Citikon

Citikon

citicoline

Manufacturer:

Galenicum Health

Distributor:

PML Pharma
Full Prescribing Info
Contents
Citicoline.
Description
Each 1 sachet contains: Citicoline Sodium equivalent to Citicoline 1000 mg, Excipients, q.s.
Excipients/Inactive Ingredients: Sorbitol liquid, Glycerol, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Potassium Sorbate, Saccharin Sodium, Glycerol formal, Ponceau 4R [E-124], Anhydrous Citric acid, Sodium citrate, Strawberry Flavour PHL-142951, Purified Water.
Action
Citicoline is a biological product incorporating to the biochemical processes of formation of upper lipids taking part in the structures of the cellular membranes and, more specifically of the membranes of the brain neurons.
When it is administered externally it behaves in the same way as biological citicoline. As a consequence of its pharmacodynamics, the pharmacokinetics of citicoline does not adapt to the traditional kinetic patterns with a maximum of absorption an established half life and short elimination times.
As the organism has a content in biological citicoline it is hard to evaluate the levels in biological fluids and vital organs unless radioactively labeled product is administered.
In Spain and other European countries it is forbidden to administer radioactively products to human individuals.
However, a pilot test was performed with humans in a research center in UK. This test along with the tests performed in animals allows to establish that citicoline independently from the route of administration, oral or injectable, splits, there is a resynthesis at hepatic level and arrives to the brain by incorporating itself into the neuronal membranes.
The absence of radioactivity in the feces is checked, which indicates that the absorption is complete.
The elimination is chief by urinary and respiratory route, very slowly. 5 days after its administration only 16% of the administered dose is eliminated.
Indications/Uses
Stroke, Acute phase and its neurological sequelae.
Traumatic brain injury and it neurological sequelae.
Cognitive and behavioural impairment secondary to chronic vascular and and degenerative cerebral disorders.
Dosage/Direction for Use
Recommended dose: Adult: The usual dosage is from 500-2,000 milligrams daily, depending on the severity of the symptoms to be treat.
Elderly: Citicoline does not need any specific dose adjustment for elderly.
Children: Citicoline has not been adequately controlled in children, therefore. It should only be administered when the doctor considers its necessary only.
Mode of administration: Can be administered citicoline directly or dissolve it in half a glass of water (120 mL) and drink it with or between the meals.
Overdosage
There are no case report of overdose.
Contraindications
Must not be administered to patients with hypertonia of the parasympathetic or in case of previous hypersensitivity to citicoline.
Special Precautions
This product contain the inactive ingredients, which may cause allergic reactions or other problem in some patients.
(1) Ponceau 4R may cause asthma, especially in patients allergic to acetylsalicylic acid.
(2) Methyl and propyl parahydroxybenzoates may cause allergic reactions (possibly delayed).
(3) Sorbitol should not be administered in patients with rare hereditary problems of fructose intolerance.
Use In Pregnancy & Lactation
No clinical studies in pregnancy and lactation. So citicoline must not be administered in pregnancy or lactation, unless the doctor considers it necessary.
Adverse Reactions
The undesirable effects of citicoline are very rare (< 1/10,000) (include individual notifications): (1) Psychiatric disorders: hallucinations.
(2) Nervous system disorders: cephalea, vertigo.
(3) Vascular disorders: changes in arterial pressure.
(4) Respiratory, thoracic and mediastinal disorders: dyspnoea.
(5) Gastrointestinal disorders: nausea, vomiting, occasional diarrhoea.
(6) Skin and subcutaneous tissue disorders: blush, hives, exanthemas, purple.
(7) General disorders and administration site conditions: shiver, oedema.
Drug Interactions
Must not be administered along with medicaments containing meclofenoxate.
Citicoline reinforces the effects of L-Dopa.
Storage
Store below 30°C.
MIMS Class
Other CNS Drugs & Agents for ADHD
ATC Classification
N06BX06 - citicoline ; Belongs to the class of other psychostimulants and nootropics.
Presentation/Packing
Form
Citikon oral soln 1,000 mg
Packing/Price
10 mL x 10 × 1's
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