Somazina®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOMAZINA® (SOMAZINA®)

Composition:

Active substance: citicoline (as sodium salt);

One ampoule (4 ml) of solution contains citicoline (as sodium salt) 500 mg or 1000 mg;

Excipients: hydrochloric acid concentrated or sodium hydroxide for pH adjustment, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear, colorless, odorless solution, free from particles.

Pharmacotherapeutic group.

Agents acting on the nervous system. Psychoanaleptics. Psychostimulants, agents used in attention deficit hyperactivity disorder (ADHD) and nootropic agents. Other psychostimulant and nootropic agents. Citicoline.

ATC Code N06BX06.

Pharmacological Properties.

Pharmacodynamics.

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Citicoline improves the functioning of membrane mechanisms such as ion pumps and receptors, the proper regulation of which is essential for normal nerve impulse conduction. Due to its stabilizing effect on neuronal membranes, citicoline exhibits anti-edematous properties that promote 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, thereby enhancing cholinergic transmission.

Experimental evidence has demonstrated that citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Clinical studies have shown that citicoline significantly improves functional recovery rates in patients with acute cerebrovascular disorders, which correlates with a slowing of ischemic brain lesion progression as observed in neuroimaging. In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness and helps reduce symptoms of amnesia, cognitive deficits, and other neurological disorders associated with cerebral ischemia.

Pharmacokinetics.

Citicoline is well absorbed following oral, intramuscular, and intravenous administration. Plasma choline levels increase significantly after administration by these routes. Absorption after oral administration is nearly complete, and bioavailability is practically equivalent to that achieved with intravenous administration.

Depending on the route of administration, the drug is metabolized in the intestine and liver into choline and cytidine. After administration, citicoline is widely distributed into brain structures, with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. Upon reaching the brain, citicoline integrates into cellular, cytoplasmic, and mitochondrial membranes, participating in the formation of phospholipid fractions.

Only a small amount of the dose is excreted in urine and feces (less than 3%). Approximately 12% of the dose is excreted as exhaled CO₂. The excretion of the drug in urine occurs in two phases: the first phase lasts approximately 36 hours, during which the excretion rate rapidly decreases, and the second phase, in which the excretion rate declines much more slowly. A similar biphasic pattern is observed in excretion as exhaled CO₂, with the rate of CO₂ excretion rapidly decreasing after approximately 15 hours, followed by a much slower decline.

Clinical characteristics.

Indications.

• Stroke, acute phase of cerebral circulation disorders and treatment of complications and consequences of cerebral circulation disorders.
• Traumatic brain injury and its neurological consequences.
• Cognitive and behavioral disorders due to chronic cerebrovascular and degenerative cerebral disorders.

Contraindications.

Hypersensitivity to any component of the drug.

Increased parasympathetic nervous system tone.

Interaction with other medicinal products and other forms of interactions.

The drug should not be used simultaneously with preparations containing meclofenoxate. Enhances the effect of levodopa.

Special precautions for use.

In case of persistent intracranial hemorrhage, the dose should not exceed 1000 mg per day and the intravenous infusion rate should not exceed 30 drops per minute.

This medicinal product contains 4 mmol (91.76 mg)/dose of sodium. Caution should be exercised when administering this drug to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding.

There are insufficient data on the use of Somazina® in pregnant women. Data on the excretion of citicoline in breast milk and its effects on the fetus are lacking. Therefore, during pregnancy or breastfeeding, the drug should be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus.

Ability to influence reaction rate while driving or operating machinery.

In individual cases, certain adverse reactions from the central nervous system may affect the ability to drive or operate machinery.

Method of Administration and Dosage

The drug is intended for intravenous or intramuscular administration. For intravenous use, it is administered as a slow intravenous injection (over 3–5 minutes, depending on the prescribed dose) or by intravenous infusion (40–60 drops per minute).

The recommended dose for adults is 500–2000 mg/day, depending on the severity of the patient's condition.

The maximum daily dose is 2000 mg.

In acute and emergency conditions, maximum therapeutic effect is achieved when the drug is administered within the first 24 hours.

The duration of treatment depends on the course of the disease and is determined by the physician.

Dosage adjustment is not required for elderly patients.

The drug is compatible with all isotonic intravenous solutions, as well as hypertonic glucose solutions.

This solution is intended for single use only. The solution should be administered immediately after opening the ampoule. Any unused solution must be discarded.

If necessary, treatment may be continued with the drug in the form of an oral solution.

Children.

Experience with the use of the drug in children is limited; therefore, the medicinal product should be prescribed only when the expected benefit outweighs any potential risk.

Overdose.

Cases of overdose have not been reported.

Adverse reactions.

Very rare (<1/10,000) (including patient reports).

Central and peripheral nervous system disorders: severe headache, vertigo, hallucinations.

Cardiovascular disorders: arterial hypertension, arterial hypotension, tachycardia.

Respiratory system disorders: dyspnea.

Gastrointestinal disorders: nausea, vomiting, diarrhea.

Immune system disorders: allergic reactions, including: rash, hyperemia, exanthema, urticaria, purpura, pruritus, angioedema, anaphylactic shock.

General disorders: chills, reactions at the injection site.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 30 °C.

Keep out of the reach of children.

Incompatibility.

Do not use solvents not specified in the section "Instructions for use and dosage".

Packaging.

500 mg/4 ml: 5 ampoules in a blister pack; 1 blister pack in a cardboard box.

1000 mg/4 ml: 5 ampoules in a blister pack; 1 or 2 blister packs in a cardboard box.

Prescription category. Prescription only.

Manufacturer.

Ferrer Internacional, S.A., Spain.

Manufacturer's location and address of the place of business activity.

Legal address:

Gran Vía Carlos III, 94, 08028 Barcelona, Spain.

Place of manufacture:

c/Joan Busquets, 1-9, 08173 Sant Cugat del Vallès (Barcelona), Spain.