Ciaxon 500

Ciaxon 500

citicoline

Manufacturer:

Mepro Pharma

Distributor:

Royal Distribution

Marketer:

ESTI Pharma
Full Prescribing Info
Contents
Citicoline.
Description
Each film-coated tablet contains: 500 mg of citicoline.
Excipients/Inactive Ingredients: Corn starch, lactose monohydrate, povidone, crospovidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), propylene glycol, iron oxide (E 172), isopropyl alcohol, dichloromethane.
Action
Pharmacotherapeutic group: Psychostimulants. agents used in attention deficit hyperactivity disorder (ADHD), and nootropic agents. ATC code: NO6B X06.
Pharmacology: Pharmacodynamics: Citicoline stimulates the biosynthesis of structural phospholipids in the neuronal membrane, which improves the function of membranes, including the operation of ion exchange pumps and neuroreceptors. Due to the stabilizing effect on the membrane citicoline has decongestant properties and reduces cerebral edema. Citicoline weakens the severity of symptoms associated with cerebral dysfunction after pathological processes such as traumatic brain injury and acute cerebrovascular accident. Citicoline reduces amnesia, improves the state in cognitive, sensitive and motor disorders. Citicoline improves symptoms experienced during hypoxia and ischemia of the brain, including memory loss, emotional lability, difficulties in performing everyday work and self service.
Pharmacokinetics: Whereas citicoline is a natural compound found in the body, classical pharmacokinetic studies cannot be performed due to the difficulty of quantitative determination of exogenous and endogenous citicoline. Bioavailability studies have shown that the bioavailability of oral and parenteral route of administration are virtually identical. There was almost complete absorption of citicoline in pharmacokinetic study. Excretion is very slow, mainly through the respiratory tract and the urine. After 5 days of use, approximately 16% of the dose was found, suggesting that the remaining dose was included in metabolism.
Indications/Uses
Acute phase of cerebral blood flow obstruction (stroke).
Treatment of complications and consequences of impaired cerebral circulation.
Head injury and its consequences. Cognitive, sensory, motor, and neurological disorders caused by cerebral pathology of degenerative and vascular origin.
Dosage/Direction for Use
The recommended dose is from 500 to 2000 mg per day.
At doses of 500 mg: 1 to 4 tablets per day.
Dose and duration of treatment depends on the severity of brain damage and are stated by physician.
Elderly patients do not require dosage adjustment.
Overdosage
Taking into consideration low toxicity of the drug, the cases are not described, even in cases of excess administration of therapeutic doses.
Contraindications
Increased sensitivity to the drug; patients with a high tone of the parasympathetic nervous system.
Special Precautions
Use in children: No sufficient data on Citicoline use in children, so it should not be prescribed in this age group of patients.
Effects on ability to drive or operate machinery: In individual cases, some adverse reactions of central nervous system may affect the ability to drive a car or operate complex machinery. It is not recommended to drive a car or operate complex machinery.
Use In Pregnancy & Lactation
Although there were no evidences of risk to the fetus during drug administration, the drug is prescribed during pregnancy only when the expected benefit exceeds the potential risk.
Data on penetration of citicoline in breast milk and its effects on the fetus are unknown.
Adverse Reactions
Adverse reactions are very rare (<1/10,000), including isolated reports.
Central nervous system: hallucinations, headache, dizziness.
Cardiovascular system: hypertension, hypotension.
Respiratory system: dyspnoea.
Gastro-intestinal tract: nausea, vomiting, diarrhea.
Skin and subcutaneous tissue disorders: skin redness, urticaria, eczema.
General disorders: tremor, edema.
Drug Interactions
Citicoline enhances the effect of levodopa.
It should not be taken simultaneously with drugs that contain meclofenoxate.
Storage
Store below 30°C in a dry place. Protect from light.
Shelf-Life: 2 years.
ATC Classification
N06BX06 - citicoline ; Belongs to the class of other psychostimulants and nootropics.
Presentation/Packing
FC tab 500 mg x 3 x 10's.
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