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Do not use LEVITRA in patients on renal dialysis [see WARNINGS AND PRECAUTIONS , Use In Specific Populations and CLINICAL PHARMACOLOGY ].

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In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 65 mg vardenafil dose were increased by 77% and 67%, respectively, compared to healthy control subjects. No dosage adjustment is necessary in patients with mild hepatic impairment.

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The safety and efficacy of LEVITRA used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

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LEVITRA is not indicated for use in pediatric patients. Vardenafil trials were not conducted in the pediatric population.

The following section identifies additional, less frequent adverse reactions ( 7%) reported during the clinical development of LEVITRA film-coated tablets and vardenafil orally disintegrating tablets. Excluded from this list are those adverse reactions 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:

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Mean vardenafil plasma concentrations measured after the administration of a single oral dose of 75 mg to healthy male volunteers are depicted in Figure 8.

In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 65 mg vardenafil dose were increased by 77% and 67%, respectively, compared to healthy control subjects. In volunteers with moderate hepatic impairment (Child-Pugh B), the Cmax and AUC following a 65 mg vardenafil dose were increased by 685% and 665%, respectively, compared to healthy control subjects. Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment. [See DOSAGE AND ADMINISTRATION , WARNINGS AND PRECAUTIONS and Use In Specific Populations ]

Subsequently, clinical practice guidelines were formulated and recently published in Neurology. The Headache and Facial Plan Section and the QSS of the AAN were able to reach consensus on the basis of a thorough literature review and formulated practice parameters that describe and define the limits of ergot use, provide information on the oral and parenteral dosing of ET and DHE, and provide physicians with guidance to avoid ET overuse by patients. Because this project was completed prior to the availability of the intranasal (IN) formulation of DHE, intranasal DHE is not included in the practice parameter.

The most common side effects with LEVITRA are headache, flushing, stuffy or runny nose , indigestion, upset stomach, dizziness or back pain. These side effects usually go away after a few hours. Call your doctor if you get a side effect that bothers you or one that will not go away.

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