Parlazin tablets p/o 10mg №10×1

Name:
Parlazin tablets 10mg No. 10
Description:
Film-coated tablets of light orange color, biconvex, oblong, with a chamfer, with a risk on one side and an engraving “E 511” on the other side, odorless; on a break: the outer ring of the shell is light orange, the core of the tablet is white or almost white. The main active ingredient Cetirizine Release form Film-coated tablets of light orange color, biconvex, oblong, beveled, with a risk on one side and engraved “E 511” on the other side, odorless; on a break: the outer ring of the shell is light orange, the core of the tablet is white or almost white. 1 tab. Active substance: cetirizine dihydrochloride 10 mg; Excipients: anhydrous colloidal silicon dioxide, magnesium stearate, lactose monohydrate, microcrystalline cellulose. Shell composition: Opadry Y-1-7000, Ariavit Sunset Yellow (CI15985) (sunset yellow dye). 5 pieces. – blisters (1) – packs of cardboard. 7 pcs. – blisters (1) – packs of cardboard. 10 pieces. – blisters (1) – packs of cardboard. 10 pieces. – blisters (3) – packs of cardboard. Dosage 10 mg No. 10 Special instructions If hypersensitivity reactions occur, the drug should be stopped immediately. 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. Parlazin should be discontinued at least 3 days prior to performing an allergic skin test to avoid false negative results. Influence on the ability to drive vehicles and control mechanisms During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. 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 Absorption After oral administration, cetirizine is rapidly absorbed, Cmax in blood plasma is reached within 30-60 minutes. Simultaneous food intake does not affect the degree of absorption, however, food causes a delay in reaching Cmax in plasma by 1.7 hours and reduces Cmax by 23%. Distribution Cumulation after oral administration was not detected. When using the drug in doses of 5 to 60 mg, cetirizine has a linear pharmacokinetics. 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 has a very low ability to penetrate the BBB. Cetirizine passes into breast milk. Metabolism Only a small part of cetirizine is metabolized by conversion to a practically inactive O-dealkylated metabolite in the liver. Withdrawal Within 24 hours, 60% of the oral dose is excreted unchanged through the kidneys, another 10% is excreted over the next 4 days. Approximately 10% is excreted through the intestines, partly in the form of metabolites. T1 / 2 from blood plasma in adults is 8-12 hours. Pharmacokinetics in special groups of patients T1 / 2 in children aged 6 to 12 years is approximately 6 hours, in children aged 1 to 6 years – approximately 5 hours. 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, T1 / 2 of cetirizine is tripled, and clearance is reduced by 70% compared with healthy ones. In patients on hemodialysis, a three-fold increase in T1 / 2 and a 70% decrease in clearance are possible even after a single dose of cetirizine at a dose of 10 mg. Compared with the same parameters of healthy volunteers, in patients with chronic liver failure, an approximately 50% increase in T1 / 2 and a 40% decrease in clearance were observed. Indications for use Seasonal and perennial allergic rhinitis and conjunctivitis; pollinosis (hay fever); itchy allergic dermatoses; urticaria (including chronic idiopathic); angioedema. Dosage and administration The drug is taken orally. Adults and children over the age of 12 are prescribed 1 tab. (10 mg) 1 time / day, daily, preferably in the evening. Children aged 6 to 12 years – 1/2 tab. (5 mg) 2 times / day, daily in the morning and evening, or 1 tab. (10 mg) 1 time / day, daily, preferably in the evening. For children aged 1 to 6 years, it is recommended to prescribe Parlazin® in the dosage form of a drop for oral administration. It may be necessary to reduce the dose in elderly patients. 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 CC should be estimated in ml / min. After determining the concentration of serum creatinine (mg / dl), the value of CC (ml / min) can be estimated using the following formula: CC = 140 – age (years) ? body weight (kg)/72 – serum creatinine (mg/dl) For women, the value obtained should be multiplied by 0.85. Use during pregnancy and lactation There are no data from clinical studies on the use of the drug during pregnancy, and therefore Parlazin® is contraindicated in pregnancy. Cetirizine passes into breast milk, so the drug is contraindicated during breastfeeding. If it is necessary to use the drug during lactation, it is necessary to resolve the issue of stopping breastfeeding. Precautions Caution should be used in patients with moderate to severe chronic renal failure (dosage adjustment is required), as well as in elderly patients (dosage adjustment is required). Interaction with other drugs No interactions were found when used together with diazepam, cimetidine, azithromycin, erythromycin, ketoconazole, pseudoephedrine. Combined use with theophylline (400 mg / day) leads to a decrease in the total clearance of cetirizine (the kinetics of theophylline does not change). The combined use of cetirizine and macrolide antibiotics or cetirizine with ketoconazole did not cause clinically significant changes in the ECG. Ethanol: As with any antihistamine, avoid drinking alcoholic beverages during treatment. Contraindications Renal failure with CC less than 10 ml / min; pregnancy; lactation period (breastfeeding); children’s age up to 6 years; lactose intolerance and glucose-galactose malabsorption syndrome; hypersensitivity to cetirizine or other components of the drug. With caution, the drug should be used in chronic renal failure of moderate and severe severity (correction of the dosing regimen is required), as well as in elderly patients (correction of the dosing regimen is required). Composition Active substance: cetirizine dihydrochloride 10 mg; Excipients: anhydrous colloidal silicon dioxide, magnesium stearate, lactose monohydrate, microcrystalline cellulose. Shell composition: Opadry Y-1-7000, Ariavit Sunset Yellow (CI15985) (sunset yellow dye). 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, restlessness, 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 The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. Buy Parlazin tablets p/o 10mg No. 10x1 Price for Parlazin tablets p/o 10mg No. 10x1