Quanil

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KVANIL (QUANIL®)

Composition:

Active substance: citicoline;

1 ampoule contains sodium citicollinate 522.5 mg equivalent to citicoline 500 mg or sodium citicollinate 1045 mg equivalent to citicoline 1000 mg;

Excipients: solution of sodium hydroxide or hydrochloric acid for pH adjustment, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical characteristics: clear, colorless solution.

Pharmacotherapeutic group. Psychostimulants, drugs used in attention deficit hyperactivity disorder (ADHD), nootropic agents. Other psychostimulant and nootropic agents.

ATC code N06BX06.

Pharmacological Properties

Pharmacodynamics

Citicoline stimulates the biosynthesis of structural phospholipids in neuronal membranes, as confirmed by magnetic resonance spectroscopy data. Due to this mechanism of action, citicoline improves the function of membrane mechanisms such as ion pump activity and receptors, the modulation of which is essential for normal nerve impulse transmission.

Thanks to its stabilizing effect on neuronal membranes, citicoline exhibits anti-edematous properties, which contribute to the reduction of cerebral edema.

Experimental studies have shown that citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reduces the formation of free radicals, prevents the destruction of membrane systems, and preserves antioxidant defense systems such as glutathione.

Citicoline preserves neuronal energy reserves, inhibits apoptosis, and stimulates acetylcholine synthesis.

Experimental evidence has demonstrated that citicoline also exerts a preventive neuroprotective effect in focal cerebral ischemia.

Clinical studies have shown that citicoline significantly enhances functional recovery in patients with acute ischemic stroke, which correlates with a slowed progression of ischemic brain damage volume as observed by neuroimaging.

In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and severity of post-traumatic syndrome.

Citicoline improves levels of attention and consciousness, as well as cognitive and neurological disorders associated with cerebral ischemia, and helps reduce symptoms of amnesia.

Pharmacokinetics

After administration, a significant increase in plasma choline levels is observed. The drug is metabolized in the intestine and liver, forming choline and cytidine.

Following administration, citicoline is widely distributed into brain structures, with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. In the brain, citicoline integrates into cellular, cytoplasmic, and mitochondrial membranes, becoming incorporated into the phospholipid fraction.

Only a small amount of the dose is excreted in urine and feces (less than 3%). Approximately 12% of the dose is eliminated via exhaled CO₂. Renal excretion of the drug occurs in two phases: the first phase within 36 hours, during which the elimination rate decreases rapidly, and the second phase, during which elimination decreases much more slowly. The same biphasic pattern is observed in elimination via the respiratory tract. The rate of CO₂ elimination decreases rapidly, within approximately 15 hours, and then declines much more slowly.

Clinical characteristics.

Indications.

Stroke, acute phase of cerebral circulation disorders, and treatment of complications and consequences of cerebral circulation disorders.

Traumatic brain injury and its neurological consequences.

Cognitive disorders and behavioral disturbances due to chronic vascular and degenerative cerebral disorders.

Contraindications.

Hypersensitivity to citicoline or to any of the other components of the drug.

Increased parasympathetic nervous system tone.

Interaction with other medicinal products and other forms of interaction.

Citicoline enhances the effect of levodopa. The drug should not be administered simultaneously with medicinal products containing meclofenoxate.

Special precautions for use.

When administered intravenously, the drug should be injected slowly (over 3–5 minutes, depending on the dose administered).

When administered intravenously by drip infusion, the infusion rate should be 40–60 drops per minute.

In case of persistent intracranial hemorrhage, the dose should not exceed 1000 mg per day and the intravenous infusion rate (30 drops per minute).

Use during pregnancy or breastfeeding.

There are insufficient data on the use of citicoline in pregnant women. Data regarding the excretion of citicoline in breast milk and its effects on the fetus are unknown. During pregnancy or breastfeeding, the medicinal product should be administered only when the expected therapeutic benefit for the mother outweighs the potential risk to the fetus.

Ability to affect reaction rate when driving or operating machinery.

In individual cases, certain adverse reactions affecting the central nervous system may influence the ability to drive or operate complex machinery.

Method of Administration and Dosage

The recommended dose for adults is from 500 mg to 2000 mg per day depending on the severity of symptoms.

The drug is intended for intramuscular or intravenous administration. For intravenous use, the drug may be administered slowly by injection (over 3-5 minutes, depending on the dose administered) or by infusion (rate: 40-60 drops per minute).

The duration of treatment depends on the course of the disease and is determined by the physician.

Maximum daily dose – 2000 mg.

Elderly patients do not require dose adjustment.

The injection solution is intended for single use only. The drug should be used immediately after opening the ampoule. Any unused portion must be discarded. The drug may be mixed with all isotonic solutions for intravenous administration, as well as with hypertonic glucose solution.

Children.

Experience with the use of the drug in children is limited.

Overdose.

Due to the low toxicity of Quanil, intoxication is not expected even if therapeutic doses have been accidentally exceeded.

In case of accidental overdose, symptomatic treatment should be administered.

Side effects

Side effects occur very rarely (<1/10,000), including isolated cases.

Psychiatric disorders: hallucinations.

Central and peripheral nervous system: severe headache, vertigo.

Cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.

Respiratory system: dyspnea.

Gastrointestinal tract: nausea, vomiting, intermittent diarrhea.

Skin and subcutaneous tissues: pruritus, rash, hyperemia, exanthema, purpura.

Immune system: allergic reactions, including urticaria, angioedema, and anaphylactic shock.

General reactions: chills, edema, injection site reactions.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

4 ml in ampoules; 5 ampoules in a blister pack, 2 blisters in a cardboard box.

Prescription category.

Prescription only.

Manufacturer.

SOVEREIGN PHARMA PRIVATE LIMITED.

Manufacturer's address and location of business activity.

Survey No. 46/1-4, Kadaiya Village, Daman-396 210, India.