Relief of nose and eye symptoms associated with seasonal and chronic allergic rhinitis. Relief of symptoms of chronic idiopathic urticaria. The tablets are indicated for use in adults and children from 6 years, syrup in adults and children from 2 years.
Composition:
1 tabl powl. contains 10 mg of Cetirizine dihydrochloride; Table. powl. contain lactose. 1 ml of syrup contains 1 mg of cetirizine dihydrochloride; the syrup contains sodium benzoate, glycerol and xylitol.
Action:
Antihistamine - a strong and selective antagonist of peripheral histamine H receptors1. It inhibits the early phase of the allergic reaction in which histamine is involved, as well as reduces the migration of inflammatory cells and the release of mediators in the late phase of the allergic reaction. Quickly and almost completely absorbed from the gastrointestinal tract, the food does not reduce the degree of absorption, but reduces its speed. The maximum steady state blood concentration occurs within 1 h after oral administration. The drug is bound to plasma proteins in approximately 93%. The first pass metabolism is not significantly affected. About 2/3 of the dose is excreted unchanged in the urine. Final T0,5 is about 10 hours in adults, about 6 hours in children from 6 to 12 years and 5 hours in children from 2 to 6 years.
Contraindications:
Hypersensitivity to Cetirizine, hydroxyzine, piperazine derivatives or other components of the preparation. Severe renal failure (creatinine clearance <10 ml / min). Due to the lactose content of coated tablets, this form should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Precautions:
Caution should be used in patients with impaired renal and hepatic function, patients with epilepsy or risk of seizures. The tablets should not be used in children under 6 years of age. Glycerol contained in syrup can cause headache, stomach upset and diarrhea.
Pregnancy and lactation:
Animal studies do not indicate a harmful effect of cetirizine on pregnancy, embryonal / fetal development, parturition or postnatal development. Caution should be exercised when recommending cetirizine to pregnant women. It should not be used in women who are breastfeeding because cetirizine is excreted in human milk.
Side effects:
At a frequency of 1% or more, fatigue may occur; pain and dizziness; abdominal pain, dryness of the oral mucosa, nausea; somnolence; pharyngitis. With a frequency of 1% or more in children from 6 months to 12 years of age, you may experience diarrhea, drowsiness, inflammation of the nose, fatigue. In addition, the following side effects have been reported post-marketing - uncommon: agitation, paresthesia, diarrhea, pruritus, rash, asthenia, malaise; rare: hypersensitivity reactions, aggressive behavior, confusion, depression, hallucinations, insomnia, convulsions, tachycardia, abnormal liver function (increased ALT, alkaline phosphatase, GGT, increased bilirubin), urticaria, edema, weight gain; very rare: thrombocytopenia, anaphylactic shock, tics, taste disturbances, syncope, tremor, dystonia, dyskinesia, accommodation disorder, blurred vision, eyeball rotation, angioneurotic edema, drug eruption, painful or difficult urination, involuntary urination; frequency unknown: amnesia, memory problems.
Dosage:
Orally. Adults and children> 12 years: 10 mg (1 table or 10 ml of syrup) once a day; children 6-12 years: 5 mg (1/2 plateau or 5 ml of syrup) twice a day; children 2-6 years: 2.5 mg (2.5 ml of syrup) 2 times a day. In patients with hepatic impairment and in the elderly, no dosage adjustment is necessary. In patients with renal insufficiency, the dosage depends on the creatinine clearance - CCr = 50-79 ml / min: 10 mg once a day; CCr = 30-49 ml / min: 5 mg once a day; CCr <30 ml / min: 5 mg every other day; CCr <10 ml / min: do not use.In children with renal impairment, the dose should be determined individually based on the creatinine clearance and body weight of the patient. The tablets should be swallowed with a glass of water.
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