Cetirizin Sandoz coated pills 10mg N10
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Active ingredients
Cetirizine
Release form
Pills
Composition
Cetirizine dihydrochloride 10 mg. Excipients: lactose monohydrate - 80 mg, microcrystalline cellulose - 23.8 mg, colloidal silicon dioxide - 600 mcg, magnesium stearate - 600 mcg. The composition of the shell: opadry white dye (lactose monohydrate - 1.8 mg, titanium dioxide - 1.3 mg, hypromellose - 1.4 mg, macrogol 4000 - 500 μg) - 5 mg.
Pharmacological effect
Histamine H1 receptor blocker. It has antiallergic effect. Practically does not have a sedative effect when used in recommended doses and practically does not have anticholinergic and antiserotonin action, prevents the development and facilitates the course of allergic reactions. It has antipruritic and antiexudative effect. Affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; inhibits the release of mediators involved in the late allergic reaction. 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). Cetirizine significantly reduces the hyperreactivity of the bronchial tree, which occurs in response to the release of histamine in patients with bronchial asthma. The therapeutic effect of the drug appears on average 60 minutes after ingestion. Against the background of admission course tolerance does not develop.
Pharmacokinetics
Absorption After oral administration cetirizine is rapidly and fairly fully absorbed from the gastrointestinal tract. Cmax is reached in 40-60 minutes. Food intake does not have a significant effect on the amount of absorption, but in this case, the rate of absorption decreases slightly. Distribution Binding to plasma proteins is approximately 93%. Vd is low and amounts to 0.5 l / kg. Cetirizine does not penetrate the BBB and into the cells. Metabolism Cetirizine is slightly metabolized in the liver to form an inactive metabolite. When used at a dose of 10 mg / day for 10 days cumulation is not observed. Withdrawal Excreted mainly by the kidneys (70%) mostly unchanged. Systemic clearance is about 54 ml / min. After a single dose in a dose of 10 mg T1 / 2 is about 10 hours.Pharmacokinetics in special clinical situations In children aged 2 to 12 years, T1 / 2 decreases to 5-6 hours. In severe impaired renal function (CC 11–31 ml / min) and in patients on hemodialysis (CC less than 7 ml / min), T1 / 2 increases by 3 times, the system clearance decreases by 70%. Against the background of chronic diseases and in the elderly, there is an increase in T1 / 2 by 50% and a decrease in systemic clearance by 40%.
Indications
- year-round and seasonal allergic rhinitis (as a symptomatic therapy); - urticaria (including chronic idiopathic); - dermatosis, proceeding with itching (including atopic dermatitis, neurodermatitis); - allergic conjunctivitis.
Contraindications
- Severe kidney disease; - pregnancy; - lactation (breastfeeding); - hypersensitivity to the drug. With caution, the drug is prescribed for chronic pyelonephritis of moderate and severe severity (correction of the dosing regimen is required) for the elderly (due to a possible decrease in glomerular filtration in this category of patients). The drug in the form of drops for oral administration is intended for children over the age of 1 year. The drug in the form of a syrup is intended for children over the age of 2 years. The drug in the form of pills is designed for children over the age of 6 years.
Use during pregnancy and lactation
The drug is contraindicated for use in pregnancy. If necessary, the appointment of the drug during lactation should decide on the termination of breastfeeding.
Dosage and administration
Tablets Adults and teenagers over 12 years old are recommended to take 10 mg (1 tab.) Of cetirizine, preferably in the evening. Children aged 6 to 12 years and with a body weight of less than 30 kg in 5 mg (1/2 tab.) In the evening; weighing more than 30 kg - 10 mg (1 tab.) in the evening. Reception of 5 mg is possible (1/2 tab.) 2 times / days (in the morning and in the evening). Syrup Adults and adolescents over 12 years old are recommended to take 10 mg (10 ml / 2 scoops /) of cetirizine, preferably in the evening. Children aged 2 to 12 years and weighing less than 30 kg should be prescribed 5 ml (1 scoop); weighing more than 30 kg - 10 ml (2 scoops) in the evening. You can take 5 ml (1 scoop) 2 times / day (morning and evening). Drops Adults and adolescents over 12 years old are advised to take 10 mg (20 drops) of cetirizine, preferably in the evening.Children aged 1-2 years old should be prescribed 2.5 mg (5 drops) 2 times / day; at the age of 2-6 years - 2.5 mg (5 drops) 2 times / day (morning and evening) or 5 mg (10 drops) in the evening; at the age of 6-12 years - 5 mg (10 drops) 2 times / day (morning and evening) or 10 mg (20 drops) in the evening. Patients with renal insufficiency should reduce the recommended dose by 2 times. In case of abnormal liver function, the dose must be selected individually, especially carefully - with simultaneous renal failure. Elderly patients with normal renal function dose adjustment is not required. With seasonal allergic rhinitis, the duration of therapy for adults is usually from 3 to 6 weeks, and with short-term exposure to an allergen, it is enough to receive for 1 week. The duration of therapy for children over the age of 6 years is from 2 to 4 weeks, and with a short-term exposure to an allergen, it is enough to receive for 1 week. Tablets are taken orally, regardless of the meal, not chewed and squeezed with a sufficient amount of liquid, preferably in the evening.
Side effects
On the part of the digestive system: dry mouth, dyspepsia. From the side of the central nervous system: headache, drowsiness, fatigue, dizziness, agitation, migraine. Allergic reactions: skin rash, angioedema, urticaria, pruritus. The drug is usually well tolerated. Side effects are rare and have a transient nature.
Overdose
Symptoms: drowsiness, lethargy, weakness, headache, tachycardia, irritability, urinary retention, fatigue (most often when taking cetirizine in a daily dose of 50 mg). Treatment: conduct symptomatic therapy. The specific antidote is not revealed. Hemodialysis is ineffective. Conduct gastric lavage, appoint activated charcoal.
Interaction with other drugs
The clinically significant interaction of cetirizine with other drugs has not been established. Combined use with theophylline (at a dose of 400 mg / day) leads to a decrease in the total clearance of cetirizine (theophylline kinetics does not change).
special instructions
Not recommended simultaneous use of drugs that depress the central nervous system. Against the background of the drug should not use ethanol.When prescribing a patient with diabetes mellitus, it should be borne in mind that 1 tablet corresponds to less than 0.01 XE, 10 ml of syrup (2 scoops) contain 3.15 g of sorbitol (800 mg of fructose), which corresponds to 0.026 XE. In connection with the content of glycerol, propylene glycol, methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate in the syrup composition, headache, gastrointestinal disorders, bronchospasm, and urticaria are possible when taking the drug in high doses. Influence on the ability to drive vehicles and control mechanisms During the period of use of the drug should refrain from engaging in potentially hazardous activities that require high concentration of attention and speed of psychomotor reactions.