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STAXYN (VARDENAFIL): PRECAUTIONS

Alpha-Blockers

In patients taking alpha-blockers, do not initiate vardenafil therapy with Vardenafil HCl (Staxyn) tablets. Patients treated with alpha-blockers who have previously used vardenafil film-coated tablets may be changed to Staxyn at the advice of their healthcare provider. Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including Staxyn (Vardenafil), 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 (for example, 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 patients taking alpha-blockers, do not initiate vardenafil therapy with Staxyn (Vardenafil) tablets. Lower doses of vardenafil film-coated tablets should be used as initial therapy in these patients.
  • In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increases 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 and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.

    Congenital or Acquired QT Prolongation

    In a study of the effect of vardenafil on QT interval in 59 healthy males, therapeutic (10 mg film-coated tablets) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. A postmarketing study evaluating the effect of combining vardenafil 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 vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.

    Patients taking Class 1A (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using Vardenafil Hydrochloride (Staxyn).

    Hepatic Impairment

    Do not use Staxyn in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.

    Renal Impairment

    Do not use Vardenafil Hydrochloride (Staxyn) tablets in patients on renal dialysis, as vardenafil has not been evaluated in this population.

    Combination with Other Erectile Dysfunction Therapies

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

    Effects on Bleeding

    In humans, vardenafil film-coated tablet 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. Staxyn (Vardenafil HCl) has not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore Staxyn should be administered to these patients after careful benefit-risk assessment.

    Phenylketonurics

    Staxyn contains aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria. Phenylketonurics: Each Staxyn tablet contains 1.01 mg phenylalanine per pill.

    Fructose Intolerance

    Staxyn contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medication.

    Sexually Transmitted Diseases

    The use of Staxyn (Vardenafil HCl) tablets offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.

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