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US Brand Names

Description

Avanafil is used to treat men who have erectile dysfunction (also called sexual impotence). Avanafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, avanafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, avanafil will not work to cause an erection.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Avanafil is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of avanafil in the elderly.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amyl Nitrite
• Erythrityl Tetranitrate
• Isosorbide
• Isosorbide Dinitrate
• Nitroglycerin
• Pentaerythritol Tetranitrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Boceprevir
• Clarithromycin
• Conivaptan
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amlodipine
• Doxazosin
• Erythromycin
• Tamsulosin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased and this medicine should be used with caution in these patients.

• Angina (severe chest pain), unstable or
• Arrhythmia (within the last 6 months) or
• Congestive heart failure or
• Heart attack (within the last 6 months) or
• Hypertension (high blood pressure), uncontrolled or
• Hypotension (low blood pressure) or
• Retinal disorders (eye problem) or
• Retinitis pigmentosa (an inherited eye disorder) or
• Stroke (within the last 6 months)—Should not be used in patients with these conditions.

• Bleeding disorders or
• Stomach ulcers—Chance of problems occurring may be increased; it is not known if the medicine is safe for use in these patients.

• Heart disease, underlying—Chance of low blood pressure occurring is greater; avanafil should be used carefully in these patients.

• Leukemia (blood related cancer) or
• Multiple myeloma (blood related cancer) or
• Sickle-cell anemia (blood disorder)—Avanafil should be used with caution in these patients as problems with prolonged erection of the penis may occur.

• NAION (serious eye condition) in one or both eyes, history of—May increase your chance of getting NAION again.

Proper Use

Use avanafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased.

Special patient instructions come with avanafil. Read the directions carefully before you start using avanafil and each time you get a refill of your medicine.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of erectile dysfunction (as needed):
    • Adults—At first, 100 milligrams (mg) as a single dose, no more than once a day, taken 30 minutes before you think sexual activity may occur. Your doctor may adjust your dose if needed. However, the dose is usually not more than 200 mg once a day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that you tell all of your doctors that you take avanafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took avanafil.

Do not use this medicine if you are also using a nitrate medicine, often used to treat angina (chest pain) or high blood pressure. Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates.

It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

If you experience sudden loss of vision in one or both eyes, contact your doctor immediately.

Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

Do not drink excessive amounts of alcohol (e.g., more than 3 glasses of wine or 3 shots of whiskey) when taking avanafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increase your heart rate, or lower your blood pressure.

Do not take this medicine if you are also using other PDE5 inhibitors, such as sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®). If you take too much avanafil or take it together with these medicines, the chance for side effects will be higher.

This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• Dizziness
• Headache
• Nervousness
• Pounding in the ears
• Slow or fast heartbeat

• Arm, back, or jaw pain
• Bladder pain
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody or cloudy urine
• Chest pain or discomfort
• Chest tightness or heaviness
• Difficult or labored breathing
• Difficult, burning, or painful urination
• Fast, irregular, pounding, or racing heartbeat or pulse
• Frequent urge to urinate
• Increased erection
• Lower back or side pain
• Nausea and vomiting
• Pain in the groin or genitals
• Pain, redness, or swelling in the arm or leg
• Rapid weight gain
• Sharp back pain just below the ribs
• Shortness of breath
• Sweating
• Tightness in the chest
• Tingling of the hands or feet
• Unusual tiredness or weakness
• Unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Feeling of warmth
• Fever
• Muscle aches
• Redness of the face, neck, arms, and occasionally, upper chest
• Sore throat
• Stuffy or runny nose

• Acid or sour stomach
• Belching
• Body aches or pain
• Change in color vision
• Chills
• Cough
• Cough producing mucus
• Diarrhea
• Difficulty having a bowel movement (stool)
• Difficulty moving
• Ear congestion
• Heartburn
• Indigestion
• Joint pain
• Loss of appetite
• Loss of voice
• Muscle pain or stiffness
• Pain or tenderness around the eyes and cheekbones
• Rash
• Shivering
• Sneezing
• Sweating
• Trouble sleeping

• Anxiety
• Bloody nose
• Bone pain
• Burning feeling in the chest or stomach
• Confusion
• Cool, pale skin
• Depression
• Feeling of constant movement of self or surroundings
• Increased hunger
• Itching skin
• Muscle aching or cramping
• Muscle spasms
• Nightmares
• Seizures
• Sensation of spinning
• Shakiness
• Sleepiness or unusual drowsiness
• Sleeplessness
• Slurred speech
• Swollen joints
• Tenderness in the stomach area
• Unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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