Vildegra, 100 mg

Treatment of erectile dysfunctions characterized by the inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse.

Active ingredient

How to take, the dosage

Interaction

Special Instructions

To diagnose erectile dysfunction, determine its possible causes, and choose an adequate treatment, a complete medical history and a thorough physical examination must be taken. Erectile dysfunction medications should be used with caution in patients with anatomic penile deformities (angulation, cavernous fibrosis, Peyronie’s disease), or in patients with risk factors for priapism (sickle cell anemia, multiple myeloma, leukemia) (see section “Caution”). Drugs intended to treat erectile dysfunction should not be prescribed to men for whom sexual activity is undesirable.

If an erection persists for more than 4 hours, medical attention should be sought. If priapism therapy is not carried out in time, it may lead to penile tissue damage and irreversible loss of potency.
Sexual activity poses a certain risk in the presence of heart disease, so before starting any therapy for erectile dysfunction, the doctor should refer the patient to the examination of the cardiovascular system. Sexual activity is undesirable in patients with heart failure, unstable angina, myocardial infarction or stroke within the last 6 months, life-threatening arrhythmias, arterial hypertension (BP > 170/100 mm Hg) or hypotension (BP < 90/50 mm Hg). Clinical studies have shown no difference in the incidence of myocardial infarction (1.1 per 100 people per year) or cardiovascular mortality rate (0.3 per 100 people per year) in patients receiving sildenafil compared to patients receiving placebo.

Cardiovascular Complications

In the postmarketing use of sildenafil for the treatment of erectile dysfunction, adverse events such as serious cardiovascular complications (includingincluding myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, hypertension, and hypogenism) that were temporarily associated with sildenafil use. Most, but not all, of these patients had risk factors for cardiovascular complications. Many of these adverse events were observed shortly after sexual activity, and some were noted after sildenafil administration without subsequent sexual activity. It is not possible to establish a direct link between the reported adverse events and these or other factors.

Hypotension

Sildenafil has a systemic vasodilator effect resulting in a transient decrease in BP, which is not clinically significant and does not result in any effects in most patients. Nevertheless, before prescribing sildenafil, the physician should carefully assess the risk of possible adverse vasodilatory effects in patients with relevant diseases, especially against the background of sexual activity. Increased susceptibility to vasodilators is observed in patients with left ventricular outflow tract obstruction (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as with rare syndrome of multiple systemic atrophy manifested by severe BP regulation disorder of autonomic nervous system. Since co-administration of sildenafil and α-adrenoblockers may lead to symptomatic hypotension in some sensitive patients, the drug should be administered with caution in patients taking α-adrenoblockers (see section “Interaction with other medicinal products”). In order to minimize the risk of postural hypotension in patients taking α-adrenoblockers, sildenafil should be started only after hemodynamic stabilization in these patients is achieved. It should also be considered whether it is reasonable to reduce the initial dose of sildenafil (see section “Dosage and administration”). The physician should inform patients about what actions should be taken if symptoms of postural hypotension occur.

Visual impairment

There have been rare cases of development of anterior nonarteritic ischemic optic neuropathy as a cause of visual impairment or loss during use of all FDE5 inhibitors, including sildenafil. Most of these patients had risk factors such as optic disc excavation (deepening), age over 50, diabetes mellitus, arterial hypertension, coronary heart disease, hyperlipidemia, and smoking. A small number of patients with hereditary retinitis pigmentosa have genetically determined retinal phosphodiesterase dysfunction. There is no information about the safety of sildenafil use in patients with retinitis pigmentosa.

Hearing impairment

Some post-marketing and clinical studies have reported cases of sudden hearing impairment or loss associated with use of all FDE5 inhibitors, including sildenafil. Most of these patients had risk factors for sudden deterioration or hearing loss. A causal relationship between the use of FDE5 inhibitors and sudden hearing impairment or hearing loss has not been established. If there is sudden hearing loss or hearing loss while taking sildenafil, consult a physician immediately.

Bleeding

Sildenafil enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donor, on human platelets in vitro. There are no data on the safety of sildenafil administration in patients with a tendency to bleeding or exacerbation of peptic ulcer disease, so sildenafil should be used with caution in these patients (see section “Caution”). The incidence of nasal bleeding in patients with L G associated with diffuse connective tissue disease was higher (sildenafil 12.9%, placebo 0%) than in patients with primary pulmonary hypertension (sildenafil 3.0%, placebo 2.4%). Patients who received sildenafil in combination with a vitamin K antagonist had a higher rate of nasal bleeding (8.8%) than patients who did not take a vitamin K antagonist (1.7%).

The use in combination with other erectile dysfunction treatment agents

The safety and effectiveness of sildenafil in combination with other erectile dysfunction treatment agents have not been studied, so the use of such combinations is not recommended (see “Contraindications.

Impact on driving and operating ability

Because sildenafil may decrease BP, chromatopsia, blurred vision, etc., it is not recommended (see Contraindications).

Since sildenafil may decrease BP, chromatopsia, blurred vision, and similar side effects, you should be alert to the individual effect of the drug in these situations, especially at the start of treatment and when changing dosing regimens, and be careful when driving vehicles and engaging in potentially hazardous activities that require increased concentration and quick psychomotor reactions.

Contraindications

Hypersensitivity to sildenafil or any other component of the drug. Use in patients receiving nitric oxide donators, organic nitrates or nitrites in any form continuously or intermittently, since sildenafil enhances the hypotensive effect of nitrates (see section “Interaction with other medicinal products”).

The use in patients for whom sexual activity is undesirable (e.g., with severe cardiovascular disease, such as severe heart failure, unstable angina pectoris).
Arterial hypotension (blood pressure less than 90/50 mm Hg).

Severe renal insufficiency (CK < 30 ml/min). Liver failure, cirrhosis.

Performed cerebral circulation disorder or myocardial infarction within the past six months.
Hereditary degenerative retinal diseases, including retinitis pigmentosa.

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Concomitant administration of ritonavir (for 50 mg and 100 mg doses). Safety and effectiveness of sildenafil when combined with other drugs for treatment of erectile dysfunction have not been studied, so the use of such combinations is not recommended (see section “Cautions”).

According to the registered indication sildenafil is not intended for use in children under 18 years of age.

For the registered indication sildenafil is not intended for use in women.

Cautions

Anatomic deformity of the penis (angulation, cavernous fibrosis or Peyronie’s disease) (see section “Special Precautions”).

Diseases predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocythemia) (see section “Special Precautions”).

Patients with a history of episodes of anterior nonarteritic ischemic optic neuropathy.
Diseases accompanied by bleeding.

The exacerbation of peptic ulcer disease of the stomach and duodenum. Simultaneous use of alpha-adrenoblockers.
Simultaneous use with ritonavir maximum single dose of sildenafil should not exceed 25 mg, frequency of use once every 48 hours (tablet 25 mg should be used).

Simultaneous use with CYP3A4 isoenzyme inhibitors (erythromycin, saquinavir, ketoconazole, itraconazole) a starting dose of sildenafil should be 25 mg (25 mg tablet should be used).

Side effects

Overdose

Pregnancy use

Similarities