Avanafil

What is Avanafil?

• Avanafil (STENDRA) is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of erectile dysfunction.

Avanafil

Avanafil ball-and-stick

What are the uses of this medicine?

• STENDRA is a prescription medicine used to treat erectile dysfunction (ED).

How does this medicine work?

• Avanafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of NO by inhibiting PDE5, which is responsible for degradation of cGMP in the corpus cavernosum.
• Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• take medicines called “nitrates”
• use street drugs called “poppers” such as amyl nitrate and butyl nitrate
• are allergic to avanafil or any of the ingredients in STENDRA.

What drug interactions can this medicine cause?

• Administration of STENDRA to patients who are using any form of organic nitrate, is contraindicated.
• Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers.
• STENDRA can potentiate the hypotensive effect of nitrates, alpha-blockers, antihypertensives, and alcohol.
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase STENDRA exposure.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• The recommended starting dose is 100 mg. STENDRA should be taken orally as needed as early as approximately 15 minutes before sexual activity.
• Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken approximately 30 minutes before sexual activity.
• The lowest dose that provides benefit should be used.
• The maximum recommended dosing frequency is once per day.
• Sexual stimulation is required for a response to treatment.

Administration:

• Take STENDRA 100 mg or 200 mg as early as approximately 15 minutes before sexual activity.
• Take STENDRA 50 mg as early as approximately 30 minutes before sexual activity
• Do not take STENDRA more than 1 time a day.
• Your healthcare provider may change your dose if needed.
• You should take the lowest dose of STENDRA that works for you. You and your healthcare provider should decide about the lowest dose of STENDRA that works for you.
• STENDRA may be taken with or without food.
• Do not drink too much alcohol when taking STENDRA (for example, 3 glasses of wine, or 3 shots of whiskey). Drinking too much alcohol when taking STENDRA can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets: 50 mg, 100 mg, 200 mg

This medicine is available in fallowing brand namesː

• STENDRA

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• flushing
• stuffy or runny nose
• sore throat
• back pain

STENDRA may uncommonly cause:

• an erection that will not go away (priapism)
• sudden vision loss in 1 or both eyes
• sudden hearing decrease or hearing loss

What special precautions should I follow?

• Patients should not use STENDRA if sexual activity is inadvisable due to cardiovascular status or any other reason.
• Use of STENDRA with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension.
• Patients should seek emergency treatment if an erection lasts greater than 4 hours.
• Patients should stop STENDRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). STENDRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION.
• Patients should stop taking STENDRA and seek prompt medical attention in the event of sudden decrease or loss of hearing.

What to do in case of emergency/overdose?

Management of overdosage:

• In cases of overdose, standard supportive measures should be adopted as required.
• Renal dialysis is not expected to accelerate clearance because avanafil is highly bound to plasma proteins and is not significantly eliminated in the urine.

Can this medicine be used in pregnancy?

• STENDRA is not indicated for use in females.
• There are no data with the use of STENDRA in pregnant women to inform any drug-associated risks for adverse developmental outcomes.

Can this medicine be used in children?

• STENDRA is not indicated for use in pediatric patients.
• Safety and efficacy in patients below the age of 18 years has not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: avanafil
• Inactive ingredients: mannitol, fumaric acid, hydroxypropylcellulose, low substituted hydroxypropylcellulose, calcium carbonate, magnesium stearate, and ferric oxide yellow

Who manufactures and distributes this medicine?

• Manufactured for: Metuchen Pharmaceuticals, LLC, Freehold, NJ

• Manufactured By: Sanofi Winthrope Industrie, Ambares, France

STENDRA is a registered U.S. trademark of Metuchen Pharmaceuticals, LLC.

What should I know about storage and disposal of this medication?

• Store STENDRA at 68°F to 77°F (20°C to 25°C).
• Keep STENDRA out of the light.
• Keep STENDRA and all medicines out of the reach of children

• Dailymed label info on Avanafil
• FDA Avanafil

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