ULTRAZIN [Citicoline] 100 mg/1 ml Oral solution
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instructions for the medical use of
the medicinal product
ULTRAZIN
Tradename
Ultrazin, Ультразин
International non-proprietary name or generic name
Citicoline,
Цитиколин
Dosage form
Solution
for oral administration.
Composition per 1 ml of solution:
active
substance: citicoline 100 mg;
excipients: 70% sorbitol, glycerin, propylparaben, potassium sorbate, sucralose,
methylparaben, sodium citrate, anhydrous citric acid, cherry flavor, Ponceau 4R
dye, purified water.
Nootropic
medicine.
АТХ Code: N06BX06
Pharmacodynamics
Citicoline,
being a precursor of key ultrastructural components of the cell membrane (mainly
phospholipids), has a wide spectrum of action: it promotes the restoration of
damaged cell membranes, inhibits the action of phospholipases, preventing
excessive formation of free radicals, and prevents cell death by affecting the
mechanisms of apoptosis. In the acute period of stroke, it reduces the volume
of damaged tissue, improves cholinergic transmission. In traumatic brain
injury, it reduces the duration of post-traumatic coma and the severity of
neurological symptoms. Citicoline improves symptoms observed during hypoxia:
memory impairment, emotional lability, lack of initiative, difficulties in
performing everyday activities and self-care. It is effective in the treatment
of cognitive, sensory and motor neurological disorders of degenerative and
vascular etiology.
Citicoline is well absorbed when
taken orally. Absorption after oral administration is almost complete, and
bioavailability is approximately the same as after intravenous administration.
The drug is metabolized in the intestine and liver to form choline and
cytidine. After administration, the concentration of choline in the blood
plasma increases significantly. Citicoline is largely distributed in the
structures of the brain, with the rapid introduction of the choline fraction
into structural phospholipids and the cytidine fraction into cytidine
nucleotides and nucleic acids. Citicoline penetrates the brain and actively
integrates into cellular, cytoplasmic and mitochondrial membranes,
participating in the construction of the phospholipid fraction. Only 15% of the
administered dose of citicoline is excreted from the human body: less than 3% -
by the kidneys and through the intestine, and about 12% - with exhaled CO2.
• acute period of
ischemic stroke (as part of complex therapy);
• recovery period
of ischemic and hemorrhagic strokes;
• traumatic brain
injury (TBI), acute (as part of complex therapy) and recovery period;
• cognitive and
behavioral disorders in degenerative and vascular diseases of the brain.
Contraindications
• hypersensitivity
to any of the components of the drug;
• severe vagotonia
(predominance of the tone of the parasympathetic part of the autonomic nervous
system);
• children under
18 years of age.
Method of administration and dosage
Solution for oral
administration. Take during meals or between meals. Before use, the drug can be
diluted in a small amount of water (120 ml or 1/2 cup).
Recommended dosage
regimen
Acute period of
ischemic stroke and traumatic brain injury (TBI):
1000 mg (10 ml) every
12 hours.
Duration of treatment
is at least 6 weeks.
Recovery period of
ischemic and hemorrhagic strokes, recovery period of TBI, cognitive and
behavioral disorders in degenerative and vascular diseases of the brain:
500-2000 mg per
day (5-10 ml 1-2 times per day).
When prescribing
the drug to elderly patients, no dose adjustment is required.
Instructions for
use of the dosing syringe supplied with the bottle:
1. Place the dosing syringe into the bottle.
2. Gently pull the plunger of the dosing syringe until the solution
level is level with the corresponding mark on the syringe.
3. It is recommended to rinse the dosing syringe with water after each
use.
Special instructions and precautions
Consult
a doctor before using the drug.
In
the cold, a small amount of crystals may form due to partial crystallization of
the preservative. With further storage under the recommended conditions, the
crystals dissolve. The presence of crystals does not affect the quality of the
drug.
Influence on the ability to
drive vehicles and mechanisms
During treatment,
caution should be exercised when performing potentially hazardous activities
that require special attention and quick reactions.
Use during pregnancy and breastfeeding
Use during pregnancy
is possible only if the expected benefit to the mother outweighs the potential
risk to the fetus.
If use during
lactation is necessary, the issue of stopping breastfeeding should be resolved.
From the nervous system: headache, dizziness, tremor,
numbness in paralyzed limbs, hallucinations, insomnia, agitation.
From the cardiovascular system: arterial hypotension, arterial hypertension.
From the respiratory system, chest organs and
mediastinum: shortness of breath.
From the digestive system: decreased appetite, nausea, vomiting, diarrhea.
From the immune system: anaphylactic
shock.
From the skin and subcutaneous tissues: hyperemia, purpura, urticaria, rash, skin itching.
If any of the side effects listed in the instructions
worsen, or you notice any other side effects not listed in the instructions,
tell your doctor.
Interaction with
other medicinal products
Citicoline enhances the
effects of levodopa.
Should not be used
simultaneously with drugs containing meclofenoxate.
Given the low toxicity
of the drug, cases of overdose have not been described. In case of accidental
overdose, treatment is symptomatic.
Store
at a temperature not exceeding 30°C.
Keep
out of reach of children!
2
years. Do not use after the expiration date stated on the package.
Dispensed
by prescription.
30 ml of solution with a measuring syringe together with instructions for use in a cardboard box.