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Description
The instruction for medical use
of medicine СИНЕГРА® 25 СИНЕГРА® 50 СИНЕГРА® 100
the Trade name
СИНЕГРА® 25 СИНЕГРА® 50 СИНЕГРА® 100
International unlicensed
name Sildenafil Lekarstvennaya
the Tablet form, film coated, 25 mg, 50 mg, 100 mg
Structure
One tablet contains
active agent – sildenafit citrate of 35.12 mg, 70.24 mg, 140.48 mg are equivalent to 25 mg, 50 mg, 100 mg sildenafit respectively,
excipients: calcium hydrophosphate anhydrous, cellulose
microcrystalline PH 102, sodium of a kroskarmelloz, silicon dioxide colloidal (aerosil 200), magnesium stearate,
structure of a cover of Opadry II Blue 85F20578: polyethyleneglycol 3350 (macrogoal 4000), titan E 171 dioxide, talc, FD & C Blue #2/indigo carmine E 132 aluminum, iron oxide yellow E 172, polyvinyl alcohol.
The description
of the Tablet, film coated blue color, square shape with marking of arrow on one party.
Pharmacotherapeutic group
Drugs for treatment of urological diseases. Other drugs for treatment of urological diseases, including spasmolysants. Drugs for treatment of disturbances of an erection. Sildenafil
the ATX G04BE03 Code
the Pharmacological
Sildenafil Pharmacokinetics properties, active ingredient of the drug SINEGRA® is quickly soaked up after intake and the maximum concentration in plasma is reached within from 30 to 120 minutes (on average 60 minutes). The absolute bioavailability of drug is about 40%. At reception of a sildenafil along with greasy food the speed of absorption decreases in this connection time of achievement of the maximum concentration (Tmax) slows down, on average, up to 60 minutes and the maximum concentration (Cmax) in blood decreases up to 29%. Sildenafil and his main N-desmetilny a metabolite contact proteins of plasma approximately for 96%. Linking with proteins does not depend on the general concentration of drug.
Sildenafil is metabolized by mainly microsomal isoenzymes of a liver – CYP3A4 (main way) and CYP2C9 (minor way). The main metabolite which is formed as a result of N-desmetilirovaniya of a sildenafil is exposed to further metabolism. Concentration of a metabolite in plasma makes about 40% of concentration of a sildenafil and pharmacological action of a metabolite makes about 20% of pharmacological action of a sildenafil. After intake about 80% of a dose of drug also about 13% are allocated in the form of metabolites mainly with a stake – with urine.
The pharmacodynamics
the Physiological mechanism by means of which there is a penis erection includes release of nitrogen oxide (NO) in a cavernous body during sexual stimulation. Further nitrogen oxide activates enzyme guanylate cyclase that leads to increase in level of the cyclic guanozinmonofosfat (tsGMF) which causes relaxation of unstriated muscles in a cavernous body and promotes blood inflow. Sildenafil is selection inhibitor of tsGMF-specific phosphodiesterase of the 5th type (FDE5) in a cavernous body where FDE5 is responsible for disintegration of tsGMF.
Influence of a sildenafil on erectile dysfunction:
In double placebo – a controlled cross research of patients with disturbances of an erection (psychogenic, mixed) result of sexual stimulation approach of a positive erection sufficient for sexual intercourse, after purpose of a sildenafil in comparison with placebo was organic.
Influence of a sildenafil on blood pressure:
At use of drug in a dose of 100 mg the maximum lowering of arterial pressure (ABP) in a prone position averaged 8.4 mm Hg, and diastolic arterial blood pressure in a prone position of 5.5 mm Hg. More expressed, but in this way passing action on the ABP was observed at the patients who were at the same time receiving nitrates.
Influence of a sildenafil on a hemodynamics:
Single dose of a sildenafil in a dose of 100 mg. did not cause clinically significant changes in the ECG in healthy volunteers.
Influence of a sildenafil on sight:
At some patients in 1 hour after administration of drug in a dose of 100 and 200 mg the easy and passing disturbance of distinction of color blue/green is revealed), in 2 h after reception these changes were absent. The installed mechanism of disturbance of color sight consider oppression of FDE-6 which participates in transfers of color in a retina. Sildenafil does not influence visual acuity, sensitivity to contrast, the intraocular pressure or diameter of a pupil.
Indications
– treatment of the disturbances of an erection which are characterized by inability to achievement or preservation of an erection of a penis sufficient for satisfactory sexual intercourse.
СИНЕГРА® it is effective only in the presence of sexual stimulation.
To apply a route of administration and doses in order to avoid complications strictly on doctor’s orders!
The recommended dose for most of patients – 50 mg inside approximately in 1 hour prior to sexual intercourse. Taking into account efficiency and shipping the dose can be increased up to 100 mg or is reduced to 25 mg. The maximum recommended dose – 100 mg and frequency rate of use – once a day.
The renal failure
At easy and medium-weight degree of insufficiency of function of kidneys (clearance of creatinine of 30-80 ml/min.) correction of a dose is not required, at heavy (clearance of creatinine & lt, 30 ml/min.) – the dose is reduced to 25 mg.
A liver failure
At patients with insufficiency of function of a liver dose СИНЕГРЫ® can be lowered to 25 mg.
Combined use with other medicines
At combined use with ritonaviry the maximum single dose СИНЕГРЫ® has to make 25 mg, hour is not more often than 1 time during the 48th.
At combined use with inhibitors of P450 3A4 cytochrome (such as erythromycin, sakvinavir, ketokonazol, itrakonazol) initial dose СИНЕГРЫ® makes 25 mg.
For reduction of risk of developing orthostatic hypotension, the condition of the patients accepting alpha adrenoblockers has to be stable before use СИНЕГРЫ®. Decrease in a starting dose is recommended.
Elderly patients
Correction of a dose is not required.
Side effects
Undesirable phenomena usually passing and easy or moderate.
Frequency of the undesirable phenomena increases with increase in a dose.
The most frequent by-effects (& gt, 1/10)
– a headache
– a vazodilatation (inflows of blood to the person)
Frequent by-effects (& gt, 1/100 and & lt, 1/10)
– dizziness
– change of sight (the obscured sight, change of light sensitivity)
– a chromatopsia (easy and passing, mainly change of perception of shades of color)
– a cardiopalmus
– rhinitis (congestion of a nose)
– dyspepsia
not often (≥1/1000 and ≤ 1/100)
– a stethalgia, myalgia, the general weakness, drowsiness
– a hypesthesia
Seldom ((≥1/10000 and ≤ 1/1000)
– decrease or a hearing loss
– a myocardial infarction, fibrillation of auricles
– decrease or loss of sight owing to not arterial front ischemic neuropathy of an optic nerve
– serious cardiovascular events, including a myocardial infarction, a sudden cardiac death, ventricular arrhythmia, the cerebrovascular hemorrhagic and tranzitorny ischemic attacks associated with reception of a sildenafil.
The following side effects were revealed in the course of post-marketing observation:
– hypersensitivity reaction (including skin rash)
– spasms
– tachycardia, decrease in the ABP, faints, nasal bleeding
– vomiting
– eye pain, reddening of an eye/injection of scleras
– a long erection and/or a priapism.
Contraindications
– loss of sight on one eye owing to the front ischemic neuropathy of an optic nerve which is not connected with inflammation of an artery regardless of whether this episode was connected with the previous use of FDE5 inhibitor or not
– hypersensitivity to any component of drug
– a concomitant use of drugs, being donators of nitrogen oxide, organic nitrates or nitrites in any forms
– a heavy liver failure
– hereditary degenerative diseases of a retina of an eye.
With care:
anatomic deformation of a penis (including, an angulation, cavernous fibrosis or Peyroni’s disease)
the diseases contributing ment of a priapism (such as it is crescent – cellular anemia, a multiple myeloma, a leukosis, a trombotsitemiya)
the diseases which are followed by bleeding
exacerbation of a peptic ulcer
a hereditary pigmentary retinitis
heart failure,
unstable stenocardia, postponed to the last 6 months a myocardial infarction, a stroke or zhizneugrozhayushchy arrhythmias
arterial hypertension (the arterial blood pressure (ABP) & gt, 170/100 mm Hg.) or hypotonia (ABP & lt, 90/50 mm Hg.).
On the registered indication drug is not intended for use for children aged up to 18 years and at women.
Medicinal interactions
СИНЕГРА® is weak inhibitor of isoenzymes of P450 cytochrome – 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (ИК50>, 150 µmol). At reception СИНЕГРЫ® in the recommended doses of its Cmax makes about 1 µmol therefore it is improbable that СИНЕГРА® can affect clearance of substrates of these isoenzymes.
СИНЕГРА® strengthens hypotensive effect of nitrates both at prolonged use of the last, and at their appointment according to sharp indications. In this regard, use СИНЕГРЫ® in combination with nitrates or donators of nitrogen oxide contraindicated.
Signs of considerable interaction with tolbutamide (250 mg) or warfarin (40 mg) which are metabolized by CYP2C9 are not revealed.
СИНЕГРА® (100 mg) does not influence pharmacokinetics of inhibitors of HIV protease, the sakvinavir and ritonavir which are CYP3A4 substrates at their constant level in blood.
СИНЕГРА® (50 mg) does not cause additional increase in a bleeding time at intake of acetylsalicylic acid (150 mg).
СИНЕГРА® (50 mg) hypotensive effect of alcohol does not strengthen.
At simultaneous use СИНЕГРЫ® with amlodipiny at patients with an arterial hypertension significant clinical interactions are noted. Average additional decrease in the ABP in a prone position is 8 mm Hg. (systolic) and 7 mm Hg. (diastolic).
At a concomitant use of alpha adrenoblocker of a docsazozin (4 mg) and СИНЕГРЫ® (25 mg) at patients with a benign hyperplasia of a prostate both systolic, and diastolic arterial blood pressure in a prone position in addition decreases on average by 7 mm Hg. Use of higher doses СИНЕГРЫ® together with docsazoziny (4 mg) occasionally led ment of orthostatic hypotonia 1-4 hours later after administration of drugs. At the certain patients receiving an alpha – can lead adrenoblockers, simultaneous use СИНЕГРЫ® to symptomatic hypotonia. СИНЕГРА® enhances anti-aggregation effect of Sodium nitroprussidum (donator of nitrogen oxide).
Special instructions
Sildenafil has system vazodilatiruyushchy property that can lead to passing lowering of blood pressure in this connection before prescribing of the drug Sinegra® it is necessary to weigh carefully risk of undesirable manifestations at patients with cardiovascular diseases, especially against the background of sexual activity.
The increased susceptibility to vazodilatator is observed at patients with obstruction of an output path of a left ventricle (for example, an aortal stenosis, an idiopathic subaortal stenosis) and at patients with heavy disturbance of vegetative regulation of blood pressure.
In case of a condition of the erection proceeding more than 4 hours, patients have to ask for medical care immediately. If the priapism is not cured immediately, development of irreversible impotence is possible.
It is necessary to appoint with care the drug Sinegra® at combined use with ritonaviry as ritonavir considerably increases plasma concentration of a sildenafil by 11 times.
rejected to high systematic levels of a sildenafil are limited. given by the sky help. For reduction of risk of side effects at the patients receiving ritonavir it is recommended to reduce a dose of a sildenafil.
Simultaneous use of a sildenafil and alpha adrenoblockers, can lead to arterial hypotension at some patients. Therefore sildenafit doses, the exceeding 25 mg should not be accepted within 4 hours after intake of alpha adrenoblockers. At reception of the raised doses of a sildenafil and a docsazin in a dose of 4 mg the development of postural hypotension within 1 – 4 hours after reception is possible.
Safety sildenafit at patients with the diseases which are followed by bleeding and patients with a round ulcer in the period of aggravation is unknown.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Against the background of administration of drug of Sinegra® of any negative influence on ability to drive the car or other technical means was not observed. However as at administration of drug the decrease in the ABP, development of a chromatopsia, the obscured sight is possible, it is necessary to inform patients on the danger connected with control of vehicles, service of the mechanical equipment and other potentially dangerous types of activity and to show consideration for individual effect of drug in the specified situations, especially in an initiation of treatment and at change of the mode of dosing.
Overdose
Symptoms: strengthening of side effects.
Treatment: symptomatic. Dialysis does not accelerate clearance of a sildenafil as the last actively contacts proteins of blood plasma and is not removed with urine.
The form of release and packing
On 1 or 4 tablets place in blister strip packaging from a film of polyvinylchloride and printing aluminum foil.
On 1 or 4 planimetric packs with 1 tablet or on 1 or 3 planimetric packs with 4 tablets together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not above 25 °C, in dry, protected from light, the place.
To store out of children’s reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer
Almaty, Shevchenko St. 162 E.
The owner of the registration certificate of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E. Phone number: (+7 727) 399-50-50Номер fax: (+7 727) 399-60-60Адрес e-mail nobel@nobel.kz
Additional information
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