Generic Name: tadalafil (Oral route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Erectile Dysfunction Agent
Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor
Tadalafil is a medicine used to treat erectile dysfunction in men. Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis. This results in an erection. Tadalafil helps increase blood flow to the penis and may help men with erectile dysfunction get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.
Tadalafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is the high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Tadalafil helps by increasing the supply of blood to the lungs and reducing the workload of the heart.
This medicine is available only with your doctor's prescription. .
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of tadalafil in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tadalafil in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving tadalafil.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain tadalafil. It may not be specific to Adcirca. Please read with care.
Special patient directions come with tadalafil. Read the directions carefully before you start using tadalafil and each time you get a refill of your medicine.
Use tadalafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased.
You may take this medicine with or without food.
The ability to have sexual activity may be improved for up to 36 hours after taking tadalafil.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Tadalafil has not been studied with other medicines that are used for erectile dysfunction. Using them together is not recommended.
It is important that you tell all of your healthcare providers that you take tadalafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took tadalafil.
If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.
This medicine does not protect you against sexually transmitted diseases. Use protective measures and ask your doctor if you have any questions about this.
Do not use this medicine if you are also using a nitrate medicine, often used to treat angina (chest pain). Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates.
It is important to tell your doctor about any heart problems you may have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.
Do not drink alcohol to excess (e.g., 5 glasses of wine or 5 shots of whiskey) when taking tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.
If you experience sudden loss of vision in one or both eyes, stop using tadalafil and contact your doctor immediately .
Also, stop using this medicine and check with your doctor right away if you have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Less common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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