Instructions for Somazin oral solution 100 mg/ml bottle 30 ml
Composition
active ingredient: citicoline (as sodium salt);
1 ml of solution contains citicoline in the form of sodium salt 100 mg;
excipients: sorbitol (E 420), glycerin, methylparaben (E 218), propylparaben (E 216), sodium citrate, sodium saccharin, strawberry essence 1487-S, potassium sorbate, citric acid (adjustment to pH 6), purified water.
Dosage form
Solution for oral use.
Main physicochemical properties: clear and colorless to slightly yellowish solution.
Pharmacotherapeutic group
Other psychostimulants and nootropics.
ATX code N06B X06.
Pharmacological properties
Pharmacodynamics
Citicoline stimulates the biosynthesis of structural phospholipids of neuronal membranes, which is confirmed by magnetic resonance spectroscopy. Citicoline improves the functioning of membrane mechanisms such as ion pumps and receptors, without the regulation of which normal conduction of nerve impulses is impossible. Due to its stabilizing effect on the neuronal membrane, citicoline exhibits anti-edematous properties that contribute to the reabsorption of brain edema.
Clinical studies have shown that citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reducing the formation of free radicals, preventing the destruction of membrane systems, and preserving antioxidant defense systems such as glutathione.
Citicoline preserves neuronal energy reserves and inhibits apoptosis, which improves cholinergic transmission.
It has been experimentally proven that citicoline also has a preventive neuroprotective effect in focal cerebral ischemia.
Clinical studies have shown that citicoline significantly increases functional recovery rates in patients with acute stroke, which coincides with a slowdown in the growth of ischemic brain damage according to neuroimaging data. In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and intensity of post-traumatic syndrome.
Citicoline improves the level of attention and consciousness, helps reduce the manifestations of amnesia, cognitive and other neurological disorders associated with cerebral ischemia.
Pharmacokinetics
Citicoline is well absorbed after oral, intramuscular and intravenous administration. Plasma choline levels increase significantly after administration by the above routes. Absorption after oral administration is almost complete and bioavailability is almost the same as after intravenous administration.
Depending on the route of administration, the drug is metabolized in the intestine, liver to choline and cytidine. After administration, citicoline is widely distributed in brain structures with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. Having reached the brain, citicoline is incorporated into cellular, cytoplasmic and mitochondrial membranes, participating in the construction of the phospholipid fraction.
Only a small amount of the dose is excreted in the urine and feces (less than 3%). Approximately 12% of the dose is excreted in exhaled CO2. There are two phases in the excretion of the drug in the urine: the first phase is approximately 36 hours, in which the rate of excretion decreases rapidly, and the second phase, in which the rate of excretion decreases much more slowly. The same phasic nature is observed in the excretion of CO2, the rate of excretion of exhaled CO2 decreases rapidly after about 15 hours, then it decreases much more slowly.
Indication
- Stroke, acute phase of cerebrovascular disorders and treatment of complications and consequences of cerebrovascular disorders.
- Traumatic brain injury and its neurological consequences.
- Cognitive and behavioral disorders due to chronic vascular and degenerative cerebral disorders.
Contraindication
Hypersensitivity to any component of the drug. Increased tone of the parasympathetic nervous system.
Interaction with other medicinal products and other types of interactions
The drug should not be used simultaneously with drugs containing meclofenoxate. Enhances the effect of levodopa.
Application features
Patients with hereditary fructose intolerance should not take Somazin®, oral solution, as the preparation contains sorbitol. Methylparaben (E 218) and propylparaben (E 216), which are contained in the preparation, may cause allergic reactions (usually delayed).
Use during pregnancy or breastfeeding
There are no adequate data on the use of Somazina® in pregnant women. There are no data on the excretion of citicoline into breast milk and its effect on the fetus. Therefore, during pregnancy or breastfeeding, the drug should be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus.
Ability to influence reaction speed when driving vehicles or other mechanisms
In some cases, some adverse reactions from the central nervous system may affect the ability to drive or operate complex machinery.
Method of administration and doses
Internally. The recommended dose for adults is from 500 mg (5 ml) to 2000 mg (20 ml) per day, divided into 2-3 doses. Take regardless of meals.
The drug, pre-mixed with a small amount of water, should be taken using a dosing syringe. The dosing syringe should be rinsed with water after each use.
The recommended dose of the drug in sachets is 1-2 sachets (10-20 ml) per day, depending on the severity of the disease. The drug should be taken directly from the sachet or mixed with a small amount of water.
The dosage of the drug and the duration of treatment depend on the severity of the brain lesions and are determined individually by the doctor.
Elderly patients do not require dose adjustment.
Children
Experience with the use of the drug in children is limited.
Overdose
Cases of overdose have not been described.
Adverse reactions
Very rare (<1/10,000) (including patient reports).
From the side of the central and peripheral nervous systems: severe headache, vertigo, hallucinations.
From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.
Respiratory system: shortness of breath.
On the part of the digestive system: nausea, vomiting, diarrhea.
On the part of the immune system: allergic reactions, including: rash, hyperemia, exanthema, urticaria, purpura, itching, angioedema, anaphylactic shock.
General reactions: chills.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Do not freeze or refrigerate. During storage, a slight opalescence may occur, which disappears when the product is kept at room temperature (≈20 °C).
Keep out of reach of children.
Incompatibility
Not installed.
Packaging
30 ml of the drug in a bottle; 1 bottle and a dosing syringe in a cardboard box.
10 ml in a sachet; 6 or 10 sachets in a cardboard box.
Vacation category
According to the recipe.
Producer
Ferrer International, S.A., Spain.
Location of the manufacturer and its business address
Legal address
Gran Via Carlos III, 94, 08028 Barcelona, Spain.
Place of production
s/Joan Buscaya, 1-9, 08173 Sant Cugat del Bayes (Barcelona), Spain.
