Tadalafil 20mg Tablets (pah)

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). PDE5 is found in the smooth muscle of the pulmonary arteries, corpus cavernosum, and other tissues. By inhibiting PDE5, tadalafil increases the amount of cGMP, leading to smooth muscle relaxation and vasodilation in the pulmonary vascular bed and the corpus cavernosum. This results in a reduction in pulmonary arterial pressure and improved exercise capacity in patients with pulmonary arterial hypertension (PAH).

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome), such as:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Dizziness or fainting
Severe headache
Weakness on one side of the body
Trouble speaking or thinking
Change in balance
Drooping on one side of the face
Blurred eyesight
Ringing in the ears, hearing loss, or other changes in hearing
A painful erection (hard penis) or an erection that lasts longer than 4 hours, which can occur even when not having sex (if left untreated, this may lead to lasting sexual problems and impotence)

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical attention:

Flushing
Headache
Back pain
Muscle pain
Upset stomach
Heartburn
Nose or throat irritation
Stuffy nose
Signs of a common cold
* Pain in arms or legs

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have experienced.
Existing health conditions, such as kidney disease, liver disease, or certain hereditary eye problems like retinitis pigmentosa.
A medical condition called pulmonary veno-occlusive disease (PVOD) or a history of unstable angina (a specific type of chest pain).
Recent heart problems, including a heart attack within the last 90 days, chest pain during sex, heart failure, irregular heartbeat, high or low blood pressure, or a stroke within the last 6 months.
Use of recreational drugs like "poppers" (amyl nitrite and butyl nitrite).
Current medications, including:
+ Isosorbide dinitrate, isosorbide mononitrate, or nitroglycerin, which should not be taken with this medication.
+ Other prescription or over-the-counter medications, natural products, or vitamins that may interact with this medication, such as those used to treat high blood pressure, enlarged prostate, HIV, infections, or other conditions.
+ Medications that contain the same active ingredient as this medication or are used to treat erectile dysfunction (ED) or high pressure in the lungs.
* If you are taking any other medications that your doctor or pharmacist has advised against taking with this medication.

This medication is not approved for use in children.

It is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist to ensure it is safe to take this medication. Do not start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution when navigating stairs.

Before consuming alcohol, consult with your doctor to discuss potential interactions. Additionally, if you regularly drink grapefruit juice or eat grapefruit, talk to your doctor, as this may affect the medication's efficacy or increase the risk of side effects.

Tadalafil has been associated with severe and potentially life-threatening side effects, including abnormal heartbeats, heart attacks, strokes, and severely high blood pressure. Discuss these risks with your doctor to ensure you understand the potential consequences.

Be aware that a sudden decrease or loss of vision could be a symptom of a condition called non-arteritic anterior ischemic optic neuropathy (NAION). If you experience any vision changes, seek immediate medical attention, as lost vision may be permanent. The risk of NAION is higher in individuals who have previously experienced this condition in one eye.

If you have a history of bleeding disorders, consult with your doctor before taking this medication.

As you age, your sensitivity to this medication may increase. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.

• Nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate) - concomitant use can cause a dangerous drop in blood pressure.
• Riociguat (soluble guanylate cyclase stimulator) - concomitant use can cause symptomatic hypotension.

• Alpha-blockers (e.g., doxazosin, tamsulosin) - risk of symptomatic hypotension. Use with caution, start at lowest dose of alpha-blocker.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole, saquinavir, telithromycin) - significantly increase tadalafil exposure. Avoid concomitant use or reduce tadalafil dose.
• Other PDE5 inhibitors (e.g., sildenafil, vardenafil) - increased risk of adverse effects, including hypotension.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice) - may increase tadalafil exposure. Use with caution.
• Antihypertensives (e.g., amlodipine, enalapril) - additive hypotensive effects. Monitor blood pressure.

• Antacids (magnesium hydroxide/aluminum hydroxide) - may reduce tadalafil absorption rate, but not extent.

• Symptoms of hypotension (dizziness, lightheadedness, fainting)
• Visual disturbances (sudden vision loss, blurred vision, color tinge)
• Hearing impairment (sudden decrease or loss of hearing, tinnitus)
• Priapism (erection lasting >4 hours)
• Chest pain (especially if taking nitrates)
• Signs of allergic reaction (rash, swelling, difficulty breathing)

Tadalafil (Adcirca) is Pregnancy Category B. Animal studies have not shown evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.

It is not known whether tadalafil is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from tadalafil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients have not been established. Tadalafil is not indicated for use in pediatric patients.

No dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the hypotensive effects of tadalafil. Monitor blood pressure closely.

• Tadalafil for PAH (Adcirca) is dosed differently (40 mg once daily) than tadalafil for erectile dysfunction/BPH (Cialis). Ensure correct formulation and dose for the indication.
• Emphasize the absolute contraindication with nitrates and riociguat due to life-threatening hypotension.
• Patients should be advised to seek immediate medical attention for sudden vision loss, hearing loss, or an erection lasting more than 4 hours.
• Food does not affect absorption, allowing flexibility in administration.
• Due to its long half-life, the effects of tadalafil can persist for more than 24 hours, which is beneficial for once-daily dosing but also means interactions can be prolonged.

• Other PDE5 inhibitors (e.g., sildenafil for PAH)
• Endothelin Receptor Antagonists (ERAs) (e.g., ambrisentan, bosentan, macitentan)
• Prostacyclin Analogs (e.g., epoprostenol, treprostinil, iloprost)
• Soluble Guanylate Cyclase (sGC) Stimulators (e.g., riociguat)
• Calcium Channel Blockers (for select responders)
• Combination therapies involving different classes of PAH-specific agents.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.