Composition, structure and packing
Tablets, coated in white, oblong, scored and marked with "Y / Y" with one hand. 1 tab. cetirizine dihydrochloride 10 mg. Excipients: microcrystalline cellulose, lactose, colloidal silicon dioxide, magnesium stearate, gipromelloza, titanium dioxide, polyethylene glycol-400 (macrogol),.
Drops for oral colorless, transparent. 1 ml of cetirizine hydrochloride 10 mg. Other ingredients: glycerol, propylene glycol, sodium saccharinato, metilparabenzol, propilparabenzol, sodium acetate, glacial acetic acid, purified water.
Clinico-pharmacological group: blocker histamine H1-receptors. Antiallergic drug.
Antiallergic drug. Blocker histamine H1-receptor-Hydroxyzine metabolite. Prevents the development and facilitates during allergic reactions, has antipruritic and antiexudative action. Influences on the early stage gistaminozavisimuyu allergic reactions, limits the release of inflammatory mediators in the late phase allergic reactions, reduces the migration of eosinophils, neutrophils and basophils, stabilizing the membrane of mast cells.
Decreases capillary permeability, prevents the development of edema, relieves spasm of smooth muscles. Eliminates skin reaction to the introduction of histamine, specific allergens, as well as cooling (when the "cold" urticaria). It reduces histamine-induced bronchial asthma bronhokonstriktsiyu lung flow. Almost no anticholinergic and antiserotoninovogo action. In therapeutic doses, has almost no sedative effect. Start effect after single dose of 10 mg cetirizine observed after 20 min (50% of patients) and 60 min (95% of patients), the effect lasts more than 24 hours on the background of a course of treatment tolerance to antihistaminic action of cetirizine is not developed. After the cessation of treatment effect persists up to 3 days.
Once inside quickly absorbed. Cmax is achieved through 1 pm Admission drug with food did not affect the magnitude of absorption, but the rate of absorption is somewhat reduced (the time to reach Cmax increased by 1 h). Distribution of Cetirizine binds to plasma proteins by 93%. Vd - 0.5 L / kg. Provided with breast milk. Not cumulative.
In small quantities, is metabolized in the liver by O-dezalkirovaniya with the formation of pharmacologically inactive metabolite (in contrast to other blockers of histamine H1-receptors, metabolised in the liver with the participation of cytochrome P450).
Putting 2 / 3 of the drug excreted unchanged in the urine and about 10% - with the feces. Systemic clearance - 53 ml / min. T1 / 2 7-10 pm practice is not removed during hemodialysis.
Pharmacokinetics in special clinical situations
T1 / 2 in children aged 6-12 years - 6 h in children 2-6 years old - 5 h in children aged 6 months to 2 years - 3.1 hours in elderly patients T1 / 2 increased by 50% , systemic clearance - up to 40%.
The drug used in adults and children aged 6 months and older.
Treatment of symptoms:
year-round and seasonal allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, rhinorrhea, lacrimation, conjunctival hyperemia;
hay fever (pollen disease);
urticaria (including chronic idiopathic urticaria);
other allergic dermatitis (including atopic dermatitis), accompanied by itching and rash.
The drug is prescribed inside.
Children aged 6 months to 1 year appoint 2.5 mg (5 drops) 1 times / day.
Children aged 1 to 2 years appoint 2.5 mg (5 drops) up to 2 times per day.
Children aged 2 to 6 years appoint 2.5 mg (5 drops) 2 times / day or 5 mg (10 drops) 1 times / day.
Adults and children over 6 years is prescribed in doses of 10 mg (1 tab. Or 20 drops) per day.
Adults - 10 mg 1 time / d; children - 5 mg 2 times / day or 10 mg 1 time / day. Sometimes the initial dose of 5 mg may be sufficient to achieve a therapeutic effect. In renal failure dose is reduced depending on the spacecraft.
On the part of the CNS: drowsiness, headache, rarely - dizziness, headache.
On the part of the digestive system: dry mouth, seldom - diarrhea.
Allergic reactions: seldom - angioedema, itching, rash, urticaria.
Children under 6 months;
hypersensitivity to the drug's components or hydroxizine.
Precautions should be prescribed the drug in patients with chronic renal failure (moderate or severe degree of severity), as well as elderly patients (due to a possible decrease in the glomerular filtration).
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breastfeeding).
Application for violations of renal function
Precautions should be prescribed the drug in patients with chronic renal insufficiency (moderate or severe severity), as well as elderly patients (in connection with a possible decrease in glomerular filtration). In renal failure dose is reduced depending on the spacecraft.
Not received data on the interaction of the drug Zirtek when it is applied in recommended doses of alcohol (at a concentration of ethanol in the blood of 0.5 g / l), are nevertheless encouraged to abstain from alcohol during the application Zirteka.
Effects on ability to drive vehicles and management mechanisms
Objective methods of studying the capacity for studies of potentially dangerous activities were not significantly identify any adverse events when using the drug at the recommended dose of 10 mg, nonetheless recommended caution.
When receiving a single dose of the drug in doses exceeding 50 mg may experience the following symptoms: sleepiness, restlessness, irritability, urinary retention, dry mouth, constipation, mydriasis, tachycardia. Treatment: removal of the drug, gastric lavage, the appointment of activated charcoal, symptomatic therapy.
At a joint appointment Zirteka with theophylline at a dose of 400 mg 1 time per day was decreased by 16% QC. At a joint appointment with the macrolides and ketoconazole were observed changes in the ECG. Clinically meaningful interactions, while the appointment of the drug Zirtek with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, glipizidom not observed.
Terms and Conditions of storage
Tablets should be stored in a dry, away from children at or above 25 ° C. Solution-drops for oral administration should be stored at temperatures not above 25 ° C. Shelf life of the drug - 5 years.