REGISTRATION NUMBER
LRS-003338/09 [ЛРС-003338/09]
TRADE NAME
Selank®
CHEMICAL NAME
Threonyl-lysyl-prolyl-arginyl-prolyl-glycyl-proline diacetate
DOSAGE FORM
Nasal drops
COMPOSITION
Per 1 ml:
Active ingredient: Selank® (threonyl-lysyl-prolyl-arginyl-prolyl-glycyl-proline diacetate) – 1.5 mg
Excipients: Methylparahydroxybenzoate (nipagin) – 1 mg, purified water up to 1 ml
DESCRIPTION
Colorless, transparent liquid.
PHARMACOTHERAPEUTIC GROUP
Anxiolytic agent (tranquilizer)
ATC CODE
N05BX
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Selank® is a synthetic analog of the endogenous peptide tuftsin, possessing a unique neuro-specific mechanism of action on the central nervous system. It has anxiolytic effects with an antidepressant component, as well as anti-asthenic properties.
Selank® alleviates symptoms of anxiety, worry, fear, apathy, depression, and asthenia. It improves cognitive functions, enhancing memory, speech, attention, and learning processes such as memorization, analysis, and reproduction of information. It normalizes psychomotor responses.
Under stress, Selank® reduces emotional tension and stimulates adaptive behavior aimed at achieving beneficial results.
Pharmacokinetics
Selank® is administered intranasally. Its absolute bioavailability when applied to the nasal mucosa is 92.8%. The drug is rapidly absorbed, appearing in the blood plasma within 30 seconds and quickly distributed across various organs and tissues, including the brain. The plasma concentration decreases progressively within 5-5.5 minutes. No unchanged drug or metabolites are detected in daily urine due to rapid degradation by tissue peptidases.
INDICATIONS
Treatment of anxiety conditions:
- Unmotivated anxiety, worry
- Panic attacks
- Neurasthenia
- Asthenia
- Mood instability
- Sleep disturbances
- Decreased willpower, indecision, difficulty in decision-making
- Social insecurity
- Adaptation disorders
Prevention and treatment of stress-related disorders.
CONTRAINDICATIONS
- Individual hypersensitivity to the drug
- Pregnancy and lactation (lack of safety and efficacy studies)
- Children under 18 years (lack of safety and efficacy studies)
PREGNANCY AND LACTATION
Pregnancy: Controlled studies on the use of Selank® in pregnant women have not been conducted. It should not be used during pregnancy.
Lactation: If treatment with Selank® is necessary during breastfeeding, breastfeeding should be discontinued.
DOSAGE AND ADMINISTRATION
Selank® is administered intranasally using a bottle sealed with a plastic screw cap or a dropper cap.
Instructions for use
If the bottle is sealed with a screw cap, replace it with the provided dropper cap before first use. Draw the solution into the dropper.
If the bottle is sealed with a dropper cap, carefully cut off the tip and securely close it with the cap. Invert the bottle to fill the dropper before use.
Dispense the required number of drops onto the clean nasal mucosa. Pinch the nostril briefly after application.
Administer drops while seated, with the head slightly tilted backward or sideways. For optimal absorption, clear the nasal passages before use.
Recommended dosage
2 drops in each nostril, 3 times daily.
Treatment duration: 14 days. Repeat courses may be administered after 1-3 weeks, as directed by a physician.
SIDE EFFECTS
Unpleasant taste sensations upon reaching the throat due to hypersensitivity to smell and taste.
Allergic reactions in cases of individual intolerance.
Report any exacerbated side effects or unlisted adverse effects to your physician.
OVERDOSE
No cases of overdose with Selank® have been reported.
DRUG INTERACTIONS
Selank® does not influence the effects of central nervous system depressants or stimulants (e.g., haloperidol, pentobarbital, hexobarbital, or analeptics).
Compatible with other psychoactive and neuroactive therapies.
Safe for use with ethanol-containing products.
Consult your physician if taking other medications before starting Selank®.
SPECIAL INSTRUCTIONS
Selank® does not cause dependency or addiction.
Does not impair the ability to drive vehicles or operate machinery.
FORM OF RELEASE
Nasal drops in 3 ml glass bottles with either a plastic screw cap or a dropper cap. Each bottle is packed with instructions in a cardboard box.
STORAGE CONDITIONS
Store in a light-protected place at temperatures not exceeding 10°C. Do not freeze. An opened bottle should be stored at temperatures not exceeding 25°C for no more than 15 days. Keep out of reach of children.
SHELF LIFE
2 years. Do not use after the expiration date.
DISPENSING CONDITIONS
Available without a prescription.
MANUFACTURER NAME AND ADDRESS
CJSC “Innovation Research and Production Center “Peptogen”, Russia. https://selank.ru/