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Viagra is an oral medication for the treatment of erectile dysfunction. During sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.

Composition

The main active substance is sildenafil. The excipients are anhydrous calcium hydrogen phosphate, magnesium stearate, croscarmellose sodium, titanium dioxide (E 171), triacetin, MCC, hypromellose, indigo carmine aluminum varnish (E 132), lactose.

Release form

Viagra is released as coated tablets. The tablets are distributed in a blister of aluminum foil, which in turn is located in a cardboard box.

Mechanism of action

Sildenafil is a potent and selective inhibitor of cGMP-specific type 5 phosphodiesterase (PDE-5). It is responsible for the breakdown of cGMP in the cavernous bodies. Generic Viagra has a peripheral effect on an erection. It does not have a direct relaxing effect on the isolated cavernous body, but significantly enhances the relaxing effect of NO on this tissue. When the NO/cGMP metabolic pathway is activated, as occurs during sexual stimulation, inhibition of PDE-5 by sildenafil contributes to an increase in cGMP levels in the corpus cavernosum. Therefore, sexual stimulation is necessary to provide sildenafil with the desired pharmacological action.

Dosage

Generic Viagra is intended for oral administration. Sexual excitement is required to achieve the effect.

Use in adults. The recommended adult dose is 50 mg, which is taken as required approximately 1 hour before sexual intercourse. Considering the effectiveness and tolerability, Viagra dose can be increased to 100 mg or reduced to 25 mg.

The max recommended dose is 100 mg. The maximum recommended frequency of application is 1 time per day. The time of the effect’s manifestation may increase when taken with fatty food or alcohol.

Use in patients with impaired renal function. In patients with mild and moderate renal failure (creatinine clearance is 30–80 ml/min), the dosage regimen does not change. Since in patients with severe renal failure (creatinine clearance ≤30 ml/min), the clearance of sildenafil is reduced, the initial dose is a dose of 25 mg.

Use in patients with impaired liver function. Since in patients with liver failure, the clearance of sildenafil is reduced, for example with cirrhosis, the initial dosage is 25 mg.

Use in patients who apply other types of treatment. Considering the degree of interaction in patients receiving concomitant ritonavir therapy, it is recommended not to exceed the maximum single dose of 25 mg of sildenafil for 48 hours. A starting dose of 25 mg should be recommended to patients who receive concomitant treatment with CYP 3A4 inhibitors (for example, erythromycin, saquinavir, ketoconazole, itraconazole ).

In order to reduce the risk of developing postural hypotension, it is necessary to stabilize the condition of patients during therapy with α-blockers before using generic Viagra.

Use in children. Viagra is not indicated for use by persons under 18 years of age.

Use in elderly patients. For elderly patients, a dosage adjustment is not required.

Overdose

In studies on healthy volunteers with a single dose of the drug up to 800 mg, side effects were similar to those observed when taking Viagra in lower doses. But their frequency of development and severity increased. In case of an overdose, it is necessary to carry out maintenance therapy. Dialysis does not accelerate the excretion of the drug since sildenafil is firmly bound to plasma proteins and is not excreted in the urine.

Contraindications

Generic Viagra is contraindicated in patients with hypersensitivity to the active substance or to any other drug component.

Due to the effect on the NO/cGMP exchange, sildenafil enhances the hypotensive effect of nitrates during their single or long-term use, therefore its simultaneous use with NO donors, organic nitrates or organic nitrites in any form is contraindicated.

Drugs for erectile dysfunction treatment, including sildenafil, should not be used in patients for whom sexual activity is undesirable (for example, patients with severe forms of cardiovascular diseases, such as unstable angina or severe heart failure).

Viagra is contraindicated in patients with loss of vision in one eye due to non-arterial anterior ischemic optic neuropathy, regardless of whether it was acquired due to the intake of a PDE-5 inhibitor or not.

The safety of sildenafil has not been studied in such subgroups of patients, and therefore its use is contraindicated:

  • patients with severe hepatic impairment;
  • arterial hypotension (BP ≤90 / 50 mm Hg);
  • recent stroke or myocardial infarction;
  • known hereditary degenerative retinal diseases such as retinitis pigmentosa.

Side effects

Usually, the side effects caused by generic Viagra are mild/moderate, transient. In studies using a fixed-dose, it has been discovered that the frequency of some side effects increases with increasing dose. The most common side effects are:

  • nervous system: headache, dizziness, convulsions.
  • cardiovascular system: vasodilation, heart palpitations, tachycardia, decreased blood pressure, fainting, nosebleeds.
  • organs of vision: change in vision (blurred vision, change in sensitivity to light); chromatopsia (mild and transient, mainly a change in the perception of color shades), eye pain, redness of the eyes/injection of the sclera.
  • respiratory system: rhinitis (nasal congestion).
  • digestive system: dyspepsia.
  • general disorders: hypersensitivity reactions (including skin rash).
  • gastrointestinal disorders: vomiting.
  • reproductive system disorders: prolonged erection and/or priapism.