SEMAX 1% NASAL DROPS
methylparahydroxybenzoate (nipagine) - 1 g, purified water-up to 1 l.

3 ml - vials with a plastic screw cap with an attached pipette with a lid (1) - cardboard packs.
3 ml - vials with a plastic dropper cap (1) - cardboard packs.

PHARMACOLOGICAL ACTION
Semax ® nasal drops 1% is an original synthetic peptide preparation that is an analog of the ACTH4-10 fragment (methionyl-glutamyl-histidyl-phenylalanyl-prolyl-glycyl-proline), completely devoid of hormonal activity. All L-form amino acids.

The drug has an original mechanism of neurospecific action on the central nervous system. It is a synthetic analog of corticotropin, which has nootropic properties and is completely devoid of hormonal activity. The drug improves cognitive processes of the brain, such as memory, learning ability, attention; increases mental performance. Improves the adaptation of brain cells to hypoxia, anesthesia and other damaging effects.

The drug is practically non-toxic with a single and long-term administration. It does not exhibit allergic, embryotoxic, teratogenic or mutagenic properties. It does not have a local irritant effect.

PHARMACOKINETICS
Suction and distribution

It is absorbed from the nasal mucosa, while it is absorbed up to 60-70% in terms of the active substance. It is quickly distributed to all organs and tissues, and penetrates through the BBB.

Metabolism and excretion

When it enters the blood, it undergoes a fairly rapid biotransformation and excretion from the body in the urine.

INDICATIONS
·        acute period of moderate and severe ischemic stroke as part of complex therapy.
DOSAGE AND ADMINISTRATION
Semax® is used intranasally, using a vial capped with a plastic screw cap or dropper cap.

The volume of 1 drop is 0.05 ml (50 µl). 1 drop of the standard solution contains 500 micrograms of the active substance.

In a moderate stroke, 2-3 drops are injected into each nostril at one time, which is 2000 (4 drops or 0.2 ml)-3000 micrograms (6 drops or 0.3 ml). Instillation is carried out 3-4 times/day with an interval between instillations of 3-4 hours. The daily dose is 6000 (12 drops or 0.6 ml)-12,000 mcg (24 drops or 1.2 ml).

In a severe stroke, 3-4 drops are injected into each nostril at a time, which is 3000 (6 drops or 0.3 m)-4000 micrograms (8 drops or 0.4 ml). Instillation is carried out 4-5 times/day with an interval between instillations of 2.5-3 hours. The daily dose is 12,000 (24 drops or 1.2 ml)-20,000 mcg (40 drops or 2.0 ml).

The drug is prescribed daily for 10 days.

Method of application

If the vial is sealed with a plastic screw cap:

for initial use, remove the plastic screw cap and replace it with the supplied pipette with the cap;
dial the drug into the pipette;
slightly tilting your head to one side, squeeze out the required number of drops of the drug on the nasal mucosa.
If the vial is capped with a dropper cap:

it is necessary to carefully cut off the tip of the pipette, close the pipette tightly with the cap;
before use, turn the vial over so that the liquid fills the entire space of the pipette;
remove the cap and squeeze out the required amount of drops of the drug on the nasal mucosa.
The drug should be stored tightly closed with a pipette with a lid or a plastic screw cap, or a dropper cap.

SIDE EFFECTS
With prolonged use, mild irritation of the nasal mucosa may occur.

CONTRAINDICATIONS
·        acute mental disorders (no studies have been conducted);
·        anxiety disorders (no studies have been conducted);
·        a history of seizures (no studies have been conducted);
·        pregnancy (no studies have been conducted);
·        lactation period (no studies have been conducted);
·        children and adolescents under 18 years of age (no studies have been conducted);
·        hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION
Use during pregnancy and lactation is contraindicated. No clinical studies have been conducted.

SPECIAL WARNINGS
The vial with the drug should be kept tightly closed with a pipette with a lid or a plastic screw cap, or a dropper cap.

OVERDOSE
To date, no symptoms of drug overdose have been identified, even with a significant increase in the single dose.

DRUG INTERACTIONS
Pharmaceutical

Based on the chemical structure of the drug, the presence of chemically incompatible combinations is not assumed: the drug is quickly destroyed and does not enter the gastrointestinal tract.

Pharmacokinetic

Given the chemical structure of the drug (heptapeptide-a synthetic analog of ACTH, completely devoid of hormonal activity), the speed of absorption and the rate of entry into the blood, as well as the intranasal method of administration, the effect of other drugs on the pharmacokinetic parameters of the drug Semax® nasal drops 1% is not expected.

Given the method of administration of Semax ® nasal drops 1%, it is undesirable to introduce drugs that have a local vasoconstrictive effect when they are administered intranasally.

STORAGE CONDITIONS
The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 10°C; do not freeze. Shelf life - 2 years.

The opened vial should be stored at a temperature not exceeding 25°C and for no more than 30 days.