Semax® (Semax)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMethionyl histidyl-glutamyl-glycyl-phenylalanyl-prolyl-prolineMethionyl histidyl-glutamyl-glycyl-phenylalanyl-prolyl-proline
Dosage form: & nbspNasal drops 0.1%.
Composition:Semax in terms of 100% substance - 1 g, methylparahydroxybenzoate (Nipagina) - 1 g, water purified to 1 liter.
Description:Colorless transparent liquid.
Pharmacotherapeutic group:Nootropic agent.
ATX: & nbsp

N.06.B.X   Other psychostimulants and nootropic drugs

Pharmacodynamics:Semax drops nasal 0.1% - the original synthetic peptide preparation, which is an analog of the fragment of adrenocorticotropic hormone (ACTH4-10 ) (methionyl-glutamyl-histidyl-phenylalanyl-prolyl-glycyl-proline), completely devoid of hormonal activity. All amino acids are L-shaped.
Semax drops nasal 0.1% possesses an original mechanism of neurospecific action on the central nervous system (CNS). Semax drops nasal 0.1% synthetic analog of corticotropin, possessing nootropic properties and completely devoid of hormonal activity. The drug affects the processes associated with the formation of memory and learning.Semax drops nasal 0.1% strengthens attention when learning and analyzing information, improves consolidation of a memorable track in patients after neurosurgical interventions, cerebrovascular trauma, suffering from cerebrovascular diseases, including discirculatory encephalopathy; improves adaptation of the body to hypoxia, cerebral ischemia, 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 drops nasal 0.1% quickly distributed to all organs and tissues, penetrates the blood-brain barrier. Upon entering the blood of Semax, 0.1% nasal drops undergo rapid biotransformation and excretion from the urine.
Indications:Intellectual and mnestic disorders in vascular lesions of the brain, conditions after traumatic brain injury, neurosurgical operations and anesthesia, discircular encephalopathy,transient disorders of cerebral circulation (TIA), as well as neurotic disorders of various genesis, including after ionizing radiation, the recovery period after a stroke. To increase the adaptive capacity of the human body in extreme situations, the prevention of mental fatigue with monotonous operator activity in the most stressful periods of work under stressful conditions.
In ophthalmology Semax is used for atrophies of the optic nerve, neuritis inflammatory, toxic-allergic etiology.
In pediatrics: as a nootropic remedy in children aged 7 years in the treatment of minimal brain dysfunction (including ADHD - Attention Deficit Hyperactivity Disorder).
Contraindications:Hypersensitivity to the components of the drug. Children under 7 years. In ophthalmic and neurosurgical practice, children under 18 years of age. Pregnancy, lactation, acute mental conditions, disorders accompanied by anxiety, seizures in the anamnesis.
Use in children under 18 years of age in ophthalmic and neurosurgical practice is contraindicated. Clinical studies have not been conducted.
Pregnancy and lactation:Contraindicated.Clinical studies have not been conducted.
Dosing and Administration:Semax is applied intranasally, using a vial capped with a plastic stopper pipet.
Carefully cut off the tip of the pipette at the location shown in Fig. 1.
The cap should close the pipette tightly - Fig. 2.
Turn the bottle and, tapping lightly on the bottom, wait for the liquid to fill the entire space of the pipette - Fig. 3.
Remove the cap and lightly pressing on the wide part of the pipette, squeeze the required number of drops of the drug into the nasal passage (on the mucous membrane) - Fig. 4.
Store the drug with a tightly closed cap, as shown in Fig. 2.

One drop of the standard solution contains 50 μg of active substance. By pipetting, the drug solution in an amount of not more than 2-3 drops is injected into each nasal passage. If it is necessary to increase the dosage, the administration is carried out in several doses at intervals of 10-15 minutes.
With intellectual-mnestic disorders with vascular lesions of the brain, discircular encephalopathy, transient disorders of cerebral circulation, a single dose is 200-2000 μg (at a rate of 3-30 μg / kg).
The daily dose of 800-8000 mcg (at the rate of 7-70 mkg / kg).
The drug is prescribed 2-3 drops in each nasal passage 4 times a day for 10-14 days, if necessary, the treatment course is repeated.
After craniocerebral trauma, neurosurgical operations and narcosis, a single dose is 1400-3500 μg (40-50 μg / kg) 3 times a day for 3 to 5 days. If necessary, the course of treatment is extended to 14 days.
To increase the adaptive capacity of the human body and prevent mental fatigue 3-5 days 2-3 drops in each nasal passage 2-3 times in the morning. The daily dose of 400-900 mcg / day. If necessary, repeat the treatment.
With diseases of the optic nerve, the drug is digested 2-3 drops in each nasal passage 2-3 times a day. The daily dose of 600-900 mcg / day. The course of treatment is 7-10 days. In addition, the drug can be administered by endonasal electrophoresis. The drug is injected from the anode. Current strength 1 mA, duration of exposure 8 -12-15 minutes.
The daily dose of 400-600 mcg / day. The course of treatment is 7-10 days.
In pediatrics:
At children from 7 years. With minimal brain dysfunction: 1-2 drops in each nasal passage (at a rate of 5-6 μg / kg) 2 times a day (morning and afternoon). The daily dose of 200-400 mcg / day. The course of treatment is 30 days.
Side effects:With prolonged use, slight irritation of the nasal mucosa is possible.
Overdose:The phenomenon of drug overdose so far has not been detected even with a significant increase in the single dose.
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 analog of adrenocorticotropic hormone completely devoid of hormonal activity), the rate of absorption and rate of entry into the blood, as well as the intranasal route of administration, the effect of other drugs on the pharmacokinetic parameters of Semax is 0.1% nasal. Taking into account the method of Semax administration, nasal drops of 0.1% (intranasal) are not desirable for the administration of agents with a local vasoconstrictive effect when administered intranasally.
Form release / dosage:Nasal drops 0.1%.
Packaging:3 ml per bottle, sealed with a plastic stopper pipette or a bottle sealed with a plastic lid with the attached dropper nozzle. Each vial with instruction for use is packaged in a pack of cardboard.
Storage conditions:In the dark place at a temperature of no higher than 10 ° C. Do not freeze. Keep out of the reach of children.
Shelf life:2 years. Do not use after the expiry date stated on the package.
Terms of leave from pharmacies:On prescription
Registration number:LS-002553
Date of registration:30.12.2011 / 10.11.2015
Expiration Date:Unlimited
The owner of the registration certificate:Peptogen Innovative Research and Production Center, ZAO Peptogen Innovative Research and Production Center, ZAO Russia
Manufacturer: & nbsp
Information update date: & nbsp2016-08-28
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