Cialis ® (tadalafil) tablets

2.5 mg, 5 mg, 10mg, 20 mg tablets

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

CIALIS® (tadalafil): Other ED Therapies Used in Combination With tadalafil

The combination of CIALIS (tadalafil) with other PDE5 inhibitors or treatments for erectile dysfunction have not been studied.

Overview

The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or treatments for ED have not been effectively studied in randomized, placebo-controlled studies.1 

Patients should not take tadalafil with other PDE5 inhibitors, such as vardenafil, avanafil, or sildenafil.1

Open-Label Trial of Tadalafil Once Daily in Combination With Sildenafil As Needed

A prospective, open-label, single-center trial was conducted in 180 men randomized to treatment with tadalafil 5 mg once daily (n=90) or tadalafil 5 mg once daily combined with sildenafil 50 mg as needed (n=90) at the early stage of treatment for ED.2

After 12 weeks of treatment, IIEF-5 scores were significantly improved from baseline (p<.05 for both treatment groups); however, there was no difference in IIEF-5 scores between patients treated with tadalafil once daily only or tadalafil once daily in combination with sildenafil as needed.2 

When stratified by severity, only patients with severe ED (IIEF-5 score of 1-7) showed significant improvement when being treated with tadalafil 5 mg once daily plus sildenafil 50 mg as needed compared to tadalafil 5 mg once daily (p<.05).2

The incidence of AEs were similar between groups, with the most common (>2 incidences) being flushing, headache, dyspepsia, and muscle pain.2 

Enclosed Prescribing Information

CIALIS® (tadalafil) tablets, for oral use, Lilly

Reference

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1. Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.

2. Cui H, Liu B, Song Z, et al. Efficacy and safety of long-term tadalafil 5 mg once daily combined with sildenafil 50 mg as needed at the early stage of treatment for patients with erectile dysfunction. Andrologia. 2015;47(1):20-24. http://dx.doi.org/10.1111/and.12216

Glossary

AE = adverse event

ED = erectile dysfunction

IIEF-5 = International Index of Erectile Function, 5-item version

PDE5 = phosphodiesterase type 5

Date of Last Review: September 04, 2019

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