Divaza (Tablets) Instructions for Use

Marketing Authorization Holder

Materia Medica Holding NPF, LLC (Russia)

Contact Information

MATERIA MEDICA HOLDING NPF LLC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Dosage Form

Divaza

Sublingual tablets: 100 pcs.

Dosage Form, Packaging, and Composition

Sublingual tablets from white to almost white in color, flat-cylindrical in shape, with a score and a bevel; on the flat side with a score, the inscription MATERIA MEDICA is applied, on the other flat side, the inscription DIVAZA is applied.

* applied to lactose as a mixture of three active aqueous-alcoholic dilutions of the substance, diluted respectively in 100¹², 100³⁰, 100²⁰⁰ times.

Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

20 pcs. – contour cell packs (5) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Combined drug.

Antibodies to brain-specific protein S-100 have antioxidant, antihypoxic, neuroprotective, anxiolytic effects. They modify the functional activity of the S-100 protein, which couples informational and metabolic processes in the brain. They have a membrane-tropic effect, causing a decrease in the amplitude and suppression of action potential generation; they modulate synaptic plasticity in the limbic structures of the brain, hippocampus, and reticular formation; they contribute to the enhancement of inhibitory GABAergic influences in the CNS. They exhibit properties of a σ₁-receptor agonist in vitro. They inhibit lipid peroxidation processes.

They have a normalizing effect on the integrative activity of the brain, which is manifested by a wide range of balanced psychopharmacological effects: antidepressant, anxiolytic, neuroprotective, antiasthenic, anti-amnesic.

Antibodies to endothelial NO synthase increase the activity of the endothelial NO synthase enzyme, restore the production of nitric oxide (NO) by the endothelium, eliminate endothelial dysfunction, have an endothelioprotective effect, and affect NO-dependent vasodilation.

Experimental data show the stimulating effect of the drug Divaza on reparative processes in the focus of ischemic brain damage.

The combined use of the drug components is accompanied by an enhancement of the neuroprotective activity of antibodies to the S-100 protein, an enhancement of the vegetostabilizing effect, normalization of the autonomic status, a synergistic influence of both components on neuronal plasticity, and, as a result, an increase in the brain’s resistance to toxic effects; it improves integrative activity and restores interhemispheric connections of the brain, contributes to the elimination of cognitive impairments, stimulates reparative processes and accelerates the restoration of CNS functions, increases mental performance, restores learning and memory processes, normalizes somato-vegetative manifestations, and increases cerebral blood flow.

Divaza, like its constituent components, does not have a sedative or muscle relaxant effect and does not cause addiction or habituation.

Pharmacokinetics

The sensitivity of modern physicochemical methods of analysis (gas-liquid chromatography, high-performance liquid chromatography, chromatography-mass spectrometry) does not allow assessing the content of ultra-low doses of antibodies in biological fluids, organs, and tissues, which makes it technically impossible to study the pharmacokinetics of the drug Divaza.

Indications

The drug Divaza is indicated for use in adults.

• Complex treatment of astheno-neurotic and cognitive disorders caused by neurodegenerative and cerebrovascular (including ischemic) diseases of the brain.

ICD codes

Dosage Regimen

The drug is taken orally. One tablet per dose. The tablets should be held in the mouth until completely dissolved. The score is not intended for dividing the tablet.

Apply 1-2 tablets 3 times/day, between meals, at equal intervals. Depending on the severity of the condition in the acute period, the frequency of administration can be increased to 4-6 times/day.

For severe organic lesions of the CNS, the duration of course therapy can reach 4-6 months.

Adverse Reactions

Possible reactions of increased individual sensitivity to the components of the drug.

Contraindications

• Age under 18 years (due to insufficient data on efficacy and safety);
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• Increased individual sensitivity to the components of the drug.

Use in Pregnancy and Lactation

The safety of using the drug Divaza during pregnancy and lactation has not been studied. If it is necessary to prescribe the drug, the risk/benefit ratio should be taken into account.

Pediatric Use

The use of the drug in children and adolescents under 18 years of age is contraindicated (due to insufficient data on efficacy and safety).

Special Precautions

The drug contains lactose, therefore it is not recommended to prescribe it to patients with congenital galactosemia, glucose/galactose malabsorption syndrome, or congenital lactase deficiency.

The drug can be used in patients with type 1 and type 2 diabetes mellitus.

Effect on the ability to drive vehicles and mechanisms

The drug Divaza does not affect the ability to drive vehicles and other potentially dangerous mechanisms.

Overdose

In case of accidental overdose, dyspeptic phenomena are possible, due to the excipients included in the drug.

Drug Interactions

No cases of incompatibility with other drugs have been reported to date.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.