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.

Nitrates and Use of CIALIS (tadalafil)

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

Cialis® (tadalafil) for once daily use provides continuous plasma tadalafil levels. You should consider this when evaluating potential for interactions with medications (eg, nitrates). (Cialis Package Insert, 2017)

You should discuss the contraindication of tadalafil with regular and/or intermittent use of organic nitrates with your 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. (Cialis Package Insert, 2017)

Patients who experience angina chest pain after taking tadalafil should seek immediate medical attention. 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. (Cialis Package Insert, 2017)

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 (NTG) and tadalafil, should NTG be required in an emergency situation after tadalafil was taken. Co‑administration of daily doses of tadalafil (20 mg) with NTG (0.4 mg sublingual) resulted in the augmentation of hypotensive effects (such as clinically meaningful reductions in standing or supine systolic blood pressure) that are normally observed with the administration of either compound as monotherapy. Clinically meaningful augmentation of these hypotensive effects was observed in patients who took these drugs up to 24 hours apart, but was not observed when the drugs were taken 48 hours apart. (Cialis Package Insert, 2017)

Enclosed Prescribing Information

CIALIS® (tadalafil), Lilly



Date of Last Review: October 11, 2017

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