Avanafil 200mg Tablets

Avanafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes local release of nitric oxide, PDE5 inhibition by avanafil increases cGMP levels in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood into the penis, thus facilitating an erection.

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
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 (priapism) or an erection that lasts longer than 4 hours, which can occur even when not having sex. If left untreated, this may lead to lasting sexual problems and impotence.

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
Sore throat
Back pain
* Runny or stuffy nose

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

It is essential to inform your doctor about the following conditions and situations to ensure safe use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you 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 problems, such as retinitis pigmentosa.
Cardiovascular conditions, including:
+ Chest pain (including chest pain during sex)
+ 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 medications for erectile dysfunction (ED) or pulmonary hypertension
+ Certain medications for HIV, infections, depression, or other conditions that may interact with this drug
* Pregnancy, planned pregnancy, or breastfeeding, as this medication is not approved for use in these situations.

To ensure your safety, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They 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 driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution when navigating stairs.

If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with your medication. 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, or a combination of both. If you have concerns, discuss them with your doctor.

It is crucial to note that this medication does not protect against the transmission of sexually transmitted diseases, such as HIV or hepatitis. To minimize the risk of transmission, use a latex or polyurethane condom during all sexual activities. If you have 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 vision problems, consult your doctor promptly to discuss the potential risks and consequences.

• Nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate) in any form (e.g., oral, sublingual, transdermal, spray, ointment)
• Riociguat (a guanylate cyclase stimulator)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, saquinavir, atazanavir, telithromycin, nefazodone, cobicistat-containing regimens)

• Alpha-blockers (e.g., doxazosin, tamsulosin, alfuzosin, prazosin, terazosin) - risk of symptomatic hypotension. Use with caution, initiate avanafil at lowest dose (50 mg) and ensure patient is stable on alpha-blocker.
• Moderate CYP3A4 inhibitors (e.g., erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, verapamil, grapefruit juice) - dose reduction of avanafil to 50 mg and increased dosing interval (e.g., every other day) may be considered.

• Alcohol (excessive consumption, e.g., >3 units) - may increase risk of orthostatic hypotension.
• Other PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) - concomitant use not recommended due to lack of data and potential for additive hypotensive effects.

• Not specifically identified as minor interactions with clinical significance requiring specific action beyond general caution.

• Headache
• Flushing
• Nasal congestion
• Dyspepsia
• Back pain
• Dizziness
• Visual disturbances (e.g., blurred vision, color tinge)
• Sudden decrease or loss of vision (NAION)
• Sudden decrease or loss of hearing
• Tinnitus
• Priapism (erection lasting >4 hours)
• Chest pain or discomfort
• Symptoms of hypotension (e.g., lightheadedness, fainting)

Avanafil is not indicated for use in women. There are no data on the use of avanafil in pregnant women.

Avanafil is not indicated for use in women. It is not known whether avanafil is excreted in human milk.

Avanafil is not indicated for use in pediatric patients. Safety and effectiveness have not been established in this population.

No dose adjustment is required based on age alone. However, geriatric patients may be more sensitive to the hypotensive effects of PDE5 inhibitors. Use with caution, especially if co-morbidities or polypharmacy are present.

• Avanafil has a rapid onset of action (as early as 15 minutes), making it a good option for spontaneous sexual activity.
• The 200mg dose is the maximum recommended dose and should only be used if lower doses (50mg, 100mg) are ineffective and well-tolerated.
• Counsel patients strictly on the absolute contraindication with nitrates and riociguat due to the risk of life-threatening hypotension.
• Advise patients to seek immediate medical attention for erections lasting longer than 4 hours (priapism) to prevent permanent penile damage.
• Patients should be stable on alpha-blocker therapy before initiating avanafil, and avanafil should be started at the lowest dose (50 mg) to minimize the risk of orthostatic hypotension.
• Grapefruit juice should be avoided due to its potential to increase avanafil exposure via CYP3A4 inhibition.

• Sildenafil (Viagra, Revatio)
• Tadalafil (Cialis, Adcirca)
• Vardenafil (Levitra, Staxyn)
• Alprostadil (Caverject, Edex, Muse)
• Vacuum erection devices
• Penile implants
• Lifestyle modifications (e.g., diet, exercise, smoking cessation, weight loss)
• Psychological counseling

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 name of the medication taken, the amount, and the time it occurred, to facilitate prompt and appropriate treatment.