Universal reference book for medicines
Product name: CETRIN ® (CETRINE)

Active substance: cetirizine

Type: The blocker of histamine H 1 -receptors.
Anti-allergic drug
Manufacturer: DR.
REDDY`S LABORATORIES (India)
Composition, form of production and packaging
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The syrup is colorless or slightly yellowish, transparent, with a pleasant fruity odor, free from visible particles; slight opalescence is allowed.
1 ml

cetirizine dihydrochloride 1 mg

Auxiliary substances: glycerol - 100 mg, sucrose - 450 mg, benzoic acid - 1.5 mg, disodium edetate - 1 mg, sorbitol solution 70% - 200 mg, sodium citrate - 1 mg, fruit flavor - 2.07 mg, purified water - qs 1 ml.

30 ml - bottles of dark glass (1) complete with a measuring spoon - packs of cardboard.

60 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

A competitive histamine antagonist, a hydroxyzine metabolite, blocks H 1 -gistamine receptors.
Prevents development and facilitates the course of allergic reactions, has antipruritic and antiexcudative action. Affects the early stage of allergic reactions, restricts the release of inflammatory mediators at the "late" stage of the allergic reaction, reduces the migration of eosinophils, neutrophils and basophils. 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). Reduces histamine-induced bronchoconstriction with bronchial asthma of the lung course.
Virtually no anticholinergic and antiserotonin action.
In therapeutic doses, it practically does not cause sedation. The onset of the effect after a single dose of 10 mg cetirizine - 20 minutes, lasts more than 24 hours. Against the background of course treatment, tolerance to antihistaminic effects of cetirizine does not develop. After the cessation of treatment, the effect is preserved up to 3 days.
PHARMACOKINETICS

Quickly absorbed from the gastrointestinal tract, the time to reach the maximum concentration (TC max ) after ingestion is about 1 hour. Food does not affect the fullness of absorption (AUC), but lengthens TC max for 1 h and reduces the maximum concentration (C max ) on 23%.
When taken at a dose of 10 mg once a day for 10 days, the equilibrium concentration of the preparation (C ss ) in plasma is 310 ng / ml and is noted 0.5-1.5 h after administration. The connection with plasma proteins is 93% and does not change with the concentration of cetirizine in the range of 25-1000 ng / ml. The pharmacokinetic parameters of cetirizine change linearly when administered in a dose of 5-60 mg. The volume of distribution is 0.5 l / kg.
In small amounts, it is metabolized in the liver by O-dealkylation to form a pharmacologically inactive metabolite (unlike other H 1 -gistaminic receptor blockers metabolized in the liver involving the cytochrome P 450 system ).
Citirizine is not cumulated. About 2/3 of the drug is excreted unchanged by the kidneys and about 10% - with calves. Systemic clearance - 53 ml / min. The half-life (T 1/2 ) in adults is 10 hours, in children 6-12 years - 6 hours, 2-6 years - 5 hours, 0.5-2 years - 3.1 hours. In elderly patients, T 1/2 increases by 50 %, systemic clearance is reduced by 40% (decreased kidney function).
In patients with impaired renal function (clearance of creatinine below 40 ml / min), the clearance of the drug decreases, and T 1/2 is lengthened (for example, in patients on hemodialysis, the total clearance is reduced by 70% and is 0.3 ml / min / kg, and T 1/2 is extended 3 times), which requires a corresponding change in the dosage regimen.

Practically, it is not removed during hemodialysis.

In patients with chronic liver diseases (hepatocellular, cholestatic or biliary cirrhosis), the elongation of T 1/2 is 50% and the overall clearance is reduced by 40% (correction of the dosing regimen is required only with the concomitant decrease in the glomerular filtration rate).
Penetrates into breast milk.
INDICATIONS

- seasonal and year-round allergic rhinitis;

- allergic conjunctivitis;

- Pollinosis (hay fever);

- urticaria, including chronic idiopathic urticaria;

- itching allergic dermatoses (atopic dermatitis, neurodermatitis);

- angioedema (edema of Quincke).

DOSING MODE

Inside, regardless of food intake, washed down with a small amount of water, preferably in the evening.

Adults and children over 6 years of age - 10 mg (10 ml of syrup) once a day or 5 mg (5 ml of syrup) 2 times a day.

Children 2-6 years - 5 mg (5 ml syrup) once a day or 2.5 mg (2.5 ml syrup) 2 times a day, depending on the severity of the condition and the response.

In patients with decreased renal function (QC 30-40 ml / min), 5 mg / day (5 ml of syrup), in severe chronic renal failure (10-30 ml / min) , 5 mg / day (5 ml of syrup) in one day.

Elderly patients with normal renal function are not required to adjust the dose.

SIDE EFFECT

In some cases, possible: drowsiness, dry mouth;
rarely - headache, dizziness, migraine, discomfort in the digestive tract (dyspepsia, abdominal pain, flatulence), allergic reactions (angioedema, rash, hives, itching).
CONTRAINDICATIONS

- hypersensitivity (including hydroxyzine);

- pregnancy, lactation;

- Children's age up to 2 years.

Carefully

Chronic renal failure (with moderate to severe severity, correction of dosing regimen is required), elderly age (glomerular filtration may be reduced).

PREGNANCY AND LACTATION

Contraindicated in pregnancy.

Contraindicated in lactation, as the drug penetrates into breast milk.

APPLICATION FOR FUNCTIONS OF THE LIVER

It is used with caution in chronic renal failure (with moderate to severe severity, correction of the dosing regimen is required).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with impaired liver function, correction of the dosing regimen is required only with the concomitant decrease in glomerular filtration rate.

APPLICATION FOR CHILDREN

Contraindicated for children under 2 years.

APPLICATION IN ELDERLY PATIENTS

Use with caution for the elderly (possibly reducing glomerular filtration).

SPECIAL INSTRUCTIONS

When the dose is exceeded 10 mg / day, the ability for rapid reactions may worsen.
In recommended doses does not enhance the effect of ethanol (at a concentration of not more than 0.8 g / l), however, it is recommended to refrain from using it during treatment.
Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

OVERDOSE

Symptoms (occur when taking a single dose of 50 mg) - dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.

Treatment: gastric lavage, prescription of symptomatic medicines.
There is no specific antidote. Hemodialysis is ineffective.
DRUG INTERACTION

Pharmacokinetic interaction with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, diazepam and glipizide was not detected.

A joint appointment with theophylline (400 mg / day) leads to a decrease in the total clearance of cetirizine (theophylline kinetics does not change).

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

TERMS OF RELEASE FROM PHARMACY

Without recipe.

TERMS AND CONDITIONS OF STORAGE

In a dry, the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children! Shelf life - 2 years.
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