Juvena capsules 50mg №4×1

Name Juvena caps. Pharmacotherapeutic group Drug used for erectile dysfunction Pharmacological action Drug used for erectile dysfunction. Selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE 5), which is responsible for the breakdown of cGMP in the cavernous body of the penis. Actively enhances the relaxing effect of nitric oxide (NO) on the smooth muscles of the cavernous body and increases blood flow in the penis. When the NO-cGMP chain is activated, which is observed during sexual arousal, the inhibition of PDE 5 leads to an increase in cGMP in the cavernous body. The pharmacological effect is achieved only in the presence of sexual stimulation. Activity against PDE-5 is 10-10,000 times greater than activity against other PDE isoforms (1, 2, 3, 4, 6). Pharmacokinetics Absorption Tmax after oral administration, on an empty stomach, is 0.5-2 hours. Bioavailability is 25-60%. When taken with fatty foods, Cmax decreases by 20-40% and is reached after 1.5-3 hours. The distribution of Vd in the equilibrium state is 105 liters. Plasma protein binding – 96%. Metabolism Metabolized mainly by CYP3A4, CYP3A5, CYP3A7 (main route) and CYP2C9 (additional route) microsomal liver isoenzymes to form metabolites. The main circulating active metabolite is the N-desmethyl metabolite, whose activity is 50% of that of sildenafil. excretion Total clearance – 41 l / h. T1 / 2 of sildenafil and N-desmethylmetabolite – 3-5 hours. Excreted as inactive metabolites with feces (80%) and kidneys (15%). Pharmacokinetics in special clinical situations In patients with renal insufficiency (CC less than 30 ml / min), cirrhosis of the liver and in the elderly, the clearance of sildenafil is reduced. Overdose Data on overdose are not provided. Indications for use Erectile dysfunction of various etiologies (organic, psychogenic, mixed). Dosage and administration Inside adults, approximately 1 hour before the planned sexual activity. Single dose – 50 mg 1 time / day. Based on efficacy and tolerability, the dose may be increased to 100 mg or reduced to 25 mg. The maximum single dose is 100 mg. In patients with impaired liver or kidney function and in elderly patients, dose adjustment is not required. PrecautionsTo diagnose erectile dysfunction, determine their possible causes and select adequate treatment, it is necessary to take a complete medical history and conduct a thorough physical examination. Risk Factors for Cardiovascular Disease Sexual activity poses a certain risk in the presence of heart disease, so before starting any therapy for erectile dysfunction, the doctor may consider it necessary to conduct an examination of the patient’s cardiovascular system. Sildenafil has a vasodilatory effect, resulting in a slight transient decrease in blood pressure. 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 has been observed in patients with left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as the rare multiple system atrophy syndrome, manifested by severe dysregulation of blood pressure from the autonomic nervous system. Juvena enhances the hypotensive effect of nitrates. During the period of post-registration observation, cases of serious cardiovascular complications (including myocardial infarction, unstable angina pectoris, sudden coronary death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, arterial hypertension and hypotension) were reported, which had a temporal relationship with the use Juvena capsules. Most of these patients, but not all of them, had risk factors for cardiovascular events. Many of these adverse events were observed shortly after sexual activity, and some of them were noted after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct connection between these phenomena and these or other factors. Priapism Drugs for the treatment of erectile dysfunction, incl. sildenafil should be used with caution in patients with an anatomical deformity of the penis (eg, angulation, cavernous fibrosis, or Peyronie’s disease) or in patients with diseases predisposing to the development of priapism (such as sickle cell anemia, multiple myeloma, or leukemia). During the post-registration use of sildenafil, there have been reports of the development of prolonged erection and priapism. If the erection lasts more than 4 hours, the patient should seek emergency medical attention. If urgent measures are not taken in priapism, damage to the tissues of the penis and irreversible loss of potency can occur. Co-administration with other PDE-5 inhibitors or other treatments for erectile dysfunction The safety and efficacy of sildenafil when used in combination with other PDE-5 inhibitors or other drugs for the treatment of pulmonary arterial hypertension containing sildenafil, as well as other drugs for the treatment of erectile dysfunction have not been studied , so the use of such combinations is not recommended. Impact on vision Spontaneous reports of cases of visual impairment have been received when taking sildenafil and other PDE-5 inhibitors. In spontaneous reports and an observational study, cases of a rare disease – non-arteritic anterior ischemic optic neuropathy (NAION), which were associated with the use of sildenafil and other PDE-5 inhibitors, were noted. warn that in case of sudden visual impairment, stop taking the drug and consult a doctor immediately Co-administration with ritonavir Co-administration of sildenafil and ritonavir is not recommended Co-administration with alpha-blockers Since the combined use of sildenafil and alpha-blockers can lead to the development of symptomatic hypotension in selected sensitive patients, sildenafil should be administered with caution to patients taking alpha-blockers.The development of this condition is most likely to be observed within 4 hours after taking a dose of sildenafil.In order to minimize the risk of developing In orthostatic hypotension, sildenafil therapy should only be started in hemodynamically stable patients using alpha-adrenergic blockers. Consideration should also be given to the use of sildenafil at an initial dose of 25 mg. In addition, physicians should inform patients about what actions to take if symptoms of orthostatic hypotension appear. Effect on blood clotting In vitro studies on human platelets have shown that sildenafil potentiates the antiplatelet effect of sodium nitroprusside. There are no data on the safety of sildenafil in patients with bleeding disorders or acute peptic ulcer, so the use of sildenafil in this group of patients is possible only after a thorough assessment of the benefit / risk ratio. Juvena is not intended for use in women. Due to the content of lactose, the drug is not recommended for patients with congenital galactose intolerance, lactase deficiency or malabsorption of glucose-galactose. Due to the sugar content, the medicinal product is not recommended for patients with fructose intolerance or glucose-galactose malabsorption. Interaction Cimetidine, ketoconazole, erythromycin reduce clearance and increase the concentration of sildenafil in the blood. Sildenafil enhances the antiplatelet effect of sodium nitroprusside, the hypotensive effect of nitrates (the combination of sildenafil with nitrates can be fatal). Potentially life-threatening is its joint administration with slow calcium channel blockers, beta-blockers and oral hypoglycemic drugs. Shelf life Shelf life is 2 years. Packing 1 or 4 capsules in a blister pack made of PVC film and aluminum foil. 1 blister pack of 1 capsule or 4 capsules or 2 blister packs of 4 capsules, together with the leaflet, is placed in a cardboard box (No. 1×1, No. 4×1, No. 4×2). Side effects Possible: headache, flushing, dizziness, dyspepsia, nasal congestion, visual impairment (discoloration of objects / blue or green /, increased perception of light, blurred vision), sudden decrease or loss of hearing. Pregnancy and lactationJuvena is not intended for use by women. 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