Deltaran^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Comcon Research Center, LLC (Russia)

Manufactured By

State Research Institute of Occupational Health FMBA, FSUE (Russia)

ATC Code

N07BB (Drugs used for alcohol dependence)

Dosage Form

Deltaran®

Lyophilizate for preparation of solution for intranasal administration 0.3 mg: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intranasal administration in the form of a powder or porous mass of white color.

Excipients: glycine – 0.3 mg.

0.3 mg – ampoules (5) – contour cell packaging (1) – cardboard packs.
0.3 mg – ampoules (10) – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of alcohol dependence

Pharmacotherapeutic Group

Antihypoxant

Pharmacological Action

Synthetic nonapeptide, similar in structure to an endogenous substance of the human body. This peptide is present both in the human body and in the bodies of mammalian animals and does not exhibit any toxic properties.

The synthesized peptide is completely identical to the natural peptide produced in the body, known as delta sleep-inducing peptide, which possesses a wide spectrum of pharmacological action: neuroprotective, anti-stress, antioxidant, anticonvulsant, antihypoxic, antitoxic, and geroprotective. When entering the body, the exogenous delta sleep-inducing peptide compensates for the deficiency of the endogenous peptide, whether absolute or functional, which allows controlling neurons to work as adequately as possible under conditions of any type of stress and to counteract the occurrence of metabolic deviations from physiological norms.

It reduces pathological craving for alcohol and relieves manifestations of alcohol withdrawal. The mechanism of action is not known.

Pharmacokinetics

Delta sleep-inducing peptide is rapidly degraded in the body into individual amino acids and short peptides by proteolytic enzymes of the blood and is eliminated from the body.

Indications

As part of complex therapy: treatment and prevention of stress-induced conditions; alcohol withdrawal syndrome and primary pathological craving for alcohol.

ICD codes

Dosage Regimen

Administer intranasally only after reconstitution.

Reconstitute the lyophilisate in one ampoule with 1-2 mL of water for injection or 0.9% sodium chloride solution immediately before use.

For alcohol withdrawal syndrome, use a dose of 0.3 mg ( one reconstituted ampoule) three times a day for 5-7 days.

For pathological craving for alcohol, use a dose of 0.3 mg ( one reconstituted ampoule) twice a day for 10-14 days.

For stress-induced conditions, use a dose of 0.3 mg ( one reconstituted ampoule) once or twice a day for 5-10 days.

Adjust the treatment duration individually based on clinical response and severity of the condition.

Avoid use in the presence of acute rhinitis or nasal inflammation; if necessary, administer only after washing the nose or relieving congestion.

Do not exceed the recommended daily dose.

Adverse Reactions

Possible allergic reactions, irritation of the nasal mucosa.

Contraindications

Hypersensitivity to the active substance; pregnancy, breastfeeding period; age under 18 years.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

In inflammatory diseases of the nose (acute rhinitis), the absorption efficiency of the delta sleep-inducing peptide by the mucous membrane may be reduced. In such cases, it is recommended to administer the agent after washing the nose or eliminating congestion with medications.

It is not recommended to use the agent in cases of severe bradycardia.

In severe conditions (alcohol withdrawal), it is necessary to consult a doctor for the prescription of additional detoxification medications.

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.