Cetirizine tablets p/o 10mg №10×1

Name:
Cetirizine. Forms of release Tablets. MNNCetirizine. FTSH1-histamine receptor blocker.
Description:
: Film-coated tablets, white or almost white, round, biconvex, scored on one side. Composition One tablet contains: active substance: cetirizine dihydrochloride – 10.0 mg; excipients: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silicon dioxide, lactose monohydrate, opadry Y-1-7000 white; Opadry Y-1-7000 white shell composition: hypromellose, titanium dioxide (E171), macrogol 400. Pharmacotherapeutic group Antihistamines for systemic use. Piperazine derivatives. Cetirizine. ATC code: R06AE07. Pharmacological action Cetirizine prevents the development and facilitates the course of allergic reactions, has antipruritic and antiexudative effects. Cetirizine affects the “early” histamine-dependent stage of allergic reactions, limits the release of inflammatory mediators at the “late” stage of allergic reactions, and also reduces the migration of eosinophils, neutrophils, basophils, and stabilizes mast cell membranes. Reduces the permeability of capillaries, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reaction to the introduction of histamine, specific allergens, as well as to cooling (with cold urticaria). Indications for use For adults and children over 6 years of age: treatment of symptoms of seasonal and year-round allergic rhinitis (hay fever, hay fever); the maximum duration of treatment for seasonal allergic rhinitis in children is 4 weeks; allergic conjunctivitis; – chronic idiopathic urticaria. Method of application and dosage Treatment of allergic rhinitis Adults and adolescents over 12 years of age: the recommended dose is 10 mg (1 tablet) 1 time per day. Children 6 to 12 years old: 10 mg (1 tablet) once a day. The maximum duration of treatment is 4 weeks. The dose can be divided into 2 doses of 5 mg (1/2 tablet) in the morning and evening, respectively. Treatment of allergic conjunctivitis Adults and adolescents over 12 years of age: the recommended dose is 10 mg (1 tablet) 1 time per day. Children 6 to 12 years old: 10 mg (1 tablet) once a day. The maximum duration of treatment is 4 weeks. The dose can be divided into 2 doses of 5 mg (1/2 tablet) in the morning and evening, respectively. Treatment of perennial rhinitis and chronic idiopathic urticaria Adults and adolescents over 12 years of age: The recommended dose is 10 mg (1 tablet) once a day. Children 6 to 12 years old: 10 mg (1 tablet) once a day. The dose can be divided into 2 doses of 5 mg (1/2 tablet) in the morning and evening, respectively. Special categories of the population Elderly patients With an age-related decrease in glomerular filtration in elderly patients, the drug is prescribed in the same dosage as for patients with impaired renal function. Patients with impaired renal function The intervals between taking the drug are individually adjusted depending on the degree of renal insufficiency. Dosing is carried out in accordance with the table below. When using this table, creatinine clearance (CC) is calculated in ml/min. CC can be calculated from serum creatinine concentration (mg/dl) using the following formula: CC(ml/min) = CC for women can be calculated by multiplying this value by a factor of 0.85. Dosing for patients with impaired renal function Stage CC (ml / min) Dosing regimen Norm ≥ 80 10 mg (1 tablet) / day Mild 50-79 10 mg (1 tablet) / day Average 30-49 5 mg (1/2 tablet )/day Severe 10-30 5 mg (1/2 tablet), every other day End-stage – patients on dialysis < 10 body weight. Patients with impaired liver function In patients with impaired liver function, dose adjustment is not required. For patients with impaired liver and kidney function, a dosage adjustment is required (see Patients with impaired renal function). Taking the drug The drug should be taken in the evening, due to the more intense manifestation of symptoms at this time of day. The tablet is swallowed whole without chewing and washed down with water. Cetirizine is taken with or without food. In case of mild side effects in adults and adolescents over 12 years of age, it is recommended to take 5 mg (1/2 tablet) in the morning and evening, respectively. Side effects The frequency of side effects is given in the following gradation: very often (≥ 1/10); often (≥ 1/100, < 1/10); infrequently (≥ 1/1000, < 1/100); rarely (≥ 1/10000, < 1/1000); very rarely (< 1/10000); unknown (according to the available data, it is not possible to determine the frequency of occurrence). From the immune system: rarely: hypersensitivity reactions; very rarely: anaphylactic shock; Metabolic and nutritional disorders: frequency unknown: increased appetite; From the nervous system: infrequently: paresthesia; rarely: convulsions; very rarely: taste perversion, dyskinesia, dystonia, fainting, tremor; frequency unknown: deafness, amnesia, memory impairment; Psychiatric disorders: infrequently: agitation; rarely: aggression, confusion, depression, hallucinations, sleep disturbance; very rarely: tick; frequency unknown: suicidal thoughts; On the part of the organs of vision: very rarely: disturbance of accommodation, blurred vision, nystagmus; frequency unknown: vasculitis; On the part of the organs of hearing and balance: the frequency is unknown: vertigo; From the digestive system: infrequently: diarrhea; From the side of the cardiovascular system: rarely: tachycardia; From the urinary system: very rarely: dysuria, enuresis; frequency unknown: urinary retention; On the part of the blood and lymphatic system: very rarely - thrombocytopenia; On the part of the skin: infrequently: rash, itching; rarely: urticaria; very rarely: angioedema, persistent erythema; On the part of laboratory parameters: rarely: changes in liver function tests (increased levels of transaminases, alkaline phosphatase, gamma-glutamate transferase, bilirubin); General disorders: infrequently: asthenia, malaise; rarely: peripheral edema, weight gain. Contraindications hypersensitivity to cetirizine, hydroxyzine or piperazine derivatives, as well as to other components of the drug; terminal stage of renal failure (CC < 10 ml / min); congenital galactose intolerance, lactose deficiency and glucose-galactose malabsorption syndrome. Overdose With a single dose of the drug at a dose of 50 mg, the following symptoms were observed: confusion, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, weakness, anxiety, sedation, drowsiness, stupor, tachycardia, tremor, urinary retention. Treatment: immediately after taking the drug - gastric lavage or stimulation of vomiting. It is recommended to take activated charcoal, symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is not effective. Precautions In patients with renal insufficiency, the dosage should be adjusted accordingly (see section Dosage and Administration). In elderly patients, a decrease in kidney function is possible, which should be taken into account when dosing the drug. Caution should be exercised in the treatment of patients with epilepsy and with a tendency to convulsions. Film-coated tablets are not recommended for children under 6 years of age due to difficulty in swallowing. It is recommended to use other dosage forms of cetirizine in the form of syrup or drops. When taking cetirizine, you should refrain from drinking alcohol and CNS antidepressants, since cetirizine can cause increased drowsiness. Caution must be exercised in patients who have predisposing factors for urinary retention (spinal cord injury, prostatic hyperplasia), as cetirizine may increase the risk of urinary problems. Use during pregnancy and lactation When taking the drug during pregnancy, care should be taken. Cetirizine is excreted in breast milk, so breastfeeding should be stopped for the period of treatment. Influence on the ability to drive vehicles or other potentially dangerous mechanisms Cetirizine can cause increased drowsiness, so the drug affects the ability to drive vehicles or other potentially dangerous mechanisms. Interaction with other drugs When used simultaneously with pseudoephedrine, cimetidine, ketoconazole, erythromycin or azithromycin, no effect on the pharmacokinetics of cetirizine was detected. No pharmacokinetic interactions were observed. In vitro tests have shown that cetirizine does not affect the protein-binding properties of warfarin. With simultaneous use with erythromycin, azithromycin, ketoconazole, theophylline and pseudoephedrine, no clinically significant adverse interactions were detected, no changes were noted on the electrocardiogram. With the simultaneous use of cetirizine (20 mg / day) with theophylline (400 mg / day), a slight but stable increase in the area under the curve of dependence of concentration and time per day was revealed, cetirizine by 19%, theophylline - 11%. Moreover, maximum plasma levels reached 7.7% and 6.4% for cetirizine and theophylline, respectively. At the same time, the total clearance of cetirizine decreased by 16%, the clearance of theophylline - by 10%, if theophylline treatment was carried out before the appointment of cetirizine. However, when initially treated with cetirizine, there was no significant effect on theophylline pharmacokinetics. After a single dose of 10 mg of cetirizine, the effect of alcohol (0.8 ° / 00) does not increase significantly; in 1 of 16 psychometric tests, an interaction with diazepam at a dose of 5 mg was noted. With simultaneous daily use of cetirizine (10 mg) with glipizide, the glucose level slightly decreases. However, this has not been clinically proven. However, it is recommended to take these drugs separately - glipizide in the morning and cetirizine in the evening. With multiple doses of ritonavir (600 mg twice daily) and cetirizine (10 mg/day), the duration of action increased by 40%, while the effect of ritonavir changed slightly (-11%) with subsequent administration of cetirizine. A three-day "washout" period is recommended before the appointment of allergic tests. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years. Do not use after the expiry date stated on the package. Upakovka10 tablets in a blister pack of PVC film and aluminum foil. 1 or 3 blister packs together with instructions for medical use in a cardboard pack. Conditions for dispensing from pharmaciesWithout a prescription. Buy Cetirizine tablets p/o 10mg No. 10x1