Parlazin drops for oral administration 10mg/ml 20ml №1

Name:
Parlazin drops 20ml
Description:
Drops for oral administration are colorless or almost colorless, without sediment, with a slight characteristic smell of acetic acid. The main active ingredient Cetirizine Release form Drops for oral administration are colorless or almost colorless, without sediment, with a slight characteristic odor of acetic acid. 1 ml Active substance: cetirizine dihydrochloride 10 mg; Excipients: glycerol – 250 mg, propylene glycol – 350 mg, sodium saccharinate – 10 mg, sodium acetate trihydrate – 10 mg, methyl parahydroxybenzoate – 1.35 mg, propyl parahydroxybenzoate – 0.15 mg, glacial acetic acid – 0.5 mg, purified water – up to 1 ml. 20 ml – brown glass bottles with a PE dropper and a PP cap with an inner PE layer, with control of the first opening, as well as protection against opening by children (1) – packs of cardboard. Dosage 20 ml Special instructions If hypersensitivity reactions occur, the drug should be stopped immediately. Due to the 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 in the case of 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 rarely causes anticholinergic side effects or severe CNS side effects, it can accumulate (age-related decline in renal function is more likely in elderly patients) and cause anticholinergic side effects or CNS side effects even at the usual adult dose. The drops contain the excipient methyl parahydroxybenzoate, which can cause late allergic reactions. 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. In the case of oral administration in doses of 5 to 60 mg, cetirizine has a linear pharmacokinetics (zero order kinetics). 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 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 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. T1 / 2 from blood plasma is 8-12 hours in adults. Pharmacokinetics in special groups of patients T1 / 2 is approximately 6 hours in children aged 6 to 12 years and approximately 5 hours in children aged 1 to 6 years. Due to the higher incidence of decreased renal function in elderly patients, the clearance of cetirizine may be reduced in them. With repeated administration, the pharmacokinetics of cetirizine does not significantly change 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 patients with normal renal function. In patients receiving hemodialysis treatment, a three-fold increase in T1 / 2 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, 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. Method of administration and doses text Application 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 is excreted in 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 ECG changes. Ethanol: As with any antihistamine, alcohol should be avoided during treatment. Contraindications Renal failure (CC less than 10 ml / min); pregnancy; lactation period (breastfeeding); children’s age up to 1 year; 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: glycerol – 250 mg, propylene glycol – 350 mg, sodium saccharinate – 10 mg, sodium acetate trihydrate – 10 mg, methyl parahydroxybenzoate – 1.35 mg, propyl parahydroxybenzoate – 0.15 mg, glacial acetic acid – 0.5 mg, purified water – up to 1 ml. Overdose Symptoms (when taking a single dose of 50 mg): dryness of the oral mucosa, drowsiness, stupor, urinary retention, constipation, anxiety, irritability Treatment: gastric lavage, activated charcoal, symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective. Side effectsUsually the drug is well tolerated. In very rare cases, the following side effects may occur. On the part of the hematopoietic organs: thrombocytopenia. From the nervous system: drowsiness, dizziness, headache, aggression, agitation, confusion, depression, hallucinations, insomnia, tic, convulsions, dyskinesia, dystonia, parasthesia, fainting, tremor. On the part of the organ of vision: disturbance of accommodation, disturbance of visual perception, nystagmus. From the side of the cardiovascular system: tachycardia. From the respiratory system: rhinitis, pharyngitis. On the part of the digestive system: dryness of the oral mucosa, nausea, abdominal pain, diarrhea, abnormal liver function (increased activity of hepatic transaminases, alkaline phosphatase, GGT, bilirubin concentration). From the urinary system: urination disorder, urinary incontinence. From the skin and subcutaneous tissue: itching, rash, urticaria, angioedema. Allergic reactions: hypersensitivity, up to the development of anaphylactic shock. Other: weight gain, fatigue, asthenia, malaise, edema. Storage conditions The drug should be stored in a place protected from light, out of the reach of children, at a temperature not exceeding 25°C. An open bottle should be stored for no more than 4 weeks. Buy Parlazin drops for oral administration 10mg/ml 20ml No. 1