complement pharmacological treatment.
- Regular physical activity improves cardiovascular health and erectile function.
Efficacy Results in ED Patients with Diabetes Mellitus — CIALIS for once daily use was shown to be effective in treating ED in patients with diabetes mellitus.
- Cialis is not indicated for use by women despite off-label attempts.
- No clinical evidence supports Cialis for enhanced female sexual function.
- Pediatric use is strictly prohibited except in rare research settings.
- Elderly patients may be more sensitive to side effects and require lower doses.
- Renal impairment dosage adjustment is necessary for patients with CKD.
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedCialis 10mg tablets are available in bottles of 10 (NDC 21695-028-10)Cialis 20mg tablets are available in bottles of 10 (NDC 21695-029-10)Cialis 20mg tablets are available in bottles of 16 (NDC 21695-029-16)Cialis 20mg tablets are available in bottles of 30 (NDC 21695-029-30)REPACKAGED BY:REBEL DISTRIBUTORS CORP.THOUSAND OAKS, CA 91320 Cialis 10mg tablets are available in bottles of 10 (NDC 21695-028-10) Cialis 20mg tablets are available in bottles of 10 (NDC 21695-029-10) 17 PATIENT COUNSELING INFORMATION See FDA approved Patient Labeling17.1 NitratesPhysicians should discuss with patients the contraindication of CIALIS with regular and/or intermittent use of organic nitrates.
5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)
Food and alcohol intake were not restricted. Timing of sexual activity was not restricted relative to when patients took Cialis.Results in General ED Population — The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years). The population was 86% White, 6% Black, 6% Hispanic, and 2% 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 (>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). The population was 86% White, 3% Black, 0.4% Hispanic, and 10% 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.
When to take
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, 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 SEP diary (see Table 16). When taken as directed, CIALIS was effective at improving erectile function.In the 6 month double blind study, the treatment effect of CIALIS did not diminish over time.Efficacy Results in ED Patients with Diabetes Mellitus — CIALIS for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. Patients with diabetes were included in both studies in the general ED population (N=79). A third randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design trial included only ED patients with type 1 or type 2 diabetes (N=298). In this third 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 SEP diary (see Table 17). Patients should be counseled that concomitant use of CIALIS 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 CIALIS.
5. Tips
In the first of these studies, 348 patients with ED were randomized to placebo or CIALIS 20 mg. At the 36-hour timepoint (more specifically, 33 to 39 hours), 49/133 (37%) of patients reported at least 1 successful intercourse in the placebo group versus 88/137 (64%) in the CIALIS 20-mg group. In the second of these studies, a total of 483 patients were evenly randomized to 1 of 6 groups: 3 different dosing groups (placebo, CIALIS 10, or 20 mg) that were instructed to attempt intercourse at 2 different times (24 and 36 hours post-dosing). At the 36-hour timepoint, the mean, per-patient percentage of attempts resulting in successful intercourse were 33, 56, and 62% for placebo, CIALIS 10-, and 20-mg groups, respectively. The efficacy and safety of CIALIS for once daily use in the treatment of erectile dysfunction has been evaluated in 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853 patients.
Pregnancy Categories
CIALIS, when taken once daily, was shown to be effective in improving erectile function in men with erectile dysfunction (ED). CIALIS was studied in the general ED population in 2 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12- and 24-weeks duration, respectively. Timing of sexual activity was not restricted relative to when patients took Cialis. Results in General ED Population — The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years). Most (>96%) patients reported ED of at least 1-year duration. Therefore, patients who experience anginal chest pain after taking CIALIS should seek immediate medical attention [see Contraindications (4.1) and Warnings and Precautions (5.1)].17.2 Cardiovascular ConsiderationsPhysicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease.
| Storage Condition | Details | Note |
|---|---|---|
| Temperature | 15°C to 30°C (59°F to 86°F) | Keep away from moisture |
| Light | Keep in original container, protect from light | Protect from direct sunlight |
| Children and Pets | Keep out of reach | Safety warning |
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