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  • CIALIS is contraindicated in patients using any form of organic nitrate, either regularly and/or intermittently, as the combination could cause a sudden, unsafe drop in blood pressure.
  • CIALIS is contraindicated in patients with a known serious hypersensitivity to CIALIS or ADCIRCA® (tadalafil). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.
  • Patients should not use CIALIS if sex is inadvisable due to cardiovascular status. Advise patients to seek immediate medical help if they experience symptoms such as chest pain, dizziness, or nausea during sex.
  • Use of CIALIS with alpha-blockers, antihypertensives, or substantial amounts of alcohol (≥5 units) may lead to hypotension. For the treatment of BPH, CIALIS is not recommended in combination with alpha-blockers. Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers.
  • CIALIS for once daily use provides continuous plasma levels, which should be considered when evaluating the potential for interactions.
  • Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.

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CIALIS is indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and ED and the signs and symptoms of BPH (ED+BPH).

For ED patients who want to attempt sex anytime between doses.*

Erectile dysfunction (ED) is defined as the persistent inability to achieve and maintain an erection sufficient to permit satisfactory sexual intercourse.1 Estimates of the prevalence of ED in the United States range up to 18 million.2 ED has been found to be associated with age: in the Massachusetts Male Aging Study, the prevalence of ED in a cohort of men 40 to 70 years old was 52%.3 By age 70, the prevalence may be as high as 67%.3 Although ED increases progressively with age, it is not an inevitable consequence of aging.3

Etiology

ED can be classified as psychogenic, organic (neurogenic, hormonal, injury-related, or drug-induced), or mixed (combination of psychogenic and organic factors). The majority of men diagnosed with ED have a mixed etiology.4 Psychogenic aspects of ED can include performance anxiety, a strained relationship, lack of sexual arousability, and conditions such as depression and schizophrenia.4

Organic risk factors for ED include neurologic disorders, such as stroke and Alzheimer’s disease; vascular disorders, such as hypertension and hyperlipidemia; hypogonadism; and chronic diseases, such as diabetes and renal failure. In fact, about 50% of men with chronic diabetes have ED. In addition, many drugs have been reported to cause ED.4

It is important for patients to know that ED can be successfully treated in most men.5 The first line of therapy for ED is the use of oral medications known as phosphodiesterase-5 (PDE5) inhibitors, such as CIALIS.6 CIALIS for once daily use, a low-dose tablet taken every day, may be an appropriate option for your ED patients who want to attempt sex anytime, day or night, or for those who may want to be ready anytime the moment is right.* Or, for ED patients who want up to 36 hours to be ready,*† consider CIALIS for use as needed.

*Individual results may vary. Not studied for multiple attempts per dose.

†In 2 studies, men were instructed to attempt intercourse at 24 or 36 hours after taking a
  single dose of CIALIS. CIALIS was shown to improve, compared with placebo, the ability of
  men with ED to have a single successful intercourse attempt at each of these time points.



Important Safety Information for CIALIS® (tadalafil) tablets

CONTRAINDICATIONS

Nitrates: CIALIS is contraindicated in patients using any form of organic nitrate, either regularly and/or intermittently, as the combination could cause a sudden, unsafe drop in blood pressure.

Hypersensitivity Reactions: CIALIS is contraindicated in patients with a known serious hypersensitivity to CIALIS or ADCIRCA® (tadalafil). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.

WARNINGS AND PRECAUTIONS

Cardiovascular: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Treatments for erectile dysfunction (ED), including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.

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.

Patients with left ventricular outflow obstruction (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.

CIALIS was not studied and is not recommended in patients who have recently suffered a heart attack (within 90 days) or stroke (within 6 months), or patients with uncontrolled hypertension, hypotension, uncontrolled arrhythmias, heart failure (New York Heart Assocation [NYHA] ≥Class 2 in last 6 months), unstable angina or angina occurring during sexual activity.

Potential Drug Interactions: CIALIS can potentiate the hypotensive effects of alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units). CIALIS is not recommended in combination with alpha-blockers for the treatment of benign prostatic hyperplasia (BPH) symptoms because efficacy of the combination has not been adequately studied and due to the risk of blood pressure lowering. Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers. CIALIS for once daily use provides continuous plasma tadalafil levels. Physicians should consider this when evaluating the potential for interactions.

Combination with other PDE5 inhibitors: CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Instruct patients not to take CIALIS in combination with ADCIRCA or other PDE5 inhibitors.

Potent inhibitors of CYP3A4: For patients taking potent inhibitors of CYP3A4, dose should be adjusted: CIALIS for use as needed: 10 mg no more than once every 72 hours. CIALIS for once daily use: the maximum recommended dose is 2.5 mg.

Prolonged Erection: 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.

Vision/Hearing: 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 decrease or loss of 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 decrease or loss in vision or hearing he should stop taking CIALIS, and call a healthcare provider right away. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Specific Populations: Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for daily use is not recommended; CIALIS for use as needed- 5 mg not more than once every 72 hours. Creatinine clearance 30 to 50 mL/min: For CIALIS for daily use treatment of BPH or ED/BPH, start dosing at 2.5 mg and increase to 5 mg based upon individual response. CIALIS for use as needed- 5 mg not more than once per day with maximum dose 10 mg not more than once every 48 hours. Severe hepatic impairment: Use of CIALIS is not recommended. Mild or moderate hepatic impairment: CIALIS has not been extensively evaluated in patients with mild or moderate hepatic impairment; caution is advised if CIALIS is prescribed to these patients. With CIALIS for use as needed, dose should not exceed 10 mg. Additional dose adjustments may be required for patients with other concomitant medications. See full Prescribing Information for complete dosing instructions.

Sexually Transmitted Diseases: The use of CIALIS offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH: Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) with CIALIS for once daily use vs placebo, respectively, include:

In ED (2.5 and 5 mg): headache (3% and 6% vs 5%), dyspepsia (4% and 5% vs 2%), nasal congestion (2% and 2% vs 0%), flushing (1% and 3% vs 1%), and pain in extremity (1% and 2% vs 0%). Back pain (3% and 3% vs 1%) and myalgia (2% and 2% vs 1%) were also reported, sometimes with delayed onset.

In BPH and ED/BPH (5 mg): headache (4.1% vs 2.3%), dyspepsia (2.4% vs 0.2%), nasopharyngitis (2.1% vs 1.6%). Back pain (2.4% vs 1.4%) was also reported, sometimes with delayed onset.

Most common adverse reactions (≥2%) with CIALIS for use as needed in ED (5 mg, 10 mg, and 20 mg) vs placebo, respectively, include: headache (11%, 11%, and 15% vs 5%), dyspepsia (4%, 8%, and 10% vs 1%), nasal congestion (2%, 3%, and 3% vs 1%), flushing (2%, 3%, and 3% vs 1%), and pain in limb (1%, 3%, and 3% vs 1%). Back pain (3%, 5%, and 6% vs 3%) and myalgia (1%, 4%, and 3% vs 1%) were also reported, sometimes with delayed onset.

For more complete information, please see full Prescribing Information and Patient Information.

TD HCP ISI 24JAN2012

References

  • NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993;270:83-90.
  • Selvin E, Burnett AL, Platz EA. Prevalence and risk factors for erectile dysfunction in the US. Am J Med. 2007;120:151-157.
  • Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151:54-61.
  • Lue TF. Drug therapy: erectile dysfunction. N Engl J Med. 2000;342:1802-1813.
  • Wespes E, Amar E, Hatzichristou D, et al. EAU Guidelines on erectile dysfunction: an update. Eur Urol. 2006;49:806-815.
  • AUA Clinical Guidelines. The management of erectile dysfunction: an update. http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines/main-reports/edmgmt/chapter1.pdf. Accessed May 5, 2011.
  • Data on file. Lilly USA, LLC: CIA20111129A.