Cialis Warnings
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Cialis Warnings
Sexual activity carries a potential cardiac risk for patients with pre-existing cardiovascular disease. Therefore, treatments for erectile dysfunction, including Cialis, should not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. The following groups of patients with cardiovascular disease were not included in clinical trials:
- patients with myocardial infarction within the last 90 days;
- patients with unstable angina or angina occurring during sexual intercourse;
- patients with New York Heart Association Class 2 or greater heart failure in the last 6 months;
- patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension;
- patients with a stroke within the last 6 months.
Additionally, there is limited clinical trial data on the safety of Cialis in the following groups; if Cialis is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician
- patients with severe renal insufficiency (creatinine clearance = 30 mL/min);
- patients with severe hepatic insufficiency (Child-Pugh Class C).
Cialis (tadalafil) 10 mg has been the highest dose studied in patients with mild (creatinine clearance 51 to 80 mL/min), and moderate (creatinine clearance 31 to 50 mL/min) renal failure and in patients with end stage renal failure undergoing haemodialysis.
Priapism was not reported in clinical trials with Cialis. owever, priapism has been reported with another PDE5 inhibitor, sildenafil. Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Cialis should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease). The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment.
The safety and efficacy of combinations of Cialis and other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
In a clinical pharmacology study, administration of Cialis (tadalafil) 10 mg to patients with moderate renal impairment (creatinine clearance 31 to 50 mL/min) was determined to be safe but appeared to be less well tolerated in terms of back pain than in patients with mild renal impairment (creatinine clearance 51 to 80 mL/min) and healthy subjects. Cialis (tadalafil) 10 mg has been the highest dose studied in patients with mild (creatinine clearance 51 to 80 mL/min), and moderate (creatinine clearance 31 to 50 mL/min) renal failure and in patients with end stage renal failure undergoing haemodialysis. Cialis (tadalafil) exposure was increased by 107% when co-administered (10 mg dose) with ketoconazole. Although specific interactions have not been studied, some protease inhibitors, such as ritonavir and saquinavir, and other CYP3A4 inhibitors, such as erythromycin and itraconazole, would also be likely to increase Cialis (tadalafil) exposure.
Cialis (tadalafil) exposure was reduced by 88% when co-administered (10 mg dose) with rifampicin. It can be expected that concomitant administration of other CYP3A4 inducers will also decrease plasma concentrations of tadalafil.
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