Tadalafil 2.5mg 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 leads to increased levels of cGMP 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, bladder, and vascular system, which may contribute to its effects in BPH and PAH.

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 or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or 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 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 (seek immediate medical attention to prevent potential long-term sexual problems)

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Flushing
Headache
Back pain
Muscle pain
Upset stomach
Heartburn
Nose or throat irritation
Stuffy nose
Signs 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, 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

To ensure your safety while taking this medication, it is crucial that you inform your doctor about the following:

Allergies and Sensitivities
- If you are allergic to this medication, any of its components, or any other medications, foods, or substances. Be sure to describe the allergic reaction and its symptoms.

Existing Health Conditions
- Kidney disease or liver disease.
- Certain hereditary eye problems, such as retinitis pigmentosa.
- Pulmonary veno-occlusive disease (PVOD).
- Unstable angina (a type of chest pain).
- Recent 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).

Medication Interactions
- Use of "poppers" (amyl nitrite and butyl nitrite).
- Current or planned use of isosorbide dinitrate, isosorbide mononitrate, or nitroglycerin. These medications should not be taken with this drug, and you may need to avoid them for a period after your last dose of this medication.
- Any prescription, over-the-counter, natural, or vitamin medications that should not be taken with this drug. This includes certain medications for high blood pressure, enlarged prostate, HIV, infections, and others. Your doctor or pharmacist can provide a list of medications to avoid.

Duplicate Therapy
- If you are taking another medication that contains the same active ingredient as this drug.
- If you are taking another medication for erectile dysfunction (ED) or pulmonary arterial hypertension.

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

Sexual Activity
- For erectile dysfunction (ED), if you have been advised against engaging in sexual activity due to health reasons.

General Guidance
This list is not exhaustive. It is essential to discuss all your medications (prescription, over-the-counter, natural products, vitamins) and health problems 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 first 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. Additionally, 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, also talk to your doctor, as this may affect the medication's efficacy or increase the risk of side effects.

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

If you experience a sudden decrease or loss of vision, seek immediate medical attention, as this could be a sign of a condition called non-arteritic anterior ischemic optic neuropathy (NAION). It is essential to note that vision loss due to NAION may be permanent, and the risk is higher in individuals who have previously experienced NAION 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 minimize the risk of transmission, always use a latex or polyurethane condom during sex. If you have questions or concerns, discuss them with your doctor.

• Nitrates (e.g., nitroglycerin, isosorbide dinitrate): Concomitant use can cause a dangerous drop in blood pressure.
• Riociguat: Concomitant use can cause a dangerous drop in blood pressure.

• Alpha-blockers (e.g., doxazosin, tamsulosin): May lead to symptomatic hypotension. Use with caution, initiate alpha-blocker at lowest dose or tadalafil at lowest dose.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole): Significantly increase tadalafil exposure, increasing risk of adverse effects. Dose adjustment of tadalafil may be necessary.
• Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital): Significantly decrease tadalafil exposure, reducing efficacy.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil): May increase tadalafil exposure.
• Other PDE5 inhibitors (e.g., sildenafil, vardenafil, avanafil): Concomitant use is not recommended due to potential for additive hypotensive effects and increased risk of adverse events.

• Alcohol: Excessive alcohol intake (e.g., 5 units or more) in combination with tadalafil may increase the potential for orthostatic signs and symptoms, including increases in heart rate, decreases in standing blood pressure, dizziness, and headache.

• Chest pain (seek immediate medical attention)
• Sudden decrease or loss of vision (seek immediate medical attention)
• Sudden decrease or loss of hearing (seek immediate medical attention)
• Erection lasting longer than 4 hours (priapism - seek immediate medical attention)
• Dizziness or lightheadedness (especially when standing)
• Severe headache
• Severe dyspepsia or heartburn
• Muscle aches or back pain

Tadalafil is not indicated for use in women. Animal studies have shown no evidence of teratogenicity, embryotoxicity, or fetotoxicity at doses up to 1000 times the human exposure.

Tadalafil is not indicated for use in women. It is unknown whether tadalafil is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, use is not recommended.

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, geriatric patients may have age-related renal or hepatic impairment, which may necessitate dose adjustments as described in the renal and hepatic impairment sections. Increased sensitivity to the hypotensive effects may occur.

• 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 2.5 mg daily dose is particularly useful for patients who desire spontaneity in sexual activity and for those with BPH symptoms.
• Can be taken with or without food, as food does not significantly affect its absorption.
• Patients should be counseled on the absolute contraindication with nitrates due to the risk of severe, life-threatening hypotension.
• Rare but serious side effects include priapism (erection lasting >4 hours), sudden vision loss (NAION), and sudden hearing loss. Patients should be advised to seek immediate medical attention if these occur.

• Sildenafil (Viagra, Revatio)
• Vardenafil (Levitra, Staxyn)
• Avanafil (Stendra)
• Alprostadil (Caverject, Edex, Muse)
• Vacuum erection devices
• Penile implants
• Alpha-1 adrenergic blockers (for BPH, e.g., tamsulosin, alfuzosin)
• 5-alpha reductase inhibitors (for BPH, e.g., finasteride, dutasteride)
• Other pulmonary hypertension therapies (e.g., sildenafil, bosentan, ambrisentan, macitentan, selexipag, treprostinil)

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.