ULTRAZIN [Citicoline] 500 mg Solution for intramuscular injection, intravenous injection
ULTRAZIN
instructions for medical use of the medicinal product
Tradename
Ultrazin, Ультразин
International non-proprietary name
Citicoline, Цитиколин
Composition
Ultrazine 500 mg
Each ampoule (4 ml solution) contains:
active substance: citicoline (as citicoline sodium) CP 500 mg
excipients: water for injection.
Ultrazine 1000 mg
Each ampoule (4 ml solution) contains:
active substance: citicoline (as citicoline sodium) SR 1000 mg
excipients: water for injection.
Dosage form
Solution for injection .
Pharmacotherapeutic group
Nootropic
Pharmacological properties
Pharmacodynamics
Citicoline, being a precursor of key ultrastructural components of the cell membrane (mainly phospholipids), has a wide spectrum of action - it helps to restore damaged cell membranes, inhibits the action of phospholipases, prevents excessive formation of free radicals, and also prevents cell death by acting on the mechanisms of apoptosis. In the acute period of stroke, citicoline reduces the amount of brain tissue damage, improves cholinergic transmission. In traumatic brain injury , it reduces the duration of post-traumatic coma and the severity of neurological symptoms, in addition, it helps to reduce the duration of the recovery period. In chronic hypoxia of the brain, citicoline is effective in the treatment of cognitive disorders such as memory impairment, lack of initiative, difficulties in performing daily activities and self-care. Increases the level of attention and consciousness, and also reduces the manifestation of amnesia. Effective in the treatment of sensory and motor neurological disorders of degenerative and vascular etiology.
Pharmacokinetics
After injection, the concentration of this product in the blood drops rapidly to 1/3 in 30 minutes and is basically stable for 1-2 hours. Distributed mainly in the liver, accounting for 10%.
Free choline and cytidine diphosphate are metabolized in the liver and excreted primarily by the kidneys and lungs. The half-life of the active substance is 3.5 hours, and the half-life of the main choline metabolite is 2 hours.
It is difficult for this product to pass through the blood-brain barrier, and only 0.1% of the drug reaches the brain. However, the drug remains in the brain for a long time, and its concentration peaks within 3 hours after injection and remains unchanged for 24 hours.
Moreover, the content of cytidine in the damaged brain was significantly higher than in the normal brain and the damaged hemisphere compared to the undamaged hemisphere.
Indications for use
• acute period of ischemic stroke (as part of complex therapy);
• recovery period of ischemic and hemorrhagic strokes;
• traumatic brain injury, acute (as part of complex therapy) and recovery period;
• cognitive and behavioral disorders in degenerative and vascular diseases of the brain.
Contraindications
• pronounced vagotonia (the predominance of the tone of the parasympathetic part of the autonomic nervous system);
• children and adolescents up to 18 years of age.
• hypersensitivity to citicoline.
Dosage and administration
In / in, in / m, inside.
The dosage regimen and duration of treatment are determined individually, depending on the indications and the severity of the symptoms of the disease. The maximum daily dose is 2000 mg.
In / in strokes and traumatic brain injury in the acute period - 1-2 g / day, depending on the severity of the disease for 3-7 days, followed by the transition to the / m administration or oral administration.
V / m - 0.5-1 g / day.
When taken orally - 200-300 mg 3 times / day.
Special instructions and precautions
Use with caution in patients with severe acute traumatic brain injury, accompanied by cerebral hemorrhage, cerebral edema and increased cranial pressure.
Use with caution in patients with epilepsy and hypotension.
Ultrasin should not be administered concomitantly with medicinal products containing meclofenoxate.
Influence on the ability to drive vehicles and mechanisms
During the period of treatment, patients should be careful when performing potentially hazardous activities that require special attention and speed of psychomotor reactions (including driving and other vehicles, working with
moving mechanisms, the work of the dispatcher and operator).
Use during pregnancy and during breastfeeding
During pregnancy, Ultrazin is prescribed only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. During lactation, women should stop breastfeeding.
Use during pregnancy and during breastfeeding is contraindicated.
Interaction with other drugs
Citicoline enhances the effects of levodopa.
Side effect
allergic reactions (rash, pruritus, anaphylactic shock), bradycardia, tachycardia, nausea, vomiting, loss of appetite, abdominal pain, stomach burning, diarrhea, shortness of breath, laryngeal edema, dizziness, tremor, headache, insomnia, agitation, irritability .
Overdose
Symptoms: nausea, vomiting, loss of appetite, headache, insomnia, agitation.
Treatment: symptomatic treatment.
Storage conditions
Store at temperatures below 30 0 C.
Keep out of the reach of children!
Best before date
3 years. Do not use after the expiry date stated on the package.
Holiday conditions
Released by prescription.
Release form
5 ampoules of 4 ml in a blister pack. 1 cell package together with instructions for use in a cardboard box.