Proper Dosage and Administration Guide

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470 LEVITRA is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and Schering Corporation. ©2008 Bayer HealthCare Pharmaceuticals Inc.Printed in U.S.A. Repackaged by: APHENA PHARMA SOLUTIONS - TN Cookeville, TN 3850620111026AW Read the Patient Information about LEVITRA before you start taking it and again each time you get a refill. You may also find it helpful to share this information with your partner. This leaflet does not take the place of talking with your doctor. You and your doctor should talk about LEVITRA when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your doctor or pharmacist. 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.

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Concomitant Medications: The dosage of LEVITRA may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin (see WARNINGS, PRECAUTIONS, Drug Interactions). For ritonavir, a single dose of 2.5 mg LEVITRA should not be exceeded in a 72-hour period. For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg LEVITRA should not be exceeded in a 24-hour period. For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg LEVITRA should not be exceeded in a 24-hour period. For alpha-blockers, caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with alpha-blockers because of the potential for an additive effect on blood pressure. use recreational drugs called “poppers” like amyl nitrate and butyl nitrate. 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 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. LEVITRA may help a man with ED get and keep an erection when he is sexually excited. 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. LEVITRA is not for women or children. LEVITRA must be used only under a doctor’s care. When a man is sexually stimulated, his body’s normal physical response is to increase blood flow to his penis. LEVITRA 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. Talk to your doctor to decide if LEVITRA is right for you. LEVITRA 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. take any medicines called “nitrates” (See “What important information should you know about LEVITRA?”). 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.

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Vardenafil clearance is reduced in patients with moderate hepatic impairment (Child-Pugh B), and a starting dose of 5 mg LEVITRA is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. LEVITRA has not been evaluated in patients with severe hepatic impairment (Child-Pugh C) (see CLINICAL PHARMACOLOGY, Metabolism and ExcretionWARNINGS and PRECAUTIONS). Renal Impairment: For patients with mild (CLcr = 50-80 ml/min), moderate (CLcr = 30-50 ml/min), or severe (CLcr<30 ml/min) renal impairment, no dose adjustment is required. LEVITRA has not been evaluated in patients on renal dialysis (see CLINICAL PHARMACOLOGY, Metabolism and Excretion and PRECAUTIONS). 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 LEVITRA 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 LEVITRA or any of its ingredients. The active ingredient in LEVITRA is called vardenafil. See the end of this leaflet for a complete list of ingredients. WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR 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 or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome) 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 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 Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. LEVITRA 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 LEVITRA?”) 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 LEVITRA, 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. LEVITRA 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 LEVITRA no more than once a day. Doses should be taken at least 24 hours apart. Some men can only take a low dose of LEVITRA because of medical conditions or medicines they take.

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In some patients, concomitant use of these two drug classes can lower blood pressure significantly (see PRECAUTIONS,Alpha-blockers and Drug Interactions) leading to symptomatic hypotension (e.g., fainting). Concomitant treatment should be initiated only if the patient is stable on his alpha blocker therapy. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors - see Drug Interactions). LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and "5" on the other side equivalent to 5 mg of vardenafil. Vardenafil HCl (Levitra) 5mg tablets are supplied in bottles of 2 or 6 tablets per bottle. 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 LEVITRA. 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 LEVITRA. If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of LEVITRA in a 72-hour (3 days) period. Take 1 LEVITRA tablet about 1 hour (60 minutes) before sexual activity. Some form of sexual stimulation is needed for an erection to happen with LEVITRA. LEVITRA may be taken with or without meals. 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. If you take too much LEVITRA, call your doctor or emergency room right away. WHAT ARE THE POSSIBLE SIDE EFFECTS OF LEVITRA? The most common side effects with LEVITRA are headache, flushing, stuffy or runny nose, indigestion, upset stomach, or dizziness.

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The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment. Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients ≥65 years of age (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations and PRECAUTIONS). Hepatic Impairment: For patients with mild hepatic impairment (Child-Pugh A), no dose adjustment of LEVITRA is required.