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): Concomitant Use of Nitrates

Administering CIALIS (tadalafil) to patients using any form of organic nitrate, including nitroglycerin, is contraindicated.

Introduction

Tadalfil for once-daily use provides continuous plasma tadalafil levels and should be considered when evaluating potential for interactions with medications, such as nitrates.1

Administration of tadalafil to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated.1

The contraindication of tadalafil with regular and/or intermittent use of organic nitrates should be discussed with patients. Patients should be aware that concomitant use of tadalafil with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.1

Patients who experience angina chest pain after taking tadalafil should seek immediate medical attention.1

Where nitrate administration is deemed medically necessary for a life-threatening situation, for example angina chest pain requiring nitroglycerin, at least 48 hours should have elapsed after the last dose of tadalafil before nitrate administration. Nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring.1

Effects on Blood Pressure

In clinical pharmacology studies, tadalafil (5-20 mg) was shown to potentiate the hypotensive effect of nitrates. 

A study was conducted to assess the degree of interaction between nitroglycerin and tadalafil, should nitroglycerin be required in an emergency situation after tadalafil was taken. Subjects were administered tadalafil 20 mg or placebo for 7 days and, following their last dose, 0.4 mg sublingual nitroglycerin at

  • 2 hours

  • 4 hours

  • 8 hours

  • 24 hours

  • 48 hours

  • 72 hours, and

  • 96 hours.1

A significant blood pressure interaction between tadalafil and nitroglycerin was observed at each time point up to and including 24 hours.1

At 48 hours, by most hemodynamic measures, the interaction between tadalafil and nitroglycerin was not observed, although a few more tadalafil subjects experienced greater blood-pressure lowering compared to placebo. After 48 hours, the interaction was not detectable1

Enclosed Prescribing Information

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

Reference

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

Date of Last Review: January 21, 2020


Contact Lilly

Call Us

If you need information about a Lilly product or want to report an Adverse Event or Product Complaint, you may call us.

Available Mon - Fri, 8am - 7pm ET

Or you can

Chat with us

Submit a Request

Visit Us @LillyMedical