monophosphate (cGMP), producing smooth muscle relaxation in the corpus
cavernosum and allowing inflow of blood. Sildenafil has no direct relaxant effect
on isolated human corpus cavernosum, but enhances the effect of nitric oxide (NO)
by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation
of cGMP in the corpus cavernosum results in increased levels of cGMP in the
corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to
the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence
of sexual stimulation.
INDICATIONS
Indicated for the treatment of erectile dysfunction.
DOSAGE AND ADMINISTRATION
For most patients, the recommended dose of Sildenafil is 50 mg taken, as needed, approximately
1 hour before sexual activity. However, Sildenafil may be taken anywhere from 4
hours to 0.5 hour before sexual activity. Based on effectiveness and toleration,
the dose may be increased to a maximum recommended dose of 100 mg or decreased
to 25 mg. The maximum recommended dosing frequency is once per day. Age >65,
hepatic impairment and severe renal impairment are associated with increased plasma
levels of sildenafil. A starting oral dose of 25 mg should be considered in
those patients. Need to avoid high-fat meals 2 hours before taking Sildenafil.
CONTRAINDICATIONS
Sildenafil was shown to potentiate the hypotensive effects of
nitrates, and its administration to patients who are using organic nitrates,
either regularly and/or intermittently, in any form is therefore
contraindicated. Hypersensitivity to active component.
WARNINGS & PRECAUTIONS
There is a potential for cardiac risk of sexual activity in
patients with preexisting cardiovascular disease. Therefore, treatments for
erectile dysfunction, including Sildenafil, should not be generally used in men
for whom sexual activity is inadvisable because of their underlying
cardiovascular status. Caution is advised when Sildenafil co-administered with
alpha-blockers. Sildenafil and alpha-adrenergic blocking agents are both
vasodilators with blood pressure lowering
effects. The concomitant administration of the protease
inhibitor ritonavir substantially increases serum concentrations of sildenafil
(11-fold increase in AUC). If Sildenafil is prescribed to patients taking
ritonavir, caution should be used. In the event of an erection that persists
longer than 4 hours, the patient should seek immediate medical assistance. If
priapism is not treated immediately, penile tissue damage and permanent loss of
potency could result.
USE IN PREGNANCY AND LACTATION
Sildenafil is not indicated for use in newborns, children, or
women.
SIDE EFFECTS
Headache, Flushing,
Dyspepsia.
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