Avanafil 100mg Tablets
It is used to treat erectile dysfunction (ED).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Erectile Dysfunction Agent
Pharmacologic Class
Phosphodiesterase-5 (PDE5) Inhibitor
Pregnancy Category
Not applicable
FDA Approved
Apr 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Avanafil is a medication used to treat erectile dysfunction (ED), also known as impotence. It helps men get and keep an erection when they are sexually excited. It works by increasing blood flow to the penis, but it only works if you are sexually stimulated.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. Take the medication before sexual activity, as directed by your doctor. If you're unsure about when to take the medication, consult with your doctor.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Missing a Dose
Since this medication is taken as needed, you don't need to follow a regular dosing schedule. However, do not take it more often than once every 24 hours, unless your doctor instructs you to do so.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. Take the medication before sexual activity, as directed by your doctor. If you're unsure about when to take the medication, consult with your doctor.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Missing a Dose
Since this medication is taken as needed, you don't need to follow a regular dosing schedule. However, do not take it more often than once every 24 hours, unless your doctor instructs you to do so.
Lifestyle & Tips
- Take Avanafil about 15-30 minutes before sexual activity. Sexual stimulation is required for the medication to work.
- Do not take more than one dose per day.
- Avoid excessive alcohol consumption (e.g., more than 3 alcoholic drinks) as it can increase the risk of dizziness and low blood pressure.
- Avoid grapefruit and grapefruit juice, as they can increase the amount of avanafil in your body and potentially increase side effects.
- Inform your doctor about all medications you are taking, especially nitrates (used for chest pain), alpha-blockers (for high blood pressure or prostate issues), and certain antifungal or HIV medications, as these can interact dangerously with avanafil.
- This medication does not protect against sexually transmitted diseases (STDs) or pregnancy.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
100 mg orally as needed, approximately 15-30 minutes before sexual activity
Dose Range:
50 - 200 mg
Condition-Specific Dosing:
initialDose:
50 mg for patients taking moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, fluconazole)
maximumFrequency:
Once daily
maximumDose:
200 mg
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed (CrCl âĨ 50 mL/min)
Moderate:
No dose adjustment needed (CrCl 30 to < 50 mL/min)
Severe:
Not recommended (CrCl < 30 mL/min)
Dialysis:
Not recommended
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A)
Moderate:
Initial dose 50 mg, maximum 100 mg, once daily (Child-Pugh B)
Severe:
Not recommended (Child-Pugh C)
Pharmacology
Mechanism of Action
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, thus facilitating an erection.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified, but rapidly absorbed.
Tmax:
30-45 minutes (range 15-60 minutes)
FoodEffect:
High-fat meal can delay Tmax by 1.25 hours and decrease Cmax by 39%, but AUC is not significantly affected. Can be taken with or without food.
Distribution:
Vd:
Not available
ProteinBinding:
Approximately 99% (primarily to plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 6-17 hours (terminal half-life)
Clearance:
Not available
ExcretionRoute:
Mainly feces (approximately 62%), to a lesser extent urine (approximately 36%)
Unchanged:
< 4% (in urine)
Pharmacodynamics
OnsetOfAction:
As early as 15-30 minutes
PeakEffect:
Approximately 30-45 minutes
DurationOfAction:
Up to 6 hours (clinically effective duration)
Safety & Warnings
Side Effects
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 may occur even when not having sex (seek immediate medical attention to prevent potential long-term sexual dysfunction)
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. 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
Sore throat
Back pain
* Runny or stuffy nose
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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.
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 may occur even when not having sex (seek immediate medical attention to prevent potential long-term sexual dysfunction)
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. 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
Sore throat
Back pain
* Runny or stuffy nose
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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.
Seek Immediate Medical Attention If You Experience:
- Chest pain or discomfort: If you experience chest pain during or after sexual activity, do not take nitrates. Seek immediate medical attention.
- Sudden vision loss: If you experience sudden decrease or loss of vision in one or both eyes, stop taking avanafil and seek immediate medical attention.
- Sudden hearing loss: If you experience sudden decrease or loss of hearing, sometimes with ringing in the ears or dizziness, stop taking avanafil and seek immediate medical attention.
- Erection lasting longer than 4 hours (priapism): This is a medical emergency. Seek immediate medical attention to prevent permanent damage.
- Severe dizziness or fainting: Especially when standing up quickly.
Before Using This Medicine
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 treatment:
Any allergies you have, including allergies to this medication, 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 conditions, such as retinitis pigmentosa.
Cardiovascular issues, 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 like amyl nitrite and butyl nitrite (also known as "poppers").
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, as this medication is not approved for use in these situations.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications
Natural products
Vitamins
* Health problems
This information will help your healthcare team determine whether it is safe for you to take this medication with your existing health conditions and other medications. Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Any allergies you have, including allergies to this medication, 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 conditions, such as retinitis pigmentosa.
Cardiovascular issues, 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 like amyl nitrite and butyl nitrite (also known as "poppers").
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, as this medication is not approved for use in these situations.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications
Natural products
Vitamins
* Health problems
This information will help your healthcare team determine whether it is safe for you to take this medication with your existing health conditions and other medications. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
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 down position, and exercise caution when climbing 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, or a combination of these factors. If you have questions or 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 reduce the risk of transmission, use a latex or polyurethane condom during all sexual activities. 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 vision problems, consult your doctor promptly.
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 down position, and exercise caution when climbing 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, or a combination of these factors. If you have questions or 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 reduce the risk of transmission, use a latex or polyurethane condom during all sexual activities. 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 vision problems, consult your doctor promptly.
Overdose Information
Overdose Symptoms:
- Severe hypotension (very low blood pressure)
- Syncope (fainting)
- Priapism (prolonged erection)
- Severe headache
- Flushing
- Dyspepsia
- Nasal congestion
What to Do:
In case of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as avanafil is highly protein bound. Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Nitrates (e.g., nitroglycerin, isosorbide dinitrate/mononitrate) - concomitant use can cause a dangerous drop in blood pressure.
- Riociguat (soluble guanylate cyclase stimulator) - concomitant use can cause severe hypotension.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin, telithromycin, nefazodone) - significantly increase avanafil exposure.
Major Interactions
- Alpha-blockers (e.g., doxazosin, tamsulosin, alfuzosin, prazosin, terazosin) - risk of symptomatic hypotension. Use with caution, ensure patient is stable on alpha-blocker before initiating avanafil at lowest dose.
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, fluconazole, amprenavir, fosamprenavir, aprepitant) - increase avanafil exposure; limit avanafil dose to 50 mg once daily.
- Other PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) - additive hypotensive effects; not recommended.
Moderate Interactions
- Alcohol - excessive alcohol intake (e.g., >3 units) may increase the risk of orthostatic hypotension and dizziness.
- Grapefruit juice - may increase avanafil plasma concentrations due to CYP3A4 inhibition; avoid large quantities.
Minor Interactions
- Antihypertensives (non-alpha-blocker) - may have additive blood pressure lowering effects, but generally well-tolerated.
Monitoring
Baseline Monitoring
Cardiovascular status assessment
Rationale: To rule out underlying cardiovascular conditions that may contraindicate PDE5 inhibitor use or increase risk of adverse events (e.g., unstable angina, recent MI/stroke, uncontrolled hypertension/hypotension).
Timing: Prior to initiation
Blood pressure (sitting/standing)
Rationale: To establish baseline and identify patients at risk for hypotension, especially those on alpha-blockers or antihypertensives.
Timing: Prior to initiation
Routine Monitoring
Efficacy of erection
Frequency: As needed, during follow-up visits
Target: Sufficient for satisfactory sexual activity
Action Threshold: If insufficient, consider dose adjustment (up to 200mg) or alternative therapy.
Adverse effects (e.g., headache, flushing, nasal congestion, dyspepsia, visual/hearing disturbances, priapism)
Frequency: As needed, during follow-up visits
Target: Absence or mild, tolerable symptoms
Action Threshold: If severe or persistent, consider dose reduction or discontinuation. Seek immediate medical attention for priapism or sudden vision/hearing loss.
Blood pressure (if patient is on antihypertensives or alpha-blockers)
Frequency: Periodically, especially after dose adjustments or initiation of interacting medications
Target: Within patient's target range, without symptomatic hypotension
Action Threshold: If symptomatic hypotension occurs, consider dose adjustment of avanafil or concomitant medications.
Symptom Monitoring
- 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 (especially when standing up)
- Headache
- Flushing
- Nasal congestion
- Dyspepsia (indigestion)
Special Patient Groups
Pregnancy
Avanafil is not indicated for use in women. There are no data on the use of avanafil in pregnant women.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Avanafil is not indicated for use in women. It is unknown whether avanafil is excreted in human milk.
Infant Risk:
Not applicable
Pediatric Use
Avanafil is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population.
Geriatric Use
No dose adjustment is required for elderly patients (âĨ65 years) based on age alone. However, elderly patients may be more sensitive to the hypotensive effects of PDE5 inhibitors. Consider age-related decline in renal and hepatic function when assessing overall risk.
Clinical Information
Clinical Pearls
- Avanafil has a rapid onset of action (as early as 15-30 minutes), making it a good option for spontaneous sexual activity.
- It can be taken with or without food, but a high-fat meal may delay its effect.
- Patients must be warned about the absolute contraindication with nitrates due to the risk of severe, life-threatening hypotension.
- Educate patients on the signs and symptoms of priapism (erection lasting >4 hours) and the need for immediate medical attention.
- Counsel patients on the risk of sudden vision or hearing loss and to discontinue the drug and seek medical attention if these occur.
- For patients on alpha-blockers, ensure they are stable on their alpha-blocker therapy before initiating avanafil at the lowest dose (50 mg) to minimize the risk of orthostatic hypotension.
Alternative Therapies
- 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)
- Psychological counseling
Cost & Coverage
Average Cost:
$150 - $400 per 30 tablets (generic 100mg)
Generic Available:
Yes
Insurance Coverage:
Tier 3 or 4 (often requires prior authorization or is not covered by some plans for ED)
General Drug Facts
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.