Tenoten^® kid (Tablets, Drops) Instructions for Use

ATC Code

N05BX (Other anxiolytics)

Clinical-Pharmacological Group

Anxiolytic drug

Pharmacotherapeutic Group

Psycholeptics; anxiolytics; other anxiolytics

Pharmacological Action

Mechanism of action and pharmacodynamic effects

The drug has a sedative and anxiolytic effect without causing undesirable hypnotic and muscle relaxant effects. It improves tolerance to psychoemotional stress. It has stress-protective, nootropic, anti-amnesic, anti-hypoxic, neuroprotective, anti-asthenic, and antidepressant actions.

Under conditions of intoxication, hypoxia, and after acute cerebrovascular accidents, it exerts a neuroprotective effect, limits the area of brain damage, and normalizes learning and memory processes.

It inhibits the processes of lipid peroxidation.

It modifies the functional activity of the S-100 protein, which couples synaptic (informational) and metabolic processes in the central nervous system (CNS). By exerting a GABA-mimetic and neurotrophic action, it increases the activity of stress-limiting systems and promotes the restoration of neuronal plasticity processes.

Clinical efficacy and safety

Clinical studies have investigated the efficacy and safety of Tenoten^® kid in the treatment of children with anxiety disorders, attention deficit hyperactivity disorder (ADHD), and specific developmental disorders of scholastic skills.

The use of Tenoten^® kid in children with anxiety disorders leads to a significant reduction in the severity of anxiety disorders compared to baseline values and placebo. The most pronounced anxiolytic effect is observed in younger patients (5-7 years), which is expressed in a decrease in the total score on the Spence Children’s Anxiety Scale (SCAS) to a level close to normative indicators for this age, as well as in children 8-15 years old with separation anxiety, panic attacks, and agoraphobia. In both younger and older children, it reduces the level of social phobia.

In attention deficit hyperactivity disorder (ADHD) of varying severity, treatment with Tenoten^® kid for 12 weeks is accompanied by a distinct positive dynamics in the form of a decrease in indicators of inattention and hyperactivity/impulsivity, as well as an improvement in cognitive functions.

In the age group from 6 to 12 years, Tenoten^® kid leads to a significant reduction in the clinical manifestations of ADHD according to the ADHD Rating Scale (ADHDRS-IV-Home Version) with a reduction in the total score by 50% or more from baseline values. A statistically significant reduction in ADHD symptoms on this scale was noted as early as 2 weeks after the start of treatment and became even more significant during the 2nd and 3rd months of therapy.

Statistically significant clinical efficacy of Tenoten^® kid was confirmed by assessment on the Conners’ Scale (CPRS), a decrease in ADHD severity was revealed by the Clinical Global Impression-ADHD-Severity scale (CGI-ADHD-Severity). The drug has sufficient thymoleptic, nootropic, moderate relaxing effects, as well as good tolerability and high safety.

In a clinical study of the treatment of specific developmental disorders of scholastic skills in children, the assessment of results confirmed that Tenoten^® kid is an effective and safe drug. The use of Tenoten^® kid for 12 weeks led to a significant increase in the total score of the formation of scholastic skills according to comprehensive testing of 1st, 2nd, and 3rd-grade students. A significant improvement in reading, writing, and arithmetic skills after 12 weeks of taking Tenoten^® kid was noted in 85% of children, which is statistically significantly greater than with placebo therapy.

The mean value of the efficacy index (ratio of therapeutic effect and side effects) based on the final assessment by physicians in the Tenoten^® kid group was 2.36 conventional units, which was significantly higher than in the placebo therapy group (1.98).

In clinical studies of Tenoten^® kid, no serious adverse reactions or adverse events with a reliable degree of association with the drug were registered. No cases of negative interaction of Tenoten^® kid with drugs of various classes were identified.

Preclinical safety data

Preclinical safety studies on sexually mature and immature animals, including assessment of toxicity after single and repeated (multiple) administration, genotoxicity, reproductive toxicity, immunotoxicity, as well as sensitizing and local irritant properties, did not reveal the presence of toxic or potentially hazardous effects of Tenoten^® kid in humans.

Pharmacokinetics

Pharmacokinetic studies are impossible due to the complex composition of the drug.

Indications

Tenoten^® kid is indicated for use in children aged 3 years and older

• Neurasthenia and neurotic disorders (including behavioral disorders), manifested by anxiety, irritability, increased excitability, autonomic disorders as part of complex therapy;
• Attention deficit hyperactivity disorder;
• Specific developmental disorders of scholastic skills (including specific reading disorder, specific spelling disorder, specific disorder of arithmetical skills, mixed disorder of scholastic skills).

ICD codes

Dosage Regimen

Drops

Orally. 10 drops (0.5 ml) once a day 15 minutes before the child’s morning feeding at approximately the same time. Before use, the drops can be diluted in a small amount (1-5 ml) of boiled water at room temperature.

The duration of therapy is 12 weeks.

Tablets

The score line is not intended for dividing the tablet into parts.

The drug is taken orally. For a single dose – 1-2 tablets (keep in the mouth until completely dissolved – not during meals). If necessary, the tablets can be dissolved in a small amount of boiled water at room temperature.

Neurasthenia and neurotic disorders, specific developmental disorders of scholastic skills

Take 1 tablet from 1 to 3 times/day; the course of treatment is 1-3 months. If necessary, the course of treatment can be extended to 6 months or repeated after 1-2 months.

Attention deficit hyperactivity disorder

Take 2 tablets 2 times/day; the course of treatment is 1-3 months.

If there is no persistent improvement in the condition within 3-4 weeks after the start of treatment, it is necessary to consult a doctor.

Adverse Reactions

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

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the drug;
• Children under 3 years of age.

Use in Pregnancy and Lactation

During pregnancy and lactation, the drug is used only if the intended benefit to the mother outweighs the potential risk to the fetus or child. The “benefit-risk” ratio is determined by the attending physician.

Pediatric Use

The use of the drug is contraindicated in children under 3 years of age.

Special Precautions

Due to the presence of activating properties in the action of Tenoten^® kid, the last dose should be taken no later than 2 hours before bedtime.

Excipients

Patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this drug.

Effect on ability to drive vehicles and machinery

No negative effect of Tenoten^® kid on the ability to drive vehicles (including bicycles, scooters, etc.) and other potentially dangerous mechanisms has been identified.

Overdose

Symptoms of overdose may include dyspeptic phenomena due to the excipients included in the drug.

Treatment is symptomatic.

Drug Interactions

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

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). During the period of use of the drug, store the blister pack in the cardboard package provided by the manufacturer.

Shelf Life

The shelf life is 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.