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 drug is indicated in adults and children from 6 months and older for relief:
– 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.
Administration in children aged 6 to 12 months is possible only by prescription and under strict medical supervision.
Active ingredient
Cetirizine
How to take, the dosage
Orally, drip into a spoon or dissolve in water. The amount of water to dissolve the drug should correspond to the amount of liquid that the patient (especially a child) is able to swallow. The solution should be taken immediately after preparation. Adults 10 mg (20 drops) once daily.
Elderly patients
There is no need to reduce the dosage in elderly patients if renal function is not impaired.
Patients with renal insufficiency As cetirizine is eliminated from the body mainly by the kidneys, if there is no alternative treatment for patients with renal insufficiency the drug dosage regimen should be adjusted according to the renal function (CK value). CK for men can be calculated based on serum creatinine concentration in plasma according to the following formula:
CK (ml/min) = [140 – age (years)] × body weight (kg) /72 × CK serum (mg/dl)
CK for women can be calculated by multiplying the obtained value by coefficient 0,85.
Patients with hepatic dysfunction
In patients with hepatic dysfunction only the dosage regimen does not require correction. In patients with liver and kidney function disorders the dosage adjustment is recommended.
Children
Administration in children aged 6 to 12 months is possible only by prescription and under close medical supervision.
Children 6 to 12 months 2.5 mg (5 drops) once a day
Children 1 to 6 years old 2.5 mg (5 drops) twice a day
Children 6 to 12 years old 5 mg (10 drops) twice a day
Children over 12 years of age 10 mg (20 drops) once daily
Sometimes an initial dose of 5 mg (10 drops) may be sufficient if satisfactory symptom control can be achieved.
In children with renal insufficiency, the dose is adjusted for CK and body weight.
If no improvement occurs after treatment or symptoms worsen or new symptoms appear, consult a physician. Use the drug only according to the indications, the method of administration and in the doses specified in the instructions.
Interaction
Concomitant use with azithromycin, cimetidine, erythromycin, ketoconazole or pseudoephedrine does not affect the pharmacokinetic parameters of cetirizine.
Special Instructions
Due to the potential depressant effect on the central nervous system, caution should be exercised when prescribing the drug in children under 1 year of age if the following risk factors for sudden infant death syndrome are present, such as (but not limited to):
– sleep apnea syndrome or sudden infant death syndrome in a sibling;
– maternal drug or smoking abuse during pregnancy;
– young maternal age (19 years or younger);
– smoking abuse by a babysitter (one pack of cigarettes per day or more); <
– children who regularly fall asleep face down and are not placed on their backs;
– prematurely born (gestational age less than 37 weeks) or children born with low birth weight (below the 10th percentile of gestational age);
– when taking concomitant medications that have a depressant effect on the central nervous system.
Contraindications
– Hypersensitivity to cetirizine, hydroxyzine or any piperazine derivatives, as well as to other components of the drug.
– Terminal stage of renal failure (CK < 10 ml/min).
– Children under 6 months of age (due to the limited data on the effectiveness and safety of the drug).
– Pregnancy.
With caution
– Chronic renal insufficiency (at CK > 10 ml/min requires dosing regimen correction).
– Elderly patients (with age-related decrease in glomerular filtration rate).
– Epilepsy and patients with increased seizure readiness.
– Patients with predisposing factors to urinary retention (see section “Special indications”).
– Children under 1 year of age.
– The period of breastfeeding.
– In concomitant use with alcohol.
Side effects
Evidence from clinical trials Review
Pregnancy use
Pregnancy
An analysis of prospective data from more than 700 cases of pregnancy outcomes showed no cases of fetal and neonatal toxicity malformations with a clear causal relationship.
The experimental studies on animals did not reveal any direct or indirect adverse effects of cetirizine on the developing fetus (including in the postnatal period) during pregnancy and postnatal development.
There have been no adequate and strictly controlled clinical studies on the safety of the drug during pregnancy; therefore, Solonex should not be used during pregnancy.
Breastfeeding
The drug should not be used while breastfeeding because cetirizine is excreted with the breast milk.
Fertility
The available data on the effect on human fertility are limited but no negative effects on fertility have been identified.
Similarities
Zyrtec, Cetrin, Zodak, Cetirizine, Cetirizine-Teva, Cetirizine drops
Weight | 0.055 kg |
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Shelf life | 3 years. After opening the bottle – 6 months. Do not use after the expiration date! |
Conditions of storage | Store at the temperature not more than 25 ºC. Keep out of reach of children. |
Manufacturer | Grotex Ltd, Russia |
Medication form | oral drops |
Brand | Grotex Ltd |
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