Viagra, pills 100mg, 1pc

Composition

Active ingredient:

sildenafil (as sildenafil citrate) 100 mg;

additional nutrients:

microcrystalline cellulose,

calcium hydrophosphate (anhydrous),

sodium croscarmellose,

magnesium stearate,

Opadry blue and Opadry transparent film coating.

Pharmacological action

Pharmacokinetics

The pharmacokinetics of sildenafil are dose-dependent when taken orally within the recommended dose range. Suction

After oral use, sildenafil is rapidly absorbed from the gastrointestinal tract. The absolute bioavailability of sildenafil is on average about 41% (25-63%). The maximum concentration in the blood plasma of Ctax when taken orally on an empty stomach is reached within 30-120 minutes (on average,60 minutes). When taken in combination with fatty wheat, the absorption rate decreases; Cmax decreases by an average of 29%, and the time to reach the maximum concentration (Ttax) is extended by 60 minutes.

Distribution

The volume of distribution of sildenafil at steady state averages 105 liters. The plasma protein binding of sildenafil and its main circulating N – demethyl metabolite is approximately 96% and does not depend on the total concentration of the drug. 90 minutes after taking sildenafil, less than 0.0002% of the dose was detected in semen (on average,188 ng). Metabolism

Sildenafil is mainly metabolized in the liver by the microsomal cytochrom E P 450 isoenzymes: CYP3A4 (main pathway) and CYP2C9. The main circulating active metabolite formed as a result of N-demethylation of sildenafil undergoes further metabolism. The concentration of the metabolite in the blood plasma is about 40% of the concentration of sildenafil. Deduction

The total clearance of sildenafil from the body is 41 l / h, and the final half-life is 3-5 hours. After oral use, sildenafil is excreted as metabolites mainly in the faeces (approximately 80% of the dose) and to a lesser extent in the urine (approximately 13% of the dose). Elderly patients

In elderly patients (65 years and older), the clearance of sildenafil is reduced, and the concentration of free sildenafil in blood plasma is approximately 40% higher than in young patients (18-45 years). Renal insufficiency With mild (creatinine clearance 50-80 ml/ min) and moderate (creatinine clearance 30-49 ml/min) renal insufficiency, the pharmacokinetics of sildenafil after a single oral dose of 50 mg do not change. In severe renal insufficiency (creatinine clearance

Hepatic insufficiency In patients with cirrhosis of the liver (Child-Pugh A and B), the clearance of sildenafil decreases, which leads to an increase in AUC by 84% and Ctax by 47%.

Pharmacodynamics

The Active ingredient of Viagra-sildenafil is a powerful selective inhibitor of cyclo-guanosine monophosphate (cGMP) – specific phosphodiesterase type 5 (PDE5). Sildenafil does not have a direct relaxing effect on the isolated cavernous body. Sildenafil enhances the relaxing effect of nitric oxide (NO) by inhibiting PDE5, which is responsible for the breakdown of cGMP in the cavernous body.

This results in relaxation of the smooth muscles and increased blood flow in the cavernous body.

Indications

Treatment of erectile dysfunction characterized by the inability to achieve or maintain a penile erection sufficient for satisfactory sexual intercourse.

Viagra is effective only when sexual stimulation is present.

Use during pregnancy and lactation

It is not intended for use in women.

Contraindications

-Hypersensitivity to any component of the drug.

– Use in patients receiving continuous or intermittent nitric oxide donors, organic nitrates or nitrites in any form.

– Under 18 years of age.

– Not intended for use in women.

With caution: anatomical deformity of the penis (incl. angulation, cavernous fibrosis, or Peyronne’s disease), diseases that predispose to the development of priapism (such as sickle cell anemia, multiple myeloma. leukemia, thrombocythemia), diseases accompanied by bleeding, exacerbation of peptic ulcer disease, hereditary retinitis pigmentosa, heart failure, unstable angina, myocardial infarction, stroke or life-threatening arrhythmias in the last 6 months, arterial hypertension (BP > 170/100 mm Hg) or hypotension (BP >

Side effects

Adverse events are usually transient and mild to moderate. The frequency of adverse events increases with increasing dose.

From the body as a whole: asthenia, pain, abdominal pain, back pain, infection, flu-like syndrome.

From the cardiovascular system: vasodilation (side effect reported in clinical studies).

From the digestive system: diarrhea, nausea.

From the musculoskeletal system: joint pain, muscle pain.

From the central nervous system and peripheral nervous system: dizziness (side effect reported in clinical studies), increased muscle tone, insomnia.

From the respiratory system: nasal congestion, pharyngitis, rhinitis (a side effect reported in clinical studies), sinusitis, respiratory tract infections, impaired respiratory function.

Dermatological reactions: rash.

From the sensory organs: visual changes: mild and transient, mainly changes in the color of objects, as well as increased perception of light and blurred vision (a side effect reported in clinical studies), conjunctivitis.

From the urinary system: urinary tract infections.

From the side of the reproductive system: violation of the function of the prostate gland.

When using the drug in doses higher than recommended, side effects were similar to those noted above, but usually occurred more frequently.

The following lists the adverse events reported during the post-marketing application process.

From the cardiovascular system: hypotension, syncope, tachycardia, palpitations.

From the digestive system: vomiting (side effect reported in clinical studies).

On the part of the reproductive system: prolonged erection and / or priapism.

From the side of the senses: pain in the eyes, redness of the eyes.

Other: allergic reactions.

How to take, course of use and dosage

The drug is taken orally.

For most patients, the recommended dose is 50 mg; the drug is taken if necessary approximately 1 hour before sexual activity. Depending on the efficacy and tolerability, the dose can be increased to 100 mg or reduced to 25 mg.

The maximum recommended dose is 100 mg.

The maximum recommended frequency of application is 1 time/day.

Special instructions

To diagnose erectile dysfunction, determine their possible causes, and choose appropriate treatment, it is necessary to collect a complete medical history and conduct a thorough physical examination.

Treatment of erectile dysfunction should be used with caution in patients with anatomical deformity of the penis (angulation, cavernous fibrosis, Peyronie’s disease), or in patients with risk factors for priapism (sickle cell anemia, multiple myeloma, leukemia).

Drugs intended for the treatment of erectile dysfunction should not be prescribed to men for whom sexual activity is undesirable.

Form of production

Coated tablets.

Storage conditions

In a dry place, at a temperature not exceeding 30 °C

Shelf life

5 years

Active ingredient

Sildenafil

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For men, For adults as prescribed by a doctor

Indications

Erectile Dysfunction