Cetrine coated pills 10mg N30
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Active ingredients
Cetirizine
Release form
Pills
Composition
Active ingredient: Cetirizine dihydrochloride Concentration of the active substance (mg): 10
Pharmacological effect
Histamine H1 receptor blocker. Cetirizine - hydroxyzine metabolite, competitive histamine antagonist. 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 mast cell membranes. 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. Cetirizine has no anticholinergic and antiserotoninovogo action. In therapeutic doses, it does not have a sedative effect. The effect after taking drops in a single dose of 10 mg develops after 20 minutes in 50% of patients and after 60 minutes in 95% of patients, lasts more than 24 hours. After taking the tablet, the effect occurs after 20 minutes. Against the background of a course 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 change linearly with the appointment of the drug in a dose of 5-60 mg. Absorption After oral administration, cetirizine is rapidly and completely absorbed from the gastrointestinal tract. Food intake does not affect the completeness of suction, although the rate of absorption decreases and the value of Cmax decreases by 23%. In adults, after a single dose of the drug in a therapeutic dose of Cmax in the blood plasma is achieved after 1 ± 0.5 h and amounts to 300 ng / ml. DistributionPlasma binding to blood plasma is 93 ± 0.3% and does not change when cetirizine concentration is in the range of 25-1000 ng / ml . Vd is 0.5 l / kg. When taking the drug in a dose of 10 mg for 10 days, cetirizine is not cumulated. Cetirizine is excreted in breast milk. Metabolism In small quantities, it is metabolized in the body by O-dealkylation (inunlike other histamine H1 receptor antagonists, which are metabolized in the liver with the participation of the cytochrome P450 system), with the formation of a pharmacologically inactive metabolite. Intake of adults T1 / 2 is about 10 hours. About 2/3 of the dose taken is excreted in the urine unchanged, 10% - with feces. Systemic clearance - 53 ml / min. Pharmacokinetics in special groups of patients. Elderly patients and patients with chronic liver diseases, with a single dose of the drug at a dose of 10 mg T1 / 2, increase by about 50%, and systemic clearance is reduced by 40% .T1 / 2. children aged from 6 to 12 years old is 6 hours; at the age of 2 to 6 years old - 5 hours; at the age of 6 months to 2 years old - 3.1 hours. In patients with mild severity of renal insufficiency (CC> 40 ml / min a) pharmacokinetic parameters are similar to those in patients with normal renal function. In patients with renal failure of moderate severity and in patients on hemodialysis (CC <7 ml / min), when the drug is taken orally at a dose of 10 mg T1 / 2, it is 3 times longer, and the total clearance is reduced by 70% (0.3 ml / min / kg), relative to patients with normal renal function, which requires a corresponding change in dosing regimen. Cetirizine is practically not removed from the body during hemodialysis. Patients with chronic liver diseases (hepatocellular, cholestatic or biliary cirrhosis) have a T1 / 2 lengthening of 50% and a 40% reduction in total clearance (with a concomitant reduction in GFR). .
Indications
Seasonal and perennial allergic rhinitis; allergic conjunctivitis; pollinosis (hay fever); urticaria, including chronic idiopathic urticaria; pruritic allergic dermatosis (atopic dermatitis, neurodermatitis); angioedema (angioedema).
Contraindications
Hypersensitivity (including hydroxyzine); pregnancy, lactation; children's age up to 6 years (for this dosage form).
Precautionary measures
With caution, a drug should be prescribed for chronic renal failure (with CC> 10 ml / min, correction of the dosing regimen is required); patients with predisposing factors for urinary retention; in epilepsy and patients with increased convulsive readiness; elderly patients (with age-related reduction of glomerular filtration)
Use during pregnancy and lactation
Experimental studies on animals did not reveal any direct or indirect adverse effects of cetirizine on the developing fetus (including in the postnatal period), the course of pregnancy and childbirth also did not change. Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy has not been conducted, so cetirizine should not be used during pregnancy. Cetirizine is excreted in breast milk, so the issue of discontinuing breastfeeding for the period of use of the drug should be decided.
Dosage and administration
Inside, regardless of the meal, without chewing, the pills are washed down with 200 ml of water. Adults - 10 mg (1 tab.) 1 time per day or 5 mg (1/2 tab.) 2 times a day. Children over 6 years old - 5 mg (1/2 tab.) 2 times a day or 10 mg (1 tab.) 1 time a day. In patients with reduced kidney function (creatinine clearance 30–49 ml / min), 5 mg / day (1/2 tab.) Is prescribed, with severe chronic renal failure (creatinine clearance 10–30 ml / min) - 5 mg / day ( 1/2 tab.) Every other day.
Side effects
Cetrine is usually well tolerated. In some cases, possible: drowsiness, dry mouth; rarely - headache, dizziness, migraine, discomfort in the gastrointestinal tract (dyspepsia, abdominal pain, flatulence), allergic reactions (angioedema, rash, urticaria, itching).
Overdose
Symptoms: with a single dose of cetirizine in a dose of 50 mg, confusion, diarrhea, dizziness, fatigue, headache, indisposition, mydriasis, itching, anxiety, weakness, sedation, drowsiness, drowsiness, stupor, tachycardia, tremor, urinary retention were noted. immediately after taking the drug - gastric lavage or stimulation of vomiting. The use of activated carbon, symptomatic and supportive therapy is recommended. There is no specific antidote. Hemodialysis is ineffective.
Interaction with other drugs
In the study of the pharmacokinetic interaction of cetirizine with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide, diazepam and antipyrine, no clinically significant undesirable interaction has been identified. If applied simultaneously with theophylline (400 mg / day), the general clearance of unhealthy interaction was not detected. changes). When used simultaneously with ritonavir, the AUC of cetirizine increased by 40%, while the similar indicator of ritonavir slightly changed (-11%). Simultaneous use with macrolide antibiotics (azithromycin,erythromycin) and ketoconazole does not lead to changes in the patients' ECG. At therapeutic doses, cetirizine has not demonstrated a clinically significant interaction with ethanol (at an ethanol concentration in the blood of 0.5 g / l). However, one should refrain from the use of alcohol. Myelotoxic drugs increase the hematotoxicity of the drug.
special instructions
Patients with spinal cord injury, prostatic hyperplasia, as well as with other predisposing factors for urinary retention, require caution because Cetirizine may increase the risk of urine retention. A three-day washout period is recommended before prescribing allergy tests, because histamine H1 receptor inhibitors (including cetirizine) inhibit the development of allergic skin reactions. When the dose is exceeded 10 mg / day, the speed of psychomotor reactions may slow down Use in Pediatrics Impact on the ability to drive vehicles and control mechanisms In an objective assessment of the ability to drive vehicles and control mechanisms was not reliably yyavleno any adverse effects while taking the drug at the recommended dose, but in the period of treatment it is advisable to refrain from driving motor vehicles and other potentially hazardous activities that require high concentration and psychomotor speed reactions.