Tadalafil 20mg Tabltes

Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. It enhances erectile function by increasing the amount of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. Sexual stimulation causes local release of nitric oxide (NO), which activates guanylate cyclase, resulting in increased cGMP. cGMP causes smooth muscle relaxation and inflow of blood into the corpus cavernosum. PDE5 degrades cGMP. By inhibiting PDE5, tadalafil increases cGMP levels, leading to enhanced erectile response. For BPH, the mechanism is thought to involve relaxation of smooth muscle in the bladder, prostate, and urethra, and improved blood flow. For PAH, it causes vasodilation in the pulmonary vasculature.

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 notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome): red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Dizziness or fainting
Severe headache
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Ringing in the ears, hearing loss, or other changes in hearing
A painful erection (priapism) or an erection lasting longer than 4 hours, which can occur even when not having sex (seek immediate medical attention to prevent long-term sexual dysfunction)

Common Side Effects

Most people experience few or no side effects when taking this medication. However, some individuals may encounter mild side effects. If you experience any of the following symptoms or if they persist or bother you, contact your doctor:

Flushing
Headache
Back pain
Muscle pain
Upset stomach
Heartburn
Nose or throat irritation
Stuffy nose
* Symptoms of a common cold

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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

To ensure safe treatment, inform your doctor about the following:

Allergies and Sensitivities
If you are allergic to this medication, any of its components, or other substances, including foods and drugs. Describe your allergic reactions and the symptoms you experienced.

Pre-existing Medical Conditions
If you have:
- Kidney disease or liver disease
- Certain hereditary eye problems, such as retinitis pigmentosa
- Pulmonary veno-occlusive disease (PVOD)
- Unstable angina (a specific type of chest pain)
- A history of heart attack within the last 90 days
- Chest pain during sexual activity
- Heart failure
- Abnormal heartbeat
- High or low blood pressure
- A stroke within the last 6 months

Medications and Substances to Avoid
If you use:
- "Poppers" like amyl nitrite and butyl nitrite
- Medications such as isosorbide dinitrate, isosorbide mononitrate, or nitroglycerin. Do not take these medications with this drug, and avoid taking them for a certain period after your last dose of this medication.
- Any prescription or over-the-counter drugs, natural products, or vitamins that should not be taken with this medication, including those for high blood pressure, enlarged prostate, HIV, infections, and other conditions. Your doctor or pharmacist can advise you on potential interactions.

Concomitant Medications and Therapies
If you are taking:
- Another medication containing the same active ingredient as this drug
- A different medication for erectile dysfunction (ED) or pulmonary hypertension

Age and Gender Considerations
If the patient is a child, as this medication is not approved for use in children.
If you are female, as this medication is not approved for use in females for erectile dysfunction (ED) or enlarged prostate.

General Warnings
This list is not exhaustive. It is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use. Do not start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and Cautions

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

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.

Before consuming alcohol, consult with your doctor to discuss potential interactions. If you regularly drink grapefruit juice or eat grapefruit, talk to your doctor about potential risks.

This medication has been associated with severe and potentially life-threatening side effects, including abnormal heartbeats, heart attacks, strokes, and severe high blood pressure. Discuss these risks with your doctor.

A sudden decrease or loss of vision may be a symptom of a condition called non-arteritic anterior ischemic optic neuropathy (NAION). If you experience a sudden change in vision, seek medical attention immediately. Note that the risk of NAION is higher in individuals who have previously experienced this condition in one eye, and lost vision may be permanent.

If you have a history of bleeding problems, consult with your doctor before taking this medication. Additionally, if you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Specific Considerations for Erectile Dysfunction (ED)

This medication does not protect against the transmission of diseases like HIV or hepatitis during sexual activity. Always use a latex or polyurethane condom to minimize the risk of disease transmission. If you have questions or concerns, consult with your doctor.

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

• Alpha-blockers (e.g., doxazosin, tamsulosin, alfuzosin, prazosin, terazosin) - concurrent use can lead to symptomatic hypotension. Use with caution, start tadalafil at lowest dose.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, telithromycin, nefazodone, saquinavir, atazanavir) - significantly increase tadalafil exposure, increasing risk of adverse effects. Dosage adjustment required.
• Other PDE5 inhibitors (e.g., sildenafil, vardenafil, avanafil) - increased risk of hypotension and other adverse effects.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil, grapefruit juice) - may increase tadalafil exposure, requiring caution.
• Antihypertensives (e.g., ACE inhibitors, ARBs, beta-blockers, diuretics) - may cause additive hypotensive effects.

• Antacids (magnesium hydroxide/aluminum hydroxide) - may reduce tadalafil absorption rate, but not extent.
• Alcohol - excessive alcohol intake (e.g., 5 units or more) may increase the potential for orthostatic signs and symptoms.

• Chest pain or discomfort (seek immediate medical attention)
• Sudden decrease or loss of vision in one or both eyes (NAION - seek immediate medical attention)
• Sudden decrease or loss of hearing (with or without tinnitus and dizziness - seek immediate medical attention)
• Priapism (erection lasting >4 hours - seek immediate medical attention)
• Dizziness or lightheadedness (especially when standing up)
• Headache
• Flushing
• Dyspepsia (indigestion)
• Back pain
• Myalgia (muscle aches)

Tadalafil is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.

Tadalafil is excreted into the milk of lactating rats. It is not known whether tadalafil or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, 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. Lactation Risk Category L3 (Moderately Safe).

Safety and efficacy have not been established in pediatric patients for ED or BPH. For PAH, specific dosing exists for pediatric patients, but this 20mg strength is typically for adult use and not the primary formulation for pediatric PAH.

No dosage adjustment is required based on age alone. However, geriatric patients may be more sensitive to the hypotensive effects and may have age-related renal or hepatic impairment requiring dose adjustment. Use with caution.

• Tadalafil's long half-life (up to 36 hours) allows for greater spontaneity compared to other PDE5 inhibitors, earning it the nickname 'The Weekend Pill'.
• It can be taken with or without food, unlike sildenafil, which is affected by high-fat meals.
• Patients should be advised to seek immediate medical attention for erections lasting longer than 4 hours (priapism) to prevent permanent damage.
• Caution is advised when co-administering with alpha-blockers due to the risk of symptomatic hypotension; a minimum of 6 hours should separate doses if possible, and tadalafil should be initiated at the lowest dose.
• Patients with pre-existing cardiovascular disease should be thoroughly evaluated before prescribing tadalafil, as sexual activity itself poses a cardiac risk.
• Sudden vision or hearing loss are rare but serious side effects that require immediate medical attention.

• For Erectile Dysfunction: Sildenafil (Viagra), Vardenafil (Levitra, Staxyn), Avanafil (Stendra), Alprostadil (Caverject, Muse), Vacuum erection devices, Penile implants, Penile revascularization surgery.
• For Benign Prostatic Hyperplasia: Alpha-blockers (e.g., tamsulosin, alfuzosin), 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), Combination therapy (alpha-blocker + 5-ARI), Minimally invasive procedures, Surgery (TURP).
• For Pulmonary Arterial Hypertension: Other PDE5 inhibitors (e.g., sildenafil), Endothelin receptor antagonists (e.g., bosentan, ambrisentan), Prostacyclin analogues (e.g., epoprostenol, treprostinil), Soluble guanylate cyclase stimulators (e.g., riociguat).

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 medication taken, the amount, and the time it happened.