Web Page: http://www.rotapharm.co.uk/
Ronocit (Injections)
(Citicoline)
CONTENT:
Ampoules. Ampoule contains citicoline (in the form of sodium salt) 500 mg or 1000 mg.
PHARMACOLOGICAL PROPERTIES:
PHARMACODINAMICS. Citicoline, being the precursor of key ultrastructural components of a cellular membrane (mainly phospholipids), possesses wide range of activities, promotes restoration of the damaged cell membranes, inhibits action of phospholipases, what prevents excessive formation of free radicals and destruction of cells, affects the mechanisms of apoptosis. In the acute period of stroke it reduces the volume of damaged tissue, improves cholinergic transmition. In head injury it reduces duration of a post-traumatic coma and intensity of neurologic symptoms. Citicoline improves observed during hypoxia symptoms, such as memory impairment, emotional liability, lack of initiative, difficulties at conducting of daily actions and self-service. The drug product does not influence breath, pulse and arterial pressure; therefore long treatment is possible. PHARMACOKINETICS. As citicoline is natural compound which is found in organism, it is impossible to provide classical pharmacokinetic research in connection with complexity of quantitative analysis of exogenous and endogenous citicoline.
THERAPEUTIC INDICATIONS:
- acute period of ischemic stroke;
- rehabilitation period after ischemic and hemorrhagic stroke;
- head injury, acute and rehabilitation period;
- cognitive abnormalities at degenerate and vascular diseases of brain.
CONTRAINDICATIONS:
- gotonia (predominance of tone of parasympathetic part of vegetative nervous system);
- children and teenage age before 18 years (in connection with absence of data);
- hypersensitivity to components of drug.
SIDE EFFECTS:
From CNS and peripheral nervous system: sleeplessness, headache, dizziness, excitation, tremor, numbness in the paralyzed limbs.
From digestive system: nausea, appetite decrease, change of activity of hepatic enzymes.
Allergic reactions: rash, skin itch, anaphylactic shock.
The others: heat; in some cases - short-term hypotensive action, stimulation of parasympathetic nervous system.
DOSAGE AND ADMINISTRATION:
Solution for intravenous and intramuscular injections
It is prescribed intravenously in the form of a bolus intravenous injection (during 5 minutes) or slow intravenous infusion (40-60 drops per minute) at strokes and head injury in acute period by 1000 - 2000 mg daily, which depends on severity of disease during 3-7 days with the subsequent change to intramuscular administration or oral administration. The intravenous way of administration is more preferable, than intramuscular.Intramuscularly: 1-2 injections per day. It is necessary to avoid repeated administration of the drug to the same place during intramuscular administration.
At long-term impairment of consciousness continuous application of a drug from the first stages of disease is possible.
At Parkinson's disease and syndromes the recommended dose of a drug is 500 mg per day during the period of treatment throughout 3-4 weeks with breaks between them.
OVERDOSAGE:
Taking into account low toxicity of the drug overdosage cases are not described, even in case of excess of therapeutic doses.
INTERACTION WITH OTHER DRUG PRODUCTS:
Citicoline strengthens effects of L-dihydroxyphenylalanine.
Ronocit can be applied simultaneously with haemostatic agents, intracranial antihypertensive agents and with usual perfusion liquids.
PACKAGING:
5 ampoules are packed into PVC contour cellular package.
1 contour cellular package in a carton box together with packaging leaflet.