Tadalafil 20mg 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, resulting in smooth muscle relaxation and inflow of blood into the penile tissues, thus producing an erection. For BPH, PDE5 inhibition may relax smooth muscle in the bladder, prostate, and urethra, improving urinary flow.

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, 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), including:
+ 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. 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 or seek medical help:

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.

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 you may need to avoid them for a period after your last dose.
- Any prescription or over-the-counter drugs, natural products, or vitamins that should not be taken with this medication. There are many drugs that interact with this medication, so your doctor or pharmacist can advise you on specific drugs to avoid.

Duplicate Medications
If you are taking:
- Another medication containing the same active ingredient
- Another medication for erectile dysfunction (ED) or pulmonary hypertension

Age Restrictions
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 sexual activity due to health reasons
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. 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 first.

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.

Be aware that 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.

If you experience a sudden decrease or loss of vision, seek medical attention immediately, as this could be a sign of a condition called non-arteritic anterior ischemic optic neuropathy (NAION). Note that vision loss may be permanent, and the risk is higher if you 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. Always use a latex or polyurethane condom to minimize the risk of disease transmission. If you have questions or concerns, discuss them with your doctor.

• 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 severe hypotension.

• Alpha-blockers (e.g., doxazosin, tamsulosin, alfuzosin, silodosin, prazosin, terazosin) - increased risk of symptomatic hypotension. Use with caution, start tadalafil at lowest dose.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, saquinavir, clarithromycin, telithromycin, nefazodone, grapefruit juice) - significantly increase tadalafil exposure, increasing risk of adverse effects. Limit tadalafil dose and frequency.
• Other PDE5 inhibitors (e.g., sildenafil, vardenafil, avanafil) - increased risk of hypotension and other adverse effects; co-administration is not recommended.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil) - may increase tadalafil exposure.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - may decrease tadalafil exposure, reducing efficacy.
• Antihypertensives (e.g., amlodipine, ACE inhibitors, ARBs, beta-blockers) - additive hypotensive effects; monitor blood pressure.
• Alcohol - excessive alcohol intake (e.g., 5 or more units) may increase the potential for orthostatic signs and symptoms.

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

• Chest pain (angina)
• Dizziness or lightheadedness (especially upon standing)
• Fainting
• Sudden decrease or loss of vision in one or both eyes (NAION)
• Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness
• Erection lasting more than 4 hours (priapism)
• Severe headache
• Severe back pain or muscle aches
• Rash or hives
• Swelling of the face, lips, tongue, or throat (angioedema)

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

Lactation Risk L3 (Moderately Safe). Tadalafil and/or its metabolites are excreted into the milk of lactating rats. It is not known whether tadalafil is excreted in human milk. Tadalafil is not indicated for use in women.

Safety and efficacy have not been established for the treatment of ED or BPH in pediatric patients. Tadalafil (as Adcirca) is used in pediatric PAH, but Cialis 20mg is not indicated for pediatric use.

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, starting at lower doses if appropriate.

• 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 can be affected by high-fat meals.
• Daily dosing (2.5 mg or 5 mg) is an option for men who anticipate sexual activity at least twice weekly or for those with BPH symptoms.
• Patients should be thoroughly evaluated for underlying cardiovascular disease before initiating tadalafil, as sexual activity itself poses a cardiac risk.
• Counsel patients on the absolute contraindication with nitrates and the risk of severe hypotension with alpha-blockers. Advise them to carry a medical alert card if they are on tadalafil.
• Priapism (erection lasting >4 hours) is a rare but serious side effect requiring immediate medical attention to prevent permanent penile damage.
• Sudden vision loss (NAION) and sudden hearing loss are rare but serious adverse events that require immediate discontinuation and medical evaluation.

• Other PDE5 inhibitors for ED: Sildenafil (Viagra), Vardenafil (Levitra, Staxyn), Avanafil (Stendra).
• Other treatments for ED: Alprostadil (intracavernosal injection or urethral suppository), vacuum erection devices, penile implants, psychotherapy.
• Other treatments for BPH: Alpha-blockers (e.g., tamsulosin, alfuzosin), 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), combination therapy, minimally invasive procedures, surgery.

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's a good idea 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.