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LEVITRA (vardenafil hydrochloride) is administered orally 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 designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula: 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.

LEVITRA ® is indicated for the treatment of erectile dysfunction. For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally, as needed, 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.

Sexual stimulation is required for a response to treatment. A starting dose of 5 mg LEVITRA should be considered in patients ? 65 years of age [see Use In Specific Populations ].

For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg LEVITRA is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C) [see WARNINGS AND PRECAUTIONS , Use In Specific Populations and CLINICAL PHARMACOLOGY ].

Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see CONTRAINDICATIONS ].

Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see CONTRAINDICATIONS ].

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 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.

In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy.

Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil. 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 WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS .] A time interval between dosing should be considered when Levitra is prescribed concomitantly with alpha-blocker therapy [see CLINICAL PHARMACOLOGY ].

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.

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 0173-0828-13 5 mg 0173-0829-13 10 mg 0173-0830-13 20 mg 0173-0831-13.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Distributed by: GlaxoSmithKline Research Triangle Park NC 27709.

The following serious adverse reactions with the use of LEVITRA (vardenafil) are discussed elsewhere in the labeling: Cardiovascular Effects [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS ] Priapism [see WARNINGS AND PRECAUTIONS ] Effects on Eye [see WARNINGS AND PRECAUTIONS ] Sudden Hearing Loss [see WARNINGS AND PRECAUTIONS ] QT Prolongation [see WARNINGS AND PRECAUTIONS ] Clinical Studies Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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 reactions were reported (see Table 1).

Table 1: Adverse Reactions Reported By ?2% of Patients Treated with LEVITRA and More Frequent on Drug than Placebo in Fixed and Flexible a Dose Randomized, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil Adverse Reaction Percentage of Patients Reporting Reactions Placebo N = 1199 LEVITRA N = 2203 Headache 4% 15% Flushing 1% 11% Rhinitis 3% 9% Dyspepsia 1% 4% Accidental Injury b 2% 3% Sinusitis 1% 3% Flu Syndrome 2% 3% Dizziness 1% 2% Increased Creatine Kinase 1% 2% Nausea 1% 2% a) Flexible dose studies started all patients at LEVITRA 10 mg and allowed decrease in dose to 5 mg or increase in dose to 20 mg based on side effects and efficacy. b) All the events listed in the above table were deemed to be adverse drug reactions with the exception of accidental injury. 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 reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of LEVITRA.

LEVITRA film-coated tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18.89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year. In the placebo-controlled clinical trials for LEVITRA film-coated tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo. The following section identifies additional, less frequent adverse reactions ( DRUG INTERACTIONS.

Potential For Pharmacodynamic Interactions With LEVITRA.

Concomitant use of LEVITRA and nitrates and nitric oxide donors is contraindicated.

The blood pressure lowering effects of sublingual nitrates (0.4 mg) taken 1 and 4 hours after vardenafil and increases in heart rate when taken at 1, 4 and 8 hours after vardenafil were potentiated by a 20 mg dose of LEVITRA in healthy middle-aged subjects.

These effects were not observed when LEVITRA 20 mg was taken 24 hours before the nitroglycerin (NTG).

Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of LEVITRA and nitrates is contraindicated [ CONTRAINDICATIONS and CLINICAL PHARMACOLOGY ]. Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including LEVITRA and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects.

When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with co-administration of vardenafil with alfuzosin, terazosin or tamsulosin.

[See DOSAGE AND ADMINISTRATION , WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY .] Antihypertensives.



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