Somazina

Somazina

citicoline

Manufacturer:

Ferrer

Distributor:

DKSH
/
Agencia Lei Va Hong

Marketer:

Eisai
Full Prescribing Info
Contents
Citicoline (as sodium salt).
Description
Each ml contains 100 mg of citicoline (as sodium salt).
Excipients/Inactive Ingredients: Each ml of solution contains: 0.005 mg of Ponceau 4-R red colour; 0.4 mg of propyl parahydroxybenzoate; 1.6 mg of methyl parahydroxybenzoate; 200 mg of sorbitol and other excipients in q.s.
Sodium saccharin (E-954), Liquid sorbitol (E-420), Glycerol (E-422), Methyl parahydroxybenzoate (E-218), Propyl parahydroxybenzoate (E-217), Sodium citrate (E-331), Glycerol formal, Potassium sorbate (E-202), Strawberry essence, Ponceau 4-R red colour (E-124), Citric acid (E-330), Purified water.
Action
Pharmacotherapeutic group: Other psychostimulants and nootropics. ATC code: N06BX06.
Pharmacology: Pharmacodynamics: Citicoline stimulates the biosynthesis of structural phospholipids of the neuronal membrane as it is demonstrated in the magnetic resonance spectroscopy studies. Citicoline, through its action, improves the function of the membrane mechanisms, such as the functioning of the ionic exchange pumps and receptors inserted in the latter, the modulation of which is indispensable in the neurotransmission.
Citicoline due to its membrane stabilizing activity has properties which favour brain oedema reabsorption.
Experimental studies have shown that Citicoline inhibits the activation of some phospholipases (A1, A2, C and D), reducing the formation of free radicals, avoiding the destruction of membranous systems and preserving antioxidant defence systems as glutathione.
Citicoline preserves the neuronal energetic reserve, inhibits apoptosis and stimulates acetylcholine synthesis.
It has been experimentally shown that Citicoline also exerts a prophylactic neuroprotective effect in focal brain ischemic models.
Clinical trials have shown that Citicoline significantly increases the functional evolution of patients with acute ischemic cerebrovascular accident, coinciding with a lower growth of the brain ischemic injury in neuroimaging tests.
In patients with craniocerebral traumatisms, citicoline speeds up their recuperation and reduces duration and intensity of the post-concussional syndrome.
Citicoline improves the level of attention and consciousness and acts favourably over amnesia and cognitive and neurological disorders associated to brain ischemia.
Pharmacokinetics: Citicoline is well absorbed after oral, intramuscular or intravenous administration. Plasma choline levels significantly increase after the aforementioned routes. Oral absorption is nearly complete and its bioavailability is approximately the same as the intravenous route. The medication is metabolized in the intestine and in the liver to choline and cytidine. The administered citicoline is widely distributed in brain structures, with a quick incorporation of the choline fraction in structural phospholipids and the cytidine fraction in cytidinic nucleotides and nucleic acids. Citicoline reaches the brain and it is actively incorporated to cellular, cytoplasmatic and mitochondrial membranes, taking part of the structural phospholipids fraction.
Only a small amount of the dose appears in urine and faeces (less than 3%). Approximately 12% of the dose is eliminated via expired CO2. In the urinary excretion of the medication, two phases can be distinguished: a first phase, around 36 hours, where the excretion speed rapidly decreases, and a second phase where excretion speed decreases much slower. The same happens with expired CO2, the elimination speed rapidly decreases after approximately 15 hours and later it decreases much slower.
Toxicology: Preclinical safety data: Oral and intraperitoneal chronic toxicity studies (1.5 g/kg/day during 6 months in dogs) did not show significant abnormalities related with the administration of the medication. Intravenous administration of 300-500 mg/kg/day of citicoline during 3 months in dogs, only produced toxic signs immediately after the injection, such as occasional vomiting, diarrhea and hyper-salivation.
800 mg/kg of Citicoline was administered to albino rabbits during the organogenesis phase, from 7th to 18th gestation day. The animals were sacrificed the 29th day and a detailed exam of foetus and their mothers was carried out. No toxicity sign were observed neither maternal nor embryo-foetal. The effects over organogenesis were inappreciable, only 10% of the treated foetus has a slight delay in brain osteogenesis.
Indications/Uses
Treatment of cognitive and neurological disorders associated with acute and sub-acute stroke.
Treatment of cognitive and neurological disorders associated with traumatic brain injuries.
Dosage/Direction for Use
Posology: Adults: The recommended dose is from 500 to 2,000 mg/day, depending on the severity of the symptoms to be treated.
Elderly: SOMAZINA does not need any specific dose adjustment for this age group.
Children: The experience in children is limited; therefore, it may only be administered when the expected therapeutic benefit is higher than any possible risk.
Method of administration: It may be taken directly or dissolved in half glass of water (120 ml).
See the instructions for preparation in Cautions for Usage.
Overdosage
No case of overdose has been reported.
Contraindications
In case of allergy to Citicoline or any excipient.
It must not be administered to patients with hypertonia of the parasympathetic.
Special Precautions
Due to Ponceau 4-R red colour (or E-124), it may cause allergic reactions.
It may cause asthma, especially in patients with allergy to acetylsalicylic acid.
SOMAZINA contains Sorbitol (E-420) as excipients, because of that patients with rare hereditary problems of fructose intolerance should not take this medication.
SOMAZINA contains Propyl parahydroxybenzoate (E-217) and Methyl parahydroxybenzoate (E-218) as excipients, because of that it may cause allergic reactions (possibly delayed).
Effects on the ability to drive and use machines: SOMAZINA has no influence on the ability to drive and use of machines.
Use In Pregnancy & Lactation
There are no adequate data from the use of Citicoline in pregnant women.
SOMAZINA should not be used during pregnancy unless clearly necessary. That is, only when the expected therapeutic benefit is higher than any possible risk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Adverse Reactions
Very rare (<1/10,000) (including individual notifications): Psychiatric disorders: hallucinations.
Nervous system disorders: cephalea, vertigo.
Vascular disorders: arterial hypertension, arterial hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
Gastrointestinal disorders: nausea, vomiting, occasional diarrhoea.
Skin and subcutaneous tissue disorders: blush, hives, exanthemas, purpura.
General disorders and administration site conditions: shiver, oedema.
Drug Interactions
Citicoline potentiates the effects of the medication containing L-Dopa.
It should not be administered concomitantly with medication containing Meclofenoxate.
Caution For Usage
Special precautions for disposal and other handling: Handling instructions for the medication are the following: The product is administered with the aid of the dosing syringe, according to the following scheme: 1) Introduce the dosing syringe with the piston pressing to the bottom.
2) Aspirate the indicated dose making the piston turn, taking into account that the liquid contained in the syringe coincides exactly with the prescribed level.
3) Administer the preparation directly or dissolved in half glass of water (120 ml).
After each administration, it is recommended to wash the dosing syringe with water.
Incompatibilities: Not applicable.
Storage
Store below 30°C.
ATC Classification
N06BX06 - citicoline ; Belongs to the class of other psychostimulants and nootropics.
Presentation/Packing
Oral soln 100 mg/mL (transparent and pink-coloured liquid, with strawberry smell and taste) x 30 mL x 1's.
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