tadalafil

Pronunciation

Generic Name: tadalafil (ta DAL a fil)
Brand Name: Adcirca, Cialis

What is tadalafil?

Tadalafil relaxes muscles and increases blood flow to particular areas of the body.

Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Do not take Cialis while also taking Adcirca, unless your doctor tells you to.

Tadalafil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about tadalafil?

You should not use tadalafil if you are allergic to it.

Do not take tadalafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Slideshow: Flashback: FDA Drug Approvals 2013

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Stop using tadalafil and get emergency medical help if you have sudden vision loss.

What should I discuss with my healthcare provider before taking tadalafil?

You should not take tadalafil if you are allergic to it.

Do not take tadalafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

To make sure tadalafil is safe for you, tell your doctor if you have any of these other conditions:

  • heart disease or heart rhythm problems, coronary artery disease;

  • a recent heart attack (within the past 90 days);

  • a recent history (in the past 6 months) of a stroke, or congestive heart failure;

  • angina (chest pain), high or low blood pressure;

  • liver or kidney disease (or if you are on dialysis);

  • a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

  • a bleeding disorder such as hemophilia;

  • a stomach ulcer;

  • retinitis pigmentosa (an inherited condition of the eye);

  • a physical deformity of the penis (such as Peyronie's disease); or

  • if you have been told you should not have sexual intercourse for health reasons.

Tadalafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking tadalafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. Stop using tadalafil and get emergency medical help if you have sudden vision loss.

FDA pregnancy category B. Tadalafil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Adcirca.

It is not known whether tadalafil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take tadalafil?

Tadalafil is usually taken only once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Tadalafil can be taken with or without food.

For erectile dysfunction, take Cialis just before sexual activity but not more than once per day.

Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of tadalafil.

Do not break or split a Cialis tablet. Swallow it whole.

Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If tadalafil is used as needed, you are not likely to be on a dosing schedule.

If you take tadalafil every day and you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking tadalafil?

Grapefruit and grapefruit juice may interact with tadalafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Drinking alcohol can increase certain side effects of tadalafil.

Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor.

Tadalafil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Stop using tadalafil and call your doctor at once if you have:

  • vision changes or sudden vision loss;

  • ringing in your ears, or sudden hearing loss;

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • irregular heartbeat;

  • swelling in your hands, ankles, or feet;

  • shortness of breath;

  • seizure (convulsions); or

  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • headache;

  • redness or warmth in your face, neck, or chest;

  • cold symptoms such as stuffy nose, sinus pain, sore throat, cough;

  • upset stomach; or

  • muscle pain, back pain, pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Tadalafil dosing information

Usual Adult Dose for Erectile Dysfunction:

Use as needed for ED:
-Initial dose: 10 mg orally once a day, as needed, prior to sexual activity
-Maintenance dose: 5 to 20 mg orally once a day, as needed, prior to sexual activity based on individual efficacy and tolerability

Comment: Consider that this drug has shown to improve erectile dysfunction up to 36 hours following dosing, when used as needed.

Once a day use for ED:
-Initial dose: 2.5 mg orally once a day at approximately the same time, without regard to timing of sexual activity
-Maintenance dose: 2.5 to 5 mg orally once a day based on individual efficacy and tolerability.

Once daily use for ED and Benign Prostatic Hyperplasia (BPH):
-5 mg orally once a day at approximately the same time, without regard to timing of sexual activity

Use: Treatment of erectile dysfunction (ED)

Usual Adult Dose for Pulmonary Hypertension:

Adcirca (R):
-40 mg orally once a day

Comment: Dividing the 40 mg dose over the course of the day is not recommended.

Usual Adult Dose for Benign Prostatic Hyperplasia:

Once daily use for BPH:
-5 mg orally once a day at approximately the same time

Concomitant administration with finasteride:
-5 mg orally once a day at approximately the same time, for up to 26 weeks

Comments: The incremental benefit of this drug decreases from 4 weeks until 26 weeks. The incremental benefit of this drug beyond 26 weeks is unknown.

Once daily use for ED and BPH:
-5 mg orally once a day at approximately the same time, without regard to timing of sexual activity

Use: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)

What other drugs will affect tadalafil?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with tadalafil, especially:

  • bosentan;

  • imatinib;

  • nefazodone;

  • St. John's wort;

  • an antibiotic--clarithromycin, erythromycin, telithromycin;

  • antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

  • heart or blood pressure medication--amlodipine nicardipine, quinidine;

  • hepatitis C medications--boceprevir, telaprevir;

  • HIV/AIDS medication--atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;

  • seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or

  • tuberculosis medication--isoniazid, rifabutin, rifampin, rifapentine.

This list is not complete. Other drugs may interact with tadalafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about tadalafil.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 10.01. Revision Date: 2013-05-24, 1:44:18 PM.

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