Composition, form of production and packaging
Nasal drops 0.15% 1 ml
threonyl-lysyl-prolyl-arginyl-prolyl-glycine-proline diacetate 1.5 mg
3 ml - a bottle-droppers (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
SelancВ® is a synthetic analogue of the endogenous peptide taftcin, has an original mechanism of neurospecific action on the CNS, binds to specific receptors on the membranes of nerve cells.
It affects the exchange of monoamines in the emotionogenic structures of the brain (hypothalamus, diencephalon, hemispherical cortex) and the activity of brain enzymes of tyrosine and tryptophan hydroxylase. It shows tropicity to the serotonergic system, normalizing the serotonin level of the brain under conditions of experimentally caused its decrease.
Selank В® stabilizes the processes of excitation and inhibition in the brain and increases the stability of neurons of the cortex of the hemispheres to functional loads of high intensity.
In the spectrum of the pharmacological action of the drug, an anxiolytic (counter-anxiety) effect with a stimulating (activating) component predominates. The drug does not possess hypnotic and muscle relaxant properties. Positively affects the mnestic and cognitive functions of the brain, including their violation. Activates the learning, memory, analysis and playback of information, improves attention and short-term memory. Increases the motivational stability and adequacy of adaptive behavior.
Selank В® has a vegetotrophic effect, it improves the vegetative maintenance of activity in conditions of emotional stress, it has an optimizing effect on the adaptive reserve of the organism. SelankВ® does not reveal undesirable side effects and toxic effects at a 200-300-fold increase in dose compared with ED 50 .
It does not have embryotoxic, teratogenic, allergic and local irritant effects, does not show mutagenic properties.
The drug has no undesirable long-term effects. SelancВ® does not cause drug dependence.
PHARMACOKINETICS
Absolute bioavailability of Selanca with intranasal administration is 92.8%. The drug is rapidly absorbed from the nasal mucosa and after 30 sec is detected in the blood plasma. Concentration in the blood plasma progressively decreases within 5-5.5 minutes. Metabolites with intranasal route of administration are not detected.Penetrates into the brain tissue. The drug is quickly distributed to organs and tissues, is found unchanged in well-vascularized organs (liver, kidneys, heart). In daily urine, neither unchanged drug nor metabolites are determined, which is due to the rapid degradation of Selanca under the influence of tissue peptidases.
INDICATIONS
In adults:
- with anxiety and anxiety-asthenic disorders, corresponding to the diagnostic criteria of generalized anxiety disorders;
- neurasthenia;
- Adaptation disorders.
DOSING MODE
Instillation of the drug in the nasal passages is carried out in the sitting position of the patient with a slightly tossed head, after which for a short time the finger is clamped by each nostril. The effectiveness of absorption can be reduced in the presence of increased secretions of the nasal mucosa.
At a time, no more than 2-3 drops are injected into each nostril, which is 300 Ојg (4 drops - 0.2 ml) -450 Ојg (6 drops - 0.3 ml). To increase the dose of a single dose, repeated administration of the drug is carried out after 15 minutes. The optimal single doses - 300-900 mcg (4-12 drops), daily - 900-2700 mcg (12-36 drops), distributed on 3 doses during the day. The duration of the course use of the drug is 10-14 days. If necessary, the course of treatment can be repeated in 1-3 weeks.
SIDE EFFECT
With increased sensitivity to the perception of odor and taste, if the preparation gets from the nasal cavity to the mucous membrane of the pharynx, unpleasant gustatory sensations may appear.
Perhaps the development of allergic reactions with individual intolerance.
CONTRAINDICATIONS
- Pregnancy;
- lactation period;
- Hypersensitivity to the drug.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
SPECIAL INSTRUCTIONS
The lack of hypnose-sedative and muscle relaxant properties in the preparation and the presence of a positive effect on cognitive functions make it possible to use SelankВ® in persons of various professions, including those requiring increased attention and coordination of movements (vehicle drivers, operators).
OVERDOSE
When using Selanca due to rapid degradation of the drug, overdose and intoxication are not observed.
DRUG INTERACTION
Selank В® does not affect the effects of drugs that depress and stimulate the CNS - haloperidol, pentobarbital, hexobarbital, analeptics.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. Store In a dark place at a temperature of no higher than +10 В° C, do not allow freezing. Keep out of the reach of children. Shelf life - 2 years. Do not use after the time specified on the package.
