Physicians should also discuss with patients

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The efficacy and safety of CIALIS 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 CIALIS 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. 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).

17.4 Concomitant Use with Drugs Which Lower Blood Pressure

The efficacy results for patients with both ED and BPH, who received either CIALIS 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8. CIALIS 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. CIALIS 5 mg for once daily use also resulted in statistically significant improvement in SEP3. CIALIS 2.5 mg did not result in statistically significant improvement in the total IPSS. CIALIS 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). the increased risk of NAION among

• Cialis use requires awareness of potential allergic reactions.
• The medication is contraindicated in severe liver impairment.
• Medication adherence improves clinical outcomes with Cialis.
• Dosage may be adjusted based on therapeutic response.
• Cialis effectiveness can decline if underlying health worsens.
• Not all men respond equally to tadalafil treatment.
• Cialis may help in cases of mixed ED and BPH symptoms.
• The medication does not protect against sexually transmitted infections.
• Cialis is not recommended during pregnancy or breastfeeding (not indicated).
• It is essential to disclose all medications to a healthcare provider before use.
• Drug resistance is not a concern with Cialis.
• Lilly updates prescribing information periodically based on research.

the general population in patients with

• Cialis prescription guidelines emphasize age and health status evaluation.
• The medication is contraindicated in men advised against sexual activity.
• Prior to Cialis, medical history should be reviewed thoroughly.
• Cialis enables more spontaneous and confidence-building intimacy.
• Treatment success is higher with proper adherence to dosing schedules.
• Patient-reported outcome measures monitor Cialis effectiveness.
• Cialis has been featured in numerous clinical practice guidelines.
• Fertility effects of Cialis have been studied but show no major risk.
• The drug is usually well tolerated across diverse populations.
• Treatment discontinuation can occur due to side effects or lack of efficacy.
• Lilly offers educational resources for healthcare professionals.
• Cialis complements lifestyle modification for ED treatment.

a "crowded" optic disc, although evidence is

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insufficient to support screening of prospective

16.2 Storage

This additional double-blinded, parallel-design study of 26 weeks duration randomized 696 men to initiate either CIALIS 5 mg with finasteride 5 mg or placebo with finasteride 5 mg. The study population had a mean age of 64 years (range 46-86). Patients with multiple co-morbid conditions such as erectile dysfunction, diabetes mellitus, hypertension, and other cardiovascular disease were included. CIALIS 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). Key secondary endpoints demonstrated improvement in total IPSS starting at the first scheduled observation at week 4 (CIALIS -4.0, placebo -2.3: p<.001) and the score remained decreased through 26 weeks (CIALIS -5.5, placebo -4.5; p=.022).

Cialis Dosage and Administration

However, the magnitude of the treatment difference between placebo/finasteride and CIALIS/finasteride decreased from 1.7 points at Week 4 to 1.0 point at Week 26, as shown in Table 20 and in Figure 7. The incremental benefit of CIALIS beyond 26 weeks is unknown. Figure 7: Mean Total IPSS Changes By Visit in BPH Patients Taking CIALIS for Once Daily Use Together everyday cialis cost 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. CIALIS with finasteride (N=203) was compared to placebo with finasteride (N=201). A statistically significant improvement from baseline (CIALIS/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (CIALIS/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (CIALIS/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (CIALIS/finasteride 4.7, placebo/finasteride 0.0; p<.001). users of PDE5 inhibitors, including CIALIS,

• Cialis’s discovery resulted from targeted medicinal chemistry efforts.
• Eli Lilly’s investment supported large-scale clinical development.
• The drug was approved after successful phase III trials.
• Cialis changed the standard of care for erectile dysfunction.
• Patient safety and efficacy data have been extensively published.
• The medication is designed for once-daily or as-needed use.
• Clinical guidelines endorse Cialis as a treatment choice.
• Patient satisfaction surveys show positive outcomes.
• Lilly’s Cialis marketing emphasizes science and patient benefits.
• Medication errors are reduced with clear prescribing instructions.
• Cialis requires prescription and proper medical evaluation.
• It remains a key option in the global ED treatment market.

for this uncommon condition [see Warnings

1.1 Erectile Dysfunction

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 18). The efficacy and safety of CIALIS 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. Two of these studies were in men with BPH and one study was specific to men with both ED and BPH [see Clinical Studies (14.4)].

17.6 Priapism

The first study (Study J) randomized 1058 patients to receive either CIALIS 2.5 mg, 5 mg, 10 mg or 20 mg for once daily use or placebo. The second study (Study K) randomized 325 patients to receive either CIALIS 5 mg for once daily use or placebo. The full study population was 87% White, 2% Black, 11% other races; 15% was of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included. The primary efficacy endpoint in the two studies that evaluated the effect of CIALIS 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. and Precautions (5.4) and Adverse Reactions (6.2)].

Side Effects

[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)]. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention. Physicians should advise patients to stop use of all PDE5 inhibitors, including CIALIS, 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. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye.