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Instructions for use Gliatilin (Gliatilin) International Nonproprietary Name: Choline alphoscerate Composition: One ampoule of solution for injection (4 ml) contains: Active ingredient: Choline alphoscerate – 1000 mg Inactive ingredients: Water for injection q.s. up to 4 ml. One soft gelatin capsule contains: Active ingredient: Choline alphoscerate – 400 mg Inactive ingredients: Purified water – 140 mg, Glycerin – 50 mg Capsule shell composition: Gelatin 152 mg, Etsitol – 41 mg, Sorbitan – 33 mg, Sodium ethyl p-hydroxybenzoate – 0.8 mg, Sodium propyl p-hydroxybenzoate – 0.4 mg, Titanium dioxide (E171) – 2.4 mg, Iron (III) meta-hydroxide (E172) – 1.1 mg. Pharmacotherapeutic group: Nootropic agent. ATX code: N07AX02. Pharmacological action: Gliatilin is an original compound belonging to the group of central cholinomimetics that affects the CNS. The preparation contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. It has been established that Gliatilin has a significant positive effect on memory functions and abilities, as well as on emotional state and performance indicators that have deteriorated due to the development of involutional pathology of the brain. The mechanism of action is based on the following: after entering the body, choline alphoscerate is broken down by enzymes into choline and glycerophosphate: choline participates in the biosynthesis of acetylcholine (ACh) – one of the main mediators of nerve excitation; glycerophosphate is a precursor of neuronal membrane phospholipids (phosphatidylcholine). Thus, Gliatilin improves the transmission of nerve impulses in cholinergic neurons, positively affects the plasticity of neuronal membranes and receptor function. Gliatilin improves cerebral blood flow, enhances metabolic processes in the brain, activates the reticular formation of the brain, and restores consciousness in cases of traumatic brain injury. Pharmacokinetics When taken orally, on average, 88% of the administered dose is absorbed. Its elimination occurs mainly through the lungs – in the form of carbon dioxide (CO2). Approximately 15% of the preparation is excreted by the kidneys and intestines. Pharmacodynamics Experimental studies have shown that Gliatilin dose-dependently stimulates the release of acetylcholine under physiological conditions of neurotransmission. Gliatilin, on the one hand, as a choline donor, increases acetylcholine synthesis, which in turn positively affects neurotransmission; on the other hand, it is a donor of glycerophosphate, which participates in the synthesis of phosphatidylcholine (membrane phospholipid), resulting in improved membrane elasticity and receptor function, which positively affects synaptic transmission. Indications for use - Acute period of craniocerebral trauma, mainly in case of brainstem damage (loss of consciousness, comatose state, focal hemispheric symptomatology, symptoms of brainstem damage). - Degenerative or involutional psychoorganic syndromes, resulting from cerebrovascular disorders, such as: primary or secondary cognitive impairments in the elderly, characterized by memory impairment, confusion, disorientation. - Decreased motivation and initiative, reduced attention span, changes in behavior and emotional state: emotional lability, irritability, lack of interest. - Pseudodementia in the elderly. Contraindications Established individual hypersensitivity to the preparation. Pregnancy and lactation The use of the preparation during pregnancy and lactation is contraindicated. Side effects Effect on the ability to drive vehicles It does not affect the ability to drive a car or other vehicles. Method of administration and dosage In acute conditions, Gliatilin is administered intramuscularly or intravenously (slowly) at a dose of 1.0 g (1 ampoule) per day. In chronic cerebrovascular insufficiency and dementia syndromes, Gliatilin is prescribed 2-3 times a day at a dose of 400 mg (1 capsule), preferably before meals. The duration of treatment is 3-6 months. Interaction with other medicinal products: Not identified. Dosage form Gliatilin solution for injection: The package contains 3 ampoules of 4 ml each (1000 mg of the preparation per ampoule). Ampoules in a plastic container and instructions for use are placed in a cardboard box. Gliatilin capsules: The package contains 14 capsules in a PVC/aluminum blister and is placed in a cardboard package along with instructions for use. Shelf life: Ampoules – 5 years. Capsules – 3 years. Storage conditions Store at a temperature not exceeding 25°C Keep out of reach of children! Dispensed from pharmacies by prescription Manufacturer: Italfarmaco, Italy "ITALFARMACO" S.p.A. V.le Fulvio Testi, 330, 1-20126 Milano – Italy