Xizal, 5 mg 7 pcs.

Xizal is an anti-allergic agent.

The active substance of the drug is levocetirizine, an enantiomer of cetirizine, belongs to the group of competitive histamine antagonists.

Levocetirizine acts on histamine-dependent stage of allergic reactions, reduces migration of eosinophils, decreases vascular permeability and limits release of inflammatory mediators.

It prevents and facilitates the development of allergic reactions, has antiexudative, antipruritic action, practically has no anticholinergic and antiserotonic action.

In therapeutic doses it has practically no sedative effect.

Indications

For adults and children over 6 years: Treatment of symptoms of year-round and seasonal allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, lacrimation, conjunctival hyperemia;

Hay fever (pollinosis);

Hives, including chronic idiopathic urticaria, Quincke’s edema;

other allergic dermatoses with itching and rashes.

Active ingredient

Composition

1 tablet contains:

The core:

the active ingredient: levocetirizine dihydrochloride 5.0 mg;

the excipients: lactose monohydrate 63.50 mg, microcrystalline cellulose 30.00 mg, colloidal silicon dioxide 0.50 mg, magnesium stearate 1.00 mg.

The shell: opadray Y-1-7000 3.00 mg (contains hypromellose 62.5%, titanium dioxide (E171) 31.25%, macrogol 400 6.25%).

How to take, the dosage

It is taken orally with food or on an empty stomach with a small amount of water, without chewing. Adults and children over 6 years of age: daily dose is 5 mg (1 tablet). In elderly patients (on condition of normal renal function) the dose is not required.

In patients with chronic renal insufficiency the dose is reduced twice (1 tablet every other day) in case of CK of 30 to 49 ml/min and 3 times (1 tablet every 3 days) in case of CK of 10 to 29 ml/min. Patients with hepatic insufficiency do not require dosage regimen adjustment.

The duration of treatment depends on the disease. For the treatment of pollinosis it is prescribed for 1-6 weeks on average. In chronic diseases (year-round rhinitis, atonic dermatitis) the treatment duration may be increased up to 18 months.

Interaction

Co-administration with macrolides or ketoconazole caused no significant ECG changes. Co-administration with theophylline (400 mg/day) decreases total clearance of levocetirizine by 16% (theophylline kinetics is not changed).

When used in therapeutic doses, no data on interaction with alcohol have been obtained. Nevertheless, it is necessary to refrain from drinking alcohol-containing beverages.

Special Instructions

An objective assessment of driving and operating ability has not shown any undesirable events with the recommended dose of 5 mg, however, it is advisable to refrain from potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

Contraindications

Hypersensitivity to any of the drug components or piperazine derivatives. Severe form of chronic renal failure (creatinine clearance less than 10 ml/min).

Children (under 6 years).

With caution – chronic renal insufficiency (dosage regimen should be corrected), old age (decrease of glomerular filtration is possible).

Side effects

Headache, drowsiness, dry mouth, fatigue.

Rarely – migraine, dizziness, dyspeptic disorders, allergic reactions (angioedema, rash, urticaria, itching).

Overdose

Symptoms: may be accompanied by signs of intoxication in the form of drowsiness, in children overdose of the drug may be accompanied by anxiety and increased irritability.

Treatment: in case of overdose symptoms (especially in children) the drug should be stopped, gastric lavage, activated charcoal, symptomatic therapy should be used. There is no specific antidote.

Pregnancy use

Pregnancy

The data on the use of levocetirizine during pregnancy are almost non-existent or limited (less than 300 pregnancy outcomes). However, the use of cetirizine racemate levocetirizine in pregnancy (more than 1000 pregnancy outcomes) was not accompanied by malformations and intrauterine and neonatal toxic effects. No direct or indirect adverse effects on fetal and foetal development and postnatal development were found in animal studies.

The administration of levocetirizine in pregnancy may be considered if necessary.

Breastfeeding period

The cetirizine racemate levocetirizine is excreted with breast milk. Therefore, excretion of levocetirizine with breast milk is also likely. Breast-fed children may have adverse reactions to levocetirizine. Therefore it is necessary to observe caution when prescribing levocetirizine during breastfeeding.

Fertility

There are no clinical data on levocetirizine.

Consult your doctor before using the drug if you are pregnant or think you might be pregnant or are planning to become pregnant.

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