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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.

Click here for more complete Important Safety Information for CIALIS

 
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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.*

 

Help protect your patients from the dangers of counterfeit medication

In today's environment of global trade and online commerce, counterfeit medication has become a dangerous reality for patients around the world.1 The World Health Organization (WHO) estimates that medications purchased online from illegal Web sites not offering a physical address are counterfeit more than half the time.1 And medications used to treat erectile dysfunction (ED)—including CIALIS—have been known targets of counterfeiting in the past.1

Counterfeit medications put your patients at risk of failed therapy and potential harm.1 But you can play a vital role in helping to keep your patients safe by taking these steps:

  • Learn more about counterfeit medication so that you can better inform your patients and learn how to recognize the warning signs of suspicious products or sales offers. Educational materials for healthcare professionals are available from the Partnership for Safe Medicines—a nonprofit coalition of organizations dedicated to protecting consumers from counterfeit medications.2
  • When you prescribe CIALIS to your ED patients, take a few moments to educate them about the dangers of counterfeit medication.

    Explain to your patients that counterfeit medications:1,3-5
    • May contain the wrong ingredients, including crude mixtures of chalk, talcum powder, brick dust, or other substances
    • May contain too much or too little of the active ingredient, or even no active ingredient at all
    • May cause the intended treatment to fail
    • May cause harmful interactions with other medications
    • May cause adverse reactions or even death
  • Help your ED patients to safely purchase CIALIS online. While many patients today are using the Internet to buy their medications, buying online can be a risky endeavor. According to the National Association of Boards of Pharmacy® (NABP), 96% of nearly 7000 Internet sites reviewed by the organization are not in compliance with United States (US) pharmacy laws and standards of practice. A full 83% of these sites do not require patients to have a valid prescription, and 20% are located outside of the US and selling drugs illegally to patients in the US.4

    Here are some tips you can offer your patients for safer online shopping:

    • Only use Internet pharmacies that are accredited through the Verified Internet Pharmacy Practice Site (VIPPS) program. A site with VIPPS accreditation has undergone an extensive review of its policies and procedures and an on-site inspection of all of its facilities. Patients can find a list of VIPPS-accredited sites at the National Association of Boards of Pharmacy Web site and can check the legitimacy of specific sites at www.legitscript.com.4
    • Purchase from US companies only. Many patients falsely believe that Canadian Web sites are without risk. However, in addition to the fact that imported medicines are not regulated by the FDA, sites that claim to be from Canada are often misleading, and may actually purchase the medications they sell from other countries—in Asia and other parts of the world where quality standards vary and the chance of counterfeiting is much higher.4
    • Stay away from Web sites that offer CIALIS at a price that's much lower than the price at the local pharmacy or at a price that seems "too good to be true."2,5
    • Avoid sites that sell prescription medications without requiring a prescription from you—the patient’s doctor—or after a short online survey or review by a remotely located physician.4
    • Do not purchase generic, "soft tab," or "fast dissolve" CIALIS. There is no generic for CIALIS, and CIALIS only comes as an almond-shaped tablet that is swallowed whole.6
    • Never respond to an unsolicited e-mail advertisement for CIALIS. Eli Lilly and Company, the maker of CIALIS, will never send e-mails to patients unless they have expressly requested such communications and will never attempt to sell CIALIS directly to a patient in any communication.
  • Help your patients learn to identify counterfeit medication. Instruct your patients to take the following steps to inspect their medication before taking it:
    • Compare the medication with a sample they've received from your office or with the image of the original manufacturer's drug below. Differences in the feel or look of the actual pills or differences in the paper, printing, color, or fonts used in packaging may be signs that a medication is counterfeit.2,6
    • Pay attention to how the medication tastes and how it makes them feel. An odd taste or any unusual symptoms may be signs that a medication is counterfeit. Tell your patients to call you immediately if a medication tastes different than normal or if they experience any unusual symptoms.2
  • Look for signs of a patient using a counterfeit medication. If a patient reports that his treatment is not working, or he is experiencing unwanted effects, be sure to ask where he purchased his medication in addition to addressing any symptoms.2
  • Report any suspicious sales offers or counterfeit medications. If you or your patient suspects that a medication may be counterfeit, contact the Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) and/or the Federal Drug Administration (FDA) at www.fda.gov/medwatch or 1-800-FDA-1088 (1-800-332-1088).

For more information about counterfeit medication, you can direct your patients to the following online sources:

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



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

  • World Health Organization. Medicines: counterfeit medicines. http://www.who.int/mediacentre/factsheets/fs275/en/. Accessed May 12, 2011.
  • The Partnership for Safe Medicines. L.E.A.D.E.R.'s guide for pharmacists. http://www.safemedicines.org/resources/PSM%20LEADERs%20Guide.pdf. Accessed May 13, 2011.
  • Jackson G, ed. Faking it: the dangers of counterfeit medicine on the internet. Int J Clin Pract. 2009;63:181.
  • National Association of Boards of Pharmacy. Buying medicine online. http://www.nabp.net/programs/consumer-protection/buying-medicine-online/. Accessed May 12, 2011.
  • US Food and Drug Administration Consumer Health Information. The possible dangers of buying medicines over the Internet. http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM204943.pdf. Accessed May 13, 2011.
  • Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2011.
  • Data on file. Lilly USA, LLC. CIA20111129A.