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Important Safety Information for CIALIS® (tadalafil)
CIALIS is indicated for the treatment of erectile dysfunction.
Use of CIALIS in patients using any form of organic nitrate is contraindicated. CIALIS was shown to potentiate the hypotensive effect of nitrates. CIALIS should not be used if sexual activity is not advisable due to cardiovascular status.
PDE5 inhibitors, including CIALIS, are mild systemic vasodilators. While this effect should not be of consequence in most patients, physicians should consider this potential when prescribing CIALIS. Due to potential increased blood-pressure-lowering effects, caution is advised when CIALIS is co-administered with alpha blockers and/or substantial consumption of alcohol (5 units or greater). CIALIS for once daily use provides continuous plasma tadalafil levels. Physicians should consider this when evaluating the potential for interactions.
For patients taking potent inhibitors of CYP3A4, dose should be adjusted: CIALIS for use as needed: ≤10 mg every 72 hours. For once daily use: dose not to exceed 2.5 mg. Dose adjustments may be required for special populations (e.g., renal and hepatic impairment and with other concomitant medications). See Dosing Guidelines and full Prescribing Information for complete dosing instructions.
There have been rare reports of priapism with this class of compounds. Patients should be advised to seek immediate medical attention should this occur. Use CIALIS with caution in patients who have conditions that might predispose them to priapism.
The following events have been reported in men taking PDE5 inhibitors including CIALIS: (1) Sudden decrease or loss of vision in one or both eyes; (2) Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness. It is not possible to determine whether these events are related directly to the medicines, other health conditions, or to a combination of these. If a patient experiences a sudden change in vision or hearing he should stop taking CIALIS, and call a healthcare provider right away.
Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb.
For more complete information see Important Safety Information and full Prescribing Information.
