Label: LEVITRA- vardenafil hydrochloride tablet, film coated

Nitrates are commonly used to treat angina.

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Angina is a symptom of heart disease and

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can cause pain in your chest, jaw, or down your arm.Medicines called

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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. 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).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).

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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. 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). nitrates include nitroglycerin that

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is found in tablets,

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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). For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally approximately 60 minutes before sexual activity. 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).

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Hepatic Impairment: For patients with mild hepatic impairment (Child-Pugh A), no dose adjustment of LEVITRA is required. 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). sprays, ointments, pastes, or patches.

Pharmacist Certification Level	Recommended Retail Price ($)	Average Customer Price ($)	Comments
Certified Pharmacist	20.00	19.50	Competitive and fair
Pharmacy Manager	20.50	20.00	Slightly higher profit margin
Senior Pharmacist	19.80	19.00	Budget-friendly options

Nitrates can also be found in other

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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 any medicines called “nitrates.”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.WHAT IS 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.LEVITRA does not:cure EDincrease a man’s sexual desireprotect a man or his partner from sexually transmitted diseases, including HIV.

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Speak to your doctor about ways to guard against sexually transmitted diseases.serve as a male form of birth controlLEVITRA is only for men with ED. LEVITRA is not for women or children. LEVITRA must be used only under a doctor’s care.HOW DOES LEVITRA WORK?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.WHO CAN TAKE LEVITRA?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.WHO SHOULD NOT TAKE LEVITRA?Do not take LEVITRA if you: take any medicines called “nitrates” (See “What important information should you know about LEVITRA?”). medicines such as isosorbide

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Cases of sudden decrease or loss of hearing have been reported post-marketing in temporal association with the use of PDE5 inhibitors, including LEVITRA. OVERDOSAGE The maximum dose of LEVITRA for which human data are available is a single 120 mg dose administered to eight healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision.”In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine. The maximum dose of LEVITRA for which human data are available is a single 120 mg dose administered to eight healthy male volunteers.

Side Effects

The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision.” In cases of overdose, standard supportive measures should be taken as required. DOSAGE AND ADMINISTRATION For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally approximately 60 minutes before sexual activity. 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. LEVITRA can be taken with or without food. dinitrate or isosorbide mononitrate.

Insurance Company	Coverage Amount ($)	Co-Payment ($)	Notes
HealthPlus	200	5	Requires prescription approval
MedInsurance	150	10	Limited to specific plans
CareWell	0	20	Not covered
TrustHealth	300	0	Full coverage available

Some recreational drugs called “poppers” also contain

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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). HOW SUPPLIED LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” visa levitra great britain cross on one side and “10” and “20” on the other side equivalent to 10 mg and 20 mg of vardenafil, respectively.Vardenafil HCl (Levitra) 10mg tablets are supplied in bottles of 2, 4, 6, 12 and 18 tablets per bottle.Vardenafil HCl (Levitra) 20mg tablets are supplied in bottles of 2, 3, 4, 6, 12 and 18 tablets per bottle.Recommended Storage:Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Manufactured by:Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470Made in GermanyMarketed ByGlaxoSmithKlineResearch Triangle Park NC 27709Distributed and Marketed By:Schering-PloughSchering CorporationKenilworth, NJ 07033LEVITRA is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and Schering Corporation.Rx Only08918646IP, R.7 12/08 14272©2008 Bayer HealthCare Pharmaceuticals Inc.Printed in U.S.A.Repackaged by:APHENA PHARMA SOLUTIONS - TNCookeville, TN 3850620111027AW LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “10” and “20” on the other side equivalent to 10 mg and 20 mg of vardenafil, respectively. Vardenafil HCl (Levitra) 10mg tablets are supplied in bottles of 2, 4, 6, 12 and 18 tablets per bottle. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. LEVITRA is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and Schering Corporation.

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PATIENT PACKAGE INSERT Patient InformationLEVITRA® (Luh-VEE-Trah)(vardenafil HCl) TabletsRead 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. nitrates, such as amyl nitrate and butyl nitrate.

Package Size	Price per Tablet ($)	Total Price ($)	Savings (%)
10 tablets	2.00	20.00	-
20 tablets	1.80	36.00	10
30 tablets	1.65	49.50	17.5
60 tablets	1.50	90.00	25