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Sildenafil

Pronunciation

Generic Name: sildenafil (sil-DEN-a-fil)
Brand Name: Revatio Injection

Sildenafil is used for:

Treating high blood pressure in the lungs (pulmonary arterial hypertension [PAH]). It may also be used for other conditions as determined by your doctor.

Sildenafil is a phosphodiesterase type 5 (PDE5) inhibitor. It works by relaxing and dilating the blood vessels in the lungs. This lowers the blood pressure in the lungs and helps to improve your ability to exercise.

Do NOT use sildenafil if:

  • you are allergic to any ingredient in sildenafil
  • you have pulmonary veno-occlusive disease (PVOD)
  • you are taking nitrates (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, spray, patch, ointment) or nitroprusside
  • you take another medicine that contains sildenafil, another PDE5 inhibitor (eg, tadalafil, vardenafil), or ritonavir
  • you use certain recreational drugs called "poppers" (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using sildenafil:

Some medical conditions may interact with sildenafil. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)
  • if you have a deformed penis (eg, cavernosal fibrosis, Peyronie disease), certain blood cell problems (eg, leukemia, multiple myeloma, sickle cell anemia), or any other condition that may increase the risk of a prolonged or painful erection (priapism)
  • if you have a history of certain eye problems (eg, macular degeneration, optic neuropathy, retinitis pigmentosa, sudden vision loss in one or both eyes) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
  • if you are dehydrated or have a history of liver or kidney problems, high or low blood pressure, stroke, ulcers, bleeding problems, heart problems (eg, aortic stenosis, angina, irregular heartbeat, heart attack, heart failure), blood vessel problems, or nervous system problems
  • if you have pulmonary hypertension caused by sickle cell anemia
  • if you are taking bosentan or medicine for erectile dysfunction (ED)

Some MEDICINES MAY INTERACT with sildenafil. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Alpha-blockers (eg, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, light-headedness, and fainting may occur
  • Azole antifungals (eg, itraconazole, ketoconazole), H2 antagonists (eg, cimetidine), HIV protease inhibitors (eg, ritonavir, saquinavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of sildenafil's side effects
  • Barbiturates (eg, phenobarbital), bosentan, carbamazepine, efavirenz, nevirapine, phenytoin, rifabutin, or rifampin because they may decrease sildenafil's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if sildenafil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use sildenafil:

Use sildenafil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Sildenafil is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using sildenafil at home, a health care provider will teach you how to use it. Be sure you understand how to use sildenafil. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use sildenafil if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Use sildenafil on a regular schedule to get the most benefit from it. Use it at the same times each day.
  • Continue to use sildenafil even if you feel well. Do not miss any doses.
  • Do not suddenly stop using sildenafil or change your dose without talking to your doctor.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of sildenafil, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use sildenafil.

Important safety information:

  • Sildenafil may cause drowsiness, dizziness, fainting, or blurred vision. These effects may be worse if you use it with alcohol or certain medicines. Use sildenafil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Sildenafil may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Patients with heart problems who use sildenafil may be at increased risk of heart-related side effects, including a heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
  • Sildenafil may rarely cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems, such as impotence. Contact your doctor right away if you have an erection that lasts more than 4 hours.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Sildenafil may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
  • Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took sildenafil. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
  • Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken sildenafil. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
  • Tell your doctor or dentist that you take sildenafil before you receive any medical or dental care, emergency care, or surgery.
  • Do not use medicines or treatments for ED while you are using sildenafil without first checking with your doctor.
  • Use sildenafil with caution in the ELDERLY; they may be more sensitive to its effects.
  • Sildenafil is not approved for use in children. An increase in death has been seen in children as the dose of sildenafil gets higher. However, your child's doctor may decide the benefits of taking sildenafil may outweigh the risks. Talk with the doctor if you have questions about giving sildenafil to your child.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using sildenafil while you are pregnant. It is not known if sildenafil is found in breast milk. If you are or will be breast-feeding while you use sildenafil, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of sildenafil:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; flushing; headache; mild pain, redness, or swelling at the injection site; muscle aches; nausea; nosebleed; sore throat; stuffy or runny nose; trouble sleeping; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; chest pain; confusion; fainting; fast or irregular heartbeat; fever; memory loss; numbness of an arm or leg; one-sided weakness; painful or prolonged erection; persistent or severe pain, redness, or swelling at the injection site; ringing in the ears; seizure; severe or persistent dizziness or nosebleed; severe or persistent vision changes; shortness of breath; speech problems; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of sildenafil:

Sildenafil is usually handled and stored by a health care provider. If you are using sildenafil at home, store sildenafil as directed by your pharmacist or health care provider. Keep sildenafil out of the reach of children and away from pets.

General information:

  • If you have any questions about sildenafil, please talk with your doctor, pharmacist, or other health care provider.
  • Sildenafil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take sildenafil or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about sildenafil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sildenafil. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sildenafil.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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