Tadalafil

Erectile Dysfunction

Tadalafil is used to treat erectile dysfunction (ED), a condition where a man cannot get or keep an erection firm enough for sexual activity. It helps increase blood flow to the penis when a person is sexually stimulated.

Benign Prostatic Hyperplasia

This medication is also used to treat the signs and symptoms of benign prostatic hyperplasia (BPH), which is an enlarged prostate gland. It helps relieve urinary symptoms, such as:

• Difficulty starting the flow of urine
• A weak urine stream
• The need to urinate urgently or frequently, including during the middle of the night

Pulmonary Arterial Hypertension

Tadalafil is used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the vessels that carry blood to the lungs. It works by relaxing the blood vessels in the lungs to allow blood to flow more easily, which can improve the ability to exercise.

Combined Treatment

In some cases, healthcare providers prescribe tadalafil to treat men who have both erectile dysfunction and symptoms of BPH at the same time.

Mechanism of Action

Tadalafil works by blocking the action of an enzyme called phosphodiesterase type 5 (PDE5). This enzyme is found in various tissues, including the blood vessels of the penis, the lungs, and the smooth muscles of the prostate and bladder.

Erectile Dysfunction

For the treatment of erectile dysfunction, tadalafil helps increase blood flow to the penis during sexual stimulation. When a person is sexually aroused, the body releases nitric oxide, which triggers the production of a substance called cyclic guanosine monophosphate (cGMP). This substance relaxes the smooth muscles and allows blood to flow into the penis. PDE5 is the enzyme that breaks down cGMP. By inhibiting PDE5, tadalafil allows cGMP levels to stay higher for longer, supporting an erection. Note: Tadalafil does not cause an erection on its own; sexual stimulation is still required for the medication to work.

Benign Prostatic Hyperplasia (BPH)

In cases of an enlarged prostate, tadalafil works by relaxing the smooth muscles in the prostate and the bladder. This relaxation helps relieve symptoms of BPH, such as:

• Difficulty starting the flow of urine
• A weak urine stream
• The need to urinate frequently or urgently, including during the middle of the night

Pulmonary Arterial Hypertension (PAH)

When used for pulmonary arterial hypertension, tadalafil relaxes the blood vessels in the lungs. This action lowers the blood pressure in the lungs, which allows the heart to pump blood more efficiently and improves the ability to exercise.

Common Side Effects

• Headache
• Indigestion or heartburn
• Back pain
• Muscle aches
• Flushing (warmth or redness in the face, neck, or chest)
• Stuffy or runny nose
• Pain in the arms or legs

Serious Side Effects

Seek medical attention immediately if you experience any of the following:

• An erection lasting longer than 4 hours (priapism)
• Sudden decrease or loss of vision in one or both eyes
• Sudden decrease or loss of hearing, or ringing in the ears
• Chest pain, dizziness, or nausea during sexual activity
• Signs of an allergic reaction, such as a rash, hives, or swelling of the face, tongue, or throat
• Blurred vision or changes in color vision
• Shortness of breath

Nitrate Interactions

Tadalafil should not be taken by individuals who use any form of organic nitrates, such as nitroglycerin, for chest pain or heart problems. Using these together can cause a sudden, life-threatening drop in blood pressure. This also applies to the use of recreational drugs known as poppers, which contain amyl nitrite or butyl nitrite.

Cardiovascular Risks

Because sexual activity puts a strain on the heart, healthcare providers typically evaluate cardiovascular health before tadalafil is used. It is generally not recommended for people with unstable angina, severe heart failure, or those who have had a recent heart attack or stroke. If chest pain, dizziness, or nausea occurs during sexual activity, the activity should be stopped and medical help sought immediately.

Priapism

A prolonged erection lasting more than four hours is a serious medical condition called priapism. If an erection lasts longer than four hours, immediate medical assistance is necessary to prevent permanent damage to the penis.

Vision and Hearing

• Vision: Sudden vision loss in one or both eyes can occur, which may be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). If sudden vision loss occurs, the medication should be stopped.
• Hearing: Some people have reported a sudden decrease or loss of hearing, sometimes with dizziness or ringing in the ears.

Additional Considerations

Tadalafil may interact with alpha-blockers used for prostate problems or high blood pressure, potentially causing blood pressure to drop too low. It is also important to avoid excessive alcohol consumption while taking this medication, as it may increase the risk of headache, increased heart rate, or low blood pressure. Individuals with kidney or liver problems may require dose adjustments or special monitoring.

Pregnancy

There are no adequate and well-controlled studies of tadalafil use in pregnant women. While animal studies have not shown evidence of harm to the fetus at high doses, animal data does not always predict how a human will respond. Tadalafil is typically only prescribed during pregnancy when there is a clear medical necessity, such as for the treatment of pulmonary arterial hypertension.

If you are pregnant or planning to become pregnant, discuss the potential risks and benefits of this medication with your healthcare provider.

Breastfeeding

It is not known whether tadalafil passes into human breast milk. Research in animals has shown that the drug can be excreted in milk, but human data is unavailable. Because many drugs are excreted in human milk and there is a potential for adverse reactions in nursing infants, a decision must be made whether to stop breastfeeding or stop the medication.

Consult your doctor to weigh the risks and benefits of breastfeeding while taking tadalafil to determine the safest approach for you and your infant.

Dosage Forms

Tadalafil is primarily available in the following form:

• Oral Tablet: This medication is provided as a film-coated tablet to be taken by mouth.

The tablets are typically swallowed whole and can be taken with or without food. The frequency of administration depends on the specific condition being treated.

FDA Approval and Indications

Tadalafil was first approved by the U.S. Food and Drug Administration (FDA) in 2003. It is approved for several specific medical conditions:

• Erectile Dysfunction (ED): To treat the inability to achieve or maintain an erection.
• Benign Prostatic Hyperplasia (BPH): To treat the symptoms of an enlarged prostate.
• Pulmonary Arterial Hypertension (PAH): To improve exercise capacity in patients with high blood pressure in the lungs.

Regulatory Safety Communications

The FDA has issued several safety communications and label updates for tadalafil based on post-marketing surveillance:

• Vision Changes: The FDA required labeling updates to include warnings about sudden vision loss, which may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
• Hearing Loss: Warnings have been added regarding the potential for sudden decrease or loss of hearing, sometimes accompanied by dizziness or ringing in the ears.
• Serious Skin Reactions: The FDA has monitored potential signals for serious skin conditions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, through its adverse event reporting system.

Tadalafil is a prescription-only medication and is not approved for over-the-counter sale. It is not indicated for use in children for ED or BPH.

What is Cialis?

Cialis is a brand name for the medication tadalafil, which belongs to a class of drugs called phosphodiesterase 5 (PDE5) inhibitors. It works by relaxing the muscles in the blood vessels to increase blood flow to specific parts of the body.

Approved Uses

Cialis is FDA-approved for the treatment of several conditions in men:

• Erectile Dysfunction (ED): It helps men achieve and maintain an erection when combined with sexual stimulation.
• Benign Prostatic Hyperplasia (BPH): It helps relieve symptoms of an enlarged prostate, such as a weak urine stream or the frequent need to urinate.
• Combined ED and BPH: It can be used to treat both conditions at the same time.

How Cialis is Taken

Cialis is unique among similar medications because it offers two different dosing options for erectile dysfunction:

• As-needed use: A dose is taken at least 30 minutes before sexual activity. The effects of a single dose can last for up to 36 hours.
• Daily use: A lower dose is taken at the same time every day, allowing for sexual activity at any time between doses.

For the treatment of BPH, Cialis is typically taken as a once-daily tablet.

Important Considerations

Cialis does not cure erectile dysfunction, increase sexual desire, or protect against sexually transmitted diseases. It only works when a man is sexually stimulated. While tadalafil is also used to treat pulmonary arterial hypertension, that condition is usually treated with a different brand-name version of the drug.