Atarax (Hydroxysine) 25 mg, 25 pills

YUSB Pharma S.A., Belgium

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Product Overview

Composition

1 tab.:
- hydroxysine hydrochloride 25 mg


Excipients:

microcrystalline cellulose (Avicel PH102®),

colloidal silicon anhydride (Aerosil 200®),

magnesium stearate,

lactose monohydrate,

Opadray® Y-1-7000 (titanium dioxide, hydroxypropyl methylcellulose 2910 5cP, macrogol 400).

Pharmacological action

Pharmaceutical group:

anxiolytic agent (tranquilizer).

Pharmacy:

The derivative of diphenyl methane has moderate anxiolytic activity; it also has a sedative, antiemetic, antihistamine and m-choline-blocking effect.

Blocks the central m-choline and H1-histamine receptors and inhibits the activity of certain subcortical zones. It does not cause mental dependence and addiction. The clinical effect occurs 15-30 minutes after taking pills orally. It has a positive effect on cognitive abilities, improves memory and attention. Relaxes skeletal and smooth muscles, has bronchodilator and analgesic effects, moderate inhibitory effect on gastric secretion. Hydroxyzine significantly reduces itching in patients with hives, eczema and dermatitis.

With prolonged use, there was no syndrome of withdrawal and deterioration of cognitive functions. Polysomnography in patients with insomnia and anxiety clearly demonstrates the lengthening of sleep duration, reducing the frequency of night awakenings after taking hydroxyzine once or again at a dose of 50 mg. A decrease in muscle tension in anxiety patients was noted when taking the drug at a dose of 50 mg 3 times a day.

Indications

- adults to relieve anxiety, psychomotor arousal, feelings of internal tension, increased irritability in neurological, mental (generalized anxiety and adaptation disorder) and somatic diseases, as well as chronic alcoholism, alcohol withdrawal syndrome accompanied by symptoms of psychomotor arousal;

- as a sedative for premedication;

- symptomatic itching therapy.

Contraindications

hypersensitivity to any of the components of Atarax, cetirizine and other derivatives of piperazine, aminophyllin or ethylenediamine;
porphyria;
pregnancy;
the period of childbirth;
breastfeeding period.
hereditary galactose intolerance, impaired absorption of glucose-galactose (because the tablets include lactose).

With caution: myasthenia; prostate hyperplasia with clinical manifestations, including difficulty urination, constipation; increased intraocular pressure; dementia; tendency to convulsive seizures; patients prone to arrhythmia or receiving drugs that can cause arrhythmia; patients who simultaneously receive treatment with other means that oppressing the CNS or choline blockers (the dose should decrease); patients with severe and moderate severity of renal failure, as well as liver failure (it is necessary to reduce the dose); elderly patients (the dose decreases in case of reduced glomerular filtration.

Side effects

Weakly pronounced and transiable usually disappear a few days after the beginning of treatment or after reducing the dose.

Side effects are mainly related to CNS suppression or paradoxical stimulating effect on CNS, anticholinergic activity or hypersensitivity reaction.

Anticholinergic effects: dry mouth, urination delay, constipation or accommodation disorders are rare and mainly in elderly patients. Drowsiness, general weakness may occur, especially at the beginning of treatment with the drug. If these effects do not disappear a few days after the start of therapy, the dose of the drug should be reduced.

There were reports of other side effects, such as headache, dizziness, increased sweating, arterial hypotension, tachycardia, allergic reactions, nausea, fever, changes in functional liver samples, bronchospasm. There was no clinically significant respiratory depression when prescribing the recommended doses.

Involuntary motor activity, including very rare cases of tremors and convulsions, disorientation was observed with a significant overdose.

Interaction

Atarax® potentiates the action of drugs that oppress the CNS, such as opioid analgesics, barbiturates, tranquilizers, sleeping pills, ethanol (in combinations require individual selection of doses of drugs).

Atarax®, when used simultaneously, prevents the pressor effect of epinephrine (adrenaline) and anticonvulsant activity of phenytoin, as well as prevents the action of betahistin and cholinesterase blockers.

When used simultaneously, Atarax® does not affect the activity of atropine, belladonna alkaloids, cardiac glycosides, hypotensive agents, histamine H2 receptor blockers.

The joint appointment of Atarax with MAO inhibitors and choline blockers should be avoided.

Hydroxyzine is an inhibitor of the CYP2D6 isoenzyme and can cause interaction with CYP2D6 substrates when used at high doses. Since hydroxyzine is metabolized in the liver, it can be expected to increase its concentration in the blood when administered together with liver enzyme inhibitors.

How to take, course of administration and dosage

Inside.

Children: for symptomatic itching treatment. At the age of 12 months to 6 years - from 1 to 2.5 mg/kg/day Atarax in several doses, from 6 years and older - from 1 to 2 mg/kg/day in several doses.

For premedication - 1 mg/kg 1 hour before surgery, as well as additionally on the night before anesthesia.

Adults: for symptomatic treatment of anxiety - 25-100 mg per day in a separate dosage during the day or at night. The standard dose of Atarax is 50 mg per day (12.5 mg in the morning, 12.5 mg during the day and 25 mg per night).

In serious cases, the dose can be increased to 300 mg per day.

For premedication in surgical practice - 50-200 mg (1.5-2.5 mg/kg w/m) is administered 1 hour before surgery.

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

In elderly patients, treatment begins with half a dose of Atarax. In case of renal and/or liver failure, doses should be reduced.

A single maximum dose should not exceed 200 mg, the maximum daily dose should not exceed 300 mg.

Overdose

An overdose of Atarax can be a pronounced anticholinergic effect, depression or paradoxical stimulation of the CNS.

Symptoms (with a significant overdose): nausea, vomiting, involuntary motor activity, hallucinations, consciousness disorders, arrhythmia, arterial hypotension.

Treatment: if there is no spontaneous vomiting, it is recommended to rinse your stomach immediately and cause vomiting artificially. General supportive measures are shown, including monitoring of vital functions of the body and monitoring of the patient until the symptoms of intoxication disappear and in the next 24 hours. If it is necessary to obtain a vasopressor effect, norepinephrine or metaraminol is prescribed. Epinephrine should not be prescribed. Hemodialysis is not effective. There is no specific antidote.

Special instructions

If allergic tests are necessary, the use of Atarax should be stopped 5 days before the study.

Since hydroxyzine can affect the attention and speed of psychomotor reactions, patients should be warned about it if they need to drive a car and mechanisms.

Release form

Atarax tablets coated with white color, oblong, with separating cross risk on both sides.

Storage conditions

In a dry place, at a temperature not exceeding 25°C

Shelf life

5 years

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