Use of Cetirizine
To relieve the nasal and ocular symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis (itching, sneezing, nasal congestion, rhinorrhoea, lacrimation, conjunctival hyperemia); symptoms of pollinosis (hay fever); symptoms of urticaria (hay fever); allergic rhinitis.including chronic idiopathic), other allergic dermatosis, including allergic dermatitis, accompanied by itching and rashes, in adults and children from 6 months (in the form of drops) or from 6 years of age (in the form of pills).
Use in children from 6 to 12 months is possible only as prescribed by a doctor and under strict medical supervision.
Hypersensitivity to cetyrizine, hydroxysine or any piperazine derivatives; terminal stage of renal failure (Cl creatinine <10 ml/min); age up to 6 months (for the pharmaceutical form of a drop, due to limited data on the efficacy and safety of the application of cetyrizine); age up to 6 years (for the pharmaceutical form of the pill); pregnancy.
Restrictions on use Cetirizine Hydrochloride Dosage
Chronic renal insufficiency (correction of dosing regime is required at Cl creatinine >10 ml/min); elderly patients (at age-related decrease of tangle filtration); epilepsy and patients with increased convulsive readiness; patients with factors predisposing to urine delay (see “Precautions”); age up to 1 year (for the medicinal form of a drop); period of breastfeeding.
Application during pregnancy and breastfeeding
In the analysis of prospective data on more than 700 cases of pregnancy outcomes, no cases of malformation, embryonic and neonatal toxicity with a clear causal link with the use of cethyrizine have been identified.
Experimental studies on animals have not revealed any direct or indirect adverse effects of cethirisine on the developing fetus, the course of pregnancy and postnatal development.
Adequate and strictly controlled clinical trials have not been conducted on the safety of cethirisin administration during pregnancy, so it should not be used in pregnancy.
Fetal action category by FDA is B.
Ceticisin is excreted with breast milk – from 25 to 90% of its concentration in plasma, depending on the time after administration. During the breastfeeding period, it is used after consultation with a doctor if the expected benefit to the mother exceeds the potential risk to the child.
Fertility. Available data on the impact on human fertility is limited, but no negative impact on fertility has been detected.
Side effects of the substance Cetyrizine
Data from clinical trials
Clinical studies have shown that the use of cetyrizine in recommended doses leads to the development of minor adverse effects on the CNS, including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.
Although cetyrizine is a selective blocker of peripheral H1 receptors and has virtually no anticholinergic effect, isolated cases of urinary difficulty, accommodation disorders and dry mouth have been reported.
Liver function disorders have been reported, accompanied by elevated liver enzymes and bilirubin levels. In most cases, undesired effects have been resolved after cessation of cetyrizine intake.