Adaptol^® (Tablets) Instructions for Use

Marketing Authorization Holder

Onlinepharm, JSC (Latvia)

ATC Code

N06BX21 (Temgicoluril)

Active Substance

Temgicoluril (Rec.INN registered by WHO)

Dosage Form

Adaptol®

Tablets 500 mg: 20 pcs.

Dosage Form, Packaging, and Composition

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

Excipients: methylcellulose – 3.3 mg, calcium stearate – 1.7 mg.

10 pcs. – blister packs (2) – cardboard packs.

The pack may have a sticker applied that provides control of the first opening.

Clinical-Pharmacological Group

Anxiolytic (tranquilizer)

Pharmacotherapeutic Group

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

Pharmacological Action

The agent is close in chemical structure to natural metabolites of the body – its molecule consists of two methylated fragments of urea that are part of a bicyclic structure.

It acts on the activity of structures included in the limbic-reticular complex, in particular, on the emotionogenic zones of the hypothalamus, and also has an effect on all 4 main neurotransmitter systems: GABA-, cholinergic, serotonin-, and adrenergic, promoting their balance and integration, but does not have a peripheral adrenoblocking action.

It eliminates or reduces anxiety, worry, fear, internal emotional tension, and irritability. The calming effect is not accompanied by muscle relaxation and impaired coordination of movements.

It does not reduce mental and motor activity, so this agent can be used during the working day or studies. It does not create elevated mood, a feeling of euphoria.

It does not have a hypnotic effect, but enhances the effect of hypnotics and improves the course of sleep in case of its disorders.

It facilitates or relieves nicotine withdrawal.

In addition to the calming effect, it has a nootropic action. It improves cognitive functions, attention, and mental performance without stimulating the symptoms of productive psychopathological disorders – delirium, pathological emotional activity.

Pharmacokinetics

Absorption

After oral administration, it is well absorbed from the gastrointestinal tract (77-80%). C_max of the active substance in blood plasma is reached 0.5 hours after administration. A high concentration of the active substance persists for 3-4 hours, then gradually decreases.

Distribution

Up to 40% of the taken dose binds to erythrocytes. The remaining part is not bound to plasma proteins and is in the blood plasma in a free form, so the active substance is freely distributed throughout the body and freely overcomes cell membranes.

Metabolism

The active substance is not metabolized and does not accumulate in the body.

Excretion

About 55-70% of the taken dose is excreted from the body with urine, the rest – with feces unchanged within 24 hours.

Indications

• Neuroses and neurosis-like states (irritability, emotional lability, anxiety, and fear);
• To improve the tolerability of neuroleptics and tranquilizers in order to eliminate the somatovegetative and neurological side effects caused by them;
• Cardialgia of various origins (not associated with coronary artery disease);
• Nicotine withdrawal (as part of complex therapy as a means of reducing the craving for tobacco smoking).

ICD codes

Dosage Regimen

Administer orally, regardless of meals.

For adults, the standard dosage is 500 mg taken two to three times daily.

Do not exceed a single dose of 3 g or a maximum daily dose of 10 g.

The typical treatment duration ranges from several days to two to three months.

For nicotine withdrawal in complex therapy, administer 500 mg to 1000 mg three times daily.

Continue this regimen for a period of five to six weeks to reduce craving for tobacco smoking.

Adverse Reactions

Rarely: dizziness, decreased blood pressure, dyspeptic disorders, allergic reactions (skin rash, itching).

When used in high doses: bronchospasm, decreased body temperature, weakness.

Contraindications

• Pregnancy;
• Lactation period (breastfeeding);
• Children and adolescents under 18 years of age;
• Hypersensitivity to this agent.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

If blood pressure and/or body temperature decrease (possibly by 1-1.5°C (29.3°F)), it is not required to discontinue the use of this agent. Blood pressure and body temperature normalize on their own.

If allergic reactions occur, use should be discontinued.

Habituation, dependence (psychological and physical), and withdrawal syndrome have not been established with the use of this agent.

Effect on the ability to drive vehicles and operate machinery

The drug can cause a decrease in blood pressure and weakness, which may negatively affect the ability to drive vehicles and operate machinery. Caution should be exercised when using in patients engaged in potentially hazardous activities.

Drug Interactions

Simultaneous use of this agent with neuroleptics, tranquilizers (including benzodiazepines), hypnotics, antidepressants, and psychostimulants is possible.

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.