Eroton (sildenafil) tablets 100 mg. №2

Description

Eroton №2 Composition
active substance: sildenafil;

1 tablet contains sildenafil citrate in doses equivalent to 100 mg of sildenafil;

excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, copolyvidone, colloidal silicon dioxide, talc, magnesium stearate, croscarmellose sodium, potato starch.

Dosage form
Pills.

Basic physical and chemical properties: tablets of white color, biconvex, hexagonal (“HEXAGON” form), marked “F” on both sides.

Eroton №2  Pharmacotherapeutic group
Drugs used for erectile dysfunction. Sildenafil ATX code G04B E03.

Pharmacodynamics
Mechanism of action. Sildenafil is an oral drug used to treat erectile dysfunction in men. With sexual arousal, the drug restores reduced erectile function by increasing blood flow to the penis.

The physiological mechanism that leads to an erection, including the release of nitric oxide (NO) in the corpora cavernosa during sexual arousal. The released nitric oxide activates the enzyme guanylate cyclase, which stimulates an increase in the level of cyclic guanosine monophosphate (cGMP), which, in turn, causes relaxation of the smooth muscles of the corpora cavernosa, promoting blood flow.

Pharmacokinetics
Absorption. Sildenafil is rapidly absorbed. The maximum plasma concentration of the drug is reached within 30-120 minutes (with a median of 60 minutes) after oral administration on an empty stomach. The average bioavailability after oral administration is 41% (with a range of values ​​from 25 to 63%). In the recommended dose range (from 25 to 100 mg), the AUC and maximum concentration of sildenafil after oral administration increase in proportion to the dose.

With the use of sildenafil with food, the degree of absorption decreases with an average lengthening of Tmax up to 60 minutes and an average decrease in Cmax by 29%.

Distribution. The average equilibrium volume of distribution (Vd) is 105 liters, which indicates the distribution of the drug in the tissues of the body. After a single oral administration of sildenafil at a dose of 100 mg, the average maximum total plasma concentration of sildenafil is approximately 440 ng / ml (coefficient of variation is 40%). Since the binding of sildenafil and its main N-desmethyl metabolite to plasma proteins reaches 96%, the average maximum plasma concentration of free sildenafil reaches 18 ng / ml (38 nmol). The degree of binding to blood plasma proteins does not depend on the total concentration of sildenafil.

Eroton №2 Indications
The drug is recommended for men with erectile dysfunction, which is defined as the inability to achieve or maintain an erection of the penis necessary for successful intercourse.

For the effective action of the drug, sexual arousal is necessary.

Contraindications
Hypersensitivity to sildenafil or any of the excipients of the drug;
simultaneous use with nitric oxide donors (such as amyl nitrite) or nitrates in any form – sildenafil affects the pathways of nitric oxide / cyclic guanosine monophosphate (cGMP) metabolism and potentiates the hypotensive effect of nitrates;
the simultaneous use of PDE-5 inhibitors (including sildenafil) with guanylate cyclase stimulants such as riociguat is contraindicated because it can lead to symptomatic hypotension (see Section “Interaction with other medicinal products and other types of interactions”);
conditions in which sexual activity is undesirable (severe cardiovascular disorders such as unstable angina or severe heart failure);
the drug is contraindicated in patients who have lost vision in one eye due to non-arterial anterior ischemic neuropathy of the optic nerve, regardless of whether this pathology is associated with previous use of PDE-5 inhibitors or not;
the presence of diseases such as severe liver dysfunction, arterial hypotension (blood pressure below 90/50 mm Hg), recent stroke or myocardial infarction, and hereditary degenerative retinal diseases such as retinitis pigmentosa (such patients may have genetic disorders Retinal PDE) – the safety of sildenafil has not been studied in these patient subgroups.