Loxidan (Tablets) Instructions for Use

Marketing Authorization Holder

V.V. Zakusov Research Institute of Pharmacology (Russia)

Manufactured By

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

N06BA (Centrally acting sympathomimetics)

Active Substances

Adamantile bromphenyl amine (Grouping name)

Mesocarb (Rec.INN registered by WHO)

Dosage Form

Loxidan

Tablets 10 mg+10 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel.

Excipients: ludipress (lactose monohydrate 93%; soluble polyvinylpyrrolidone 3.5%; insoluble polyvinylpyrrolidone 3.5%) – 178 mg, magnesium stearate – 2 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – polyethylene jars (1) – cardboard packs.

Clinical-Pharmacological Group

Psychostimulant drug

Pharmacotherapeutic Group

Psychostimulant

Pharmacological Action

It has a stimulating effect on the central nervous system, not accompanied by manifestations of euphoria and peripheral sympathomimetic action. The psychostimulating effect of this combined drug is characterized by a longer duration compared to the similar effects of mesocarb and adamantylbromphenylamine.

The mechanism of action is due to the fact that Mesocarb realizes its psychoactivating effect through stimulation of catecholaminergic, including noradrenergic and dopaminergic systems, which can lead to depletion of neuronal depots, while the included Adamantylbromphenylamine enhances the de novo synthesis of dopamine, stimulates the expression of the tyrosine hydroxylase gene, and has antioxidant and immunomodulatory effects.

When using the drug to increase mental and physical performance, including under exhausting loads and developed fatigue, its action begins to manifest 40-60 minutes after administration and lasts for more than 4 hours. During prolonged and intensive operator activity, the drug helps to maintain (or increase) the productivity and quality of operator performance, due to an increase in the speed of thought processes, improvement in attention indicators, working memory, sensorimotor coordination and response. Under exhausting physical loads, it increases physical performance by increasing the share of generated energy in aerobic (primarily oxidative) systems, while preserving the reserve capabilities of the lactate energy system. A more pronounced effect is achieved in individuals with good physical fitness and with existing manifestations of fatigue. It increases the level of wakefulness and helps maintain performance under conditions of sleep deprivation.

Pharmacokinetics

After oral administration, both components of the drug are well distributed in organs and tissues, penetrate the blood-brain barrier, and are biotransformed in the liver. T_1/2 for mesocarb is 18.2 hours, for adamantylbromphenylamine 55.4 hours.

Indications

As a specialized means of pharmacological protection of the functional state and professional performance in adults: to increase physical performance, including under extreme loads; to increase mental performance, including in individuals performing operator functions in extreme and stressful conditions of activity; to maintain and increase the effectiveness of physical and mental activity carried out with developed fatigue; to optimize the functional state and effectiveness of professional performance during sleep deprivation.

ICD codes

Dosage Regimen

Administer orally with water.

Initiate therapy with one tablet (10 mg+10 mg) once daily, typically in the morning.

Adjust the dosage according to an individual regimen based on specific indications and tolerability.

For increasing mental performance during operator activities, take one tablet 40-60 minutes before the anticipated period of high load.

For enhancing physical performance under extreme or exhausting loads, administer one tablet approximately one hour before activity.

To maintain effectiveness during sleep deprivation, a single daily dose is typically sufficient.

The maximum single dose is one tablet.

The maximum daily dose is two tablets.

The duration of use is determined by the prescribing physician based on the clinical situation.

Do not take the drug in the evening to avoid sleep disturbances.

Discontinue use if significant adverse reactions occur.

Adverse Reactions

Possible sleep disorders, headache, irritability, increased blood pressure.

Contraindications

Hypersensitivity to the components of the drug, psychomotor agitation, severe forms of arterial hypertension, pronounced manifestations of atherosclerosis; pregnancy, breastfeeding period; age under 18 years; predisposition to IgE-dependent allergic conditions.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

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

Drug Interactions

This drug is not compatible with MAO inhibitors and with tricyclic antidepressants. After discontinuation of these drugs, this drug can be used no earlier than 2 weeks later.

Reduces the hypnotic effect of thiopental.

Does not weaken the anxiolytic effect of benzodiazepines.

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.