Instructions for Kvanil film-coated tablets 500 mg blister No. 30
Composition
active ingredient: citicoline sodium;
1 tablet contains citicoline sodium equivalent to citicoline 500 mg;
excipients: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, Opadry 03F58750 white coating.
Dosage form
Film-coated tablets.
Main physicochemical properties: capsule-shaped, smooth tablets, coated with a white shell.
Pharmacotherapeutic group
Psychostimulants. Drugs used for attention deficit hyperactivity disorder (ADHD) and nootropics.
ATX code N06B X06.
Pharmacological properties
Pharmacodynamics
Citicoline stimulates the biosynthesis of structural phospholipids in the neuronal membrane, which is confirmed by magnetic resonance spectroscopy. Due to this mechanism of action, citicoline stimulates the functioning of ion exchange pumps and receptors, the modulation of which is necessary for the normal conduction of nerve impulses. Due to its stabilizing effect on the neuronal membrane, citicoline accelerates the reabsorption of brain edema, i.e. exhibits anti-edematous properties.
Citicoline inhibits the activation of some phospholipases (A1, A2, C and D), reduces the formation of free radicals, prevents the destruction of membrane systems and preserves protective antioxidant systems such as glutathione.
Citicoline preserves neuronal energy reserves, inhibits apoptosis, and improves cholinergic transmission by stimulating acetylcholine synthesis. Citicoline also has a prophylactic neuroprotective effect in focal cerebral ischemia.
Citicoline significantly increases the functional rehabilitation of patients with acute ischemic cerebrovascular accidents, slowing the growth of ischemic brain tissue damage according to neuroimaging data.
In traumatic brain injuries, citicoline accelerates recovery and reduces the duration and intensity of post-traumatic syndrome.
Citicoline improves the level of attention and consciousness, reduces cognitive and neurological disorders associated with cerebral ischemia, and helps reduce the manifestations of amnesia.
Pharmacokinetics
Citicoline is well absorbed when administered orally. After taking the drug, a significant increase in the level of choline in the blood plasma is observed. When administered orally, the drug is almost completely absorbed. Bioavailability is almost the same when administered orally and parenterally.
The drug is metabolized in the intestines and liver to form choline and cytidine. After administration, citicoline is absorbed by brain tissues, with cholines acting on phospholipids, cytidine on cytidine nucleoids and nucleic acids. Citicoline quickly reaches brain tissues and is actively incorporated into cell membranes, cytoplasm and mitochondria, activating the activity of phospholipids.
Only a small amount of the administered dose is excreted in the urine and feces (less than 3%). Approximately 12% of the administered dose is excreted through the respiratory tract. The excretion of the drug with urine and through the respiratory tract has two phases: the first phase is rapid excretion (with urine - during the first 36 hours, through the respiratory tract - during the first 15 hours), the second phase is slow excretion.
Indication
- Stroke, acute phase of cerebrovascular accidents and their neurological consequences.
- Traumatic brain injury and its neurological consequences.
- Cognitive and behavioral disorders due to chronic vascular and degenerative cerebral disorders.
Contraindication
- Hypersensitivity to citicoline or to any other components of the drug.
- Increased tone of the parasympathetic nervous system.
Interaction with other medicinal products and other types of interactions
Citicoline enhances the effect of levodopa. It should not be administered simultaneously with drugs containing meclofenoxate.
Application features
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Use during pregnancy or breastfeeding
There are no adequate data on the use of citicoline in pregnant women. Citicoline should not be used during pregnancy unless clearly necessary. During pregnancy, the drug should be prescribed only if the expected benefit to the mother outweighs the potential risk. Data on the penetration of citicoline into breast milk and its effect on the child are unknown.
Ability to influence reaction speed when driving vehicles or other mechanisms
In individual cases, some adverse reactions from the central nervous system may affect the ability to drive or operate complex machinery.
Method of administration and doses
The recommended dose is 500 to 2000 mg per day (1-4 tablets), depending on the severity of symptoms and the patient's condition.
The dosage of the drug and the duration of treatment are determined by the doctor.
Elderly patients do not require dose adjustment.
Experience with the drug in children is limited, so the drug should only be prescribed when the expected benefit outweighs any potential risk.
Overdose
No cases of overdose have been reported.
Adverse reactions
From the psyche: hallucinations, agitation, insomnia.
From the nervous system: severe headache, dizziness, tremor.
From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.
On the part of the respiratory system: dyspnea (shortness of breath).
On the part of the digestive tract: nausea, vomiting, stomach pain, hypersalivation, slight changes in liver function tests, episodic diarrhea.
On the part of the immune system: allergic reactions, including rash, itching, angioedema, anaphylactic shock, flushing, urticaria, exanthema, purpura.
General disorders: chills, fever, feeling hot, swelling.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 1 blister in a cardboard box.
3 or 10 packs in a cardboard box No. 30 (10´1×3) or No. 100 (10×1×10).
Vacation category
According to the recipe.
Producer
KUSUM HEALTHCARE PVT LTD/KUSUM HEALTHCARE PVT LTD.
Location of the manufacturer and address of its place of business
Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India/Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India
