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FDA-approved patient labeling
STAXYN® (stax-in)
• Or any family members have a rare heart condition known as prolongation of the QT (vardenafil HCl)
orally disintegrating tablets
• Have liver problems.
• Have kidney problems and require dialysis.
Read the Patient Information about STAXYN before you start taking it and again each time you get a refill. There may be new information. You may also find it helpful to share • Have retinitis pigmentosa, a rare genetic (runs in families) eye disease.
this information with your partner. This leaflet does not take the place of talking with • Have ever had severe vision loss, or if you have an eye condition called non-arteritic your doctor. You and your doctor should talk about STAXYN when you start taking it anterior ischemic optic neuropathy (NAION).
and at regular checkups. If you do not understand the information, or have questions, • Have stomach ulcers. talk with your doctor or pharmacist.
• Have a bleeding problem.
• Have a deformed penis shape or Peyronie’s disease. WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT STAXYN?
• Have had an erection that lasted more than 4 hours.
STAXYN is not interchangeable with vardenafil film-coated tablets (LEVITRA).
• Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia.
STAXYN can cause your blood pressure to drop suddenly to an unsafe level if it is • Have hearing problems.
taken with certain other medicines. With a sudden drop in blood pressure, you could • Have phenylketonuria.
get dizzy, faint, or have a heart attack or stroke. STAXYN contains phenylalanine which can be harmful to people who have phenylketonuria. Talk to your doctor if you have phenylketonuria.
CAN OTHER MEDICATIONS AFFECT STAXYN?
Do not take STAXYN if you:
Tell your doctor about all the medicines you take including prescription and non- prescription medicines, vitamins, and herbal supplements. STAXYN and other • Take any medicines called “nitrates” (often used to control chest pain, also known as medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take any of the following: • Use recreational drugs called “poppers” like amyl nitrate and butyl nitrate. • Medicines called nitrates (see “What important information should you know about (See “Who Should Not Take STAXYN?”) Tell all your healthcare providers that you take STAXYN. If you need emergency • Medicines that treat abnormal heartbeat. These include quinidine, procainamide,
medical care for a heart problem, it will be important for your healthcare provider to • Ritonavir (Norvir®) or indinavir sulfate (Crixivan®) saquinavir (Fortavase® or Invirase®) WHAT IS STAXYN?
or atazanavir (Reyataz®) or other HIV protease inhibitors.
STAXYN is a prescription medicine taken by mouth for the treatment of erectile • Ketoconazole or itraconazole (such as Nizoral® or Sporanox®).
• Erythromycin or clarithromycin.
ED is a condition where the penis does not harden and expand when a man is sexually • Other medicines or treatments for ED.
excited, or when he cannot keep an erection. A man who has trouble getting or keeping Patients taking these drugs should not use STAXYN.
an erection should see his doctor for help if the condition bothers him. STAXYN may Patients taking alpha-blockers should not initiate vardenafil therapy with STAXYN. help a man with ED get and keep an erection when he is sexually excited. Patients taking alpha-blockers who have previously used vardenafil film-coated tablets STAXYN does not:
may switch to STAXYN at the advice of their healthcare provider.
• Medicines called alpha-blockers. These include Hytrin® (terazosin HCl), Flomax® • Increase a man’s sexual desire.
(tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl) or • Protect a man or his partner from sexually transmitted diseases, including HIV. Speak Uroxatral® (alfuzosin HCl), Rapaflo® (silodosin). Alpha-blockers are sometimes to your doctor about ways to guard against sexually transmitted diseases. prescribed for prostate problems or high blood pressure. In some patients the use of PDE5 inhibitor drugs, including STAXYN, with alpha-blockers can lower blood • Serve as a male form of birth control. pressure significantly leading to fainting.
STAXYN is only for men with ED. STAXYN is not for women or children. STAXYN must • Patients should contact the prescribing physician if alpha-blockers or other drugs that be used only under a doctor’s care.
lower blood pressure are prescribed by another healthcare provider.
HOW DOES STAXYN WORK?
HOW SHOULD YOU TAKE STAXYN?
When a man is sexually stimulated, his body’s normal physical response is to increase Take STAXYN exactly as your doctor prescribes. STAXYN comes in 10 mg orally blood flow to his penis. This results in an erection. STAXYN helps increase blood flow disintegrating tablets. The dose is one STAXYN tablet. Do not take more than one
to the penis and may help men with ED get and keep an erection satisfactory for sexual STAXYN a day. Doses should be taken at least 24 hours apart.
activity. Once a man has completed sexual activity, blood flow to his penis decreases, • If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, you should not start treatment for erectile dysfunction with WHO CAN TAKE STAXYN?
STAXYN. Your doctor may prescribe a lower dose of vardenafil film-coated tablet.
Talk to your doctor to decide if STAXYN is right for you. Take 1 STAXYN tablet about 1 hour (60 min) before sexual activity. Some form of sexual STAXYN has been shown to be effective in men over the age of 18 years who have stimulation is needed for an erection to happen with STAXYN. STAXYN may be taken erectile dysfunction, including men with diabetes.
WHO SHOULD NOT TAKE STAXYN?
Place on the tongue where it will dissolve rapidly. The tablet should be taken whole and Do not take STAXYN if you:
The tablet should not be taken with liquid.
• Take any medicines called “nitrates” (see “What important information should you
know about STAXYN?”). Nitrates are commonly used to treat angina. Angina is a It should be taken immediately upon removal from the blister.
symptom of heart disease and can cause pain in your chest, jaw, or down your arm.
Call your doctor or emergency room immediately if you accidentally took more STAXYN Medicines called nitrates include nitroglycerin that is found in tablets, sprays, than prescribed.
ointments, pastes, or patches. Nitrates can also be found in other medicines such If you receive STAXYN in a blisterpack, examine the blisterpack before use. Do not use as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called if blisters are torn, broken, or missing.
“poppers” also contain nitrates, such as amyl nitrate and butyl nitrate. Do not use WHAT ARE THE POSSIBLE SIDE EFFECTS OF STAXYN?
STAXYN if you are using these drugs. Ask your doctor or pharmacist if you are not The most common side effects with STAXYN are headache, flushing, stuffy or runny sure if any of your medicines are nitrates.
nose, indigestion, upset stomach, dizziness, and back pain. These side effects usually • Have been told by your healthcare provider to not have sexual activity because of go away after a few hours. Call your doctor if you get a side effect that bothers you or
health problems. Sexual activity can put an extra strain on your heart, especially if one that will not go away.
your heart is already weak from a heart attack or heart disease.
STAXYN may uncommonly cause:
WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING STAXYN?
• An erection that won’t go away (priapism). If you get an erection that lasts more
Before taking STAXYN, tell your doctor about all your medical problems, including if you:
than 4 hours, get medical help right away. Priapism must be treated as soon as • Have heart problems such as angina, heart failure, irregular heartbeats, or have had a possible or lasting damage can happen to your penis including the inability to have heart attack. Ask your doctor if it is safe for you to have sexual activity. • Have low blood pressure or have high blood pressure that is not controlled.
• Color vision changes, such as seeing a blue tinge to objects or having difficulty
telling the difference between the colors blue and green. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines,
including vardenafil) reported a sudden decrease or loss of vision in one or both
eyes. It is not possible to determine whether these events are related directly to
these medicines, to other factors such as high blood pressure or diabetes, or to
a combination of these. If you experience sudden decrease or loss of vision, stop
taking PDE5 inhibitors, including STAXYN, and call a doctor right away.
Sudden loss or decrease in hearing, sometimes with ringing in the ears and
dizziness, has been rarely reported in people taking PDE5 inhibitors, including
vardenafil. It is not possible to determine whether these events are related directly
to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a
combination of factors. If you experience these symptoms, stop taking STAXYN and
contact a doctor right away.
These are not all the side effects of STAXYN. For more information, ask your doctor
or pharmacist.
HOW SHOULD STAXYN BE STORED?
• Store STAXYN at room temperature between 59–86° F (15–30° C).
• Keep STAXYN and all medicines out of the reach of children.
GENERAL INFORMATION ABOUT STAXYN
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use STAXYN for a condition for which it was not prescribed. Do not give STAXYN to other people, even if they have the same symptoms This leaflet summarizes the most important information about STAXYN. If you would like more information, talk with your healthcare provider. You can ask your doctor or pharmacist for information about STAXYN that is written for health professionals. For more information you can also visit www.STAXYN.com or call 1-888-825-5249.
WHAT ARE THE INGREDIENTS OF STAXYN?
Active Ingredient: vardenafil hydrochloride
Inactive Ingredients of STAXYN: Aspartame, peppermint flavor, magnesium stearate
and Pharmaburst™ B2 (crospovidone, mannitol, silica colloidal hydrated, and sorbitol) Phenylketonurics: STAXYN contains 1.01 mg phenylalanine per tablet.
Products cited in STAXYN USPI
LEVITRA is a registered trademark of Bayer AG and is used under license by Norvir (ritonavir) is a trademark of Abbott Laboratories Crixivan (indinavir sulfate) is a trademark of Merck & Co., Inc.
Invirase or Fortavase (saquinavir mesylate) is a trademark of Roche Laboratories Inc. Reyataz (atazanavir sulfate) is a trademark of Bristol-Myers Squibb Company Nizoral (ketoconazole) is a trademark of Johnson & Johnson Sporanox (itraconazole) is a trademark of Johnson & Johnson Hytrin (terazosin HCl) is a trademark of Abbott Laboratories Flomax (tamsulosin HCl) is a trademark of Yamanouchi Pharmaceutical Co., Ltd.
Cardura (doxazosin mesylate) is a trademark of Pfizer Inc.
Minipress (prazosin HCl) is a trademark of Pfizer Inc.
Rapaflo (silodosin) is a trademark of Watson Pharma Inc.
Uroxatral (alfuzosin HCl) is a trademark of Sanofi-Synthelabo Pharmaburst B2 is a trademark of SPI Pharma Inc.
Bayer HealthCare Pharmaceuticals Inc.
STAXYN is a registered trademark of Bayer Pharma AG and is used under license by GlaxoSmithKline.
Rx Only
2013 Bayer HealthCare Pharmaceuticals Inc.

Source: http://www.staxyn.com/assets/pdf/PPI.pdf