Composition, form of production and packaging
? The syrup is transparent, from colorless to light yellow in color.
5 ml (1 measuring spoon)
cetirizine dihydrochloride 5 mg
Excipients: methylparahydroxybenzoate, propyl parahydroxybenzoate, glycerol, propylene glycol, sorbitol, sodium saccharinate dihydrate, sodium acetate trihydrate, acetic ice acid, banana flavor, purified water.
100 ml - bottles of dark glass (1) complete with a measuring spoon - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Cetirizine belongs to the group of competitive histamine antagonists, blocks H 1 -gistamine receptors, practically does not have anticholinergic and antiserotonin action. Has a pronounced anti-allergic effect, prevents development and facilitates the course of allergic reactions. It has an antipruritic and antiexudative effect. It affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; oppresses the selection of mediators involved in a late allergic reaction. Reduces the permeability of capillaries, prevents the development of edema of tissues, relieves spasm of smooth muscles. Eliminates the skin reaction to the administration of histamine, specific allergens, and also to cooling (with cold urticaria). In therapeutic doses, it practically does not have a sedative effect. Against the background of the course, tolerance does not develop.
The effect of the drug begins in 20 minutes (in 50% of patients), after 1 hour (in 95% of patients), and persists for 24 hours.
PHARMACOKINETICS
Suction: after intake of cetirizine quickly and well absorbed from the gastrointestinal tract. The maximum level of concentration is determined after about 30-60 minutes.
Eating does not have a significant effect on the amount of absorption, but in this case, the rate of absorption is slightly reduced.
Distribution: cetirizine binds to plasma proteins approximately 93%. The size, volume of distribution (V d ) is low (0.5 l / kg), the preparation does not penetrate into the cell.
The drug does not penetrate the blood-brain barrier.
Metabolism: cetirizine is poorly metabolized in the liver with the formation of an inactive metabolite.
At 10-day application in a dose of 10 mg accumulation of the drug is not observed.
Excretion: approximately 70% of the kidneys are mostly unchanged. The system clearance is about 54 ml / min.
After a single dose of a single dose, the half-life is about 10 hours. In children aged 2 to 12 years, the half-life is reduced to 5-6 hours.
If the renal function is impaired (creatinine clearance is less than 11-31 ml / min) and hemodialysis patients (creatinine clearance less than 7 ml / min), the half-life period increases by 3 times, the clearance decreases by 70%. Against the background of chronic diseases and in elderly patients there is an increase in the half-life of 50% and a decrease in clearance by 40%. Hemodialysis is ineffective.
INDICATIONS
- seasonal and year-round allergic rhinitis and conjunctivitis;
- itching allergic dermatoses;
- Pollinosis (hay fever);
- urticaria (including chronic idiopathic);
- Quincke's edema.
DOSING MODE
Inside, regardless of food intake.
Adults and children over 12 years: 2 measuring spoons of Zod В® В® (10 mg cetirizine) once a day.
Children 6 to 12 years: 2 measuring spoons (10 mg cetirizine) once a day or 1 measuring spoon (5 mg cetirizine) 2 times a day - in the morning and in the evening.
Children from 2 to 6 years: 1 measuring spoon (5 mg cetirizine) 1 time per day or 1/2 measuring spoon (2.5 mg cetirizine) 2 times a day - morning and evening.
In renal failure: should reduce the recommended dose in 2 times.
If there is a violation of the liver : it is necessary to select a dose individually, especially carefully with simultaneous renal failure.
Elderly patients with normal renal function are not required to adjust the dose.
Instructions for opening the vial with a safety lid. The bottle is closed with a lid with a safety device that prevents its opening by children. The bottle opens when the lid is pressed hard down and then unscrewed against the clockwise direction. After use, the lid of the vial must be tightened again firmly.
SIDE EFFECT
On the part of the digestive system : dry mouth, indigestion.
From the side of the central nervous system: headache, drowsiness, fatigue, dizziness, agitation, migraine.
Allergic reactions: skin rash, angioedema, hives, itching.
The drug is usually well tolerated. Adverse events occur rarely and have a transient nature.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
- Children under 2 years;
- Pregnancy;
lactation period.
With caution: chronic renal failure of moderate to severe severity (correction of dosing regimen is required), elderly age (glomerular filtration may be reduced).
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use of the drug with caution in chronic renal failure of moderate to severe severity (correction of the dosing regimen is required). In renal failure, the recommended dose should be reduced by a factor of 2.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
If liver function is impaired, it is necessary to select the dose individually, especially with caution in case of simultaneous renal failure.
APPLICATION FOR CHILDREN
The drug is used in children over 2 years (contraindicated for children under 2 years).
APPLICATION IN ELDERLY PATIENTS
Use of the drug with caution for the elderly (possibly reducing glomerular filtration).
Elderly patients with normal renal function are not required to adjust the dose.
SPECIAL INSTRUCTIONS
It is not recommended simultaneous use of drugs that depress the central nervous system, alcohol.
Indication for patients with diabetes mellitus:
10 ml of syrup (2 measuring spoons) contains 3.0 g of sorbitol, which corresponds to 0.25 bread units.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.
OVERDOSE
Symptoms: drowsiness, retardation, weakness, headache, tachycardia, increased irritability, urinary retention, fatigue (usually with a daily intake of 50 mg cetirizine)are possible.
Treatment: conduct symptomatic therapy. A specific antidote has not been identified. Hemodialysis is ineffective. The stomach is washed, activated charcoal is prescribed.
DRUG INTERACTION
Clinically significant interactions of cetirizine with other drugs have not been established.
Joint reception with theophylline (400 mg / day) leads to a decrease in the total clearance of cetirizine (the kinetics of theophylline does not change).
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
Does not require special storage conditions. Keep out of the reach of children! Shelf life - 3 years.
