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Components:
Hydroxyzine
Method of action:
Antiemetic, Anxiolytic, Muscle Relaxant, Psychoanaleptics, Sedative
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2020.01.26

Name of the medicinal product

Krust

Qualitative and quantitative composition

Hydroxyzine

Therapeutic indications

The information provided in Therapeutic indications of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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Atarax is indicated to assist in the management of anxiety in adults.

Atarax is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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Posology

Atarax should be used at the lowest effective dose and for the shortest possible duration.

In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day.

Anxiety

Adults 50-100mg daily in divided doses

Pruritus

Adults Starting dose of 25mg at night increasing as necessary to 25mg three or four times daily.

Elderly

In the elderly, the maximum daily dose is 50 mg per day.'Pharmacokinetic properties')

Paediatric Population

In children up to 40 kg in weight, the maximum daily dose is 2 mg/kg/day.

From 6 months to 6 years, 5-15mg daily in divided doses adjusted depending on the child's weight.

In children and adolescents over 40kg in weight, the maximum daily dose is 100mg per day.

For children over 6 years, starting at 15-25mg and increasing to 50-100mg daily in divided doses adjusted according to the child's weight.

As with all medications, the dosage should be adjusted according to the patient's response to therapy.

Hepatic impairment

The total daily dose should be reduced by 33%.'Special Warnings and Precautions for Use')

Renal impairment

<'Special Warnings and Precautions for Use').

Method of administration: oral.

Contraindications

The information provided in Contraindications of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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<'Fertility, pregnancy and lactation')

Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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')

Renal impairment

<'Special Warnings and Precautions for Use').

Method of administration: oral.

4.3 Contraindications <'Fertility, pregnancy and lactation')

Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.4 Special warnings and precautions for use

Cardiovascular effects

Hydroxyzine has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been cases of QT interval prolongation and torsade de pointes in patients taking hydroxyzine. Most of these patients had other risk factors, electrolyte abnormalities and concomitant treatment that may have been contributory.

Hydroxyzine should be used at the lowest effective dose and for the shortest possible duration.

Treatment with hydroxyzine should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should seek immediate medical attention.

Patients should be advised to promptly report any cardiac symptoms.

Patients with hepatic impairment

Due to its sedative properties, use of hydroxyzine should be avoided in severe liver disease due to an increased risk of coma, and in patients with hepatic failure due to possibility of hepatic encephalopathy.

Hydroxyzine elimination is impaired in patients with hepatic dysfunction secondary to primary biliary cirrhosis.'Posology and Method of Administration')

Patients with renal impairment

<'Posology and Method of Administration'). It is uncertain whether the drug may accumulate or have other adverse effects in such patients. Atarax is completely metabolised and one of the metabolites is the active metabolite cetirizine. Cetirizine is renally excreted and clearance is reduced in patients with moderate renal impairment and on dialysis compared to normal volunteers.

Elderly patients

<'''Interaction with other medicinal products and other forms of interaction').

Treatment should be stopped for one week before skin testing for allergy is undertaken, and for 96 hours prior to a methocholine test.

Children and the elderly are more susceptible to side-effects.

Patients should be warned of impaired judgement and dexterity.

Atarax 10mg Film-coated tablets contain Sunset Yellow (E110) which may cause allergic reactions.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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Patients should be warned that Atarax may impair their ability to perform activities requiring mental alertness or physical co-ordination such as operating machinery or driving a vehicle.'Interaction with other medicinal products and other forms of interaction).

Undesirable effects

The information provided in Undesirable effects of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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The most common adverse effect of the sedating antihistamines is CNS depression. Effects vary from slight drowsiness to deep sleep, and include lassitude, dizziness, and incoordination. Paradoxical stimulation may occasionally occur, especially at high doses and in children and the elderly. If sedative effects occur, they may diminish after a few days of treatment. Other common adverse effects include headache, psychomotor impairment and antimuscarinic effects.

Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: >1/10

Common: >1/100 to <1/10

Uncommon: >1/1,000 to <1/100

Rare: >1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

System Organ Class

Undesirable Effect

Frequency

Blood and lymphatic system disorders

blood disorders, including agranulocytosis, leucopenia, haemolytic anaemia, and thrombocytopenia

Not known

Immune system disorders

hypersensitivity reactions, anaphylaxis, angioedema

Not known

Metabolic and nutritional disorders

porphyria, anorexia

Not known

Psychiatric disorders

agitation, confusion, disorientation, hallucinations, sleep disturbances, depression, increased anxiety, nightmares

Not known

Nervous system disorders

dyskinesia4, insomnia, sedation, drowsiness, dizziness, weakness, headache, tremor1 convulsions2, psychomotor impairment, paraesthesias, extrapyramidal effects, seizure, coma, somnolence, disturbance in attention, involuntary motor activity3, ataxia, slurred speech, bitter taste in mouth, faintness

Not known

Eye disorders

accommodation disorder, blurred vision

Not known

Ear and labyrinth disorders

tinnitus, labrynthitis, vertigo

Not known

Cardiac disorders

ventricular arrhythmias (e.g. Torsade de Pointes), QT interval prolongation , tachycardia, palpitation

Not known

Vascular disorders

hypotension, flushing

Not known

Respiratory, thoracic and mediastinal disorders

bronchospasm, thickened respiratory tract secretions, wheezing, nasal stuffiness, dryness of throat

Not known

Gastrointestinal disorders

constipation, dryness of the mouth, nausea, vomiting, increased gastric reflux, diarrhoea, epigastric pain, increased GI peristalsis

Not known

Hepatobiliary disorders

liver dysfunction

Not known

Skin and subcutaneous tissue disorders

dermatitis, fixed drug eruption, pruritis, erythema, papular rash, sweating increased, urticaria, hair loss, eczema, acute generalised exanthematous pustulosis (AGEP), toxic epidermal necrolysis

Stevens-Johnson syndrome, erythema multiforme

Not known

 

 

 

Very rare

Muscoskeletal and connective tissue disorders

myalgia

Not known

Renal and urinary disorders

urinary retention, dysuria

Not known

Reproductive system and breast disorders

priapism, impotence, early menses

Not known

General disorders and administration site conditions

fatigue, malaise, lassitude, pyrexia, dryness of respiratory mucosae, asthenia, tightness of chest, irritability, chills

Not known

Investigations

liver function tests abnormal

Not known

Footnotes

1,2, 3 reported usually with doses considerably higher than those recommended. Continuous therapy with over 1g/day has been employed in some patients without these effects having been encountered

4 dyskinesia may follow termination of prolonged antihistamine therapy.

Children and the elderly are more susceptible to side-effects.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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Overdosage with sedating antihistamines is associated with antimuscarinic, extrapyramidal, and CNS effects.'Pharmacokinetic properties').

There is no specific antidote. It is doubtful whether haemodialysis or peritoneal dialysis has any value in the treatment of overdosage with Atarax. However, if other agents such as barbiturates have been ingested concomitantly, dialysis may be indicated.

Consider activated charcoal only if the patient presents within 1 hour of ingestion of a potentially toxic amount. Gastric lavage is rarely required; for substances that cannot be removed effectively by other means, it should be considered only if a life-threatening amount has been ingested within the previous hour. It should be carried out only if the airway can be protected adequately. Induction of emesis is not recommended.

General supportive care, including frequent monitoring of the vital signs and close observation of the patient is indicated. Clear airways should be maintained, and there should be adequate ventilation. Assisted ventilation is indicated if hypercapnia is present. Observation for 6 hours after ingestion, without any other specific treatment, will be sufficient for the majority of patients. Monitor BP, pulse and body temperature. In symptomatic patients measure U&Es and creatine kinase. Perform a 12-lead ECG and monitor cardiac rhythm. Patients who have been unconscious may be hypothermic.

Hypotension, though unlikely, may be controlled with intravenous fluids. In adults, if severe hypotension persists, determine the cause and consider treatment with the following; if hypotension is mainly due to decreased systemic vascular resistance, drugs such as noradrenaline or high dose dopamine may be beneficial, if hypotension is due to reduced cardiac output dobutamine, or in severe cases adrenaline may be beneficial. However it should be noted that hydroxyzine has been shown to inhibit and reverse the vasopressor effect of adrenaline.

Analeptic agents should not be used since they may cause seizures.

As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Anxiolytics

ATC code: N05B B01

Atarax is unrelated chemically to benzodiazepines, phenothiazines, reserpine and meprobamate.

Mechanism of action

Hydroxyzine is a first generation antihistamine, a piperazine derivative, with antimuscarinic and sedative properties.

Antihistamines act as competitive antagonists of histamine at H1 histamine receptors, thus inhibiting H1 receptor-mediated reactions, such as vasodilation, flare and itch reactions and sneezing.

First-generation H1 antagonists easily cross the blood-brain barrier, consequently producing well-documented sedative and anticholinergic effects.

First-generation antihistamines also have affinity for 5-HT receptors, alpha-adrenoreceptors, and muscarinic receptors. They also reduce cyclic GMP concentrations, increase atrioventricular nodal conduction, and inhibit activation of airway vagal afferent nerves.

Pharmacodynamic effects

Hydroxyzine has CNS depressant, anticholinergic, antispasmodic, and local anaesthetic activity, in addition to antihistaminic effects. The drug also has sedative, antiemetic and primary skeletal muscle relaxant activity.

An onset of sedative action of hydroxyzine is usually noted within 15 to 30 minutes after oral administration. Sedative effects persist for 4-6 hours following administration of a single dose.

Hydroxyzine suppresses the inflammatory response (wheal and flare reaction) and pruritus for up to 4 days after intradermal skin tests with allergens and histamine.

The therapeutic range for plasma hydroxyzine concentrations and the relationship of plasma concentration to clinical response or toxicity have not been established.

Hydroxyzine does not appear to increase gastric secretions or acidity, and usually has mild antisecretory effects.

It induces a calming effect in anxious tense adults. It is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system.

Clinical efficacy and safety

Atarax has been shown clinically to be a rapid-acting anxiolytic with a wide margin of safety.

Antihistamine effects have been demonstrated experimentally and confirmed clinically; it is highly effective in alleviating pruritus.

Paediatric population

The pharmacokinetics and antipruritic effects of hydroxyzine were studied in 12 children (mean age 6.1 +/- 4.6 years) with severe atopic dermatitis, each given a single 0.7 mg/kg oral dose. Pruritis was significantly suppressed from 1 to 24 hours after the administration of the dose, with greater than 85% suppression from 2 to 12 hours. The potent antipruritic effect persists even when serum concentrations of the drug are low (only 10% of the maximum levels achieved). In children, the biologic effects of hydroxyzine appear to be much more prolonged than would be predicted from the half life values.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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Absorption

Hydroxyzine is rapidly absorbed from the gastrointestinal tract.

After a single oral dose of hydroxyzine, 0.7 mg/kg (mean dose 39.0 +/- 5.4 mg) a mean maximum serum hydroxyzine concentration of 72.5 +/- 11.1 ng/ml has been shown to occur at a mean time of 2.1 +/- 0.4 hours.

Distribution

Distribution of hydroxyzine into human body tissues and fluids has not been fully characterised. Following administration of hydroxyzine to animals, the drug is widely distributed into most body tissues and fluids with highest concentrations in the liver, lungs, spleen, kidneys, and adipose tissue. The drug is also distributed into bile in animals.

Hydroxyzine crosses the placental barrier which may lead to higher foetal than maternal concentrations.

Serum hydroxyzine concentrations do not necessarily reflect hydroxyzine tissue binding or distribution to skin receptor sites. Suppression of wheals, flares, and associated pruritis has been shown to persist even when serum hydroxyzine concentrations are low.

First-generation H1 antagonists easily cross the blood-brain barrier.

In a study group of healthy adults, the mean apparent volume of distribution has been found to be 16.0 +/- 3.0 L/kg.

Biotransformation

Hydroxyzine is metabolised in the liver. Metabolites include cetirizine, which has antihistaminic activity. Cetirizine is formed from hydroxyzine via an oxidative biotransformation step.

Elimination

An elimination half life of 20.0 +/- 4.1 hours and of 14.0 hours has been reported for hydroxyzine.

Total body clearance in adults is generally in the range of 5 to 12 ml/min/kg.

Hydroxyzine is eliminated by hepatic metabolism in humans. Cetirizine is mainly renally excreted.

Special populations

Elderly patients

The pharmacokinetics of hydroxyzine were studied in nine healthy elderly (mean age 69.5 +/- 3.7 years) subjects who ingested a single dose of hydroxyzine, 0.7 mg/kg (mean dose 49.0 +/- 6.7 mg).'Posology and Method of Administration')

Paediatric patients

The pharmacokinetics and antipruritic effects of hydroxyzine hydrochloride was studied in 12 children aged 1 to 14 years (mean age 6.1 +/- 4.6 years) with severe atopic dermatitis.'Posology and Method of Administration')

Hepatic impairment

The pharmacokinetics and pharmacodynamics of hydroxyzine were studied in eight patients (mean age 53.4 +/- SD11.2 years) with primary biliary cirrhosis, given a single dose of 0.7 mg/kg (mean dose 43.9 +/- 6.6mg) hydroxyzine.'Posology and Method of Administration')

Renal impairment

The pharmacokinetics of hydroxyzine and of its active metabolite cetirizine were studied in patients with reduced kidney function.'Posology and Method of Administration')

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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Anxiolytics

Preclinical safety data

The information provided in Preclinical safety data of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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None stated.

Incompatibilities

The information provided in Incompatibilities of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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Hydroxyzine hydrochloride has been reported to be incompatible with aminophylline, benzylpenicillin salts, chloramphenicol sodium succinate, dimenhydrinate, doxorubicin hydrochloride (in a liposomal formulation), thioridazine, and some soluble barbiturates.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Krust is based on data of another medicine with exactly the same composition as the Krust of the medicine (Hydroxyzine). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Krust directly from the package or from the pharmacist at the pharmacy.
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No special requirements.

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