Sildenafil

Sildenafil is used to treat erectile dysfunction (ED) in adult men or pulmonary arterial hypertension (PAH) in adults and children, depending on the brand or formulation.

• Sildenafil tablets (25 mg, 50 mg, 100 mg; Viagra, generic) and sildenafil oral film (25 mg, 50 mg, 75 mg, 100 mg; Vybrique) are used for ED.
• Sildenafil tablets (20 mg; Revatio, generic), sildenafil oral suspension (Revatio, generic), and sildenafil injection (Revatio, generic) are used for PAH.

Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor, which breaks down cyclic GMP and enhances nitric oxide (NO) -mediated smooth muscle relaxation. In erectile dysfunction (ED), this increases blood flow to penile tissue, facilitating an erection. In pulmonary arterial hypertension (PAH), it dilates pulmonary vessels by the same mechanism, reducing pulmonary blood pressure and improving exercise capacity.

Sildenafil first gained FDA approval on March 27, 1998. It is available as a generic.

Sildenafil Tablets for ED

Take sildenafil oral tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much to take and when to take it. Your healthcare provider may change your dose if needed.

• Take 1 hour before sexual activity. You may take sildenafil between 30 minutes to 4 hours before sexual activity if needed.
• Take with or without food.
• If you take sildenafil after a high-fat meal (such as a cheeseburger and fries), sildenafil may take a little longer to start working.
• Do not take sildenafil more than 1 time a day.
• If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away.

Sildenafil can help you have an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil.

Sildenafil Oral Film for ED

Take sildenafil oral film (Vybrique) exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much sildenafil to take and when to take it. Your healthcare provider may change your dose if needed.

• Take sildenafil by mouth about 1 hour before sexual activity. You may take sildenafil between 30 minutes and 4 hours before sexual activity if needed.
• Sildenafil can be taken with or without food.
• Do not cut or chew the oral film.
• Do not take more than once a day.
• If you take too much sildenafil, call your healthcare provider or go to the nearest hospital emergency room right away.
• Do not remove the film from the pouch unless ready for immediate use.
• Do not handle the oral film with wet hands.
• Place the oral film directly onto your tongue. It will dissolve in your mouth and can be swallowed with saliva without water or other liquids.
• See the Vybrique Prescribing Information for more information about how to take sildenafil oral film.

Sildenafil can help you have an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil.

Sildenafil Tablets or Oral Suspension for PAH

Take sildenafil exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Do not change your dose or stop taking this medicine on your own. Talk to your doctor first.

• Take sildenafil tablet or oral suspension 3 times a day, about 4 to 6 hours apart.
• Take at approximately the same times every day.
• Sildenafil oral suspension will be mixed for you by your pharmacist. Do not mix with other medicines or flavorings.
• Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not use sildenafil if you:

• Have allergies to sildenafil, Viagra, Revatio, Vybrique, or any of the ingredients in the sildenafil formulation you are taking
• Take other medicines for pulmonary arterial hypertension, such as riociguat (Adempas)
• Take other medicines that lower your blood pressure, such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs that also contain nitrates, such as "poppers". Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

To make sure sildenafil is safe for you, tell your healthcare provider about all your medical conditions, including if you have:

• Or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
• Had heart surgery within the last 6 months
• Pulmonary hypertension
• Had a stroke
• Low blood pressure, or high blood pressure that is not controlled
• A physical deformity of the penis (such as Peyronie's disease)
• Been told you should not have sexual intercourse for health reasons and you are a male
• Had an erection that lasted for more than 4 hours
• Problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia
• Retinitis pigmentosa, a rare genetic (runs in families) eye disease
• Ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)
• Pulmonary veno-occlusive disease (PVOD)
• Bleeding problems
• Have had stomach ulcers
• Liver problems
• Kidney problems or are having kidney dialysis
• Are pregnant or intending to become pregnant (for patients with PAH)
• Are breastfeeding or intending to breastfeed (for patients with PAH).

Sildenafil for ED is not approved for males <18 years old.

Pregnancy

Sildenafil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Women with pulmonary arterial hypertension should not stop taking sildenafil without talking to their doctor if they discover they are pregnant.

Breastfeeding

It is not known whether sildenafil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby. Women with pulmonary arterial hypertension should not stop taking sildenafil without talking to their doctor.

Warnings

Drug Interactions

Do not take sildenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Some medicines can cause unwanted or dangerous effects when used with sildenafil. Tell your doctor about all your current medicines, especially riociguat (Adempas). Do not take sildenafil with riociguat.

Common Side Effects

The most common side effects of sildenafil tablets for ED are:

• Headache
• Flushing
• Upset stomach
• Abnormal vision, such as changes in color vision (such as having a blue color tinge) andblurred vision
• Stuffy or runny nose
• Back pain
• Muscle pain
• Nausea
• Dizziness
• Rash

The most common side effects of sildenafil oral film for ED are:

• Headache
• Flushing
• Upset stomach
• Stuffy or runny nose
• Dizziness.

Other side effects include:

• Abnormal vision, such as changes in color and blurred vision
• Back pain
• Muscle pain
• Nausea
• Rash.

The most common side effects of sildenafil tablets/ oral suspension, and injection for PAH are:

• Bleeding nose
• Headache
• Dyspepsia
• Flushing
• Sleeplessness (insomnia)
• Redness
• Shortness of breath (dyspnea)
• Nasal congestion (rhinitis).

Serious Side Effects

Sildenafil can cause the following serious side effects. These are rare.

An Erection That Will Not Go Away (Priapism)

If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.

Sudden Vision Loss in One or Both Eyes

A small number of people taking sildenafil have had sudden vision loss in one or both eyes. Most of these people also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and were smokers or over 50 years old. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether sildenafil directly causes this vision loss. Stop taking sildenafil and call your healthcare provider right away if you have sudden vision loss in one or both eyes.

Sudden Hearing Decrease or Hearing Loss

Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking sildenafil and contact a doctor right away.

Heart Attack, Stroke, Irregular Heartbeats, and Death

In addition, heart attack, stroke, irregular heartbeats, and death have happened rarely in people taking sildenafil. Most, but not all, of these people had heart problems before taking this medicine. It is not known if sildenafil caused these problems.

Tell all your healthcare providers that you take sildenafil. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil. Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.

Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Sildenafil does not protect you or your partner from getting sexually transmitted diseases, including Human Immunodeficiency Virus (HIV).

Low Blood Pressure

Sildenafil may cause low blood pressure, which may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.

More Shortness of Breath Than Usual (For Patients with PAH)

Tell your doctor if you get more short of breath after you start sildenafil. More shortness of breath than usual may be due to your underlying medical condition.

Notes:

Do not take Viagra while also taking Revatio.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of sildenafil. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

When sildenafil is used for ED, it is used as needed, so you are not likely to miss a dose.

If you are taking sildenafil for PAH and you miss a dose, take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

If you take too much sildenafil, call your doctor or go to the nearest hospital emergency room.

Drinking alcohol with sildenafil can cause side effects.

Grapefruit juice and products may interact with sildenafil, leading to unwanted side effects. Avoid the use of grapefruit products.

Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-countermedicines, vitamins, and herbal supplements. Sildenafil may affect the way other medicines work, and other medicines may affect the way sildenafil works, causing side effects. Especially tell your healthcare provider if you take:

• Nitrates for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure
• Guanylate cyclase stimulators, such as riociguat
• Alpha blockers such as doxazosin. Alpha-blockers are sometimes prescribed for prostate problems orhigh blood pressure. In some patients, the use of sildenafil with alpha-blockers can lead to a drop in blood pressure or fainting
• Other drugs to treat high blood pressure or a prostate disorder
• Medicines to treat HIV, such as protease inhibitors, such as ritonavir and saquinavir
• Some types of oral antifungal medicines, such as ketoconazole and itraconazole
• Some types of antibiotics, such as erythromycin
• Other medicines that treat high blood pressure
• Medicines or treatments for ED, such as avanafil (Stendra), tadalafil (Cialis), or vardenafil (Levitra). Tell your doctor about all other medications you use for erectile dysfunction.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

This list is not complete. Other drugs may interact with sildenafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Store sildenafil tablets and oral film at room temperature, between 20°C and 25°C (68°F and 77°F).

Store sildenafil reconstituted oral suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Throw away the reconstituted oral suspension after 60 days.

Keep out of reach of children.

Revatio Tablets

Active ingredients: sildenafil citrateInactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin.

Revatio for Oral Suspension

Active ingredients: sildenafil citrateInactive ingredients: sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide, sodium benzoate, colloidal silicon dioxide anhydrous, and grape flavor.

Revatio Injection

Active ingredient: sildenafil citrateInactive ingredients: dextrose and water for injection.

Viagra Tablets

Active ingredient: sildenafil citrateInactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake.

Vybrique Oral Film

Active ingredient: sildenafil citrateInactive ingredients: Blue Videojet ink, FD&C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide.

Contains no ingredients made from gluten-containing grain (eg, wheat, barley, or rye).

Revatio is distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017.

Viagra is distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017.

Vybrique is manufactured by Altergon Italia Srl, Via Zona Industriale, Morra de Sanctis, Avellino 83040, Italy, for IBSA Institut Biochimique SA, CH-6912 Pazzallo, Switzerland. It is distributed by: IBSA Pharma Inc, Parsippany, NJ 07054 USA.

• Cialis vs Viagra - What's the difference between them?
• Do you know these 11 amazing facts about Viagra?
• Is generic Viagra available in the U.S.?