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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.
Can CIALIS® (tadalafil) be administered concomitantly with nitrates?
Administering CIALIS (tadalafil) to patients using any form of organic nitrate, including nitroglycerin, is contraindicated.
Introduction
Tadalafil 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
Physicians should discuss with patients the contraindication of tadalafil with regular and/or intermittent use of organic nitrates. Patients should be counseled 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 anginal chest pain after taking tadalafil should seek immediate medical attention.1
Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil. In such a patient, who has taken tadalafil, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil before nitrate administration is considered. In such circumstances, nitrates should still 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. 1
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 daily doses of 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 with placebo. After 48 hours, the interaction was not detectable.1
Enclosed Prescribing Information
Reference
1Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.
Date of Last Review: February 02, 2023