Prescription Guidelines for Vardenafil

LEVITRA may help a man with ED get and keep an erection when he is sexually excited.

Section snippets

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 “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. 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.

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©2008 Bayer HealthCare Pharmaceuticals Inc.Printed in U.S.A. Repackaged by: APHENA PHARMA SOLUTIONS - TN Cookeville, TN 3850620111027AW 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. protect a man or his partner

from sexually transmitted diseases, including HIV.

Speak to your doctor about ways

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If you do not understand the information, or have questions, talk with your doctor or pharmacist. WHAT generic levitra pills canada 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. use recreational drugs called “poppers” like amyl nitrate and butyl nitrate. to guard against sexually transmitted diseases.

Study design

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.

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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). For ritonavir, a single dose of 2.5 mg LEVITRA should not be exceeded in a 72-hour period.

Frequently asked questions

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). Concomitant treatment should be initiated only if the patient is stable on his alpha blocker therapy. serve as a male form of birth control LEVITRA is only for men with ED.

LEVITRA is not for women or children.

Dosage and how to take Levitra 20mg

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients). Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in post-marketing experience. It is not possible to determine whether these events are related levitra tablets 5mg directly to the use of LEVITRA. Seizure, seizure recurrence and transient global amnesia have been reported post-marketing in temporal association with LEVITRA. Cases of sudden decrease or loss of hearing have been reported post-marketing in temporal association with the use of PDE5 inhibitors, including LEVITRA.

Diagnosis and treatment of erectile dysfunction

In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of LEVITRA, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients). 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.

Non-surgical management of erectile dysfunction

Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine. 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. LEVITRA must be used only under a doctor’s care.

Secondary Outcome

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. When a man is sexually stimulated, his body’s normal

• Levitra 20mg can cause dizziness; users should avoid driving if affected.
• Allergic reactions like rashes or swelling require immediate medical attention.
• Individuals with liver or kidney issues should consult a doctor before use.
• Levitra is not suitable for treating the underlying causes of ED.
• Combining Levitra with other ED drugs can increase side effect risks.

physical response is to increase blood flow to his penis.

Overdose/Missed Dose

Based on the results of the pre- and postnatal study, the developmental NOAEL is less than 1 mg/kg/day. Based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg. There are no adequate and well-controlled trials of vardenafil in pregnant women. Elderly males age 65 years and older have higher vardenafil plasma concentrations than younger males (18 – 45 years), mean Cmax and AUC were 34% and 52% higher, respectively (see CLINICAL PHARMACOLOGY,Pharmacokinetics in Special Populations, and DOSAGE AND ADMINISTRATION). Phase 3 clinical trials included more than 834 elderly patients, and no differences in safety or effectiveness of LEVITRA 5, 10, or 20 mg were noted when these elderly patients were compared to younger patients.

Can Levitra 20mg be taken daily?

However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg LEVITRA should be considered in patients ≥65 years of age. LEVITRA was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer, and 880 patients were treated for at least 1 year. In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for LEVITRA compared to 1.1% for placebo. When LEVITRA was taken as recommended in placebo-controlled clinical trials, the following adverse events were reported (see Table 5).

How is vardenafil supplied (dosage forms)?

Back pain was reported in 2.0% of patients treated with LEVITRA and 1.7% of patients on placebo. Placebo-controlled trials suggested a dose effect in the incidence of some adverse events (headache, flushing, dyspepsia, nausea, rhinitis) over the 5 mg, 10 mg, and 20 mg doses of LEVITRA. The following section identifies additional, less frequent events (<2%) reported during the clinical development of LEVITRA. Excluded from this list are those events that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. LEVITRA helps increase blood flow to the penis and may help

• Levitra 20mg is contraindicated in men using nitrate medications.
• The medication can interact with certain antibiotics and antifungals.
• Some users report mild side effects that resolve without medical help.
• If an erection lasts more than 4 hours, seek emergency medical attention.
• Use proper storage to maintain medication potency and safety.

men with ED get and keep an erection satisfactory for sexual activity.

• Levitra 20mg interacts with nitrates used for chest pain.
• Avoid grapefruit or grapefruit juice when taking Levitra.
• Store tablets in a cool, dry place away from children.
• Levitra does not protect against sexually transmitted diseases.
• It's essential to follow the prescribed dosage for safety.