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LEVITRA (VARDENAFIL): PRECAUTIONS

The evaluation of erectile dysfunction should include a determination of potential underlying causes, a medical assessment, and the identification of appropriate treatment.

Before prescribing Levitra (Vardenafil HCl) tablets, it is important to note the following: Alpha-blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. Phosphodiesterase Type 5 (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. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (e.g., fainting). Consideration should be given to the following:

  • Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
  • In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose.
  • In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor.
  • Safety of combined use of PDE5 inhibitors, including Vardenafil (Levitra), and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.

    General

    In humans, Vardenafil HCl (Levitra) alone in doses up to 20 mg does not prolong the bleeding time. There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. Vardenafil has not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore Levitra should be administered to these patients after careful benefit-risk assessment.

    Treatment for erectile dysfunction should generally be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

    Hepatic Insufficiency

    In volunteers with moderate impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased 130% and 160%, respectively, compared to healthy control subjects. Consequently, a starting dose of 5 mg is recommended for patients with moderate hepatic impairment and the maximum dose should not exceed 10 mg. Vardenafil (Levitra) tablets have not been evaluated in patients with severe hepatic impairment (Child-Pugh C).

    Congenital or Acquired QT Prolongation

    In a study of the effect of Levitra (Vardenafil Hydrochloride) on QT interval in 59 healthy males, therapeutic (10 mg) and supratherapeutic (80 mg) doses of Levitra and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. A postmarketing study evaluating the effect of combining Levitra with another drug of comparable QT effect showed an additive QT effect when compared with either drug alone. These observations should be considered in clinical decisions when prescribing Levitra (Vardenafil Hydrochloride) tablets to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval. Patients taking Class 1A (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using Levitra.

    Renal Insufficiency

    In patients with moderate (CLcr = 30-50 ml/min) to severe (CLcr < 30 ml/min) renal impairment, the AUC of vardenafil was 20-30% higher compared to that observed in a control group with normal renal function (CLcr > 80 ml/min). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis.

    The safety and efficacy of Vardenafil HCl (Levitra) tablets used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Vardenafil was not carcinogenic in rats and mice when administered daily for 24 months. In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite were approximately 400- and 170-fold for male and female rats, respectively, and 21- and 37-fold for male and female mice, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 20 mg. Vardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V79 cells. Vardenafil was not clastogenic as assessed in either the in vitro chromosomal aberration test or the in vivo mouse micronucleus test. Vardenafil (Levitra) tablets did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in male, and for 14 days prior to mating and through day 7 of gestation in females. In a corresponding 1-month rat toxicity study, this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg.

    There was no effect on sperm motility or morphology after single 20 mg oral doses of vardenafil in healthy volunteers.

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