Delecit (Capsules, Solution) Instructions for Use
ATC Code
N07AX02 (Choline alfoscerate)
Active Substance
Choline alfoscerate (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Nootropic drug. Central-acting cholinomimetic
Pharmacotherapeutic Group
Nootropic agent
Pharmacological Action
Cholinomimetic. It is a precursor of acetylcholine. It acts mainly on cholinergic receptors in the CNS.
Glycerophosphate, which is formed during the breakdown of choline alfoscerate, is a precursor of neuronal membrane phospholipids (phosphatidylcholine).
It facilitates the transmission of nerve impulses in cholinergic neurons, improves the plasticity of neuronal membranes and receptor function.
Pharmacokinetics
After oral administration, an average of about 88% of the choline alfoscerate dose is absorbed, with rapid distribution in organs and tissues.
It penetrates the BBB. It accumulates mainly in the brain (the concentration in the brain reaches 45% of that in plasma), lungs and liver.
85% is excreted by the lungs as carbon dioxide, the remaining amount (15%) is excreted through the kidneys and through the intestines.
Indications
Cerebrovascular disorders of the ischemic type (acute and recovery period) and hemorrhagic type (recovery period); psycho-organic syndrome against the background of involutional and degenerative processes of the brain; consequences of cerebrovascular insufficiency or primary and secondary cognitive impairments in the elderly, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased concentration; behavioral and affective disorders in old age – emotional lability, increased irritability, decreased interest; senile pseudomelancholia; multi-infarct dementia.
ICD codes
| ICD-10 code | Indication |
| F01 | Vascular dementia |
| F03 | Unspecified dementia |
| F07 | Personality and behavioral disorders due to disease, damage or dysfunction of the brain |
| G93.4 | Unspecified encephalopathy |
| I61 | Intracerebral hemorrhage (cerebrovascular accident of hemorrhagic type) |
| I63 | Cerebral infarction |
| I69 | Sequelae of cerebrovascular diseases |
| ICD-11 code | Indication |
| 6D81 | Dementia due to cerebrovascular disease |
| 6D8Z | Dementia, unknown or unspecified cause |
| 6E68 | Secondary emotionally labile personality disorder |
| 6E6Z | Unspecified secondary mental or behavioral syndromes |
| 8B00.Z | Intracerebral hemorrhage of unspecified site, unspecified |
| 8B11 | Cerebral ischemic stroke |
| 8B25.Z | Sequelae of cerebrovascular disease, unspecified |
| 8E47 | Encephalopathy, not elsewhere classified |
| 8E4A.0 | Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord |
| 8E63 | Post-cardiopulmonary bypass encephalopathy |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer orally, intramuscularly, or intravenously. Set the dosage regimen individually based on the clinical picture, disease characteristics, and patient tolerance.
For oral administration using capsules or solution, the typical adult dose is 400 mg taken three times daily. Administer doses in the morning, at midday, and in the evening. Take capsules with a sufficient amount of water.
For intramuscular or intravenous administration, the typical adult dose is 1000 mg administered once daily. Alternatively, divide the daily dose into two administrations of 500 mg each. Adjust the injection rate for intravenous administration to ensure patient comfort and safety.
For the acute phase of cerebrovascular disorders, initiate treatment with parenteral administration. Transition to oral therapy for long-term management and during the recovery period.
For chronic conditions such as cognitive impairment or dementia, use oral administration as the primary route for maintenance therapy. The standard treatment course typically lasts from 3 to 6 months. Reevaluate the patient’s condition upon completion of the initial course to determine the need for continued therapy.
If nausea occurs, which may result from dopaminergic activation, reduce the dose to improve tolerability. Do not administer to patients with a known hypersensitivity to choline alfoscerate.
Avoid use during pregnancy and lactation. Do not use in children and adolescents under 18 years of age. Monitor patient response and adjust the regimen as necessary under medical supervision.
Adverse Reactions
From the digestive system nausea, abdominal pain.
From the nervous system short-term confusion.
Contraindications
Hypersensitivity to choline alfoscerate; pregnancy, breastfeeding period; children and adolescents under 18 years of age.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and lactation (breastfeeding).
Pediatric Use
Use in children and adolescents under 18 years of age is contraindicated.
Special Precautions
Nausea may be a consequence of dopaminergic activation. If nausea occurs, the dose of choline alfoscerate should be reduced.
Effect on ability to drive vehicles and mechanisms
During the use of choline alfoscerate, patients should be cautious when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules 400 mg: 14 pcs.
Marketing Authorization Holder
ITF, LLC (Russia)
Manufactured By
Catalent Italy, S.P.A. (Italy)
Dosage Form
| Delecit | Capsules 400 mg: 14 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Choline alfoscerate | 400 mg |
14 pcs. – PVC/aluminum foil blisters (1) – cardboard packs.
Oral solution 600 mg: 7 ml bottle 10 pcs.
Marketing Authorization Holder
ITF, LLC (Russia)
Manufactured By
Mipharm S.p.A. (Italy)
Dosage Form
| Delecit | Oral solution 600 mg: 7 ml bottle 10 pcs. |
Dosage Form, Packaging, and Composition
Oral solution transparent, colorless.
| 1 fl. | |
| Choline alfoscerate | 600 mg |
Excipients : methylparahydroxybenzoate 8 mg, propylparahydroxybenzoate 2.4 mg, sodium saccharinate 3 mg, orange flavor 29 mg, purified water up to 7 ml.
7 ml – brown glass bottles (10) – cardboard packs.
Solution for intravenous and intramuscular administration 1000 mg: 4 ml amp. 3 or 5 pcs.
Marketing Authorization Holder
ITF, LLC (Russia)
Manufactured By
Biologici Italia Laboratories, S.r.l. (Italy)
Dosage Form
| Delecit | Solution for intravenous and intramuscular administration 1000 mg: 4 ml amp. 3 or 5 pcs. |
Dosage Form, Packaging, and Composition
| Solution for IV and IM administration | 1 amp. |
| Choline alfoscerate | 1000 mg |
4 ml – ampoules (3) – contour cell packaging (1) – cardboard packs.
4 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
