Tadalafil 5mg Tablets

Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes local release of nitric oxide, PDE5 inhibition by tadalafil increases cGMP levels in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, causing an erection. Tadalafil also relaxes smooth muscle in the prostate and bladder, which may improve symptoms of BPH.

Urgent Side Effects: Seek Medical Help Right Away

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

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, rapid heartbeat, or irregular heartbeat
Dizziness or fainting
Severe headache
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Ringing in the ears, hearing loss, or other changes in hearing
A painful erection (hard penis) or an erection lasting longer than 4 hours, which can occur even when not having sex (seek immediate medical attention to prevent potential long-term sexual dysfunction)

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:

Flushing
Headache
Back pain
Muscle pain
Upset stomach
Heartburn
Nose or throat irritation
Stuffy nose
* Common cold symptoms

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

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reactions you've experienced.
Existing health conditions, such as kidney disease, liver disease, certain hereditary eye problems like retinitis pigmentosa, or pulmonary veno-occlusive disease (PVOD).
A history of unstable angina or specific cardiovascular conditions, including:
+ Heart attack within the last 90 days
+ Chest pain during sexual activity
+ Heart failure
+ Abnormal heartbeat
+ High or low blood pressure
+ Stroke within the last 6 months
Use of recreational drugs called "poppers" (e.g., amyl nitrite and butyl nitrite).
Current medications, including:
+ Isosorbide dinitrate, isosorbide mononitrate, or nitroglycerin (do not take these with this medication, and avoid taking them for some time after your last dose)
+ Other prescription or over-the-counter drugs, natural products, or vitamins that may interact with this medication, such as those used for high blood pressure, enlarged prostate, HIV, infections, or other conditions
+ Medications that contain the same active ingredient as this drug
+ Other erectile dysfunction (ED) or pulmonary hypertension treatments
If you are a child, as this medication is not approved for pediatric use.
For erectile dysfunction (ED) treatment:
+ If you have been advised against engaging in sexual activity due to health concerns
For erectile dysfunction (ED) or enlarged prostate treatment:
+ If you are female, as this medication is not approved for use in women.

This list is not exhaustive, and it is essential to discuss all your medications, health conditions, and concerns with your doctor and pharmacist to ensure safe treatment. 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 engaging in 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, as this may affect the medication's efficacy or increase the risk of side effects.

Rare but severe side effects, including abnormal heartbeats, heart attacks, strokes, and severe high blood pressure, have been associated with tadalafil. Discuss these risks with your doctor to 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 permanent vision loss may occur. The risk of NAION is higher in individuals who have previously experienced this condition in one eye.

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. To reduce the risk of disease transmission, always use a latex or polyurethane condom during sex. If you have questions or concerns, consult with your doctor to discuss safe sex practices.

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

• Alpha-blockers (e.g., doxazosin, tamsulosin, alfuzosin, silodosin, prazosin, terazosin) - increased risk of symptomatic hypotension. Use with caution, consider lower starting dose of tadalafil.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, saquinavir, clarithromycin, telithromycin, nefazodone) - significantly increase tadalafil exposure. Reduce tadalafil dose.
• Other PDE5 inhibitors (e.g., sildenafil, vardenafil, avanafil) - increased risk of adverse effects, not recommended.
• Antihypertensives (e.g., amlodipine, enalapril, metoprolol) - additive hypotensive effects.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem) - may increase tadalafil exposure, monitor for adverse effects.
• Alcohol - excessive alcohol intake (e.g., 5 units or more) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including increases in heart rate, decreases in standing blood pressure, dizziness, and headache.

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

• Chest pain or discomfort (seek immediate medical attention)
• Sudden decrease or loss of vision in one or both eyes (non-arteritic anterior ischemic optic neuropathy - NAION)
• Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness
• Erection lasting longer than 4 hours (priapism)
• Dizziness or lightheadedness (especially when standing up)
• Severe headache
• Muscle aches or back pain (usually transient)
• Dyspepsia (indigestion)

Tadalafil is Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It is not indicated for use in women.

Tadalafil is not indicated for use in women. It is unknown if tadalafil is excreted in human milk. Due to potential for serious adverse reactions in a breastfed infant, a decision should be made whether to discontinue nursing or 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 dosage adjustment is required based on age alone. However, geriatric patients may be more sensitive to the vasodilatory effects of tadalafil and may have age-related renal or hepatic impairment requiring dose adjustment. Monitor for adverse effects.

• Tadalafil's long half-life (up to 36 hours) allows for a longer window of opportunity for sexual activity compared to other PDE5 inhibitors, earning it the nickname 'the weekend pill'.
• The 5mg daily dose is commonly used for both ED and BPH, offering convenience for patients with both conditions.
• Patients should be counseled on the absolute contraindication with nitrates due to the risk of severe, life-threatening hypotension.
• Sudden vision or hearing loss are rare but serious adverse events that require immediate medical attention.
• Priapism (erection lasting >4 hours) is a medical emergency and requires immediate intervention to prevent permanent penile damage.
• Food does not significantly affect absorption, allowing flexibility in administration.

• Other PDE5 inhibitors for ED (e.g., sildenafil, vardenafil, avanafil)
• Alprostadil (intracavernosal injection or urethral suppository) for ED
• Vacuum erection devices for ED
• Penile implants for ED
• Alpha-blockers (e.g., tamsulosin, alfuzosin) for BPH
• 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) for BPH
• Surgical interventions (e.g., TURP) for BPH

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, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.