Staxyn (Vardenafil Hydrochloride)

(var den' a fil)

Vardenafil is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Vardenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It works by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Vardenafil does not cure erectile dysfunction or increase sexual desire. Vardenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

Vardenafil comes as a tablet and a rapidly disintegrating (dissolves in the mouth and is swallowed without water) tablet to take by mouth. It is usually taken as needed, with or without food, 60 minutes before sexual activity. Vardenafil usually should not be taken more often than once every 24 hours. If you have certain health conditions or are taking certain medications, your doctor may tell you to take vardenafil less often. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vardenafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you are taking the rapidly disintegrating tablet, check the blister pack before you take your first dose. Do not use any of the medication from the pack if any of the blisters are torn, broken, or do not contain tablets. Follow the package directions to remove the tablet from the blister package. Do not try to push the tablet through the foil. After you remove the tablet from the blister package, immediately place it on your tongue and close your mouth. The tablet will quickly dissolve. Do not take the rapidly disintegrating tablet with water or other liquids. Your doctor will probably start you on an average dose of vardenafil tablets and increase or decrease your dose depending on your response to the medication. If you are taking the rapidly disintegrating tablets, your doctor will not be able to adjust your dose because the rapidly disintegrating tablets are only available in one strength. If you need a higher or lower dose, your doctor may prescribe the regular tablets instead. Tell your doctor if vardenafil is not working well or if you are experiencing side effects. Vardenafil rapidly disintegrating tablets cannot be substituted for vardenafil tablets. Be sure that you receive only the type of vardenafil that was prescribed by your doctor. Ask your pharmacist if you have any questions about the type of vardenafil you were given.

Before taking vardenafil,
• tell your doctor and pharmacist if you are allergic to vardenafil,any other medications. or any of the ingredients in vardenafil tablets. Ask your pharmacist for a list of the ingredients.
• do not take vardenafil if you are taking or have recently taken riociguat (Adempas) or nitrates such as isosorbide dinitrate (Dilatrate-SR, Isordil, in BiDil), isosorbide mononitrate (Monoket), and nitroglycerin (Minitran, Nitro-Dur, Nitromist, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure if any of your medications contain nitrates.
• do not take street drugs containing nitrates such as amyl nitrate and butyl nitrate ('poppers') while taking vardenafil.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax, in Jalyn), and terazosin; amiodarone (Cordarone, Pacerone); antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral); clarithromycin (Biaxin, in Prevpac); disopyramide (Norpace); erythromycin (E.E.S., E-Mycin, Erythrocin); haloperidol (Haldol); HIV protease inhibitors including atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); medications for high blood pressure or irregular heartbeat; other medications or treatments for erectile dysfunction; methadone (Dolophine, Methadose); moxifloxacin (Avelox); pimozide (Orap); procainamide; quinidine (in Nuedexta); sotalol (Betapace, Sorine, Sotylize); thioridazine; and verapamil (Calan, Covera, Verelan, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may interact with vardenafil, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you smoke and if you have ever had an erection that lasted more than 4 hours. Also tell your doctor if you have or have ever had a condition that affects the shape of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease; diabetes; high cholesterol; high or low blood pressure; irregular heartbeat; a heart attack; angina (chest pain); a stroke; ulcers in the stomach or intestine; a bleeding disorder; blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); seizures; and liver, kidney, or heart disease. Also tell your doctor if you or any of your family members have or have ever had long QT syndrome (a heart condition) or retinitis pigmentosus (an eye disease) or if you have ever had severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see. Tell your doctor if you have ever been advised by a health care professional to avoid sexual activity for medical reasons.
• you should know that vardenafil is only for use in males. Women should not take vardenafil, especially if they are or could become pregnant or are breast-feeding. If a pregnant woman takes vardenafil, she should call her doctor.
• if you are having surgery, including dental surgery or any dental procedure, tell the doctor or dentist that you are taking vardenafil.
• you should know that sexual activity may be a strain on your heart, especially if you have heart disease. If you have chest pain during sexual activity, call your doctor immediately and avoid sexual activity until your doctor tells you otherwise.
• tell all your health care providers that you are taking vardenafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took vardenafil.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the rapidly disintegrating tablets are sweetened with aspartame, a source of phenylalanine.
• if you have fructose intolerance (an inherited condition in which the body lacks the protein needed to break down fructose,[a fruit sugar found in certain sweeteners such as sorbitol]), you should know that the the rapidly disintegrating tablets are sweetened with sorbitol. Tell your doctor if you have fructose intolerance.

Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine.

Vardenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• upset stomach
• heartburn
• flushing
• stuffy or runny nose
• flu-like symptoms

Some side effects can be serious. If you experience any of the following symptoms , call your doctor immediately:

• erection that lasts longer than 4 hours
• sudden severe loss of vision (see below for more information)
• blurred vision
• changes in color vision (seeing blue tinge on objects, difficulty telling the difference between blue and green, or difficulty seeing at night)
• dizziness
• sudden decrease or loss of hearing
• ringing in ears
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• fainting
• hives
• rash

Vardenafil may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. Some patients experienced a sudden loss of some or all of their vision after they took vardenafil or other medications that are similar to vardenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking vardenafil, call your doctor immediately. Do not take any more doses of vardenafil or similar medications such as sildenafil (Viagra) or tadalafil (Cialis) until you talk to your doctor. Some patients experienced a sudden decrease or loss of hearing after they took vardenafil or other medications that are similar to vardenafil. The hearing loss usually involved only one ear and may not get better. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking vardenafil, call your doctor immediately. Do not take any more doses of vardenafil or similar medications such as sildenafil (Viagra) or tadalafil (Cialis) until you talk to your doctor.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.