Tradename
Somazina
Generic Name
Citicoline
Category
Cardiovascular System
Form
Ampoule
Composition
Each ampoule contains:
Citicoline (INN) (sodium salt).........500 mg
Water for injection...............q.s.........4 ml
Description
Properties/Actions
Somazina stimulates the biosynthesis of the structural phospholipids of the neuronal membranes, and thus improves the function of the membrane mechanisms (e.g. the functioning of the ion exchange pumps and membrane receptors); this improvement is essential for proper neuro-transmission. Due to its membrane stabilizing effect, Somazina has cerebral anti-edematous properties. Clinical trials have demonstrated that Somazina improves the smyptoms associated with cerebral dysfunction following cranio-encephalic traumatisms and acute cerebrovascular accidents. Somazina improves the level of attention and consciousness, amnesia, cognitive, sensory and motor disorders associated with these pathologies.
Indications
Somazina 500 mg ampoules are indicated for the treatment of:
  • Acute and sub-acute cerebrovascular accidents.
  • Recent head traumatisms and their sequence.
Contraindications
Drug Interactions
The following drug-drug interactions have proved relevant:
  • Coadministration of Citocoline with medicaments containing Meclofenoxate is not recommended.
  • Citocoline potentiates the effects of L-dopa.
Side Effects/Adverse Effects
Occasionally, Citicoline may exert a parasympathomimetic stimulating effect, as well as, a mild and transient hypotensive effect.
Pregnancy & Lactation
Although animal studies did not demonstrate any teratogenic effects, yet there are no available data for the use of Citocoline in pregnant women.
In women suggested to be pregnant or during lactation, the drug should be administered only in cases where the benefit outweighs the potential risk.
Dosage & Administration
The usual dose is 1-4 ampoules/day for six weeks depending on the seriousness of the condition to be treated.
Somazina 500 mg ampoules can be administered by intramuscular or slow (3 to 5 minutes) intravenous route or by intravenous infusion (dripping speed: 40-60 drops per minute). Somazina is compatible with all intravenous isotonic solutions; it can also be mixed with hypertonic glucose solution.
Overdosage
In reference to the scarce toxicity of the preparation, the appearance of poisoning is not foreseen, even in those who have accidentally exceeded the therapeutic doses.
Warnings
In case of persistent intracranial hemorrhage, the dose of 1000 mg/day of Somazina is not to be exceeded.
Very slow intravenous administration is recommended (30 drops/minute).
Notes
To open the ampoules:
  1. Hold the ampoule well.
  2. Push downwards to break the top off.
Storage
Store at room temperature (below 30°C).
Packaging
Boxes of 5 (IV/IM) ampoules.
Manufacturer
Ferrer Internacional
Date Added/Updated
7th October 2011 2:11 am
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