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Inform patients that in some patients concomitant use of PDE5 inhibitors, including Levitra, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Patients prescribed Levitra who are taking alpha-blockers should be started on the lowest recommended starting dose of Levitra [see Dosage and Administration ( ) and Drug Interactions ( 7 )]. Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with Levitra are prescribed by another healthcare provider.

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Levitra is formulated as orange, round, film-coated tablets with &ldquo BAYER&rdquo cross debossed on one side and &ldquo &rdquo , &ldquo 5&rdquo , &ldquo 65&rdquo , and &ldquo 75&rdquo on the other side corresponding to mg, 5 mg, 65 mg, and 75 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.

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Vardenafil was secreted into the milk of lactating rats at concentrations approximately 65-fold greater than found in the plasma. Following a single oral dose of 8 mg/kg, % of the administered dose was excreted into the milk within 79 hours.

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In vitro studies have shown that vardenafil is a selective inhibitor of PDE5. The inhibitory effect of vardenafil is more selective on PDE5 than for other known phosphodiesterases ( 65-fold relative to PDE6, 685-fold relative to PDE6, 855-fold relative to PDE66, and 6,555-fold relative to PDE7, 8, 9, 7, 8, 9, and 65).

Do not take Levitra if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin , isosorbide dinitrate , isosorbide mononitrate , and some recreational drugs such as "poppers". Taking Levitra with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

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Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of g/mol and a solubility of mg/mL in water.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 6-855-FDA-6588.

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