Atarax 25mg 20 tablets — Made in Belgium — Free Delivery

Indication

Application

The preparation is prescribed orally.

adults

For the symptomatic treatment of anxiety states: 50 mg/day in 3 doses (12.5 mg - in the morning, 12.5 mg - in the afternoon, 25 mg - at night). In severe cases, the dose can be increased to 300 mg/day.

For premedication in surgical practice: 50-200 mg in 1 or 2 doses 1 hour before surgery, and may additionally be preceded by 1 application at night before anesthesia.

For symptomatic treatment of itching: the initial dose is 25 mg, if necessary, the dose can be increased (25 mg 3-4 times a day).

The single maximum dose should not exceed 200 mg, the maximum daily dose - no more than 300 mg.

Children

For symptomatic treatment of itching:

from 3 to 6 years (children with a body weight of 15 kg): 1-2.5 mg/kg/day in divided doses;

≥6 years: 1-2.0 mg/kg/day in divided doses.

For premedication: 1 mg/kg of body weight 1 hour before surgery, as well as additionally at night before anesthesia.

Dose correction

The dosage is selected individually, depending on the patient's response to treatment, within the recommended dosage range.

Elderly patients are recommended to start with half the recommended dose due to the prolonged effect of the preparation.

Patients with impaired liver function are recommended to reduce the daily dose by 33%.

Doses should be reduced for patients with moderate or severe renal insufficiency due to reduced excretion of the metabolite - cetirizine.

Contraindication

The preparation is contraindicated in patients with increased sensitivity to any of its components, cetirizine, other derivatives of piperazine, aminophylline or ethylenediamine. also contraindicated in persons with porphyria. It is not recommended to use Atarax during pregnancy and breastfeeding. The preparation contains lactose, so patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Side effects

Side effects are mainly related to CNS depression or paradoxical CNS stimulatory effects, anticholinergic activity, or hypersensitivity reactions.

The following side reactions, which were noted during the use of the preparation, are distributed by frequency as follows: very often (1/10); often (1/100 to ≤1/10); infrequently (1/1000 to ≤1/100); rarely (≥1/10,000, ≤1/1,000); very rare (1/10,000); frequency is unknown (cannot be estimated from available data).

Cardiovascular disorders: rarely - tachycardia, arterial hypotension.

On the part of the organ of vision: rarely - a violation of accommodation, blurred vision.

From the side of the gastrointestinal tract: often - dry mouth; infrequently - nausea; rarely - constipation, vomiting.

General disorders: often - fatigue; infrequently - general weakness, fever.

From the side of the immune system: rarely - hypersensitivity; very rarely - anaphylactic shock.

Research: rarely - changes in functional tests of the liver.

Neurological disorders: very often - drowsiness; often - headache, sedation; infrequently - dizziness, insomnia, tremor; rarely - convulsions, dyskinesia.

Mental disorders: infrequently - disorders, confusion of consciousness; rarely - disorientation, hallucinations.

From the urinary system: rarely - urinary retention.

From the side of the respiratory system, organs of the chest and mediastinum: very rarely - bronchospasm.

From the side of the skin and subcutaneous tissue: rarely - itching, erythematous rash, maculopapular rash, urticaria, dermatitis; very rarely - angioneurotic edema, increased sweating, fixed medicinal erythema, acute generalized exanthematous pustulosis, exudative erythema multiforme, Stevens-Johnson syndrome.

Special instructions

Hydroxyzine is prescribed with caution to patients prone to convulsive reactions.

Young children are more susceptible to the development of side effects from the central nervous system. Seizures were reported more often in children than in adults.

Due to the presence of an anticholinergic effect, the preparation should be prescribed with caution to patients with glaucoma, with difficulty urinating, constipation, myasthenia gravis, dementia.

For patients simultaneously receiving treatment with other means that suppress the function of the central nervous system, or anticholinergics, the dose must be adjusted.

You should avoid taking alcohol or other sedative preparations during the treatment of ataraxia.

Care must be taken when prescribing to patients prone to cardiac arrhythmias or receiving antiarrhythmic preparations. Alternative therapy should be considered in patients with pre-existing Q-T prolongation.

In the elderly, treatment should be started with half the therapeutic dose. Patients with impaired liver function or moderate or severe renal insufficiency should reduce the dose.

If it is necessary to conduct allergy tests, the preparation should be stopped 5 days before the study.

Pregnancy period and breastfeeding.

Reproductive toxicity of the preparation has been demonstrated in animal studies.

Hydroxyzine penetrates the placental barrier, which leads to higher concentrations of the preparation in the fetus compared to the mother's body. Currently, there are no relevant epidemiological data on the effect of Atarax during pregnancy.

In newborns whose mothers received Atarax during pregnancy and / or delivery, the following phenomena were noted immediately or a few hours after birth: hypotonia, movement disorders, including extrapyramidal disorders, clonic movements, suppression of CNS function, neonatal hypoxic conditions or urinary retention . Therefore, Atarax should not be used during pregnancy.

Atarax is contraindicated during breastfeeding. If treatment for ataraxia is necessary, breast-feeding should be discontinued.

Children. Use of the preparation in children - see APPLICATION. Taking into account the dosage form, the preparation is prescribed for children aged 3 years and with a body weight of 15 kg.

The ability to influence the speed of reaction when driving a motor vehicle or working with mechanisms. Since hydroxyzine can affect attention and reaction speed, patients should be warned about this and avoid driving vehicles or working with precision mechanisms.

Interactions

It is necessary to take into account the strengthening of the action of Atarax when used simultaneously with preparations that suppress the function of the central nervous system or exhibit anticholinergic properties. in this case, their dosage is selected individually. alcohol also potentiates the effects of atarax.

Simultaneous use with MAO inhibitors and cholinergic blockers should be avoided. The preparation interferes with the pressor action of adrenaline and the anticonvulsant activity of phenytoin, and also interferes with the action of betahistine and preparations - cholinesterase blockers.

When using cimetidine 600 mg 2 times a day, the concentration of hydroxyzine in the blood serum increases by 36% and the C max of the cetirizine metabolite decreases by 20%.

Atarax is a CYP 2D6 inhibitor and in high doses may lead to preparation interactions with CYP 2D6 substrates.

Atarax does not have an inhibitory effect at a concentration of 100 μmol on isoforms of uridine diphosphate (UDP)-glucuronyltransferase in human liver microsomes. It inhibits isoforms of cytochrome P450 2C9, 2C19 and 3A4 at concentrations exceeding C max in blood plasma. Therefore, it is unlikely that Atarax can disrupt the metabolism of preparations that are substrates for these enzymes.

Metabolite cetirizine at a concentration of 100 μmol does not have an inhibitory effect on human liver cytochrome P450 and isoforms of UDP-glucuronyltransferase.

Hydroxyzine is metabolized by alcohol dehydrogenase and CYP 3A4 / 5, an increase in the concentration of hydroxyzine in the blood can be expected when hydroxyzine is used simultaneously with preparations - powerful inhibitors of these enzymes. However, when a decrease in only one metabolic pathway is noted, other pathways may partially compensate for this.

Overdose

A manifestation of an overdose of the preparation can be a pronounced anticholinergic effect, suppression or paradoxical stimulation of the function of the central nervous system. symptoms of a significant overdose may include nausea, vomiting, tachycardia, hyperthermia, drowsiness, violation of the pupillary reflex, tremors, hallucinations, impaired consciousness, respiratory depression, convulsions, arterial hypotension, cardioarrhythmia. deepening coma and cardiorespiratory collapse may develop.

In the absence of spontaneous vomiting, immediate gastric lavage is recommended. Vomiting must be induced artificially. General supportive measures are shown, which include control over the vital functions of the body and the doctor's observation of the patient's condition.

If it is necessary to obtain a vasopressor effect, norepinephrine or metaramenol is prescribed. Epinephrine should not be prescribed.

Syrup of ipecac should not be administered to patients with symptoms or potential for rapid desensitization, coma, or convulsions, as this may lead to aspiration pneumonia.

Patients with severe overdose symptoms should be tested for the presence of alcohol or other preparations in their blood. Assign oxygen, naloxone, glucose, thiamine.

Data from the literature indicate that in the presence of severe, life-threatening anticholinergic effects, poorly amenable to treatment and unresponsive to other preparations, trial therapeutic doses of physostigmine may be useful. Physostigmine should not be used only to maintain the patient's consciousness. If cyclic antidepressants were taken at the same time, the use of physostigmine can lead to seizures and cardiac arrest, which is resistant to therapy. Physostigmine should not be prescribed for sinus arrhythmia.

There is no specific antidote. The use of hemodialysis or hemoperfusion is inappropriate.

Storage conditions

In a dry place, at a temperature not higher than 25 °C.