Instructions for Vildegra (VIAGRA) Sildenafil for erection
Composition
The composition of one tablet:
Active substance:
sildenafil citrate - 140.4800 mg,
in terms of sildenafil base - 100.0000 mg.
Excipients (core):
hypromellose - 110.0000 mg,
lactose monohydrate (milk sugar) - 82.5200 mg,
povidone - C25 - 14.0000 mg,
magnesium stearate - 3.0000 mg.
Excipients (shell):
opadry II 85F205024 blue - 12.0000 mg,
polyvinyl alcohol - 4.8000 mg,
macrogol-4000 - 2.4240 mg,
aluminum varnish with indigocarmine and brilliant blue dyes - 0.7476 mg,
iron dye oxide yellow - 0.0324 mg,
talc - 1.7760 mg,
titanium dioxide - 2.2200 mg.
pharmachologic effect (VIAGRA analog)
Selective inhibitor cycloguanosine monophosphate (cGMP) -specific PDE5. PDE5, which is responsible for the decay of cGMP, is contained not only in the cavernous body of the penis, but also in the vessels of the lungs. Restores impaired erectile function and provides a natural response to sexual arousal. Sildenafil does not have a direct relaxing effect on the cavernous body, but actively enhances the relaxing effect of nitric oxide on this tissue.
During sexual arousal, the local release of NO under the influence of sildenafil leads to the inhibition of PDE5 and an increase in the level of cGMP in the cavernous body, resulting in the relaxation of smooth muscles and increased blood flow in the cavernous body. Being an inhibitor of PDE5, sildenafil increases the cGMP content in the smooth muscle cells of the pulmonary vessels and causes them to relax. In patients with pulmonary hypertension, taking sildenafil leads to dilation of the pulmonary vessels and, to a lesser extent, other vessels.
Sildenafil is selective for in vitro PDE5. Its activity against PDE5 exceeds the activity against other known PDE isoenzymes: PDE6, which participates in the transmission of a light signal in the retina, 10 times; PDE1 - 80 times; PDE2, PDE4, PDE7-PDE11 - more than 700 times. The activity of sildenafil in relation to PDE5 is more than 4000 times greater than its activity in relation to PDE3, cAMP-specific PDE, which participates in the contraction of the heart. Sildenafil can cause a mild and transient disorder in color (blue / green). A supposed mechanism of color vision impairment is the inhibition of PDE6, which is involved in the process of transmitting light in the retina. In vitro studies have shown
Indications
- The drug is used for the treatment of disorders of potency, expressed inability to achieve or maintain an erection of the penis, to ensure full sexual intercourse.
- The active substance of the drug (sildenofril) is effective only when exposed to sexual arousal.
Recommendations for use
Treatment of erectile dysfunction: take orally about 1 hour before planned sexual activity. A single dose is 50 mg. Given the efficacy and tolerability, the dose may be increased to 100 mg or reduced to 25 mg. The maximum single dose is 100 mg. The maximum frequency of use is 1 time / day.
For elderly patients over the age of 65 years and with concomitant violations of the kidney or liver function, the dose is 25 mg. Pulmonary hypertension: by mouth 20 mg 3 times / day with an interval of about 6-8 hours, regardless of the meal. The maximum daily dose is 60 mg. Patients with impaired renal function dose adjustment is not required, but in case of poor tolerance the dose is reduced to 20 mg 2 times / day.
Contraindications:
- Before taking this drug, you should consult a doctor, as there are some contraindications:
- individual intolerance to sildenafril or any other component included in the preparation;
- half a year ago, suffered a heart attack, stroke;
- rehabilitation period after abdominal surgery;
- chronic heart disease and vascular systems;
- not intended for guys under 18;
- liver failure, liver cirrhosis;
- chronic renal failure;
- degenerative retinal changes;
- not intended for admission by women.
Side effects
Like any drug, Vildegra has side effects:
nervous system:
headache,
possibly dizziness,
drowsiness, sometimes fainting,
stroke (rarely),
convulsions;
cardiovascular system:
tachycardia,
(rarely) increase (decrease) in blood pressure,
myocardial infarction (rarely);
organs of vision:
visual impairment,
color perception;
organs of hearing:
tinnitus,
sometimes vertigo;
respiratory system:
symptoms of rhinitis (nasal congestion),
nasal bleeding (rare);
musculoskeletal system:
myalgia (muscle pain);
gastrointestinal tract:
dyspepsia,
rarely vomiting,
sometimes nausea;
in the genital area: rarely - hematospermia (blood admixture in semen), bleeding from the sexual organ, extremely rarely - priapism (prolonged and painful erection, not associated with sexual arousal), prolonged erection;
allergic manifestations: very rarely - a rash on the skin;
other: sudden fatigue, chest pain.
Description
Tablets with prolonged release, film-coated dark blue, round, biconvex; two layers are visible on the cross-section - the core is white or almost white in color and the film envelope.
Special instructions
Before starting sildenafil to treat erectile dysfunction, a cardiovascular system should be examined. Caution should be used in patients with anatomical deformation of the penis (for example, angulation, cavernous fibrosis or Peyronie’s disease) and people with diseases that predispose to the development of priapism (such as sickle cell anemia, multiple myeloma or leukemia). Should not be used in patients for whom sexual activity is undesirable. Use with caution in patients with a tendency to bleeding, with gastric ulcer and duodenal ulcer in the acute phase, with hereditary pigmentary retinitis. Sildenafil is not used in patients under the age of 18 years.
Dosage
Inside.
The recommended dose for most adult patients is 50 mg approximately 1 hour before sexual activity. Given the effectiveness and tolerability, the dose can be increased to 100 mg. The maximum recommended dose is 100 mg. The maximum recommended frequency of use is once a day. Impairment of renal function In mild to moderate degree of renal failure (CC 30-80 ml / min) dose adjustment is not required. Combined use with other drugs To minimize the risk of postural hypotension in patients taking alpha-blockers, sildenafil should only be started after hemodynamic stabilization is achieved in these patients. The feasibility of lowering the initial dose of sildenafil should also be considered (see sections "Special Instructions" and "Interaction with Other Medicines"). Elderly patients No dose adjustment of sildenafil is required.
Overdose
With a single dose of the drug up to 800 mg, adverse events were comparable to those when taking the drug in lower doses, but were more common.
The treatment is symptomatic. Hemodialysis does not accelerate the clearance of sildenafil, since the latter actively binds to plasma proteins and is not excreted by the kidneys.