Parlazin tablets p/o 10mg №10×3

Name:
Parlazin tablets 10mg No. 30
Description:
Light orange, biconvex, oblong, beveled film-coated tablets, scored on one side and engraved E 511 on the other side, odorless. Type of tablets on a break: the outer ring of the shell is light orange, and the core of the tablet is white or almost white. The main active substance Cetirizine Release form Film-coated tablets 10 mg. Dosage 10 mg No. 30 Special instructions If hypersensitivity reactions occur, the drug should be stopped immediately. Kidney diseases. Due to a decrease in the rate of excretion of cetirizine, it can accumulate in the body of patients with impaired renal function; this may increase the frequency and severity of adverse anticholinergic effects or effects on the central nervous system, even when taking the usual dose for adults. Therefore, in such cases, it is recommended to reduce the dose. Elderly patients are particularly sensitive to the anticholinergic effects of antihistamines (eg, dry mouth, urinary retention). If these side effects are observed for a long time, as well as with an increase in their intensity, the drug should be discontinued. Although cetirizine is less likely to cause anticholinergic side effects or severe CNS side effects, it can accumulate (age-related decline in renal function is more likely in older patients) and cause anticholinergic side effects or CNS side effects even at the usual adult dose. Coated tablets contain lactose, therefore this drug should not be administered to patients with lactose intolerance and/or glucose-galactose malabsorption syndrome. Skin tests: Parlazin must be discontinued at least 3 days before an allergic skin test is performed to avoid false negative results. Pharmacological action Cetirizine is a carboxylated metabolite of hydroxyzine, belongs to the class of antihistamines of piperazine derivatives. The action of cetirizine and its antiallergic effects are based on the selective blockade of peripheral histamine H1 receptors. Through this mechanism, cetirizine suppresses early histamine-mediated allergic reactions, reduces inflammatory cell migration and the release of mediators associated with late allergic reactions. Cetirizine has only minor anticholinergic and antiserotonergic effects. Pharmacokinetics After oral administration, cetirizine is rapidly absorbed, and its maximum plasma concentration is reached within 30-60 minutes. Cumulation after oral administration was not detected. In the case of oral doses of 5 to 60 mg, cetirizine has a linear pharmacokinetics. Simultaneous ingestion of food does not affect the degree of absorption, however, food causes a delay in reaching the maximum plasma concentration by 1.7 hours and reduces the maximum concentration by 23%. Plasma protein binding is 93% and does not depend on concentration in the range from 25 to 1000 ng / ml; this range includes therapeutic plasma concentrations. Being the main metabolite of hydroxyzine, cetirizine is more hydrophilic than the parent substance, and therefore it has a very low ability to penetrate the blood-brain barrier. Only a small part of cetirizine is metabolized by conversion to a practically inactive O-dealkylated metabolite in the liver. Within 24 hours, 60% of the oral dose is excreted as unchanged substance through the kidneys, and another 10% is excreted over the next 4 days. Approximately 10% is excreted through the intestines, partly in the form of metabolites. Cetirizine passes into breast milk. The plasma elimination half-life is 8-12 hours in adults, approximately 6 hours in children 6 to 12 years of age, and approximately 5 hours in children 1 to 6 years of age. Due to the higher incidence of decreased renal function in elderly patients, the clearance of cetirizine in this age group may be reduced. With repeated administration, the pharmacokinetics of cetirizine does not change significantly in mild renal failure compared with healthy volunteers. However, in patients with moderate renal insufficiency, the half-life of cetirizine is tripled, and clearance is reduced by 70% compared with healthy people. In patients on hemodialysis, a three-fold increase in the half-life and a 70% decrease in clearance are possible even after a single dose of 10 mg of cetirizine. Compared with the same parameters of healthy volunteers, patients with chronic liver failure experienced an approximately 50% increase in half-life and a 40% decrease in clearance. Indications for use seasonal and year-round allergic rhinitis and conjunctivitis – itchy allergic dermatoses – pollinosis (hay fever) – urticaria (including chronic idiopathic) – Quincke’s edema Dosage and administrationFor oral administration Adults and children over 12 years of age Usual dose: 1 time 1 tablet (1 x 10 mg) daily, preferably in the evening. Children 6 to 12 years old Usual dose: 1/2 tablet 2 times a day (2 x 5 mg) daily in the morning and evening or 1 tablet (1 x 10 mg) once daily, preferably in the evening. Children aged 1 to 6 years are recommended to prescribe Parlazin in the dosage form of a drop for oral administration. Special groups of patients It may be necessary to reduce the dose in elderly patients (see also section “Special Instructions”). In case of impaired renal function, the dose should be set individually in accordance with renal function. The table below will assist in dose selection. To use this table, the patient’s creatinine clearance (CC) should be estimated in ml/min. After determining the serum creatinine concentration (mg / dl), the CC value (ml / min) can be estimated using the following formula: CC u003d (140 – age (years)) x body weight (kg) / 72 – serum creatinine (mg / dl ) x 0.85 (in women) Use during pregnancy and lactation There are no data from clinical studies on the use of the drug during pregnancy, and therefore this drug is contraindicated in pregnancy. Precautions With caution, the drug is prescribed for moderate to severe chronic renal failure (correction of the dosage regimen is required), as well as for elderly patients (correction of the dosage regimen is required). Interaction with other drugs No interactions were found when used together with diazepam, cimetidine, azithromycin, erythromycin, ketoconazole, pseudoephedrine. Co-administration with theophylline (400 mg / day) leads to a decrease in the total clearance of cetirizine (theophylline kinetics does not change). The combined use of cetirizine and macrolide antibiotics or cetirizine with ketoconazole did not cause clinically significant ECG changes. Alcohol: As with any antihistamine, you should avoid drinking alcoholic beverages during treatment. Contraindications Hypersensitivity to the active or any auxiliary component of the drug. Children’s age up to 6 years (for this dosage form). Renal failure with creatinine clearance less than 10 ml / min. Pregnancy and lactation (see section “Pregnancy and lactation”). Lactose intolerance and glucose-galactose malabsorption syndrome (for this dosage form, see the “special instructions” section). Composition Active substance: 10 mg of cetirizine dihydrochloride in each tablet, excipients: anhydrous colloidal silicon dioxide, magnesium stearate, lactose monohydrate (11.5 mg), microcrystalline cellulose, Opadray Y-1-7000 (hypromellose, titanium dioxide, macrogol 400), Ariavit Sunset Yellow (dye Sunset Yellow). Overdose Symptoms (when taking a single dose of 50 mg): confusion, dizziness, headache, fatigue, weakness, malaise, sedation, drowsiness, stupor, mydriasis, itching, tremor, diarrhea, urinary retention. Treatment: gastric lavage, provocation of vomiting; activated charcoal, symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective. Side effectsUsually the drug is well tolerated. The most common (? 2%) side effects are drowsiness (frequency increases with dose), fatigue, headache, migraine, dizziness, dry mouth, nausea, abdominal pain, diarrhea, anxiety, increased motor activity. The intensity of these side effects can be reduced by dividing the daily dose into two doses. Rarely (<2%), allergic reactions occur (angioneurotic edema, rash). Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. Buy Parlazin tablets p/o 10mg No. 10x3 Price for Parlazin tablets p/o 10mg No. 10x3