Homepage: http://semax.ru

Synonyms: Minisem.

Active substance: Methionyl-glutamyl-histidyl-phenylalanyl-prolyl-glycyl-proline.

Semax 0.1%

Country of manufacturer: Russia.

ATC

N06BX Other psychostimulants and nootropics.

Pharmacological group

Nootropics.

Nosological classification (ICD–10)

  • F43 Reaction to severe stress and adjustment disorders;
  • F48.9 Neurotic disorder, unspecified;
  • F84.4 Overactive disorder associated with mental retardation and stereotyped movements;
  • G93.4 Encephalopathy, unspecified;
  • H47.2 Optic nerve atrophy;
  • I64 Stroke, not specified as hemorrhage or infarction;
  • M79.2 Neuralgia and neuritis, unspecified;
  • R41.8.0 * Disorders Intellectual mnestic;
  • T66 Unspecified effects of radiation;
  • T90.5 Effects of intracranial injury;
  • Z100 * Chapter XXII Surgical Practice;
  • Z60.0 Problems related to adaptation to changes in lifestyle.

Composition, structure and packing

Colorless transparent liquid.

Vials of 3 ml dropper with cork, cardboard pack 1 bottle.

Characteristic

Synthetic heptapeptide - analogue fragment ACTH 4–10 (methionyl-glutamyl-histidyl-phenylalanyl-prolyl-glycyl-proline), devoid of hormonal activity. All amino acids are L-shaped.

Pharmacological action

Cerebroprotective, antihypoxia, nootropic and antioxidant.

Pharmacodynamics

Semax has an original mechanism of action on the CNS neurospecific.

Semax has a pronounced neurometabolic effect exerted even when administered in very small doses. Higher doses Semax, keeping neurometabolic properties of small doses, have anti-oxidant, antihypoxia, angioprotective and neurotrophic effect. When administered intranasally Semax 4 minutes penetrate the BBB, and the therapeutic effect of a single injection lasts 20–24 hours, due to its consistent degradation in which most of the effects of neuropeptide is stored in fragments.

Neurometabolic

The drug affects the processes associated with the formation of memory and learning. Semax enhances attention to the training and analysis of information, improves the memory trace consolidation, improves the body’s adaptation to hypoxia, cerebral ischemia, anesthesia and other damaging influences.

Semax has a stimulating effect on the population of cholinergic neurons of the basal forebrain nuclei.

Directed action Semax on cholinergic neurons is accompanied by a significant increase in activity of the enzyme acetylcholinesterase specific brain structures, which correlates with improved learning and memory formation.

Neuroprotection

Semax affects the processes of delayed neuronal death, including local inflammation, nitric oxide, oxidative stress and dysfunction of trophic factors. Powerful comparable with the effect of NGF, trophotropic Semax action on cholinergic neurons of the group in complete medium and in difficult conditions, due to deprivation of oxygen and glucose. Semax at the gene level involves the synthesis of neurotrophins - regulators of growth and differentiation of neural tissue (factor BDNF).

Semax has a direct effect on the molecular trigger mechanisms for the normalization of cytokine balance and raise the level of anti-inflammatory factors, reducing the formation of nitric oxide, causing inhibition of lipid peroxidation (LPO), superoxide dismutase activation synthesis (ODS) and the reduction of cyclic guazinmonofosfata (cGMP).

Antioxidant, antihypoxia

Semax has a positive effect on the body’s adaptation to hypoxia. The ability of the drug to stop post hyper ventilation EEG effects caused by a compensatory decrease in cerebral blood flow.

The drug is practically non-toxic in single and prolonged administration. Shows no allergic, embryotoxic, teratogenic and mutagenic properties. Has no local irritating action. Pharmacokinetics

Absorbed from mucous membranes of the nasal cavity, wherein the absorbed to 60–70% based on the active substance. Semax is rapidly distributed to all organs and tissues, penetrate the BBB. When injected into the blood Semax exposed sufficiently rapid degradation and excretion of urine.

Indications drug Semax

Semax nasal drops 0.1%

  • intellectual-mental disorders in vascular lesions of the brain;
  • state after TBI, neurosurgery and anesthesia;
  • encephalopathy;
  • transient ischemic attacks, and neurotic disorders of various origins, including after ionizing radiation;
  • recovery period after a stroke;
  • increase adaptive capacity of the human body in extreme situations;
  • prevention of mental fatigue during monotonic operator activity in the most intense periods of work in a stressful environment;
  • atrophy of the optic nerve;
  • inflammatory neuritis, toxic-allergic etiology;
  • as nootropic agents in children aged 5 years in the treatment of minimal brain dysfunction (including attention deficit hyperactivity disorder).

Semax nasal drops 1%

  • Ischemic stroke (acute phase).

Contraindications

Semax nasal drops 0.1%

  • hypersensitivity to the drug;
  • pregnancy;
  • lactation;
  • acute psychosis;
  • disorders accompanied by anxiety;
  • seizures in history;
  • Children up to age 5 years.

Semax nasal drops 1%

  • hypersensitivity to the drug;
  • pregnancy;
  • lactation;
  • acute psychosis;
  • disorders accompanied by anxiety;
  • a history of seizures.

Side effects

With long-term use may be slight irritation of the nasal mucosa.

Interaction

Pharmaceutical. Based on the chemical structure of the drug availability chemically incompatible combinations not expected: the drug is rapidly degraded in the gastrointestinal tract and does not act.

Pharmacokinetic. Given the chemical structure of the drug (heptapeptide - a synthetic analogue of ACTH completely devoid of hormonal activity), quickness and speed of absorption into the blood, and intranasal administration, the effect of other drugs on the pharmacokinetic parameters Semax is not assumed. Given the route of administration Semax (intranasal) undesirably intranasal means having a local vasoconstrictive action.

Dosing and Administration

Intranasally using a bottle, a sealed plastic stopper pipette.

Method of using the dropper bottle: 1. Cut off the tip of the pipette in the specified location. 2. pipette closed cap. 3. Method of use of the solution: turn the bottle and easily by tapping your finger on the bottoms, wait to fluid filled the entire space of the pipette. 4. Method instillation solution. Remove the cap and light pressure on the wide part of the pipette to squeeze out the required amount of drops of the drug in the nasal passage (the mucous membrane).

Store this medication with cap tightly closed.

Semax nasal drops 0.1%

One drop of the standard solution contains 50 mg of active substance. Pipette solution of the drug in an amount of not more than 2–3 drops injected into each nostril. The need to increase the dosage administration is in several stages at intervals of 10–15 min.

A single dose of 200–2000 mg (calculated as 3–30 mg/kg).

The daily dose - 500–5000 mcg (calculated as 7–70 mg/kg).

The drug is administered daily for 3–5 days, if necessary, treatment extend to 14 days.

In diseases of the optic nerve preparation dug 2–3 drops in each nostril 2–3 times a day. Daily dose - 600–900 mg. The course of treatment - 7–10 days.

Furthermore, the drug can be administered by intranasal electrophoresis. The drug is injected from the anode. Current - 1 mA, duration of exposure - 12/08/15 min.

Daily dose - 400–600 mg. The course of treatment - 7–10 days.

In pediatrics: with minimal brain dysfunction drug instilled 1–2 drops in each nostril 2 times a day (morning and afternoon). Daily dose - 200–400 mg. The course of treatment - 30 days.

Semax nasal drops 1%

The volume of one drop is 0.05 ml (50 ul). One drop of the standard solution contains 500 mg of active substance.

At moderate stroke at a time is introduced by 2–3 drops into each nostril, that is 2000 mg (four drops or 0.2 ml) - 3000 mcg (6 drops or 0.3 ml.) Digging is performed 3–4 times per day, with an interval between 3–4 hours daily instillation, the dose is 6000 mg (12 drops or 0.6 ml) - 12 000 mg (24 drops or 1.2 ml.)

In severe stroke at once entered 3–4 drops in each nostril, which is 3000 micrograms (6 drops or 0.3 ml) - 4000 mg (8 drops or 0.4 ml). Instill spend 4–5 times a day with an interval between instillation of 2.5–3 hours daily dose is 12,000 mg (24 drops or 1.2 ml) - 20000 mg (40 drops or 2.0 ml).

The drug is administered daily for 10 days.

Overdose

Phenomena of overdose so far failed to identify even with a significant increase in single dose.

Storage conditions of the drug Semax

In the dark place at a temperature not exceeding 10° C (do not freeze).

Keep out of reach of children.

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