Composition:

Each 4 ml ampoule contains:

Citicoline 500 mg (as sodium salt).

Excipients: Sodium hydroxide or HCl and water for injection.

Solution for IM, Slow IV Injection or IV Infusion.

Pharmacodynamics:

Fortamind, citicoline, 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 neurotransmission.

Due to its membrane stabilizing effect, citicoline has cerebral anti-edematous properties. 

Clinical trials have demonstrated that Fortamind improves the symptoms associated with cerebral dysfunction following cranio-encephalic traumatisms and acute cerebrovascular accidents. 

Fortamind improves the level of attention and consciousness, amnesia, cognitive, sensory and motor disorders associated with these pathologies.

Therapeutic Indications:

Fortamind 500 mg ampoules are indicated for the treatment of:

Acute and sub-acute cerebro-vascular accidents.

Recent head traumatisms and their sequelae.

Dosage and Administration:

Fortamind 500 mg ampoules: 1-4 ampoules/day for six weeks depending on the seriousness of the condition to be treated.

Norms for proper administration of the preparation:

Fortamind 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). 

Fortamind is compatible with all intravenous isotonic solutions: it can also be mixed with hypertonic glucose solution.

Overdose :

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.

Drug-Drug Interactions:

Co-administration of citicoline with medicaments containing meclofenoxate is not recommended.

Citicoline potentiates the effects of L-Dopa.

Precautions:

In case of persistent intracranial hemorrhage, the dose of 1000 mg/day of Fortamind is not to be exceeded; very slow intravenous administration is recommended (30 drops/minute).

Pregnancy and lactation:

Although animal studies did not demonstrate any teratogenic effects, yet there are no available data for the use of citicoline in pregnant women, those suggested to be pregnant or during lactation therefore the drug should be administered only in cases where the benefit outweighs the potential risk.

Contraindications:

Parasympathetic hypertonia.

Known allergy to citicoline.

Adverse Reactions:

Occasionally, citicoline may exert parasympathetic stimulating effect, as well as mild and transient hypotensive effect.

Presentation & Storage:

Fortamind 500 mg ampoules are supplied in boxes of 5 transparent (Type I) glass ampoules of 4 ml solution each.