Solonex, drops 10 mg/ml 20 ml

Cetirizine, the active ingredient of the drug, is a metabolite of hydroxyzine, belongs to the group of competitive histamine antagonists and blocks H1-histamine receptors.

Indications

The use of the drug is indicated in adults and children from 6 months and older to relieve:

– nasal and ocular symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis: itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;
– symptoms of chronic idiopathic urticaria.

Use in children from 6 to 12 months is possible only as prescribed by a doctor and under
strict medical supervision.

Pharmacological effect

Cetirizine, the active ingredient of the drug, is a metabolite of hydroxyzine, belongs to the group of competitive histamine antagonists and blocks H1-histamine receptors.

Special instructions

Due to the potential for central nervous system depressant effects, caution should be exercised when prescribing the drug to children under 1 year of age who have the following risk factors for sudden infant death syndrome, such as (but not limited to):
– sleep apnea syndrome or sudden infant death syndrome in a brother or sister;
– maternal drug abuse or smoking during pregnancy;
– young age of mother (19 years and younger);
– smoking abuse by a nanny caring for a child (one pack of cigarettes a day or more);
– children who regularly fall asleep face down and are not placed on their back;
– premature (gestational age less than 37 weeks) or born with insufficient body weight (below the 10th percentile of gestational age) children;
– when taking drugs together that have a depressing effect on the central nervous system.

The drug contains excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions, including delayed ones. In patients with spinal cord injury, prostatic hyperplasia, or other factors predisposing to urinary retention, caution is required as cetirizine may increase the risk of urinary retention.

Active ingredient

Cetirizine

Composition

1 ml of the drug contains:

Pregnancy

Pregnancy

An analysis of prospective data from more than 700 cases of pregnancy outcomes revealed no cases of developmental malformations of embryonic and neonatal toxicity with a clear cause-and-effect relationship.

Experimental studies in animals have not revealed any direct or indirect adverse effects of cetirizine on the developing fetus (including in the postnatal period), pregnancy and postnatal development.

Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy have not been conducted, therefore Solonex should not be used during pregnancy.

Breast-feeding

The drug should not be used during breastfeeding since cetirizine is excreted in breast milk.

Fertility

Available data on the effects on human fertility are limited; however, no negative effects on fertility have been identified.

Contraindications

– Hypersensitivity to cetirizine, hydroxyzine or any piperazine derivatives, as well as to other components of the drug.
– End-stage renal failure (CC < 10 ml/min).
– Children under 6 months of age (due to limited data on the effectiveness and safety of the drug).
– Pregnancy.

With caution

– Chronic renal failure (with CC > 10 ml/min, dosage regimen adjustment is required).
– Elderly patients (with an age-related decrease in glomerular filtration rate).
– Epilepsy and patients with increased convulsive readiness.
– Patients with predisposing factors to urinary retention (see section “Special instructions”).
– Children under 1 year of age.
– Breastfeeding period.
– When used simultaneously with alcohol

Side Effects

Evidence from Clinical Studies Review

Interaction

Concomitant use with azithromycin, cimetidine, erythromycin, ketoconazole or pseudoephedrine does not affect the pharmacokinetic parameters of cetirizine.

Overdose

Symptoms

Storage conditions

Store at a temperature not exceeding 25 ºС.
Keep out of the reach of children.

Shelf life

3 years. After opening the bottle – 6 months.
Do not use after the expiration date!

Manufacturer

Grotex LLC, Russia