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VIAGRA (SILDENAFIL CITRATE): PRECAUTIONS

General

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

Before prescribing Sildenafil Citrate (Viagra) tablets, it is important to note the following:

Caution is advised when Phosphodiesterase Type 5 (PDE5) inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including Viagra, 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 (see Drug Interactions) leading to symptomatic hypotension (e.g. dizziness, lightheadedness, 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 dose.
  • In those patients already taking an optimized dose of a 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 when 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.

    Viagra (Sildenafil) has systemic vasodilatory properties and may augment the blood pressure lowering effect of other anti-hypertensive medications.

    Patients on multiple antihypertensive medications were included in the pivotal clinical trials for Viagra (Sildenafil) tablets. In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and Viagra (Sildenafil Citrate), 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted.

    The safety of Viagra (Sildenafil Citrate) tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration.

    Sildenafil (Viagra) should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

    The safety and efficacy of combinations of Sildenafil (Viagra) tablets with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

    In humans, Sildenafil Citrate (Viagra) has no effect on bleeding time when taken alone or with aspirin. In vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). The combination of heparin and Sildenafil Citrate (Viagra) tablets had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.

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