WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT LEVITRA?
- LEVITRA 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.
- Do not take LEVITRA if you:
- Take nitrates (often used to control chest pain, also known as angina).
- Use recreational drugs called “poppers” like amyl nitrate and butyl nitrate.
- Take riociguat (Adempas®), a guanulate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.
- LEVITRA may cause serious side effects, including:
- 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. If you are experiencing priapism, seek medical help right away.
- Changes in vision. 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 LEVITRA) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including LEVITRA, and call a doctor right away.
- Sudden loss or decrease in hearing. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including LEVITRA. 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 LEVITRA and contact a doctor right away.
- Tell all your healthcare providers that you take LEVITRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took LEVITRA.
- LEVITRA does not:
- Cure ED
- Increase a man’s sexual desire
- Protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your doctor about ways to guard against sexually transmitted diseases. Serve as a male form of birth control.
- LEVITRA is only for men with ED, and is not intended for women and children.
- LEVITRA must be used only under a doctor’s care.
WHO SHOULD NOT TAKE LEVITRA?
Do not take LEVITRA if you:
- Take any medicines called “nitrates”. Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm. Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrate and butyl nitrate.
- Take riociguat, a guanylate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-throembolic pulmonary hypertension.
- Have been told by your healthcare provider to not 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.
WHAT SHOULD I TELL MY PROVIDER BEFORE TAKING LEVITRA?
Before taking LEVITRA, 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 pulmonary hypertension.
- 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.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take any of the following:
- Medicines called nitrates.
- Ketoconazole or itraconazole (such as Nizoral® or Sporanox®).
- Ritonavir (Norvir®) or indinavir sulfate (Crixivan®) saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®).
- Erythromycin or clarithromycin.
- Medicines called alpha-blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Rapaflo® (silodosin) or Uroxatral ® (alfuzosin HCl). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to fainting.
- Medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone and sotalol.
- Other medicines or treatments for ED.
HOW SHOULD I TAKE LEVITRA?
- Take Levitra as prescribed by your doctor.
- Do not change your dose of LEVITRA without talking to your doctor. Your doctor may lower your dose or raise your dose, depending on how your body reacts to LEVITRA.
- Call your doctor or emergency room immediately if you accidentally take more LEVITRA than prescribed.
WHAT ARE THE MOST COMMON SIDE EFFECTS OF LEVITRA?
The most common side effects with LEVITRA are:
- stuffy or runny nose
- upset stomach
- dizziness or back pain
Call your doctor if you get a side effect that bothers you or one that will not go away.
These are not all the side effects of LEVITRA. For more information, ask your doctor or pharmacist. You may also refer to the full Prescribing Information for LEVITRA for additional information.
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Levitra (vardenafil HCl) is a trademark of Bayor HealthCare Pharmaceuticals, Inc.
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