Composition and form of release

in a blister 25 pcs.; in a box 1 blister.

Description of the dosage form

Coated tablets: White, oblong film-coated tablets with a separating cross line on both sides.

pharmachologic effect

pharmachologic effect- anxiolytic.

Pharmacodynamics

Derivative of diphenylmethane, has moderate anxiolytic activity; also has a sedative, antiemetic, antihistamine and m-anticholinergic effect. It blocks the central m-cholinergic and H 1 -histamine receptors and inhibits the activity of certain subcortical zones. Does not cause psychological dependence and addiction. The clinical effect occurs 15-30 minutes after ingestion of tablets. It has a positive effect on cognitive abilities, improves memory and attention. Relaxes skeletal and smooth muscles, has bronchodilating and analgesic effects, moderate inhibitory effect on gastric secretion. Hydroxyzine significantly reduces itching in patients with urticaria, eczema and dermatitis. With long-term use, there was no withdrawal syndrome and deterioration of cognitive functions. Polysomnography in patients with insomnia and anxiety clearly demonstrates an increase in sleep duration, a decrease in the frequency of nocturnal awakenings after taking a single or repeated dose of hydroxyzine at a dose of 50 mg. A decrease in muscle tension in patients with anxiety was noted when taking the drug at a dose of 50 mg 3 times a day.

Pharmacokinetics

Absorption is high. The time to reach Cmax after oral administration is 2 hours; T 1/2 in adults - 14 hours. Metabolites are found in breast milk.

After taking a single dose of 25 mg, the concentration in adults is 30 mg / ml, after taking 50 mg of hydroxyzine - 70 mg / ml. Bioavailability when taken orally and / m administration is 80%. Hydroxyzine is more concentrated in the skin than in plasma. The distribution coefficient is 7-16 l / kg in adults. Hydroxyzine crosses the BBB and the placenta, concentrating to a greater extent in fetal than in maternal tissues. Hydroxyzine is metabolized in the liver. Cetirizine - the main metabolite (45%), is a pronounced H 1 blocker. The total Cl of hydroxyzine is 13 ml / min / kg. Only 0.8% of hydroxyzine is excreted unchanged through the kidneys.

In children, the total Cl is 4 times shorter than in adults, T 1/2 - 11 hours in children aged 14 years and 4 hours at the age of 1 year.

In elderly patients, T 1/2 is 29 hours, the distribution coefficient is 22.5 l / kg.

In patients with liver diseases, T 1/2 increased to 37 hours, the concentration of metabolites in the blood serum is higher than in young patients with normal liver function. The antihistamine effect may be prolonged up to 96 hours after ingestion.

Indications for Atarax ®

adults for the relief of anxiety, psychomotor agitation, feelings of internal tension, increased irritability in neurological, mental (generalized anxiety and adjustment disorder) and somatic diseases, as well as in chronic alcoholism, alcohol withdrawal syndrome, accompanied by symptoms of psychomotor agitation;

as a sedative during premedication;

symptomatic treatment of itching.

Contraindications

hypersensitivity to any of the components of the drug, cetirizine and other piperazine derivatives, aminophylline or ethylenediamine;

porphyria;

pregnancy;

the period of childbirth;

breastfeeding period.

hereditary galactose intolerance, malabsorption of glucose-galactose (because the tablets contain lactose).

Carefully: myasthenia gravis; prostatic hyperplasia with clinical manifestations, incl. difficulty urinating, constipation; increased intraocular pressure; dementia; tendency to convulsive seizures; patients prone to arrhythmias or receiving drugs that can cause arrhythmias; patients simultaneously receiving treatment with other drugs that depress the central nervous system, or anticholinergics (the dose should be reduced); patients with severe and moderate severity of renal failure, as well as with liver failure (dose reduction is necessary); elderly patients (the dose is reduced in case of reduced glomerular filtration.

Side effects

Mild and transient, as a rule, disappear after a few days from the start of treatment or after a dose reduction.

Side effects are mainly associated with CNS depression or a paradoxical CNS stimulatory effect, anticholinergic activity or hypersensitivity reaction.

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

There have been reports of other side effects such as headache, dizziness, increased sweating, arterial hypotension, tachycardia, allergic reactions, nausea, fever, changes in liver function tests, bronchospasm. No clinically significant respiratory depression was observed when prescribing the recommended doses.

Involuntary motor activity, incl. very rare cases of tremor and convulsions, disorientation have been observed with significant overdose.

Interaction

It is necessary to take into account the potentiating effect of hydroxyzine when co-administered with drugs that depress the central nervous system, such as narcotic analgesics, barbiturates, tranquilizers, hypnotics, alcohol. In this case, their dosages should be selected individually. Co-administration with MAO inhibitors and anticholinergics should be avoided. The drug interferes with the pressor action of adrenaline and the anticonvulsant activity of phenytoin, and also interferes with the action of betahistine and drugs - cholinesterase blockers. The effect of atropine, belladonna alkaloids, digitalis, antihypertensive drugs, H 2 receptor antagonists does not change under the action of hydroxyzine. It is an inhibitor of P450 2D6 and in high doses can cause interaction with substrates CYP2D6. Since hydroxyzine is metabolized in the liver, an increase in its concentration in the blood can be expected when co-administered with drugs - inhibitors of liver enzymes.

Dosage and administration

inside.

Children: for the symptomatic treatment of itching. At the age of 12 months to 6 years - from 1 to 2.5 mg / kg / day 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, and additionally on the night before anesthesia.

Adults: For the symptomatic treatment of anxiety, 25-100 mg daily in divided doses during the day or at night. The standard dose is 50 mg per day (12.5 mg in the morning, 12.5 mg in the afternoon and 25 mg at night).

In severe cases, the dose may be increased to 300 mg per day.

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

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

In elderly patients, treatment begins with a half dose. In renal and / or hepatic insufficiency, doses should be reduced.

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

Overdose

A manifestation of an overdose of the drug may be a pronounced anticholinergic effect, depression or paradoxical stimulation of the central nervous system.

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

Treatment: if there is no spontaneous vomiting, it is recommended to immediately wash the stomach and induce vomiting artificially. General supportive measures are shown, including monitoring of the vital functions of the body and monitoring 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 given. Hemodialysis is not effective. There is no specific antidote.

special instructions

If it is necessary to conduct allergic tests, the drug should be discontinued 5 days before the study.

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

Terms of dispensing from pharmacies

On prescription.

Storage conditions of the drug Atarax ®

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

Keep out of the reach of children.

Shelf life of Atarax ®

5 years.

Do not use after the expiry date stated on the packaging.

Synonyms of nosological groups

Category ICD-10	Synonyms of diseases according to ICD-10
F10.2 Alcohol dependence syndrome	Alcoholism
	Alcohol addiction
	dipsomania
	alcohol addiction
	Drunken drinking
	drunken state
	alcohol abuse
	Ideation disorder in alcoholism
	Quarter binge
	Obsessive craving for alcohol
	Neurotic symptoms in alcoholism
	Pathological attraction to alcohol
	Psychoorganic syndrome in chronic alcoholism
	Decreased craving for alcohol
	Chronic alcoholism
F10.3 Withdrawal state	Withdrawal alcohol syndrome
	withdrawal syndrome
	Withdrawal syndrome in alcoholism
	abstinence
	alcohol withdrawal
	alcohol withdrawal
	Alcohol withdrawal state
	alcohol withdrawal syndrome
	post-withdrawal disorder
	Post-withdrawal state
	hangover syndrome
	withdrawal syndrome
	alcohol withdrawal syndrome
	alcohol withdrawal syndrome
	Withdrawal state
F10.4 Withdrawal with delirium	Alcoholic delirium
	Delirium tremens alcoholic
	Delirium
	Delirious state in alcoholism and drug addiction
F41 Other anxiety disorders	Relief of anxiety
	Nonpsychotic Anxiety Disorders
	Alarm state
	Anxiety
	Anxious and suspicious states
	chronic anxiety
	Sense of anxiety
F48 Other neurotic disorders	Neurosis
	Neurological diseases
	Neurotic disorders
	neurotic state
	Psychoneurosis
	Anxiety-neurotic states
	Chronic neurotic disorders
	Emotional Reactive Disorders
L29 Itching	Dermatitis itchy
	Dermatosis with persistent itching
	Other pruritic dermatoses
	Itching of the scalp
	Itchy skin
	Itching with partial obstruction of the biliary tract
	Itchy eczema
	Itchy dermatoses
	Itchy allergic dermatosis
	Itchy dermatitis
	Itchy dermatosis
	Skin itching
	Skin itching with dermatosis
	Excruciating itching
	Limited pruritic dermatitis
	severe itching
	Endogenous pruritus
R45.1 Restlessness and agitation	Agitation
	Anxiety
	Explosive excitability
	Internal arousal
	Excitability
	Excitation
	Acute excitation
	Excitation psychomotor
	hyperexcitability
	motor excitation
	Relief of psychomotor agitation
	Nervous excitement
	restlessness
	night restlessness
	Acute stage of schizophrenia with arousal
	Acute mental agitation
	Paroxysm of arousal
	overexcitation
	Hyperexcitability
	Increased nervous excitability
	Increased emotional and cardiac excitability
	Increased arousal
	Mental arousal
	Psychomotor agitation
	Psychomotor agitation
	psychomotor agitation
	Psychomotor agitation in psychosis
	Psychomotor agitation of an epileptic nature
	Psychomotor paroxysm
	psychomotor seizure
	Symptoms of arousal
	Symptoms of psychomotor agitation
	state of agitation
	state of anxiety
	State of arousal
	A state of heightened anxiety
	State of psychomotor agitation
	Anxiety states
	Excitation states
	Anxiety states in somatic diseases
	State of excitation
	Feeling restless
	Emotional arousal
R45.4 Irritability and anger	outbursts of anger
	Anger
	Dysphoria
	Neurosis with increased irritability
	Anger
	Increased irritability
	Increased irritability of the nervous system
	Irritability
	Irritability in neurosis
	Irritability in psychopathic disorders
	Symptoms of irritability
Z100* CLASS XXII Surgical practice	Abdominal surgery
	Adenomectomy
	Amputation
	Angioplasty of coronary arteries
	Angioplasty of the carotid arteries
	Antiseptic skin treatment for wounds
	Antiseptic hand treatment
	Appendectomy
	Atherectomy
	Balloon coronary angioplasty
	Vaginal hysterectomy
	Crown bypass
	Interventions on the vagina and cervix
	Bladder interventions
	Intervention in the oral cavity
	Restorative and reconstructive operations
	Hand hygiene of medical personnel
	Gynecological surgery
	Gynecological interventions
	Gynecological operations
	Hypovolemic shock during surgery
	Disinfection of purulent wounds
	Disinfection of wound edges
	Diagnostic interventions
	Diagnostic procedures
	Diathermocoagulation of the cervix
	Long-term surgery
	Replacement of fistula catheters
	Infection during orthopedic surgery
	Artificial heart valve
	cystectomy
	Brief outpatient surgery
	Short-term operations
	Short term surgical procedures
	Cricothyrotomy
	Blood loss during surgery
	Bleeding during surgery and in the postoperative period
	Culdocentesis
	Laser coagulation
	Laser coagulation
	Laser coagulation of the retina
	Laparoscopy
	Laparoscopy in gynecology
	CSF fistula
	Minor gynecological surgeries
	Minor surgical interventions
	Mastectomy and subsequent plasty
	Mediastinotomy
	Microsurgical operations on the ear
	Mucogingival operations
	Suturing
	Minor surgical interventions
	Neurosurgical operation
	Immobilization of the eyeball in ophthalmic surgery
	Orchiectomy
	Complications after tooth extraction
	Pancreatectomy
	Pericardectomy
	The period of rehabilitation after surgical operations
	The period of convalescence after surgical interventions
	Percutaneous transluminal coronary angioplasty
	Pleural thoracocentesis
	Pneumonia postoperative and post-traumatic
	Preparation for surgical procedures
Preparing for surgery
Preparation of the surgeon's hands before surgery
Preparing the colon for surgery
Postoperative aspiration pneumonia in neurosurgical and thoracic operations
Postoperative nausea
Postoperative bleeding
Postoperative granuloma
Postoperative shock
Early postoperative period
Myocardial revascularization
Resection of the apex of the tooth root
Resection of the stomach
Bowel resection
Uterine resection
Liver resection
Resection of the small intestine
Resection of a part of the stomach
Reocclusion of the operated vessel
Bonding tissue during surgery
Removal of stitches
Condition after eye surgery
Condition after surgery
Condition after surgical interventions in the nasal cavity
Condition after resection of the stomach
Condition after resection of the small intestine
Condition after tonsillectomy
Condition after removal of the duodenum
Condition after phlebectomy
Vascular surgery
Splenectomy
Sterilization of the surgical instrument
Sterilization of surgical instruments
Sternotomy
Dental operations
Dental intervention on periodontal tissues
Strumectomy
Tonsillectomy
Thoracic Surgery
Thoracic operations
Total gastrectomy
Transdermal intravascular coronary angioplasty
Transurethral resection
Turbinectomy
Removal of a tooth
Cataract removal
Removal of cysts
Tonsil removal
Removal of fibroids
Removal of mobile milk teeth
Removal of polyps
Removal of a broken tooth
Removal of the body of the uterus
Suture removal
Urethrotomy
CSF fistula
Frontoethmoidogaimorotomy
Surgical infection
Surgical treatment of chronic leg ulcers
Surgery
Surgery in the anus
Surgical operation on the large intestine
Surgical practice
surgical procedure
Surgical interventions
Surgical interventions on the gastrointestinal tract
Surgical interventions on the urinary tract
Surgical interventions on the urinary system
Surgical interventions on the genitourinary system
Surgical interventions on the heart
Surgical manipulations
Surgical operations
Surgical operations on the veins
Surgical intervention
Surgical intervention on the vessels
Surgical treatment of thrombosis
Surgery
Cholecystectomy
Partial resection of the stomach
Transperitoneal hysterectomy
Percutaneous transluminal coronary angioplasty
Percutaneous transluminal angioplasty
Bypass coronary arteries
Tooth extirpation
Extraction of milk teeth
Pulp extirpation
extracorporeal circulation
Tooth extraction
Extraction of teeth
Cataract Extraction
Electrocoagulation
Endourological interventions
Episiotomy
Ethmoidectomy

Catad_pgroup Anxiolytics (tranquilizers)

Atarax - instructions for use

INSTRUCTIONS
(information for specialists)
on the medical use of the drug

ATARAX® (ATARAX®)
(hydroxyzine | hydroxyzine)

Registration number:

No. PN011405/01 dated 10.03.2006

Trade name: ATARAX ® (ATARAX ®)

International non-proprietary name: hydroxyzine

Chemical Name: ethanol, 2[-2-[-4-[(4-chlorophenyl)phenylmethyl]-1-piperazine]ethoxy]-, dihydrochloride.

Dosage forms: Solution for intramuscular injection; coated tablets.

Compound

Tablets: active substance - hydroxyzine hydrochloride 25 mg; excipients: microcrystalline cellulose (Avicel RN 102 ®), magnesium stearate, colloidal silicon anhydride (Aerosil 200 ®), lactose monohydrate, Opadry ® Y-1-7000: titanium dioxide, hydroxypropyl methylcellulose 2910 5cP, macrogol 400.

Solution for intramuscular injection: active substance - hydroxyzine hydrochloride 100 mg in 2 ml; inactive ingredients: sodium hydroxide, water for injection.

Description

White, oblong film-coated tablets with a separating cross line on both sides.

Solution for intramuscular injection - a clear, colorless solution.

Pharmacotherapeutic group:

anxiolytic agent (tranquilizer).

ATX code: No. 05BB01.

PHARMACOLOGICAL PROPERTIES

Derivative of diphenylmethane, has moderate anxiolytic activity; also has a sedative, antiemetic, antihistamine and M-anticholinergic effect. It blocks the central M-holino - and H 1 -histamine receptors and inhibits the activity of certain subcortical zones. Does not cause psychological dependence and addiction. The clinical effect occurs 15-30 minutes after ingestion of tablets. It has a positive effect on cognitive abilities, improves memory and attention. Relaxes skeletal and smooth muscles, has bronchodilating and analgesic effects, moderate inhibitory effect on gastric secretion. Hydroxyzine significantly reduces itching in patients with urticaria, eczema and dermatitis. With long-term use, there was no withdrawal syndrome and deterioration of cognitive functions. Polysomnography in patients with insomnia and anxiety clearly demonstrates an increase in sleep duration, a decrease in the frequency of nocturnal awakenings after taking a single or repeated dose of hydroxyzine at a dose of 50 mg. A decrease in muscle tension in patients with anxiety was noted when taking the drug at a dose of 50 mg 3 times a day.

Pharmacokinetics. Absorption is high. The time to reach the maximum concentration (T Cmax) after oral administration is 2 hours; the half-life (T 1/2) in adults is 14 hours. Metabolites are found in breast milk. After taking a single dose of 25 mg T Cmax in adults is 30 mg / ml and 70 mg / ml after taking 50 mg of hydroxyzine. Bioavailability when administered orally and intramuscularly is 80%.

Hydroxyzine is more concentrated in the skin than in plasma. The distribution coefficient is 7-16 l/kg in adults. Hydroxyzine crosses the blood-brain barrier and the placenta, concentrating more in fetal than maternal tissues. Hydroxyzine is metabolized in the liver. Cetirizine - the main metabolite (45%), is a pronounced H 1 blocker. The total clearance of hydroxyzine is 13 ml / min / kg. Only 0.8% of hydroxyzine is excreted unchanged through the kidneys.

In children, the total clearance is 4 times shorter than in adults, T 1/2 - 11 hours in children aged 14 years and 4 hours at the age of 1 year.
In elderly patients, T 1/2 was 29 hours, the distribution coefficient is 22.5 l / kg.
In patients with liver disease, T 1/2 increased to 37 hours, the concentration of metabolites in the blood serum is higher than in young patients with normal liver function. The antihistamine effect may be prolonged up to 96 hours after ingestion.

INDICATIONS FOR USE

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

as a sedative during premedication;

symptomatic treatment of itching.

P CONTRAINDICATIONS

The drug is contraindicated in patients with hypersensitivity to any of the components of the drug, cetirizine and other piperazine derivatives, aminophylline or ethylenediamine. Also contraindicated in patients with porphyria; during pregnancy, during labor and breastfeeding. Since the tablets contain lactose, patients with hereditary galactose intolerance, with malabsorption of glucose-galactose, the drug is not recommended.

CAREFULLY

With myasthenia gravis, prostatic hyperplasia with clinical manifestations, difficulty urinating, constipation, increased intraocular pressure, dementia, a tendency to convulsive seizures. Patients prone to arrhythmias or receiving drugs that can cause arrhythmias. Patients simultaneously receiving treatment with other drugs that depress the central nervous system, or anticholinergics, the dose should be reduced. Patients with severe and moderate renal insufficiency, as well as with hepatic insufficiency, need to reduce the dose. For elderly patients, the dose is reduced in case of reduced glomerular filtration.

METHOD OF APPLICATION AND DOSES

The drug is administered orally in the form of tablets or injected intramuscularly.

children

For the symptomatic treatment of itching. Ages 12 months to 6 years: 1 mg/kg to 2.5 mg/kg/day in divided doses. Ages 6 years and older: 1 mg/kg to 2.0 mg/kg/day in divided doses. For premedication - 1 mg/kg 1 hour before surgery, and additionally on the night before anesthesia.

Adults

For the symptomatic treatment of anxiety: 25-100 mg daily in divided doses during the day or at night. The standard dose is 50 mg per day (12.5 mg in the morning, 12.5 mg in the afternoon and 25 mg at night). In severe cases, the dose may be increased to 300 mg per day.

For premedication in surgical practice: 50-200 mg (1.5-2.5 mg/kg intramuscularly) is administered 1 hour before surgery. For the symptomatic treatment of itching: the initial dose is 25 mg, if necessary, the dose can be increased four times (25 mg 4 times a day), and additionally on the night before anesthesia.

In elderly patients, treatment begins with a half dose.

In renal and / or hepatic insufficiency, doses should be reduced.

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

SIDE EFFECT

Mild and transient, as a rule, disappear after a few days from the start of treatment or after a dose reduction. Side effects are mainly associated with CNS depression or a paradoxical stimulatory effect on the CNS, anticholinergic activity or hypersensitivity reaction. Anticholinergic effects: dry mouth, urinary retention, constipation or disturbance of accommodation are rare and occur mainly in elderly patients. Drowsiness, general weakness may occur, especially at the beginning of drug treatment. If this effect does not disappear after a few days from the start of therapy, the dose of the drug should be reduced. There have been reports of other side effects such as headache, dizziness, increased sweating, arterial hypotension, tachycardia, allergic reactions, nausea, tachycardia, fever, changes in liver function tests, bronchospasm. No clinically significant respiratory depression was observed when prescribing the recommended doses. Involuntary motor activity, including very rare cases of tremor and convulsions, disorientation have been observed with significant overdose.

OVERDOSE

A manifestation of an overdose of the drug may be a pronounced anticholinergic effect, depression or paradoxical stimulation of the central nervous system. Symptoms of a significant overdose may include nausea, vomiting, involuntary motor activity, hallucinations, impaired consciousness, arrhythmia, arterial hypotension. If there is no spontaneous vomiting, immediate gastric lavage is recommended. Vomiting must be induced artificially. General supportive measures are shown, including monitoring of vital body functions 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 metaramenol is prescribed. Epinephrine should not be prescribed. Hemodialysis is not effective. There is no specific antidote.

INTERACTIONS WITH OTHER DRUGS

It is necessary to take into account the potentiating effect of hydroxyzine when co-administered with drugs that depress the central nervous system, such as narcotic analgesics, barbiturates, tranquilizers, hypnotics, alcohol. In this case, their dosages should be selected individually. Co-administration with MAO inhibitors and anticholinergics should be avoided. The drug interferes with the pressor action of adrenaline and the anticonvulsant activity of phenytoin, and also interferes with the action of betahistine and drugs - cholinesterase blockers. The effect of atropine, belladonna alkaloids, digitalis, antihypertensive drugs, H 2 receptor antagonists do not change under the action of hydroxyzine. It is an inhibitor of P450 2D6 and at high doses may cause interaction with CYP2D6 substrates. Since hydroxyzine is metabolized in the liver, an increase in its concentration in the blood can be expected when co-administered with drugs - inhibitors of liver enzymes.

SPECIAL INSTRUCTIONS

If it is necessary to conduct allergic tests, the drug should be discontinued 5 days before the study. Since hydroxyzine can affect attention and the speed of psychomotor reactions, patients should be warned about this if it is necessary to drive a car and mechanisms. Injectable forms of the drug are intended for intramuscular injection only and should not be administered intravenously, intraarterially or subcutaneously. When administered intramuscularly, make sure that the needle does not enter any vessel. When injected under the skin, the drug may cause tissue damage. During treatment with hydroxyzine, alcohol should be avoided.

RELEASE FORM

Film-coated tablets of 25 mg. 25 tablets in a blister; The blister, together with the instructions for use, is packed in a cardboard box. Ampoules for intramuscular injection of 100 mg / 2 ml of a clear, white glass solution, 6 ampoules are enclosed in a plastic holder, which is packed with instructions for use in a cardboard box.

STORAGE CONDITIONS

Tablets - in a dry place at a temperature not exceeding 25 ° C.

Ampoules - at a temperature not higher than 25 ° C. You should not take the drug after the expiration date. Keep out of the reach of children.

BEST BEFORE DATE

TERMS OF DISCOUNT FROM THE PHARMACY:

By prescription.

YUSB S.A. Pharma Sector
Chemin du Foret, Brain-l'allu,
B-1420 Belgium Representative office in Moscow: 117312, Moscow, st. Gubkina 14-44

In this article, you can read the instructions for using the drug Atarax. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Atarax in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Analogues of Atarax in the presence of existing structural analogues. Use for the treatment of irritability, pruritus and withdrawal syndrome in chronic alcoholism in adults, children, as well as during pregnancy and lactation.

Atarax- a derivative of diphenylmethane, has a moderate anxiolytic activity; also has a sedative, antiemetic, antihistamine and m-anticholinergic effect. It blocks the central m-cholinergic receptors and histamine H1 receptors and inhibits the activity of certain subcortical zones. Does not cause psychological dependence and addiction. The clinical effect occurs within 15-30 minutes after taking the drug inside.

It has a positive effect on cognitive abilities, improves memory and attention. Relaxes skeletal and smooth muscles, has bronchodilating and analgesic effects, moderate inhibitory effect on gastric secretion. Hydroxyzine significantly reduces itching in patients with urticaria, eczema and dermatitis. With long-term use, there was no withdrawal syndrome and deterioration of cognitive functions. Polysomnography in patients with insomnia and anxiety clearly demonstrates an increase in sleep duration, a decrease in the frequency of nocturnal awakenings after a single or repeated administration of hydroxyzine at a dose of 50 mg. A decrease in muscle tension in patients with anxiety was noted when taking the drug at a dose of 50 mg 3 times a day.

Compound

Hydroxyzine hydrochloride + excipients.

Pharmacokinetics

Atarax is highly absorbed from the gastrointestinal tract. Bioavailability when administered orally and intramuscularly is 80%. Hydroxyzine is more concentrated in tissues (in particular, in the skin) than in plasma. Hydroxyzine crosses the blood-brain barrier (BBB) ​​and the placental barrier, concentrating more in the tissues of the fetus than in the mother's body. Metabolites are found in breast milk. Hydroxyzine is metabolized in the liver. The main metabolite (45%) is cetirizine, which is a blocker of histamine H1 receptors. Only 0.8% of hydroxyzine is excreted unchanged in the urine.

Indications

• to relieve anxiety, psychomotor agitation, feelings of internal tension;
• increased irritability in neurological, mental (including generalized anxiety, adaptation disorders) and somatic diseases, chronic alcoholism;
• withdrawal syndrome in chronic alcoholism, accompanied by psychomotor agitation;
• as a sedative during premedication;
• pruritus (as a symptomatic therapy).

Release form

Film-coated tablets 25 mg.

Solution for intramuscular injection (injections in ampoules for injection).

Instructions for use and dosing regimen

The drug is taken orally.

For symptomatic treatment of itching in children aged 12 months to 6 years, the drug is prescribed in a daily dose of 1-2.5 mg / kg of body weight in several doses; children over the age of 6 years - at a dose of 1-2 mg / kg per day in several doses.

For premedication in children, the drug is prescribed at a dose of 1 mg/kg of body weight 1 hour before surgery, and additionally on the night before surgery.

Adults for the symptomatic treatment of anxiety are prescribed at a dose of 25-100 mg per day in divided doses during the day or at night. The average dose is 50 mg per day (12.5 mg in the morning, 12.5 mg in the afternoon and 25 mg at night). If necessary, the dose can be increased to 300 mg per day.

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).

The maximum single dose should not exceed 200 mg, the maximum daily dose is not more than 300 mg.

In elderly patients, the initial dose should be reduced by 2 times.

Side effect

• dry mouth;
• urinary retention;
• constipation;
• disturbance of accommodation;
• drowsiness;
• general weakness (especially at the beginning of treatment);
• headache;
• dizziness;
• tremor;
• convulsions;
• disorientation;
• arterial hypotension;
• tachycardia;
• nausea;
• increased sweating;
• allergic reactions;
• fever;
• bronchospasm.

Contraindications

• porphyria;
• pregnancy;
• the period of labor activity;
• lactation period (breastfeeding);
• hypersensitivity to the components of the drug;
• hypersensitivity to cetirizine and other piperazine derivatives, aminophylline or ethylenediamine.

Use during pregnancy and lactation

Atarax is contraindicated for use during pregnancy, during labor.

If necessary, the use of Atarax during lactation should stop breastfeeding.

special instructions

If allergy testing is required, Atarax should be discontinued 5 days before the test.

Patients taking Atarax should refrain from drinking alcohol.

Influence on the ability to drive vehicles and control mechanisms

Patients taking Atarax, if it is necessary to drive a car and mechanisms, should be warned that the drug can affect the concentration of attention and the speed of psychomotor reactions.

drug interaction

Atarax potentiates the action of drugs that depress the central nervous system, such as opioid analgesics, barbiturates, tranquilizers, hypnotics, ethanol (alcohol) (with combinations, individual selection of drug doses is required).

Atarax, when used simultaneously, prevents the pressor action of epinephrine (adrenaline) and the anticonvulsant activity of phenytoin, and also interferes with the action of betahistine and cholinesterase blockers.

With simultaneous use, Hydroxyzine does not affect the activity of atropine, belladonna alkaloids, cardiac glycosides, antihypertensive drugs, histamine H2 receptor blockers.

Co-administration of Atarax with MAO inhibitors and anticholinergics should be avoided.

Analogues of the drug Atarax

Structural analogues for the active substance:

• Hydroxyzine.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Atarax (INN hydroxyzine) is a tranquilizer from the Belgian pharmaceutical company UCB Pharma, S.A. It was developed in the mid-50s of the last century and became the world's first non-benzodiazepine tranquilizer. He laid the foundation for a new class of medicines, called ataractics. Largely thanks to Atarax (and only then to Viagra), the then small pharmaceutical company Pfizer, which received a license to distribute the drug in the United States, grew into a global giant and industry leader.

As a tranquilizer, Ataracas exhibits an anxiolytic (suppresses anxiety) and sedative effects. In addition to this, the drug has an antihistamine (blocks histamine H1 receptors), m-anticholinergic (inactivates central m-cholinergic receptors) and antiemetic effects. It is important that the drug does not develop pathological dependence. Pharmacological action develops 20-30 minutes after the active substance enters the gastrointestinal tract. The drug normalizes cognitive functions (memory, mental performance, attention). Relaxes striated and smooth muscles. Expands the bronchi. Has an analgesic effect. Suppresses the release of digestive enzymes into the lumen of the stomach. Reduces itching in allergic manifestations and dermatological diseases (dermatitis, eczema). With a long course of medication after the end of taking the drug, withdrawal syndrome does not develop and there is no "rebound" deterioration in cognitive activity.

A polysomnographic study in patients suffering from insomnia and anxiety disorders demonstrates a significant increase in sleep duration, a decrease in the number of episodes of awakenings at night after taking a single dose of Atarax. A decrease in muscle hypertonicity with increased anxiety was demonstrated when taking Atarax at a dose of 50 mg three times a day. The drug is well absorbed in the gastrointestinal tract: its maximum plasma concentration is recorded two hours after oral administration. The bioavailability of hydroxyzine is 80%. Penetrates through the BBB, metabolic products enter breast milk. The half-life is 14 hours. The side effects inherent in the drug are mainly associated with the anticholinergic effect: hyposalivation, difficulty urinating, constipation, accommodation spasm. Atarax is incompatible with ethanol, therefore, during the drug course, one should refrain from consuming ethanol-containing products. While taking the drug, it must be borne in mind that hydroxyzine can slow down the reaction rate, impair concentration. Atarax enhances the effect of drugs that suppress the activity of the central nervous system: opioid painkillers, tranquilizers, barbiturates, sedatives. If necessary, their combination should be approached with particular care in the choice of drugs.

Pharmacology

Anxiolytic and sedative, histamine H1 receptor blocker, piperazine derivative. It has a moderate m-anticholinergic activity. It has an antiemetic effect.

Pharmacokinetics

Has high absorption. Cmax after oral administration is achieved after 2 hours; T 1/2 in adults is 12-20 hours, in children - 7 hours. Metabolites are found in breast milk.

Release form

The solution for i / m administration is colorless, transparent.

Excipients: water for injection, sodium hydroxide.

2 ml - ampoules (6) - plastic trays (1) - cardboard packs.

Dosage

For oral administration, a single dose for adults varies from 25 mg to 100 mg; the frequency of admission, depending on the indications, is 1-4 times / day.

To quickly achieve a therapeutic effect, a solution of hydroxyzine is administered deeply intramuscularly at a dose of 50-100 mg; then you can enter with an interval of 4-6 hours.

Interaction

With the simultaneous use of hydroxyzine enhances the effects of analgesics, anxiolytics, barbiturates, ethanol.

Side effects

From the side of the central nervous system and peripheral nervous system: drowsiness, fatigue, tremor, convulsions, headache, dizziness, ataxia, weakness.

On the part of the organ of vision: acute glaucoma, disturbance of accommodation.

From the urinary system: acute urinary retention.

From the side of the cardiovascular system: tachycardia, decreased blood pressure.

From the digestive system: dry mouth, constipation, increased activity of transaminases.

Other: bronchospasm, allergic reactions, excessive sweating.

Indications

Neuroses and neurotic states, manifested by increased excitability, a feeling of emotional stress, anxiety; organic lesions of the central nervous system, accompanied by increased excitability; withdrawal syndrome in chronic alcoholism; premedication before surgical operations, prevention and relief of vomiting in the postoperative period; skin itching.

Contraindications

Porphyria, benign prostatic hyperplasia, angle-closure glaucoma, childbirth, pregnancy, lactation, hypersensitivity to hydroxyzine, the period of labor.

Application features

Use during pregnancy and lactation

Hydroxyzine is contraindicated for use during pregnancy, during childbirth. Lactation (breastfeeding) is a contraindication to use.

Application for violations of liver function

Use with caution in patients with hepatic impairment.

Application for violations of kidney function

Use with caution in patients with renal insufficiency.

special instructions

Use with caution in patients with renal insufficiency, myasthenia gravis, difficulty urinating, constipation, dementia, a tendency to convulsive seizures, arrhythmias or taking antiarrhythmic drugs, liver failure.

With s / c administration of hydroxyzine, tissue damage is possible, with i / v administration - hemolysis.

If allergy testing is required, hydroxyzine should be discontinued 5 days prior to testing.

Influence on the ability to drive vehicles and control mechanisms

During the period of therapy, it is necessary to refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

Atarax is a universal drug that is produced in the form of tablets and is intended for the treatment of various pathological conditions of the nervous system. It is a tranquilizer that has a sedative effect.

In contact with

Drug properties

The drug was developed on the basis of hydroxyzine dihydrochloride. Atarax is not a central nervous system depressant.

It is characterized by the presence of antihistamine and bronchodilating properties. If you take it in a therapeutic dosage, then the secretory and acid-forming functions of the stomach will not be disturbed. The drug is widely used for the treatment of dermatitis of various etiologies.

If the patient has impaired liver function, then the duration of the antihistamine action can reach 96 hours. Atarax has antispasmodic, sympatholytic and analgesic properties. Thanks to the universal effect of the tablets, an increase in the duration of sleep and a decrease in awakenings at night are ensured. With the help of this tool, a decrease in muscle tone is provided.

Active ingredient of Atarax rapidly absorbed from the digestive system. After 2 hours after taking the medication, the maximum concentration of the active substance in the body is observed. The active substance crosses the placenta and may also pass into breast milk.

Indications for use

The use of Atarax should be carried out in strict accordance with the indications. It widely helps with itching, which occurs against the background of allergic reactions. This medicine is often used to treat patients after surgery.

Indications for use - disturbances in the work of the central nervous system, which are accompanied by anxiety and nervous overexcitation. If a patient is diagnosed with anxiety and other disorders on the background of a bruise or concussion, then he needs to take this medicine.

With the help of medication, neurosis is often cured. The indication for the use of Atarax is neurotic enuresis. Pharmacists recommend prescribing the drug to patients diagnosed with Tourette's disease.

Atarax is recommended for children if there are genetic disorders of the nervous system. If during panic attacks a lack of air, dizziness, nausea, fear of death and other symptoms are diagnosed, then he is shown taking the medication.

Important! Atarax tablets should be used in strict accordance with the indications, which will eliminate the possibility of developing undesirable effects.

Contraindications

Atarax tablets are characterized by the presence of contraindications, which must be taken into account without fail before use.

With a hereditary predisposition, the use of the drug is not recommended. Contraindications to the use of the drug are porphyria.

With closed-angle glaucoma, the use of the drug is not recommended. Women of the weaker sex during pregnancy are prohibited from using the medicine. If a woman is breastfeeding a newborn baby, then the treatment with the drug should also be abandoned. If there is an urgent need to use the remedy, then during the treatment period it is recommended replace breastfeeding with artificial.

Atarax for children and adults is not prescribed for impaired absorption of fructose and galactose. If the patient is hypersensitive to the components of the drug, then it is not recommended to use it. It should be taken with extreme caution when:

• myasthenia gravis;
• dementia;
• difficult urination.

If a man has prostatic hyperplasia, then the use of the medicine is allowed only after prior consultation with the doctor. With increased intraocular pressure Atarax is taken with caution.

Attention! If the human body is predisposed to arrhythmia, then it is first recommended to consult a doctor.

Features of use

Instructions for use contains information about the features of the use of Atarax. The medication should be taken orally. The dosage is determined only by the doctor in accordance with the severity of the disease and the individual characteristics of the patient.

If the patient has a state of anxiety, then every day it is recommended to take half a tablet. With a severe degree of pathology, you can take 0.3 grams of the drug.

In the treatment of itching, the use of 0.025 grams of the drug is recommended. If necessary, the drug can be taken 3-4 times a day at this dosage. The daily dose of the drug should not exceed 0.3 grams. If children are being treated, then the dosage of the drug should be from 0.001 to 0.0025 grams per kilogram of the baby's weight. That, how long it takes to take pills, the doctor determines in accordance with the individual characteristics of the patient.

After the production of the drug, its use is allowed for 5 years. Storage of the medicine should be carried out in a dry place, protected from direct sunlight. During the storage period of the medicine, it is necessary to ensure that the temperature is not more than 25 degrees.

Unwanted Effects

Improper medication can lead to the development of negative consequences. The drug can adversely affect the cardiovascular system, which manifests itself in the form of an increase heart rate and lower blood pressure. Patients may complain of decreased vision during the course of treatment. Side effects may manifest as disturbed accommodation.

Improper intake of tablets can also lead to disturbances in the functioning of the gastrointestinal tract. Some complain of dry mouth. Some patients may experience vomiting, nausea, impaired peristalsis.

Atarax tablets lead to hypersensitivity. Some patients are diagnosed with anaphylactic shock. During treatment with the drug, the process of excretion of urine is delayed.

Treatment with Atarax in rare cases leads to bronchospasm. Enough a serious side effect is choking. The tool can cause a variety of neurological disorders, which manifest themselves in the form of:

• headache;
• drowsiness;
• dizziness;
• insomnia;
• convulsions.

In rare cases, there is the occurrence of mental disorders in the form of overexcitation, hallucinations and disorientation. During treatment, some patients experience a rash and itching. Rarely diagnosed swelling of the skin. Irrational use of the drug leads to the occurrence of general disorders - fever and weakness. Patients report the appearance of constant fatigue, even when doing their usual activities.

Overdose and analogues

It is necessary to take the drug in strict accordance with the recommendations of the doctor. Otherwise, an overdose will occur. In this case, patients have increased anticholinergic effects. Taking the drug in excessively large doses can cause paradoxical stimulation or depression of the nervous system. Also, patients may experience involuntary motor activity.

An excessive amount of the drug can cause nausea and vomiting. In some individuals, hallucinations were observed with an overdose. Some patients noted the occurrence of disturbances in consciousness. Patients may diagnose arterial hypotension or arrhythmia. Quite rarely, an excess amount of the drug caused tremors and seizures. Sometimes at accepting Atarax observed a disorientation.

If the patient has signs of an overdose of the drug, then he needs to be urgently prescribed serious treatment. In the absence of spontaneous vomiting, the patient is recommended to perform artificial gastric lavage.

In this case, it is recommended to carry out general activities that support the vital functions of the body. In case of an overdose, it is recommended to give activated charcoal in the amount of 1 tablet per 10 kilograms of the patient's weight. It is also recommended to monitor the patient's condition during the day.

If the patient has contraindications to the use of Atarax, then it is recommended to use analogues for his treatment. In most cases, it is recommended to take:

• Afobazole;
• Sedavita;
• Sedamina;
• Herbastres;
• Nervonorma, etc.

The selection of analogues should be carried out in strict accordance with the indications. Self-administration of the drug is strictly prohibited. That is why in the presence of contraindications or the appearance of undesirable effects, it is recommended to seek help from a doctor.

Important! Atarax and alcohol are incompatible concepts. That is why the patient during the period of treatment must refuse to take alcoholic beverages.

Useful video: features of taking Atarax tablets