Important Safety Information:

  • STAXYN is not interchangeable with vardenafil film-coated tablets (LEVITRA® [ vardenafil HCl ]).
  • STAXYN can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.
Additional Important Safety Information Continued Below

Risks and Side Effects of STAXYN

The most common side effects with STAXYN are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness, or back pain. These side effects usually go away after a few hours. Call your doctor if you get a side effect that bothers you or one that will not go away.

Side effects ≥2% and more frequent with STAXYN than placebo in controlled trials

n = number of patients

STAXYN may uncommonly cause:

  • An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections.
  • 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.

Indication

STAXYN is a prescription medicine used for the treatment of erectile dysfunction (ED) in men.

Important Safety Information

  • STAXYN is not interchangeable with vardenafil film-coated tablets (LEVITRA® [vardenafil HCl]).
  • STAXYN can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.
  • STAXYN contains phenylalanine, which can be harmful to people who have phenylketonuria.
  • Do not take STAXYN if you:
    • Take any medications called "nitrates" (often used to control chest pain, also known as angina), or if you use recreational drugs called "poppers" like amyl nitrate and butyl nitrate. Nitrates may cause abnormally low blood pressure and STAXYN may increase that risk.
    • Have been told by your healthcare provider not to have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.
  • Tell all your healthcare providers that you take STAXYN. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took STAXYN.
  • STAXYN does not protect a man or his partner from sexually transmitted diseases, including HIV.
  • Before taking STAXYN, tell your doctor about all your medical problems, including if you:
    • have heart problems such as angina, heart failure, irregular heartbeats, or have had a 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
    • have had a stroke
    • have had a seizure
    • or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome)
    • have liver problems
    • have kidney problems and require dialysis
    • have retinitis pigmentosa, a rare genetic (runs in families) eye disease
    • have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION)
    • have stomach ulcers
    • have a bleeding problem
    • have a deformed penis shape or Peyronie’s disease
    • have had an erection that lasted more than 4 hours
    • have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
    • have hearing problems
    • have phenylketonuria
    • have fructose intolerance
  • Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. STAXYN and other medicines may affect each other. Especially tell your doctor if you take any of the following:
    • Ritonavir (Norvir®) or indinavir sulfate (Crixivan®), saquinavir (Foravase® or Invirase®) or atazanavir (Reyataz®), or other HIV protease inhibitors.
    • Ketoconazole or itraconazole (Nizoral® or Sporanox®).
    • Erythromycin or clarithromycin.
  • Patients taking these drugs should not use STAXYN.

    • If you take medicines called alpha-blockers, which are sometimes prescribed for prostate problems or high blood pressure, you should not start treatment for erectile dysfunction with STAXYN. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), or Rapaflo® (silodosin). In some patients the use of STAXYN with alpha-blockers can lower blood pressure significantly, leading to fainting. If you take alpha-blockers and have previously used vardenafil film-coated tablets, you may switch to STAXYN at the advice of your doctor.
    • Patients should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider.
  • Tell your doctor if you take medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol. Patients taking these drugs should not use STAXYN.
  • Do not use STAXYN with other medicines or treatments for ED.
  • The slide-pack is portable, so whether you take STAXYN at home or away, always follow these guidelines: STAXYN comes in 10-mg orally disintegrating tablets. The dose is one tablet of STAXYN. Do not take more than one tablet of STAXYN a day. Doses should be taken at least 24 hours apart. Take one tablet of STAXYN about one hour before sexual activity. Some form of sexual stimulation is needed for an erection to happen with STAXYN. Always keep STAXYN at room temperature, between 59°–86°F (15°–30°C).
  • The tablet should not be taken with liquid. Place STAXYN on the tongue where it will dissolve quickly. The tablet should be taken whole and not crushed or split. It should be taken immediately upon removal from the blister. Take STAXYN exactly as your doctor prescribes.
  • The most common side effects with STAXYN are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness, and back pain.
  • STAXYN may uncommonly cause:

    • An erection that lasts more than 4 hours. Get medical help right away to avoid lasting damage to your penis.
    • 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 or a sudden decrease or loss in hearing, sometimes with ringing in the ears and dizziness. 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 sudden decrease or loss of vision or hearing, stop taking STAXYN and contact a doctor right away.

Please click links for Complete Prescribing Information, including Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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