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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 Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

ITF, LLC (Russia)

Manufactured By

Catalent Italy, S.P.A. (Italy)

Dosage Form

Bottle Rx Icon 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.

Marketing Authorization Holder

ITF, LLC (Russia)

Manufactured By

Mipharm S.p.A. (Italy)

Dosage Form

Bottle Rx Icon 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.

Marketing Authorization Holder

ITF, LLC (Russia)

Manufactured By

Biologici Italia Laboratories, S.r.l. (Italy)

Dosage Form

Bottle Rx Icon 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.

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