Cetirizine-Teva, pills 10mg 30pcs

Composition

Tablets covered with a film-coated white or almost white color, biconvex oblong shape; on one side there is a dividing line, on the other – an engraving “C10”.

1 tab. cetirizine dihydrochloride 10 mg

Auxiliary substances:

microcrystalline cellulose 40 mg,

lactose monohydrate 63.5 mg,

colloidal silicon dioxide 0.5 mg,

magnesium stearate 1 mg.

Shell composition:

Opadray OY-GM-28900 white: hypromellose (E 464) 0.94 mg, polydextrose 0.94 mg, titanium dioxide (E 171) 0.94 mg, macrogol-4000 0.18 mg

Pharmacological action

Histamine H1-receptor blocker of the third generation. Affects the “early” stage of an allergic reaction and reduces the migration of eosinophils; limits the release of mediators at the” late ” stage of an allergic reaction. Practically does not have anticholinergic and antiserotonin effects. In therapeutic doses, it does not cause sedation.

Pharmacokinetics

Rapidly absorbed from the gastrointestinal tract, Cmax after oral use is reached in 1 h. The bioavailability of cetirizine when taken in the form of tablets and syrup is the same. Food does not affect the fullness of absorption (AUC), but it extends the time to reach Cmax by 1 h and reduces the Cmax value by 23%. When taken at a dose of 10 mg 1 time/day for 10 days, Css in plasma is 310 ng / ml and is noted 0.5-1.5 hours after use.

Binding to plasma proteins is 93% and does not change at cetirizine concentrations in the range of 25-1000 ng / ml. The pharmacokinetic parameters of cetirizine vary linearly when administered at a dose of 5-60 mg. Vd – 0.5 l / kg. In small amounts, it is metabolized in the liver by O-dealkylation to form a pharmacologically inactive metabolite (unlike other H1-histamine receptor antagonists, which are metabolized in the liver by the cytochrome system).

It doesn’t accumulate. 2/3 of the dose is excreted unchanged by the kidneys and about 10% is excreted in the faeces. Systemic clearance-53 ml / min. T1 / 2 in adults – 7-10 hours, in children aged 6-12 years-6 hours, from 2 to 6 years-5 hours, from 6 months to 2 years-3.1 hours. In elderly patients, T1 / 2 increases by 50%, and systemic clearance decreases by 40% (decreased renal function). In patients with impaired renal function (CC) is prolonged (for example, in patients on hemodialysis, the total clearance decreases by 70% and is 0.3 ml / min / kg, and T1 / 2 is extended by 3 times), which requires a corresponding change in the dosage regimen.

It is practically not removed during hemodialysis. In patients with chronic liver diseases (hepatocellular, cholestatic, or biliary cirrhosis), T1/2 is prolonged by 50% and total clearance is reduced by 40% (dosage adjustment is required only with a concomitant decrease in glomerular filtration rate). Penetrates into breast milk.

Indications

Hay fever; allergic rhinitis, conjunctivitis, dermatitis; urticaria, angioedema.

Contraindications

Renal failure, pregnancy, lactation, hypersensitivity to cetirizine.

Side effects

Possible: dry mouth, drowsiness, headache, fatigue.

Rarely: skin manifestations of allergic reactions, angioedema.

In some cases: dyspepsia, agitation.

Composition

No pharmacokinetic interactions were observed with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, diazepam, and glipizide.

Co-use with theophylline (400 mg / day) resulted in a 16% decrease in the total clearance of cetirizine (theophylline kinetics did not change).

How to take, course of use and dosage

Adults and children over 12 years of age – 10 mg / day in 1-2 doses. Children aged 2-6 years – 5 mg / day in 1-2 doses.

In patients with moderate or severe renal insufficiency, the dose should be reduced by 2 times.

Special instructions

With caution, cetirizine is prescribed to patients with CRF (moderate to severe severity – dosage adjustment is required), elderly patients (glomerular filtration rate may decrease).

Elderly patients with normal renal function do not need to adjust the dose.

Use in pediatrics

Caution should be exercised when prescribing cetirizine to children (there is insufficient experience of using it in children under 1 year of age).

Influence on the ability to drive motor vehicles and manage mechanisms

If the dose is exceeded 10 mg/day, the ability to react quickly may worsen. During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

See expiration date. on the packaging.

Active ingredient

Cetirizine

Dosage form

Tablets

Indications

Dermatosis, Angioedema, Pollinosis, Allergic Rhinitis, Urticaria