Semax® – 1%

International Non-Proprietary Name (INN): methionyl-glutamyl-histidyl-phenylalanil-prolyl-glycyl-proline.
Dosage Form: nasal drops 1% (3 ml)
Structure: 

Active substance: Semax in terms of 100% substance – 10 g;

Excipients: methyl parahydroxybenzoate (Nipagin) – 1 g, purified water up to 1 l.

Description: colorless transparent liquid in 3 ml dropper bottle
Pharmacological classification: nootropics
ATC code: N06BX
Pharmacological action: nootropic, antioxidant, antihypoxic, cerebroprotective.

Pharmacodynamics

Semax nasal drops have an original mechanism of neuro-specific action on the central nervous system (CNS). Semax drops are a nasal synthetic analogue of Corticotropin; it has nootropic properties and is completely devoid of hormonal activity. The drug has an influence on the processes associated with the formation of memory and learning. Semax nasal drops increase attention during the learning process and the analysis of information. The drug enhances the consolidation of the memory trace in patients after neurosurgical interference, craniocerebral injury and in patients suffering from cerebrovascular diseases, including dyscirculatory encephalopathy; it improves the body adaptation to hypoxia, cerebral ischemia, anesthesia and other damaging effects. The drug is almost non-toxic both in a single and in prolonged administration. It does not demonstrate allergic, embryo-toxic, teratogenic and mutagenic properties. It does not have a local irritative effect.

Semax 1% is a “First Aid” after stroke. Due to its form (nasal drops) the drug begins to act instantly, preventing the nerve cells from damage and minimizing the consequences of acute brain blood supply disruption. Semax also prevents from repeated strokes and removes post-depression depression.

Pharmacokinetics

Semax is absorbed from the nasal mucosa. At least 60-70% of the active substance is absorbed. Semax is quickly distributed into all organs and tissues and penetrates through the blood-brain barrier. When it gets into the blood, Semax undergoes a rapid biotransformation and excretion from the body with urine.

Intended uses

Acute period of moderate to severe ischemic stroke as part of the complex therapy.

Contraindications

  • Hypersensitivity to the components of the drug;
  • Children under 7 y.o. In ophthalmic and neurosurgical practice, children under 18 y.o. (no clinical studies have been conducted);
  • Pregnancy and lactation (no clinical studies have been conducted).
  • Acute psychotic states, disorders accompanied by anxiety;
  • History of cramps.

Dosage and administration

Semax is applied intranasally using a bottle with a plastic pipette stopper.

One drop of the standard solution contains 50 mcg (Nasal drops 0.1%) / 500 mcg (Nasal drops 1%) of the active substance.

Drug solution is pipetted into each nasal passage in the amount of not more than 2-3 drops. If it is necessary to increase the dosage, the instillation is carried out in several doses at intervals of 10-15 minutes.

In a moderate stroke: 2-3 drops into each nostril at one time, which is from 2,000 mcg (4 drops or 0.2 ml) to 3,000 mcg (6 drops or 0.3 ml). The instillation is carried out 3-4 times a day, with an interval between instillations from 3 to 4 hours. The daily dose is 6,000 mcg (12 drops or 0.6 ml) – 12,000 mcg (24 drops or 1.2 ml). The duration of treatment is 10 days.
In a severe stroke: 3-4 drops are injected into each nostril at one time, which is 3,000 mcg (6 drops or 0.3 mg) – 4,000 mcg (8 drops or 0.4 ml). The instillation is carried out 4-5 times a day with an interval between instillations of 2.5-3 hours. The daily dose is 12,000 mcg (24 drops or 1.2 ml) – 20,000 mcg (40 drops or 2.0 ml). The duration of treatment is 10 days.

Side effects

Prolonged use may cause a mild irritation of the nasal mucosa.

Overdose:
No symptoms of overdose were identified after a significant dose increase.

Interaction with other drugs

Taking into account the method of Semax administration (intranasal), it is undesirable to use other intranasal agents with a local vasoconstrictive effect.

Due to the chemical structure of Semax, there are no chemically incompatible combinations: the drug is rapidly destroyed and does not enter the digestive tract.

Pregnancy and lactation: Contraindicated during pregnancy and lactation.

Influence on the ability to drive vehicles and operate machines: no data are available.

Storage conditions: Store at temperatures not exceeding 10°C, do not freeze, protect from light. An opened dropper bottle should be stored no longer than 30 days at temperatures below 25°C. Keep in a safe place out of the reach of children.

Shelf life: 2 years. Do not use beyond the expiration date printed on the package.

Country of manufacture: CJSC “Innovation Research and Production Center “Peptogen”, Russia.