Diezo^® 500 (Tablets) Instructions for Use

Marketing Authorization Holder

Novamedica, LLC (Russia)

Manufactured By

Novamedica Innotech, LLC (Russia)

ATC Code

N06BX06 (Citicoline)

Active Substance

Citicoline (Rec.INN registered by WHO)

Dosage Form

Diezo® 500

Film-coated tablets 500 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

10 pcs. – blister packs (2) – cardboard packs (20) – By prescription
10 pcs. – blister packs (3) – cardboard packs (30) – By prescription
10 pcs. – blister packs (6) – cardboard packs (60) – By prescription
10 pcs. – blister packs (9) – cardboard packs (90) – By prescription
7 pcs. – blister packs (12) – cardboard packs (84) – By prescription
7 pcs. – blister packs (2) – cardboard packs (14) – By prescription
7 pcs. – blister packs (4) – cardboard packs (28) – By prescription
7 pcs. – blister packs (8) – cardboard packs (56) – By prescription

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Psychoanaleptics; psychostimulants, agents used in attention deficit hyperactivity disorder, and nootropic agents; other psychostimulants and nootropic agents

Pharmacological Action

Citicoline, being a precursor to key ultrastructural components of the cell membrane (primarily phospholipids), has a broad spectrum of action: it promotes the restoration of damaged cell membranes, inhibits the action of phospholipases, preventing the excessive formation of free radicals, and also prevents cell death by acting on apoptosis mechanisms.

In the acute period of stroke, it reduces the volume of damaged tissue and improves cholinergic transmission.

In traumatic brain injury, it reduces the duration of post-traumatic coma and the severity of neurological symptoms, and also helps to shorten the duration of the recovery period.

Citicoline is effective in the treatment of cognitive, sensory, and motor neurological impairments of degenerative and vascular etiology.

In chronic cerebral ischemia, Citicoline is effective in treating disorders such as memory impairment, lack of initiative, and difficulties in performing daily activities and self-care. It increases the level of attention and consciousness and also reduces the manifestation of amnesia.

Pharmacokinetics

After parenteral administration, the plasma concentration of choline increases significantly. Citicoline is largely distributed in the structures of the brain, with rapid incorporation of choline fractions into structural phospholipids and cytidine fractions into cytidine nucleotides and nucleic acids. Citicoline penetrates the brain and is actively incorporated into cellular, cytoplasmic, and mitochondrial membranes, becoming part of the structural phospholipid fraction.

With IV and IM administration, Citicoline is metabolized in the liver to form choline and cytidine. Only 15% of the administered dose of citicoline is excreted from the human body: less than 3% by the kidneys and through the intestines and about 12% in exhaled air. The urinary excretion of citicoline can be divided into two phases: the first phase, lasting about 36 hours, during which the excretion rate decreases rapidly, and the second phase, during which the excretion rate decreases much more slowly. The same is observed in exhaled air – the excretion rate decreases rapidly after approximately 15 hours and then decreases much more slowly.

Indications

Acute period of ischemic stroke (as part of complex therapy); recovery period of ischemic and hemorrhagic strokes; traumatic brain injury, acute (as part of complex therapy) and recovery period; cognitive and behavioral impairments in degenerative and vascular brain diseases.

ICD codes

Dosage Regimen

Administer Diezo^® 500 orally or parenterally as dictated by the clinical situation and severity of the condition.

For parenteral administration, use intravenous slow injection or drip infusion; alternatively, administer intramuscularly.

The daily parenteral dose ranges from 500 mg to 2000 mg.

For oral administration, the daily dose is also 500 mg to 2000 mg.

Divide the total daily oral dose into one or two administrations.

In the acute phase of ischemic stroke, initiate treatment with 1000 mg every 12 hours.

Continue this dosage for a minimum of six weeks; the treatment duration may be extended based on clinical assessment.

For traumatic brain injury in the acute phase, use a similar high-dose regimen.

For chronic conditions such as vascular or degenerative cognitive impairments, typical maintenance doses are 500 mg to 1000 mg once or twice daily.

The duration of therapy for chronic disorders is long-term and determined by the treating physician.

Swallow tablets whole with a sufficient amount of water; they can be taken with or without food.

Adhere strictly to the dosage and regimen prescribed by your physician.

Adverse Reactions

Allergic reactions: very rarely – rash, skin itching, anaphylactic shock.

Nervous system disorders: very rarely – headache, dizziness, insomnia, agitation, hallucinations. In some cases, the drug may stimulate the parasympathetic system and also briefly change blood pressure.

Digestive system disorders: very rarely – nausea, vomiting, diarrhea, decreased appetite, changes in liver enzyme activity.

General reactions: very rarely – feeling of heat, tremor, shortness of breath, numbness in paralyzed limbs, edema.

Contraindications

Hypersensitivity to citicoline; vagotonia (predominance of the tone of the parasympathetic part of the autonomic nervous system); children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

During pregnancy, use is possible only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

If it is necessary to use citicoline during lactation, the issue of discontinuing breastfeeding should be considered, since data on the excretion of citicoline in breast milk are not available.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Dosage adjustment is not required.

Special Precautions

Citicoline should not be used simultaneously with medicines containing meclofenoxate.

Drug Interactions

Citicoline enhances the effects of levodopa.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.