Tadalafil

Tadalafil is a prescription medicine used to treat impotence, known medically as erectile dysfunction (ED), and symptoms of enlarged prostate (benign prostatic hyperplasia, or BPH). It is also is used to improve the ability to exercise in people with pulmonary arterial hypertension. Tadalafil is in a group of medications called phosphodiesterase 5 (PDE5) inhibitors. It works by increasing blood flow to the penis during sexual stimulation. It may also relax the prostate and bladder.

Tadalafil comes in tablet form and is either taken one time before you expect to have sexual activity, or at a lower dose, once daily.

Common side effects include headache, indigestion, back pain, and facial flushing. Do not take tadalafil if you are taking other medications called "nitrates."

Tadalafil is a prescription medicine used to treat impotence, known medically as erectile dysfunction (ED), and symptoms of enlarged prostate (benign prostatic hyperplasia, or BPH).

It is also is used to improve the ability to exercise in people with pulmonary arterial hypertension, or PAH. PAH is high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness

Tadalafil may be found in some form under the following brand names:

• Adcirca

• Cialis

Serious side effects have been reported with tadalafil. See "Drug Precautions".

The most common side effects with tadalafil are:

• headache
• indigestion
• back pain
• muscle aches
• flushing
• stuffy or runny nose

These side effects usually go away after a few hours.  Men who get back pain and muscle aches usually get it 12 to 24 hours after taking tadalafil. Back pain and muscle aches usually go away within 2 days.  

Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

 Uncommon side effects include:

• an erection that won't go away (priapism).  If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.
• color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including tadalafil) reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including tadalafil, and call a healthcare provider right away.

Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including tadalafil. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking tadalafil and contact a healthcare provider right away.

These are not all the possible side effects of tadalafil. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Tadalafil and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take any of the following:

• medicines called nitrates 
• medicines called alpha blockers. These include Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl) or Uroxatral (alfuzosin HCl). Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If tadalafil is taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.
• other medicines to treat high blood pressure (hypertension)
• medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• other medicines or treatments for ED.
• Tad alafil is marketed as both Cialis and Adcirca. Do not take both at the same time. Do not take sildenafil citrate (Revatio) with tadalafil.

This is not a complete list of tadalafil drug interactions. Ask your doctor or pharmacist for more information.

• Tadalafil can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke.
• Do not take tadalafil if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.
  • Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite.
  • Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates.
• Tell all of your healthcare providers that you take tadalafil. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took tadalafil.
• After taking a single tablet, some of the active ingredient of tadalafil remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.
• If taking tadalafil for treating ED, stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea. Sexual activity can put extra strain on your heart and worsen these symptoms.
• Seek immediate medical attention if sudden loss of vision occurs, which could be a sign of non-arteritic ischemic optic neuropathy (NAION).
• Seek immediate medical attention if sudden decrease or loss of hearing occurs.

Do not take tadalafil if you:

• take any medicines called “nitrates”.
• use recreational drugs called “poppers” like amyl nitrite and butyl nitrite
• are allergic to tadalafil or any of its ingredients. Symptoms of an allergic reaction may include:
  • rash
  • hives
  • swelling of the lips, tongue, or throat
  • difficulty breathing or swallowing

Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.

Grapefruit and grapefruit juice may interact with tadalafil and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking tadalafil, tell your healthcare provider about all your medical problems, including if you:

• have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take tadalafil if your healthcare provider has told you not to have sexual activity because of your health problems.
• have low blood pressure or have high blood pressure that is not controlled
• have had a stroke
• have liver problems
• have kidney problems or require dialysis
• have retinitis pigmentosa, a rare genetic (runs in families) eye disease
• have ever had severe vision loss, including a condition called NAION
• have stomach ulcers
• have a bleeding problem
• have a deformed penis shape or Peyronie's disease
• have had an erection that lasted more than 4 hours
• have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. This medication is not used by women. Based on animal studies, tadalafil is not predicted to increase the risk of adverse developmental abnormalities in humans.

This medication is not used by women.

• Take tadalafil exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you.
• Do not change your dose or the way you take tadalafil without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to tadalafil and your health condition.
• Tadalafil may be taken with or without meals.
• If you take too much tadalafil, call your healthcare provider or emergency room right away.

For symptoms of BPH, tadalafil is taken once daily.

• Do not take tadalafil more than one time each day.
• Take one tadalafil tablet every day at about the same time of day.
• If you miss a dose, you may take it when you remember but do not take more than one dose per day.

For ED, there are two ways to take tadalafil - either for use as needed OR for use once daily.

Tadalafil for use as needed:

• Do not take tadalafil more than one time each day.
• Take one tadalafil tablet before you expect to have sexual activity. You may be able to have sexual activity at 30 minutes after taking tadalafil and up to 36 hours after taking it. You and your healthcare provider should consider this in deciding when you should take tadalafil before sexual activity. Some form of sexual stimulation is needed for an erection to happen with tadalafil.
• Your healthcare provider may change your dose of tadalafil depending on how you respond to the medicine, and on your health condition.

OR

Tadalafil for once daily use is a lower dose you take every day.

• Do not take tadalafil more than one time each day.
• Take one tadalafil tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.
• If you miss a dose, you may take it when you remember but do not take more than one dose per day.
  Some form of sexual stimulation is needed for an erection to happen with tadalafil.
• Your healthcare provider may change your dose of tadalafil depending on how you respond to the medicine, and on your health condition.

For both ED and the symptoms of BPH, tadalafil is taken once daily.

• Do not take tadalafil more than one time each day.
• Take one tadalafil tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.
• If you miss a dose, you may take it when you remember but do not take more than one dose per day.
• Some form of sexual stimulation is needed for an erection to happen with tadalafil.
• Do not use other ED medicines or ED treatments while taking tadalafil.
• Do not drink too much alcohol when taking tadalafil (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

For treating PAH:

• Take once daily with or without food. Dividing the dose over the course of the day is not recommended.

Take tadalafil exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Tadalafil for use in PAH:

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store tadalafil at room temperature.
• Keep tadalafil and all medicines out of the reach of children.