Composition, form of production and packaging
Nasal drops 1 ml
methionyl-glutamyl-histidyl-phenylalanyl-prolyl-glycyl-proline 10 mg
3 ml - vials (1) complete with a stopper-pipette - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Semax has an original mechanism of neurospecific action on the central nervous system (CNS). Semax is a synthetic analog of corticotropin, which possesses nootropic properties and is completely devoid of hormonal activity. The drug improves cognitive, or cognitive processes of the brain, such as memory, learning. Attention. Increases mental performance; improves the adaptation of brain cells to hypoxia, anesthesia and other damaging effects. The drug is virtually non-toxic for a single and long-term administration. Does not show allergic, embryotoxic, teratogenic and mutagenic properties. Does not have a local irritant effect.
PHARMACOKINETICS
Absorbed from the mucous membrane of the nasal cavity, while digesting up to 60-70% in terms of the active substance. Semax is quickly distributed to all organs and tissues, it penetrates the blood-brain barrier. Upon entering the blood, Semax undergoes a fairly rapid biotransformation and excretion from the body with urine.
INDICATIONS
- an acute period of ischemic stroke of moderate and severe degree in the composition of complex therapy.
DOSING MODE
Semax is applied intranasally using a vial capped with a plastic stopper pipet.
The volume of one drop is 0.05 ml (50 Ојl). One drop of the standard solution contains 500 Ојg of active substance.
For a stroke of medium severity, 2-3 drops are injected into each nostril at a time, which is 2000 Ојg (4 drops or 0.2 ml) - 3000 Ојg (6 drops or 0.3 ml). Burying is carried out 3-4 times a day, with an interval between stabbing 3-4 hours. The daily dose is 6000 Ојg (12 drops or 0.6 ml) - 12,000 Ојg (24 drops or 1.2 ml).
In severe strokes , 3-4 drops are injected into each nostril at a time, which is 3000 Ојg (6 drops or 0.3 m) - 4000 Ојg (8 drops or 0.4 ml). Burial is carried out 4-5 times a day with an interval between instillations of 2.5-3 hours. The daily dose is 12,000 Ојg (24 drops or 1.2 ml) - 20,000 Ојg 40 drops or 2.0 ml). The drug is prescribed daily for 10 days.
SIDE EFFECT
With prolonged use, slight irritation of the nasal mucosa is possible.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
acute mental disorders;
- anxiety disorders;
- children's age till 18 years;
- pregnancy, lactation period;
- cramps in the anamnesis.
PREGNANCY AND LACTATION
Contraindicated. Clinical studies have not been conducted.
APPLICATION FOR CHILDREN
Contraindicated for children under 18 years.
OVERDOSE
The phenomenon of drug overdose so far has not been detected even with a significant increase in the single dose.
DRUG INTERACTION
Pharmaceutical. Based on the chemical structure of the drug, the presence of chemically incompatible combinations is not expected: the drug is rapidly destroyed and does not enter the gastrointestinal tract.
Pharmacokinetic. Given the chemical structure of the drug (heptapeptide - a synthetic analogue of adrenocorticotropic hormone, completely devoid of hormonal activity), the speed of absorption and the rate of entry into the blood, as well as the intraasal route of administration, the effect of other drugs on the pharmacokinetic parameters of Semax is not expected. Taking into account the method of introducing Semax (intranasal), it is undesirable to administer agents having a local vasoconstrictive effect when administered intranasally.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In the dark place at a temperature of not more than +10 В° C, do not allow freezing. Keep out of the reach of children. Shelf life - 2 years.