Xyzal, drops for oral use 5mg/ml, 10ml

Composition

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1 ml contains:

Active ingredient:

levocetirizine dihydrochloride 5 mg.

Auxiliary substances:  

sodium acetate, acetic acid,

propylene glycol,

glycerol 85%,

methyl parahydroxybenzoate,

propyl parahydroxybenzoate,

sodium saccharinate,

purified water.

Pharmacological action

Levocetirizine is an R-enantiomer of cetirizine, which belongs to the group of competitive histamine antagonists and blocks H1-histamine receptors. Levocetirizine has a 2-fold higher affinity for histamine H1 receptors than cetirizine.

Levocetirizine has an effect on the histamine-dependent stage of allergic reactions, and also reduces the migration of eosinophils, reduces vascular permeability, and restricts the release of inflammatory mediators.

It prevents the development and eases the course of allergic reactions, has an anti-exudative, antipruritic effect, practically does not have an anticholinergic and antiserotonin effect. In therapeutic doses, it has practically no sedative effect.

Indications

Symptomatic treatment of allergic diseases and conditions:

• year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis (itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia, nasal congestion);
• pollinosis (hay fever);
• urticaria (including chronic idiopathic urticaria);
• Quincke’s edema;
• other allergic dermatoses accompanied by itching and rashes.

Use during pregnancy and lactation

Experimental studies on animals did not reveal any direct or indirect adverse effects of levocetirizine on the developing fetus, as well as on development in the postnatal period; the course of pregnancy and childbirth also did not change.

Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy have not been conducted, so levocetirizine should not be prescribed during pregnancy.

Levocetirizine is excreted in breast milk, so its use is possible only if the intended benefit to the mother exceeds the potential risk to the child.

Contraindications

• Hypersensitivity to any of the components of Xyzal or piperazine derivatives;
• severe chronic renal failure (Cl creatinine
• ) children under 6 years of age.
• With caution:
• chronic renal failure (dosage adjustment is required);
• advanced age (glomerular filtration rate may decrease).
• Use during pregnancy and lactation
• It is not recommended to prescribe to women during pregnancy and lactation.

Side effects

  Possible side effects are listed below by body system and frequency: common (≥1/10); uncommon (≥1/100 to <1/10); rare (≥1/1000 to <1/100); very rare (≥1/10,000 to

From the central nervous system: infrequently-headache, fatigue, drowsiness; rarely-asthenia; very rarely-aggression, agitation, convulsions, hallucinations, depression, visual impairment.

From the cardiovascular system: very rarely – tachycardia.

From the respiratory system: very rarely – dyspnoea.

From the digestive system: infrequently-dry mouth; rarely-abdominal pain; very rarely-nausea, diarrhea, hepatitis, changes in liver function tests.

Musculoskeletal disorders: very rare – myalgia.

From the side of metabolism: very rarely – weight gain.

Allergic reactions: very rarely – pruritus, rash, urticaria, angioedema, anaphylaxis.

Interaction

The interaction of levocetirizine with other drugs has not been studied.

When studying the drug interaction of cetirizine racemate with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam, no clinically significant adverse interactions were detected.

When co-administered with theophylline (400 mg/day), the total clearance of cetirizine decreases by 16% (theophylline kinetics does not change).

In some cases, concomitant use of levocetirizine with alcohol or drugs that depress the central nervous system may increase their effect on the central nervous system, although it has not been proven that cetirizine racemate potentiates the effect of alcohol.

How to take, course of use and dosage

The drug is prescribed orally during meals or on an empty stomach.

Tablets are taken with a small amount of water, without chewing.

Drops for oral use are taken with a teaspoon. If necessary, the dose of the drug can be diluted in a small amount of water immediately before use.

Adults and children over 6 years of age: daily dose of 5 mg (1 tab. or 20 drops).

Children aged 2 to 6 years: 1.25 mg (5 drops) 2 times / day; daily dose-2.5 mg (10 drops).

Since levocetirizine is excreted by the kidneys, when prescribing the drug to elderly patients and patients with renal insufficiency, the dose should be adjusted depending on the creatinine clearance.

CC can be calculated based on the concentration of serum creatinine using the following formula.

For men:

CC (ml / min)= [140-age (years)] × body weight (kg)/72 × serum creatinine (mg / dl)

For women: obtained value × 0.85

Renal insufficiency CC(ml / min)Dose and multiplicity of Priemanorm>805 mg / day Light degree 50-795 mg/day Medium degree 30-495 mg / day 1 time in 2 days Heavy degree><10 The drug is contraindicated

For patients with renal and hepatic insufficiency, the dosage is carried out according to the table given above.

Patients with liver function disorders alone do not need to adjust the dosage regimen.

The duration of application depends on the indications. The average course of treatment for pollinosis is 1-6 weeks. For chronic diseases (year-round rhinitis, atopic dermatitis), the duration of treatment can be extended up to 18 months.

Overdose

Symptoms:  drowsiness (in adults), agitation and restlessness, followed by drowsiness (in children).

Treatment:  immediately after taking the drug inside, it is necessary to flush the stomach or induce artificial vomiting.

It is recommended to prescribe activated charcoal, conduct symptomatic and maintenance therapy.

There is no specific antidote.

Hemodialysis is not effective.

Special instructions

Caution is required when drinking with alcohol at the same time.

Form of production

Drops for oral use in the form of an almost colorless, slightly opalescent solution.

Storage conditions

In a dark place, at a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Levocetirizine

Conditions of release from pharmacies

By prescription

Dosage form

Drops for oral use

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor, Children over 2 years of age

Indications

Pruritus, Dermatosis, Nasal Mucosa Edema, Allergy, Allergic Rhinitis, Urticaria, Quincke’s Edema, Pollinosis, Allergic Conjunctivitis