Zyrtec coated pills 10mg N7
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Active ingredients
Cetirizine
Release form
Pills
Composition
Active ingredient: Cetirizine (Cetirizine) Active ingredient concentration (mg): 10
Pharmacological effect
Antiallergic drug. Histamine H1 receptor blocker, competitive histamine antagonist, hydroxyzine metabolite. It prevents the development and facilitates the course of allergic reactions, has antipruritic and anti-exudative action. It affects the early histamine-dependent stage of allergic reactions, limits the release of inflammatory mediators at a late stage of an allergic reaction, reduces the migration of eosinophils, neutrophils and basophils, stabilizes the membranes of mast cells. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reactions to the introduction of histamine, specific allergens, as well as cooling (with cold urticaria). Reduces histamine-induced bronchoconstriction in bronchial asthma of the lungs. Practically has no anticholinergic and antiserotoninovogo action. In therapeutic doses, it has almost no sedative effect. After a single dose of cetirizine in a dose of 10 mg, the effect begins after 20 minutes (in 50% of patients) and after 60 minutes (in 95% of patients), the effect lasts more than 24 hours. Against the background of treatment tolerance to the antihistamine effect of cetirizine does not develop. After cessation of treatment, the effect lasts up to 3 days.
Pharmacokinetics
The pharmacokinetic parameters of cetirizine vary linearly. Absorption After ingestion, the drug is rapidly and completely absorbed from the gastrointestinal tract. In adults, after a single dose of the drug in a therapeutic dose of Cmax in plasma is achieved after 1 ± 0.5 h and is 300 ng / ml. Taking the drug with food does not affect the amount of absorption. Distribution Cetirizine binds to plasma proteins by 93 ± 0.3%. Vd - 0.5 l / kg. When taking the drug in a dose of 10 mg for 10 days, cetirizine is not cumulated. Metabolism is metabolized in small amounts in the liver by O-dealkylation to form a pharmacologically inactive metabolite (unlike other histamine H1-receptor blockers metabolized in the liver with the participation of cytochrome P450 isoenzymes). Excretion of T1 / 2 in adults is approximately 10 hours.Approximately 2/3 of the accepted dose is excreted by the kidneys in an unchanged form. The pharmacokinetics in special clinical situations T1 / 2 in children aged 6-12 years is 6 hours; in children 2-6 years old - 5 hours; in children aged 6 months to 2 years - 3.1 hours. In elderly patients and patients with chronic liver diseases, a single dose of the drug in a dose of 10 mg T1 / 2 increases by about 50%, and the system clearance decreases by 40%. patients with mild renal failure (CK> 40 ml / min) pharmacokinetic parameters are similar to those in patients with normal renal function. In patients with moderately severe renal failure and in patients on hemodialysis (CK <7 ml / min), when taking the drug inside Pb 10 mg T1 / 2 is increased by 3 times, and the total clearance is reduced by 70% relative to patients with normal renal function, which requires a corresponding change mode dozirovaniya.Tsetirizin virtually eliminated from the body during hemodialysis.
Indications
Cetirizine dihydrochloride, 10 mg film-coated pills are indicated for use in adults and children 6 years and older to relieve: nasal and ocular symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis: itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia, symptoms of chronic idiopathic urticaria.
Contraindications
Hypersensitivity to cetirizine, hydroxyzine or piperazine derivatives, as well as other components of the drug, end-stage renal failure (creatinine clearance <10 ml / min), children under 6 years old (for this dosage form), pregnancy Inherited intolerance to galactose, lactase deficiency or syndrome glucose-galactose malabsorption.
Precautionary measures
Do not exceed the recommended dose. With caution, you should prescribe the drug for chronic renal failure (requires dosing regimen adjustment), for chronic liver diseases, elderly patients (due to a possible decrease in glomerular filtration).
Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy and lactation (breastfeeding).
Dosage and administration
Inside Tablets are recommended to be taken with a glass of water. Adults 10 mg (1 tablet) once a day. Sometimes an initial dose of 5 mg (1/2 tablet) may be sufficient if this allows satisfactory symptom control to be achieved. Elderly patients There is no need to reduce dosage in elderly patients , if the kidney function is not impaired. Patients with renal insufficiency: Since Zyrtec is excreted mainly by the kidneys (see the Pharmacokinetics subsection), if alternative treatment is not possible for patients with renal insufficiency awn drug dosing regimen should be adjusted depending on renal function
Side effects
Blood and lymphatic system: Very rarely: thrombocytopenia Immune system: Infrequently: hypersensitivity reactions Very rarely: anaphylactic shockImprostic metabolism and eating disorders: Frequency unknown: increased appetite Mental distress: Infrequent: agitation Rarely: aggression, confusion, depression, hallucinations, sleep disturbance. Very rare: tikChastota unknown: suicide ideiSo the nervous sistemyNechasto: paresteziiRedko: convulsions Very rare: dysgeusia, dyskinesia, dystonia, fainting, tremorChastota is unknown: memory impairment, including amneziyaSo hand zreniyaOchen organ rare: accommodation disturbance, blurred vision, nistagmSo hand organs of hearingFrequency unknown: vertigoSide of the cardiovascular systemRedko: tachycardiaIn part of the digestive systemFrequently: diarrheaHepatobiliary disordersRedko: change in function Hepatitis B , malaiseRedko: peripheral edemaResearchRedko: increase in body weight
Overdose
Symptoms: when taking the drug once in a dose of over 50 mg, confusion, diarrhea, dizziness, fatigue, headache, indisposition, mydriasis, itching, weakness, sedation, drowsiness, stupor, tachycardia, tremor, urinary retention are possible. Treatment: immediately after taking the drug should be gastric lavage or artificially induce vomiting.It is recommended the appointment of activated carbon, conducting symptomatic and supportive therapy. There is no specific antidote. Hemodialysis is ineffective.
Interaction with other drugs
When studying drug interactions of cetirizine with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam clinically significant undesired interactions are not simultaneous vyyavleno.Pri appointment with theophylline (400 mg / d) total clearance of cetirizine is reduced by 16% (theophylline kinetics does not change) In case of simultaneous administration with macrolides and ketoconazole, there were no changes on the ECG. When using the drug in therapeutic doses, data on the interaction with alcohol (with tion of alcohol in the blood - 0.5 g / L) was not obtained. However, the patient should refrain from drinking alcohol during drug therapy in order to avoid oppression of the central nervous system.
special instructions
Zirtek is prescribed in the dosage form for oral administration of 10 mg / ml to children aged from 6 months to 6 years. The impact on the ability to drive vehicles and control mechanisms When an objective assessment of the ability to drive vehicles and control mechanisms was not reliably revealed any adverse reactions with taking the drug at the recommended dose. But, nevertheless, during the period of taking the drug, it is advisable to refrain from engaging in potentially hazardous activities that require high concentration of attention and quickness of psychomotor reactions.