Atarax 25 mg Tablets

Brand name

The trade name of the drug is Atarax. Under this name it is registered and available in the pharmacy network for medical use.

International Nonproprietary Name (INN)

The international nonproprietary name is hydroxyzine. This name indicates the main active substance of the drug and is used in pharmaceutical practice worldwide.

Form of release

Atarax is available in two main forms: film-coated tablets and solution for intramuscular injection. Tablets are available in dosages of 10 mg and 25 mg, packed in blisters of 25 pieces. The solution is supplied in 2 ml ampoules containing 50 mg of hydroxyzine hydrochloride in each ampoule and is intended for use in a hospital setting or under the supervision of a physician.

Composition

Active substance

The active component of Atarax is hydroxyzine hydrochloride. Tablets contain 10 mg or 25 mg of this substance, and in 1 ml of solution for injection - 25 mg.

Auxiliary components

Tablets include such additional substances as lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silicon dioxide, as well as components of the film coating (hypromellose, titanium dioxide, macrogol). Solution for injection contains sodium hydroxide, water for injection and a small amount of hydrochloric acid to stabilize pH.

Pharmacologic Properties

Pharmacodynamics

Hydroxyzine, which is part of Atarax, belongs to the group of first-generation antihistamines with a pronounced sedative effect. Its action is based on blocking H1-histamine receptors, which reduces the manifestations of allergic reactions, such as itching and redness of the skin. In addition, the drug has an effect on the central nervous system, suppressing the activity of certain parts of the brain responsible for anxiety and excitement. Hydroxyzine also has a moderate anticholinergic and antiemetic effect, which expands the range of its use. Calming effect comes 15-30 minutes after ingestion and persists for 4-6 hours, depending on the dosage and individual characteristics of the body.

Pharmacokinetics

Absorption

When taken orally, hydroxyzine is rapidly absorbed from the gastrointestinal tract. Maximum concentration in blood plasma is reached 1-2 hours after administration. When administered intramuscularly, absorption is almost instantaneous, and the therapeutic effect is manifested in 5-10 minutes.

Distribution

Hydroxyzine is well distributed in body tissues, including the central nervous system, due to its lipophilic nature. Binding to plasma proteins is about 90%. The drug penetrates the blood-brain barrier, which provides its sedative effect.

Metabolism

The metabolism of hydroxyzine is carried out in the liver with the participation of enzymes of the cytochrome P450 system. The main metabolite - cetirizine - also has antihistaminic activity and contributes to the prolonged effect of the drug.

Excretion

Hydroxyzine half-life is about 12-20 hours in adults, in children it is shorter (about 7 hours), and in elderly people it may increase up to 29 hours. The drug is excreted mainly through the kidneys in the form of metabolites, and less than 1% of the substance is excreted unchanged.

Indications for Use

Atarax is used for the treatment of the following conditions:

• Anxiety disorders in adults, including generalized anxiety and tension states;
• Symptomatic treatment of pruritus in allergic dermatoses (eczema, urticaria, atopic dermatitis);
• Preparation for surgical interventions (as a sedative);
• Sleep disorders associated with anxiety or stress;
• Complex therapy in chronic allergic diseases.

The drug is effective as a short-term remedy to relieve acute symptoms and can be prescribed as part of a complex treatment.

Contraindications

The use of Atarax is prohibited in the following conditions:

• Hypersensitivity to hydroxyzine, cetirizine or any excipients;
• Closed-angle glaucoma;
• Severe myasthenia gravis;
• Porphyria;
• Severe renal or hepatic insufficiency;
• Pregnancy and breastfeeding period;
• Children under 3 years of age (for tablets) and under 1 year of age (for injections).

With caution, the drug is prescribed to patients with epilepsy, heart rhythm disturbance or prostatic hyperplasia.

Method of Administration and Dosage

How to take

Atarax tablets are taken orally, drinking enough water (about 100-150 ml). Food intake does not significantly affect absorption, so the drug can be taken both before and after meals. The solution for injection is administered intramuscularly, usually into the gluteal muscle, exclusively by medical personnel.

Dosages for adults and children

Adults

For anxiety: 25-100 mg per day, divided into 2-3 administrations. For the treatment of itching: 25 mg before bedtime, if necessary, the dose is increased to 25 mg 3-4 times a day. The maximum daily dose is 300 mg.

Children over 3 years of age

Dosage is calculated individually: 0.5-2 mg per 1 kg of body weight per day, divided into 2-3 receptions.

Dose adjustment for certain conditions

In renal or hepatic insufficiency the dose is reduced by 2 times due to slow excretion of the drug. In elderly patients, the initial dose is also reduced (e.g., to 10-25 mg per day) with further adjustment according to the condition.

Side Effects

The following adverse reactions are possible during the use of Atarax:

• Side of the nervous system: drowsiness, fatigue, headache, dizziness;
• Gastrointestinal tract: dry mouth, nausea, constipation;
• Cardiovascular system: tachycardia, decreased blood pressure (rare);
• Allergic reactions: skin rash, itching, in rare cases - Quincke's edema;
• Other: impaired accommodation of vision, urinary retention.

The majority of side effects are temporary and pass after dose reduction or drug withdrawal.

Overdose

Symptoms of overdose

If the recommended dose is exceeded, the following may be observed: marked drowsiness, confusion, tremor, convulsions, respiratory depression, coma. In severe cases, arrhythmias and cardiac arrest may occur.

First aid measures

If an overdose is suspected, an ambulance should be called immediately. Before the arrival of medics, you can wash the stomach (if the drug is taken orally recently) and give the patient activated charcoal. In case of an injectable overdose, urgent hospitalization is required.

Drug Interactions

Influence on the effect of other drugs

Atarax increases the effect of agents that depress the CNS (opioids, barbiturates, benzodiazepines), as well as anticholinergic drugs. Co-administration with MAO inhibitors may increase the risk of side effects.

Compatibility with alcohol and food

Alcohol significantly increases the sedative effect of Atarax, which may lead to excessive drowsiness or respiratory depression. Food does not affect the pharmacokinetics of the drug.

Special Precautions

Use in pregnancy and breastfeeding

Atarax is contraindicated during pregnancy due to the risk of teratogenic effects. During breastfeeding the drug penetrates into milk, therefore during the period of treatment it is necessary to refuse lactation.

Effect on driving and mechanisms

The drug causes drowsiness, especially at the beginning of treatment, so patients are advised to refrain from driving and working with mechanisms until individual reaction is evaluated.

Particularities of use in elderly people and children

In elderly people the dose is reduced due to slow metabolism and increased sensitivity to sedative effect. In children the drug is used with caution, strictly observing the dosage by body weight.