Brand Name: Levitra
Generic Name: vardenafil hydrochloride
Dosage Form: tablets
Vardenafil HCl Description
Vardenafil HCl is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Levitra is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.
WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT Vardenafil?
Vardenafil 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 Vardenafil if you:
* take any medicines called “nitrates.”
* use recreational drugs called “poppers” like amyl nitrate and butyl nitrate.
Tell all your healthcare providers that you take Vardenafil. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Vardenafil.
WHAT IS Vardenafil?
Vardenafil is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.
ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. Vardenafil may help a man with ED get and keep an erection when he is sexually excited.
Vardenafil 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
Vardenafil is only for men with ED. Vardenafil is not for women or children. Vardenafil must be used only under a doctor’s care.
HOW DOES Vardenafil WORK?
When a man is sexually stimulated, his body’s normal physical response is to increase blood flow to his penis. This results in an erection. Vardenafil helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.
WHO CAN TAKE Vardenafil?
Talk to your doctor to decide if Vardenafil is right for you.
Vardenafil has been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes or who have undergone prostatectomy.
WHO SHOULD NOT TAKE Vardenafil?
Do not take Vardenafil if you:
* take any medicines called “nitrates” (See “ What important information should you know about Vardenafil?”). 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. Do not use Vardenafil if you are using these drugs. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates.
* you 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.
* are allergic to Vardenafil or any of its ingredients. The active ingredient in Vardenafil is called vardenafil. See the end of this leaflet for a complete list of ingredients.
WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING Vardenafil?
Before taking Vardenafil, 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
* 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
CAN OTHER MEDICATIONS AFFECT Vardenafil?
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Vardenafil and other 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:
* medicines called nitrates (See “ What important information should you know about Vardenafil?”)
* medicines called alpha-blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl) 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 Vardenafil, with alpha-blockers can lower blood pressure significantly leading to fainting. You should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider.
* medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone and sotalol.
* ritonavir (Norvir®) or indinavir sulfate (Crixivan®)
* ketoconazole or itraconazole (such as Nizoral® or Sporanox®)
* erythromycin
* other medicines or treatments for ED
HOW SHOULD YOU TAKE Vardenafil?
Take Vardenafil exactly as your doctor prescribes. Vardenafil comes in different doses (2.5 mg, 5 mg, 10 mg, and 20 mg). For most men, the recommended starting dose is 10 mg. Take Vardenafil no more than once a day. Doses should be taken at least 24 hours apart. Some men can only take a low dose of Vardenafil because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you.
* If you are older than 65 or have liver problems, your doctor may start you on a lower dose of Vardenafil.
* If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of Vardenafil.
* If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of Vardenafil in a 72-hour (3 days) period.
Take 1 Vardenafil tablet about 1 hour (60 minutes) before sexual activity. Some form of sexual stimulation is needed for an erection to happen with Vardenafil. Vardenafil may be taken with or without meals.
Do not change your dose of Vardenafil without talking to your doctor. Your doctor may lower your dose or raise your dose, depending on how your body reacts to Vardenafil.
If you take too much Vardenafil, call your doctor or emergency room right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF Vardenafil?
The most common side effects with Vardenafil are headache, flushing, stuffy or runny nose, indigestion, upset stomach, or dizziness. 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.
Vardenafil 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 Vardenafil, and call a doctor right away.
These are not all the side effects of Vardenafil. For more information, ask your doctor or pharmacist.
How is Levitra Supplied
Levitra (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “2.5”, “5”, “10”, and “20” on the other side equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively.
Package Strength NDC Code
Bottles of 30 2.5 mg 0085-1923-01
5 mg 0085-1945-01
10 mg 0085-1901-01
20 mg 0085-1934-01
Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
