Semax, drops 0.1% 3 ml

Pharmacotherapeutic group. Notropic drug.

ATX code – [N06BX]

Pharmacological properties. Semax drops 0.1% is an original synthetic peptide preparation which is an analog of the adrenocorticotropic hormone fragment (ACTH4-10) (methionyl-glutamyl-histidyl-phenylalanyl-prolylglycyl-proline) and is absolutely devoid of hormonal activity. All amino acids are L-form.

Pharmacodynamics.

Semax nasal drops 0.1% has an original mechanism of neurospecific action on the central nervous system (CNS). Semax nasal drops 0.1% is a synthetic analog of corticotropin, which has nootropic properties and is completely devoid of hormonal activity. The drug affects processes related to memory formation and learning. Semax nasal drops 0.1% intensifies attention during learning and information analysis, improves consolidation of memory trace in patients after neurosurgical operations, craniocerebral injury, patients suffering from cerebrovascular diseases, including cerebrovascular encephalopathy; it improves adaptation of the body to hypoxia, cerebral ischemia, narcosis and other damaging influences. The drug is practically non-toxic when administered once and for a long time. It does not exhibit allergic, embryotoxic, teratogenic and mutagenic properties. It has no local irritant effect.

Pharmacokinetics.

It is absorbed from the nasal mucosa with absorption up to 60-70% of the active substance. Semax 0.1% nasal drops are rapidly distributed to all organs and tissues, penetrating through the blood-brain barrier. Once in the blood, Se-max nasal drops 0.1% undergoes rapid biotransformation and is eliminated from the body with the urine.

Indications

Intellectual and mental disorders in cases of cerebral vascular lesions, conditions after craniocerebral trauma, neurosurgical operations and anesthesia, dyscircular encephalopathy, pre-traumatic brain circulation disorders (TIA), as well as neurotic disorders of different genesis, including after ionizing radiation, the recovery period after a stroke. To increase the adaptive capacity of the human body in extreme situations, prevention of mental fatigue in a monotonous operator’s activity in the most intense periods of work under stressful conditions.

In ophthalmology Semax is used for atrophy of the optic nerve, neuritis of inflammatory and toxic-allergic etiology.

In pediatrics: as a nootropic in children over 7 years of age in the treatment of minimal brain dysfunctions (including ADHD – attention deficit hyperactivity disorder).

Active ingredient

Methionyl-glutamyl-histidyl-phenylalanyl-prolyl-glycyl-proline

Composition

semax calculated as 100% of the substance – 1 g, methyl parahydroxybenzoate (Nipaginum) – 1 g, purified water up to 1 l.

How to take, the dosage

Semax is administered intranasally using a bottle sealed with a plastic screw cap or dropper cap.

If the bottle is sealed with a plastic screw cap, remove the plastic screw cap on initial use and replace it with the supplied cap pipette. Pipette the preparation into the pipette. With a slight inclination of the head sideways, squeeze the required number of drops of the drug on the mucous membrane of the nasal passage.
If the bottle is sealed with a dropper cap, carefully cut the pipette tip, close the pipette tightly with the cap. Before use, turn the bottle upside down so that the liquid fills all the space of the pipette. Remove the cap and squeeze the required number of drops of the drug on the mucous membrane of the nasal passage.
Store the bottle with the drug tightly closed with a pipette with a cap, or a plastic screw cap, or a dropper cap.
One drop of the standard solution contains 50 mcg of the active substance. With a pipette the drug solution in an amount not exceeding 2-3 drops is injected into each nasal passage. If the dosage is to be increased the preparation is injected in several portions at 10-15 minute intervals.
In case of intellectual and mental disorders due to cerebral vascular lesions, circulatory encephalopathy, transient cerebral circulation disorders the single dose is 200-2000 mcg (at the rate of 3-30 mcg/kg). The daily dose is 800-8000 mcg (at the rate of 7-70 mcg/kg/kg).
The drug is prescribed in 2-3 drops in each nostril 4 times a day for 10-14 days and repeated if necessary.
After the craniocerebral injury, neurosurgical operations and anesthesia the single dose is 1400-3500 mcg (40-50 mcg/kg) 3 times a day for 3-5 days. The course of treatment may be prolonged up to 14 days, if necessary.
In diseases of the optic nerve the drug is placed into the nasal passages 2-3 times a day. The daily dose is 600-900 mcg/day. The course of treatment is 7-10 days.
Otherwise the drug can be administered by endonasal electrophoresis. The drug is administered from the anode. The current strength is 1 mA and the exposure time is 8-12-15 minutes. The daily dose is 400-
600 mkg/day. The course of treatment is 7-10 days.

In pediatrics: In children from 7 years old. In cases of minimal brain dysfunction: 1-2 drops in each nasal passage (at the rate of 5-6 mcg/kg) 2 times a day (morning and afternoon). The daily dose is 200-400 mcg/day. The course of treatment is 30 days.

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 is not delivered to the gastrointestinal tract.

Pharmacokinetic. Taking into account the chemical structure of the drug (heptapeptide is a synthetic analog of adrenocorticotropic hormone with absolutely no hormonal activity), rapid absorption and blood entry rate, and also intranasal route of administration, no other drugs influence on pharmacokinetic parameters of Semax Nasal Drops 0.1% is expected. Given the route of administration of Semax Nasal Drops 0.1% (intranasal), the administration of agents with a local vasoconstrictor effect when administered intranasally is not advisable.

Contraindications

High sensitivity to the components of the drug. Children under 7 years of age. In ophthalmologic and neurosurgical practice, children under 18 years of age. Pregnancy, lactation, acute mental states, disorders accompanied by anxiety, seizures in anamnesis.
Application in children under 18 years in ophthalmologic and neurosurgical practice is contraindicated. No clinical trials have been carried out.
Application during pregnancy and lactation. Contraindicated. No clinical studies have been conducted.

Side effects

Mild irritation of the nasal mucosa is possible with prolonged use.