Avanafil 50mg Tablets

Avanafil is a selective phosphodiesterase-5 (PDE5) inhibitor. It enhances the effect of nitric oxide (NO) by inhibiting PDE5, which is responsible for the degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. When sexual stimulation causes local release of NO, PDE5 inhibition by avanafil leads to increased cGMP levels, resulting in smooth muscle relaxation and inflow of blood into the penis, causing an erection.

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
Chest pain or pressure
Fast or abnormal heartbeat
Severe dizziness or fainting
Severe stomach upset or vomiting
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Changes in vision, eye pain, or severe eye irritation
Loss of 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 problems)

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people experience no side effects or only mild 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
Sore throat
Back pain
* Runny or stuffy nose

This is not an exhaustive list of possible 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

It is essential to inform your doctor about the following conditions and circumstances to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
If you have been advised against engaging in sexual activity due to health concerns.
Presence of kidney disease or liver disease.
Certain hereditary eye conditions, such as retinitis pigmentosa.
Cardiovascular conditions, including:
+ Chest pain (including chest pain during sexual activity)
+ Heart disease
+ Heart failure
+ High or low blood pressure
Recent history (within the last 6 months) of:
+ Abnormal heartbeat
+ Heart attack
+ Stroke
+ Heart procedure
Use of recreational drugs called "poppers" (e.g., amyl nitrite and butyl nitrite).
Current or planned use of the following medications:
+ Cobicistat
+ Isosorbide dinitrate
+ Isosorbide mononitrate
+ Nitroglycerin
+ Riociguat
+ Ritonavir
+ Vericiguat
+ Other erectile dysfunction (ED) medications or treatments for high pressure in the lungs
+ Certain medications for HIV, infections, depression, or other conditions that may interact with this medication
* Pregnancy, planned pregnancy, or breastfeeding status, as this medication is not approved for use in these patients.

To ensure your safety, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist will help you determine if it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.

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

When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.

If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor. Additionally, consult your doctor before consuming alcohol while taking this medication.

There have been reports of severe adverse effects, including heart attack, cardiac death, stroke, and cerebral bleeding, in patients taking this medication. These events have occurred in individuals with pre-existing risk factors for heart disease or stroke, and it is unclear whether they are directly related to the medication, the underlying risk factors, sexual activity, or a combination of these factors. If you have questions or concerns, discuss them with your doctor.

It is crucial to remember that this medication does not protect against the transmission of sexually transmitted diseases, such as HIV or hepatitis. To reduce the risk of transmission, always use a latex or polyurethane condom during sexual activity. If you have any questions or concerns, consult your doctor.

Rarely, this medication has been associated with a severe eye condition that may lead to changes in vision or even permanent vision loss. If you experience any concerns about your vision, discuss them with your doctor promptly.

• Nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate) in any form (e.g., oral, sublingual, transdermal, spray) due to risk of severe hypotension.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin) due to significantly increased avanafil exposure.

• Alpha-blockers (e.g., doxazosin, tamsulosin, alfuzosin, prazosin, silodosin) due to risk of symptomatic hypotension. Use with caution, ensure patient is stable on alpha-blocker before initiating avanafil at lowest dose.
• Other PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) due to additive hypotensive effects and increased risk of adverse events.
• Riociguat (a guanylate cyclase stimulator) due to risk of symptomatic hypotension.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole, aprepitant, fosamprenavir) may increase avanafil exposure. Consider lower starting dose of avanafil (e.g., 50mg) and limit maximum dose to 100mg.
• Alcohol: Excessive alcohol intake (e.g., >3 units) may increase the risk of orthostatic hypotension.

• Not available (most interactions are significant due to hypotensive risk or metabolic inhibition)

• Sudden decrease or loss of vision (NAION)
• Sudden decrease or loss of hearing (with or without tinnitus and dizziness)
• Priapism (erection lasting >4 hours)
• Chest pain or discomfort (especially if taking nitrates)
• Symptoms of hypotension (dizziness, lightheadedness, fainting)

Avanafil is not indicated for use in women. Pregnancy Category C: Animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Avanafil is not indicated for use in women. It is unknown if avanafil is excreted in human milk.

Safety and efficacy have not been established in pediatric patients. Not indicated for use in this population.

No dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the hypotensive effects of PDE5 inhibitors. Use with caution.

• Avanafil has a rapid onset of action (as early as 15-30 minutes), making it a good option for spontaneous sexual activity.
• It has a relatively short half-life compared to tadalafil, which may be preferred by some patients.
• Patients should be advised to avoid nitrates due to the risk of severe, life-threatening hypotension.
• Counsel patients on the importance of seeking immediate medical attention for priapism (erection lasting >4 hours) to prevent permanent penile damage.
• Food, especially high-fat meals, can delay the absorption of avanafil, so it's often recommended to take it on an empty stomach for fastest effect.

• Sildenafil (Viagra, Revatio)
• Tadalafil (Cialis, Adcirca)
• Vardenafil (Levitra, Staxyn)
• Alprostadil (intracavernosal injection or urethral suppository)
• Vacuum erection devices
• Penile implants
• Lifestyle modifications (e.g., diet, exercise, smoking cessation, stress reduction)

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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.