Cialis Contraindications and Precautions
- breast-feeding
- females
- nitrate/nitrite therapy
- retinitis pigmentosa
- angina
- cardiac arrhythmias
- cardiac disease
- children
- coronary artery disease
- elderly
- gastroesophageal reflux disease (GERD)
- heart failure
- hepatic disease
- hiatal hernia
- human immunodeficiency virus (HIV) infection
- hypertension
- hypotension
- hypovolemia
- infants
- leukemia
- multiple myeloma
- myocardial infarction
- penile structural abnormality
- polycythemia
- pregnancy
- renal impairment
- sickle cell disease
- stroke
- visual disturbance
Cialis (Tadalafil) Contraindications and Precautions
Tadalafil is contraindicated in patients with a known hypersensitivity to any component of the tablet. The safety and efficacy of combinations of tadalafil with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
Tadalafil is contraindicated in patients who are currently on nitrate/nitrite therapy. Consistent with its known effects on the nitric oxide/cGMP pathway, tadalafil may potentiate the hypotensive effects of organic nitrates and nitrites. Patients receiving nitrates in any form are not to receive tadalafil. This includes any patient who receives intermittent nitrate therapies. It is unknown if it is safe for patients to receive nitrates once tadalafil has been administered.
Tadalafil should be used cautiously in patients with renal impairment. There is no dose adjustment required in patients with mild renal insufficiency. Dosage adjustments are required in patients with moderate to severe renal impairment.
Tadalafil should be used with caution in patients with hepatic disease. Dosage modifications are needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, use of tadalafil is not recommended because of insufficient data. Additionally, tadalafil is metabolized by CYP3A4 in the liver. Dosage adjustments are necessary in patients taking potent CYP3A4 inhibitors such as ritonavir, ketoconazole, and itraconazole.
There is a degree of cardiac risk associated with sexual activity; therefore, prescribers should evaluate the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction. Tadalafil and other PDE5 inhibitors have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Health care professionals should consider whether the individual would be adversely affected by vasodilatory events. The following groups of patients with cardiac disease were excluded from clinical safety and efficacy trials for tadalafil, and, therefore, the manufacturer does not recommend the use of tadalafil in these groups until more data are available: myocardial infarction within the last 90 days; coronary artery disease resulting in unstable angina or angina occurring during sexual intercourse; NYHA Class II or greater heart failure in the last 6 months; uncontrolled cardiac arrhythmias; hypotension (< 90/50 mmHg); uncontrolled hypertension (> 170/100 mmHg); or a stroke within the last 6 months. Based on recommendations for sildenafil by the American College of Cardiology, it is recommended that tadalafil be used with caution in the following: patients with active coronary ischemia (angina) who are not taking nitrates (e.g., positive exercise test for ischemia); patients with congestive heart failure and borderline low blood pressure and borderline low volume status (hypovolemia); patients on a complicated, multidrug, antihypertensive program; and patients taking drugs that can prolong the half-life of tadalafil. Tadalafil is contraindicated in patients who are currently on nitrate/nitrite therapy. Also, patients with left ventricular outflow obstruction (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) or severely impaired autonomic control of blood pressure can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Tadalafil and other agents for the treatment of erectile dysfunction should be used with caution in patients with penile structural abnormality (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell disease, leukemia, multiple myeloma, polycythemia, or history of priapism).
Patients should be reminded that tadalafil offers no protection against sexually transmitted disease. Counseling of patients about protective measures, including the prevention of transmission of human immunodeficiency virus (HIV) infection, should be considered.
Use tadalafil cautiously in patients with pre-existing visual disturbance. Post-marketing reports of sudden vision loss have occurred with phosphodiesterase inhibitors. Vision loss is attributed to a condition known as non-arteritic anterior ischemic optic neuropathy (NAION), where blood flow is blocked to the optic nerve. Although visual disturbances have been reported rarely with tadalafil, there is no safety information on the administration of tadalafil to patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa. A minority of patients with the inherited condition retinitis pigmentosa have genetic disorders of retinal phosphodiesterases. Therefore, it is recommended that tadalafil not be administered to these patients until further data are available.
Tadalafil is not indicated for use in females. However, tadalafil is classified as FDA pregnancy risk category B. Animal data show that tadalafil and/or its metabolites cross the placenta and are excreted in milk; it is not known if tadalafil is excreted in human breast milk. Animal studies have also shown no evidence of teratogenicity, embryotoxicity, or fetotoxicity of tadalafil during organogenesis. There is no information on the use of tadalafil in humans during pregnancy or during breast-feeding.
Elderly patients (> 65 years) made up approximately 25% of patients in the primary efficacy and safety studies of tadalafil. No overall differences in efficacy and safety were observed between older and younger patients. No dose adjustment is warranted based on age alone. However, greater sensitivity to medications in some older individuals should be considered.
There is no known indication for the use of tadalafil in infants or children. Tadalafil should not be prescribed to these populations.
Tadalafil should be used cautiously in patients with gastroesophageal reflux disease (GERD) or hiatal hernia associated with reflux esophagitis. Like sildenafil, tadalafil can possibly decrease the tone of the lower esophageal sphincter and inhibit esophageal motility.
[ Last revised: 7/11/2005 9:45:00 AM ]
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