Composition, form of production and packaging
? The tablets covered with a film cover from white to cream color, oblong, biconcave, with risk on one side.
1 tab.
cetirizine dihydrochloride 10 mg
Auxiliary substances: sodium carboxymethyl starch - 2 mg, corn starch - 20 mg, silicon dioxide - 1.2 mg, lactose monohydrate - 31 mg, magnesium stearate - 2.5 mg, sodium lauryl sulfate - 0.3 mg, povidone - 4 mg, microcrystalline cellulose - 39 mg.
Composition of the membrane: hypromellose - 3.4 mg, macrogol 6000 - 0.6 mg.
7 pcs. - blisters (1) - packs of cardboard.
20 pcs. - blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
The blocker of peripheral histamine H 1 -receptors. Has anti-allergic effect. Affects the early histamine-dependent stage of allergic reactions, reduces the migration of eosinophils, limits the release of inflammatory mediators in the late, cellular stage of allergic reactions. Prevents development and facilitates the course of allergic reactions, has antipruritic effect. Virtually no anticholinergic and antiserotonin action. In therapeutic doses, it does not cause sedation.
The drug appears after 20 minutes (in 50% of patients), after 60 minutes (in 95% of patients) after taking the drug and lasts up to 24 hours.
PHARMACOKINETICS
Suction
After ingestion, cetirizine is rapidly and well absorbed from the digestive tract. C max in blood plasma is reached after 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
Binding to plasma proteins is 93%. V d is about 0.5 l / kg. It does not penetrate the GEB and into the cell. When using the drug at a dose of 10 mg for 10 days, there is no accumulation of the drug.
Metabolism
Cetirizine is poorly metabolized in the liver with the formation of an inactive metabolite.
Excretion
About 70% of the accepted dose of cetirizine is excreted by the kidneys mostly unchanged. After a single dose of a single dose, T 1/2 is about 10 hours.
Pharmacokinetics in special clinical cases
In children from 2 to 12 years, T 1/2 is 5-6 hours.
If the renal function is impaired (KC less than 11-31 ml / min) and in patients undergoing hemodialysis (CC less than 7 ml / min), T 1/2 increases 3 times, the clearance decreases by 70%.
In chronic diseases and in elderly patients there is an increase of T 1/2 by 50% and a decrease in clearance by 40%.
INDICATIONS
- seasonal and year-round allergic rhinitis;
- allergic conjunctivitis;
- Pollinosis (hay fever);
- urticaria (including chronic idiopathic);
- itching allergic dermatoses (including atopic dermatitis, neurodermatitis);
- Quincke's edema.
DOSING MODE
Adults and children over 12 years of age are prescribed 10 mg (1 tab.) / Day.
Children aged 6 to 12 years, the drug is prescribed 5 mg (1/2 tab.) 2 times / day in the morning and in the evening or 10 mg (1 tab.) 1 time / day.
With renal failure, the dose should be reduced by a factor of 2.
With violations of liver function, the dose is selected individually, especially with simultaneous renal failure.
Older patients with normal renal function are not required to adjust the dose.
The drug can be taken regardless of food intake, preferably in the evening. Tablets should be swallowed whole, not liquid, squeezed with a small amount of water.
SIDE EFFECT
On the part of the digestive system: dry mouth; in some cases - dyspepsia, abdominal pain, flatulence.
From the side of the central nervous system: in some cases - headache, drowsiness, dizziness, agitation.
Allergic reactions: in isolated cases - urticaria, angioedema, dyspnea (the patient should be warned about the need to immediately stop taking the drug).
The drug as a whole is well tolerated.
CONTRAINDICATIONS
- children's age till 6 years;
- Pregnancy;
- lactation period (breastfeeding);
- Hypersensitivity to the components of the drug.
Caution should be given to the drug for chronic renal failure of moderate and severe degree (correction of the dosing regimen is required), as well as to elderly patients (glomerular filtration may be reduced).
PREGNANCY AND LACTATION
Cetirizine-Acrychin is not recommended for use in pregnancy. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with severe renal dysfunction do not receive a dose of the drug.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Patients with severe liver function impairment dose of the drug is reduced.
APPLICATION FOR CHILDREN
Contraindicated: children under 6 years.
APPLICATION IN ELDERLY PATIENTS
With caution should prescribe the drug elderly patients (possibly reducing glomerular filtration).
SPECIAL INSTRUCTIONS
With caution appoint the drug to elderly people and patients with impaired liver and / or kidney function.
The patient should be warned about the need to inform the doctor of any side effects when taking the drug.
The patient should be warned about the need to avoid the simultaneous use of Allertec with other medicines without the appointment of a doctor.
Data on the interaction of cetirizine with ethanol have not been obtained to date, despite this use of alcohol against the background of the use of the drug Cetirizine-Acrychin is not recommended.
Use in Pediatrics
The drug is not prescribed for children under the age of 6 years .
Impact on the ability to drive vehicles and manage mechanisms
With caution appoint the drug to patients engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.
OVERDOSE
Symptoms: drowsiness (with a single dose of the drug in a dose of more than 50 mg); children - anxiety, increased irritability; possible anticholinergic effect (delay of urination, dry mouth, constipation).
Treatment: gastric lavage, reception of activated charcoal; if necessary, conduct symptomatic therapy. Hemodialysis is ineffective.
DRUG INTERACTION
With the simultaneous use of the drug Cetirizine-Akrihin with theophylline, an increase in the incidence of side effects is possible.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light, out of reach of children at a temperature of 15 В° to 25 В° C. Shelf life - 4 years.
