1. The medical product name
VIAGRA
2. Quantitative and qualitative structure
Active component: силденафил Citras
VIAGRA of 25 mg: in a tablet contains силденафил Citras in a dose equivalent of 25 mg силденафила.
VIAGRA of 50 mg: in a tablet contains силденафил Citras in a dose equivalent of 50 mg силденафила.
VIAGRA of 100 mg: in a tablet contains силденафил Citras in a dose equivalent of 100 mg силденафила.
The list of inactive components
Microcrystallic cellulose, calcium Hydronatrii phosphas (anhydrous), sodium кроскармеллоза, magnesium стеарат, гипромеллоза, the titan dioxide (Е171), lactose, триацетин, indigo a carmine an aluminium varnish (Е132).
3. Pharmacological properties
Силденафил; automatic telephone exchange Code G04В Е
3.1. Farmakodinamichesky properties
VIAGRA is the new peroral preparation intended for treatment of disturbances of an erection. It restores the broken erectile function and provides the natural answer to sex excitation.
The physiological mechanism of an erection of a sexual member assumes liberation окиси nitrogen (NO) in a cavernous body at sex stimulation. Окись nitrogen activates enzyme гуанилатциклазу, that leads to rising of level cyclic гуанозинмонофосфата (cGMP), to a relaxation of unstriated muscles of a cavernous body and blood flow intensifying in a sexual member.
Силденафил is a powerful and selective inhibitor of a cGMP-specific фосфодиэстеразы type 5 (ФДЭ5) which is responsible for cGMP disintegration in a cavernous body. VIAGRA has peripheric an effect on an erection. Силденафил does not render direct relaxing influence on a cavernous body, but activly strengthens relaxing effect NO on this tissue. At the activation of way NO/цГМФ observed at sex excitation, oppression ФДЭ5 under influence силденафила leads to augmentation of levels of a cGMP in a cavernous body. In this connection sex stimulation is necessary for implication of favorable pharmacological effect of VIAGRA
At unitary reception of VIAGRA inside in doses to 100 mg at healthy volunteers the preparation did not cause clinically significant changes of an electrocardiogram. The maximum depression of systolic arterial pressure in a prone position at preparation application inside in a dose of 100 mg averaged 8,4 mm hg Corresponding depression of diastolic arterial pressure in a prone position made 5,5 mm hg Depression of arterial pressure speaks вазодилатирующими effects силденафила, probably, at the expense of rising of level of a cGMP in unstriated muscles of vessels.
VIAGRA does not influence visual acuity and contrast of perception. At some patients through 1 ч after preparation reception in a dose of 100 mg easy and transient disturbance of distinction of colour (dark blue/green) by means of test Farnsworth-Munsell 100 is taped; through 2 ч after preparation reception these changes were absent. As the prospective mechanism of disturbance of colour sight consider oppression ФДЭ6 which participates in process of transfer of light in a retina. Researches in vitro have shown, that the effect силденафила on ФДЭ6 in 10 times concedes to its activity concerning ФДЭ5.
Researches in vitro testify that activity силденафила concerning ФДЭ5 in 10-10 000 times surpasses its activity concerning other isoforms фосфодиэстеразы (ФДЭ 1, 2, 3, 4 and 6). In particular activity силденафила concerning ФДЭ5 in 4 000 times surpasses its activity concerning ФДЭ3 - tsamf-specific фосфодиэстеразы, participating in heart reduction.
Pharmacokinetics at special groups of patients:
Older persons
At healthy elderly volunteers (65 years also are more senior) the clearance силденафила is lowered, and concentration of free medicinal substance in plasma approximately on 40 % exceeds its level at healthy young volunteers (18-45 years). However the analysis of data about safety has shown, that the age does not render influence on frequency of the undesirable phenomena.
Renal insufficiency
At volunteers with easy (a clearance of a creatinine of 50-80 ml/mines) and moderated (a clearance of a creatinine of 30-49 ml/mines) renal insufficiency the pharmacokinetics of VIAGRA after unitary intake (50 mg) did not vary. At volunteers with serious (a creatinine clearance <= 30 ml/mines) renal insufficiency the clearance силденафила decreased, that led to augmentation AUC (100 %) and Cmax (88 %) in comparison with those at the volunteers who have been picked up for age who did not suffer disturbance of function of kidneys.
4. A clinical part.
4.1. Indications to application
VIAGRA apply to treatment of disturbances of an erection.
Contraindications
VIAGRA is contraindicative to patients with hypersensitivity to any component of a tablet.
Thanks to known effect on an exchange окиси nitrogen/tsgmf (Farmakodinamichesky properties see). VIAGRA strengthened hypotensive action of Sodium nitritums, therefore its application it is contraindicative at the patients, receiving donators окиси nitrogen or Sodium nitritums in any forms.
4.3 Way of application and a dose
VIAGRA tablets accept inside.
Application for adults
Of 50 mg accept a recommended dose if necessary approximately one hour prior to planned sex activity. Taking into account efficiency and shipping the dose can be enlarged to 100 mg or is lowered to 25 mg. The maximum recommended dose makes 100 mg. The maximum recommended frequency of application - once a day.
Application for older persons and patients with the broken function of kidneys or a liver
At older persons and patients with the broken function of kidneys or a liver the recommended scheme of application the same.
