Tadalafil 10mg Tablets

Tadalafil is a selective and 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, thereby producing an erection. For BPH, PDE5 inhibition may relax smooth muscle in the bladder, prostate, and urethra, improving urinary flow. For PAH, PDE5 inhibition increases cGMP in pulmonary vascular smooth muscle cells, leading to vasodilation of the pulmonary arterial bed.

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
+ 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
Painful erection (hard penis) or an erection lasting longer than 4 hours (even when not having sex), which can lead to lasting sexual problems if not treated promptly

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 notice 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

This is not an exhaustive list of possible 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 or drugs. Describe your allergic reaction 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 type of chest pain)
- A history of heart attack within the last 90 days
- Chest pain during sex
- 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 (OTC) drugs, natural products, or vitamins that should not be taken with this medication. Your doctor or pharmacist can advise you on potential interactions.

Other Important Considerations
If you are taking:
- Another medication containing the same active ingredient
- A different medication for erectile dysfunction (ED) or high pressure in the lungs
- If the patient is a child, as this medication is not approved for use in children

Specific Conditions
For erectile dysfunction (ED):
- If you have been advised against having sex due to health concerns
For ED or enlarged prostate:
- If you are female, as this medication is not approved for use in females

General Guidance
This list is not exhaustive. Inform your doctor and pharmacist about all your medications, health problems, and allergies 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 other 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.

It is recommended that you discuss the consumption of alcohol with your doctor before drinking. If you regularly drink grapefruit juice or eat grapefruit, consult your doctor to assess any potential interactions.

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

A rare but serious eye condition called non-arteritic anterior ischemic optic neuropathy (NAION) can cause sudden vision loss or decreased vision, which may be permanent. If you experience a sudden loss of vision, seek immediate medical attention. 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 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, use a latex or polyurethane condom during all sexual encounters. If you have questions or concerns, consult your doctor for guidance.

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

• Alpha-blockers (e.g., doxazosin, tamsulosin, alfuzosin, prazosin, terazosin) - concomitant use can lead to symptomatic hypotension. Use with caution, start with lowest dose of tadalafil.
• Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, itraconazole, saquinavir, telithromycin, nefazodone) - significantly increase tadalafil exposure, requiring dose adjustment.
• Other PDE5 inhibitors (e.g., sildenafil, vardenafil, avanafil) - increased risk of adverse effects, not recommended.
• Alcohol (excessive consumption) - increased risk of symptomatic hypotension.

• Antihypertensives (e.g., amlodipine, enalapril, metoprolol) - additive hypotensive effects.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - decrease tadalafil exposure, potentially reducing efficacy.
• Grapefruit juice - may increase tadalafil exposure, though less pronounced than with potent CYP3A4 inhibitors.

• 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 (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 upon standing (orthostatic hypotension)
• Severe headache
• Severe back pain or muscle aches

Tadalafil is not indicated for use in women. Limited data from observational studies on tadalafil use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Animal studies have shown no evidence of teratogenicity.

Tadalafil is not indicated for use in women. There is no information on the presence of tadalafil in human milk, the effects on the breastfed infant, or the effects on milk production. Due to the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended if tadalafil is used.

Safety and efficacy have not been established in pediatric patients for ED or BPH. For PAH, tadalafil is not recommended for use in pediatric patients due to lack of efficacy and safety data.

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

• Tadalafil has a significantly longer half-life (up to 36 hours) compared to other PDE5 inhibitors, earning it the nickname 'The Weekend Pill'. This allows for more spontaneity in sexual activity.
• It can be taken with or without food, as food does not significantly affect its absorption.
• Patients should be strongly cautioned against taking tadalafil with any form of nitrate due to the risk of severe, life-threatening hypotension.
• Educate patients on the importance of seeking immediate medical attention for priapism (erection lasting >4 hours) to prevent permanent penile damage.
• For BPH, the once-daily 5 mg dose is effective and can also address co-existing ED.
• For PAH, tadalafil is dosed at 40 mg once daily and should not be used interchangeably with the lower doses for ED/BPH.

• For Erectile Dysfunction: Sildenafil (Viagra), Vardenafil (Levitra, Staxyn), Avanafil (Stendra), Alprostadil (intraurethral or intracavernosal), Vacuum erection devices, Penile implants, Lifestyle modifications (diet, exercise, smoking cessation).
• For Benign Prostatic Hyperplasia: Alpha-blockers (e.g., tamsulosin, alfuzosin), 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), Combination therapy, 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 is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.