$8.00
Manufacturer: Poland
Antihistamines for systemic use. Piperazine derivatives. ATX code R06A E07.
Symptomatic therapy:
- nasal and ocular symptoms of seasonal and persistent allergic rhinitis;
- chronic idiopathic urticaria.
Dosage and administration
Apply inside, washing down a tablet with a glass of water. Swallow the tablets without chewing.
Children aged 6 to 12 years 5 mg (½ tablet) 2 times a day.
Adults and children over 12 years old: 10 mg (1 tablet) once a day.
Description
Composition
active ingredient : cetirizine dihydrochloride;
1 coated tablet contains cetirizine dihydrochloride 10 mg;
excipients : lactose monohydrate, microcrystalline cellulose starch corn povidone K 25; magnesium starch sodium stearate (type C) colloidal silicon dioxide sodium lauryl sulfate;
shell composition : hypromellose, macrogol 6000.
Pharmacotherapeutic group
Antihistamines for systemic use. Piperazine derivatives. ATX code R06A E07.
Pharmacodynamics
Mechanism of action
Cetirizine, a metabolite of hydroxyzine, is a potent, selective peripheral histamine H1 receptor antagonist. An in vitro receptor binding study showed no significant affinity for receptors other than H1.
Pharmacodynamic effects
In addition to the H1 receptor antagonistic effect, cetirizine has an antiallergic effect: at a dose of 10 mg 1 or 2 times a day, the drug inhibits the late phase of migration of cells involved in the inflammatory response (mainly eosinophils) in the skin and conjunctiva of atopic individuals who were injected with antigen.
Clinical efficacy and safety
Studies in healthy volunteers have shown that cetirizine at doses of 5 and 10 mg strongly inhibits blistering and redness caused by very high concentrations of histamine in the skin, although the relationship with efficacy has not been established.
In a 6-week placebo-controlled study in 186 patients with allergic rhinitis and concomitant mild to moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms and did not affect lung function. This study confirms the safety of the use of cetirizine in patients with mild to moderate bronchial asthma.
A placebo-controlled study in which cetirizine was used at a high dose (60 mg) for 7 days showed no statistically significant prolongation of the QT interval.
The use of cetirizine in normal doses improves the quality of life of patients with chronic and seasonal allergic rhinitis.
Indications
Symptomatic therapy:
- nasal and ocular symptoms of seasonal and persistent allergic rhinitis;
- chronic idiopathic urticaria.
Contraindications
Hypersensitivity to the active substance or to any excipient that is part of the drug, to hydroxyzine or to any piperazine derivative.
Severe renal dysfunction (creatinine clearance less than 10 ml / min).
Rare hereditary forms of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Dosage and administration
Apply inside, washing down a tablet with a glass of water. Swallow the tablets without chewing.
Children aged 6 to 12 years 5 mg (½ tablet) 2 times a day.
Adults and children over 12 years old: 10 mg (1 tablet) once a day.
Elderly patients
There are no data indicating the need to reduce the dose for the elderly if renal function is not impaired.
Patients with moderate or severe renal impairment
There are no data on the benefit / risk ratio for patients with impaired renal function. But since cetirizine is excreted by the kidneys, if alternative treatment is not possible, the intervals between doses of the drug should be determined individually, depending on the function of the kidneys.
The dosage should be adjusted as indicated in the table below.
To use the table, you need to determine the creatinine clearance (Clcr) ml / min. Clcr (ml/min) can be calculated from serum creatinine concentration (mg/dl) using the formula:
Cl = ((140 – age (in years)) x body weight (kg) / 72 x serum creatinine (mg / dl)) x 0.85 for women;
Dose adjustments for adult patients with impaired renal function
Table 1
| Kidney function | QC (ml / min) | Dose and frequency of administration |
| normal function | ≥ 80 | 10 mg 1 time per day |
| Mild violation | 50-79 | 10 mg 1 time per day |
| moderate form | 30-49 | 5 mg 1 time per day |
| Severe form | < 30 | 5 mg 1 time every 2 days |
| End stage renal disease – patients undergoing dialysis | < 10 | Contraindicated |
Children with impaired renal function dose should be administered individually, taking into account creatinine clearance, age and body weight of the patient.
Patients with impaired liver function
There is no need for dose adjustment in patients with impaired liver function.
Patients with impaired renal and hepatic function
It is recommended to prescribe a dosage depending on the patient’s condition (see above “Patients with moderate or severe impaired renal function”).
The duration of treatment is determined by the doctor individually, depending on the course of the disease.
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