Elcet pills 5mg, 14pcs

Composition

Active ingredient: Levocetirizine dihydrochloride-5 mgsupport substances: microcrystalline cellulose, lactose monohydrate, calcium hydrophosphate dihydrate, sodium carboxymethyl starch, povidone, magnesium stearate; shell: hypromellose, macrogol 6000 (polyethylene glycol 6000), titanium dioxide.

Pharmacological action

Levocetirizine-the Active ingredient of Elcet-is an R-enantiomer of cetirizine, which belongs to the group of competitive histamine antagonists and blocks H1-histamine receptors. Affinity for H1-histamine receptors in levocetirizine is 2 times higher than in cetirizine.

Levocetirizine has an effect on the histamine-dependent stage of allergic reactions, and also reduces the migration of eosinophils, reduces vascular permeability, and restricts the release of inflammatory mediators and cytokines (VCAM-1, etc. ).

Levocetirizine prevents the development and eases the course of allergic reactions, has an anti-exudative, antipruritic effect, practically does not have an anticholinergic and antiserotonin effect. In therapeutic doses, it has practically no sedative effect.

Pharmacokinetics

The pharmacokinetic parameters of levocetirizine vary linearly and practically do not differ from the pharmacokinetics of cetirizine.

After oral use, the drug is rapidly and completely absorbed from the gastrointestinal tract. Food intake does not affect the completeness of absorption, although its rate decreases. In adults, after a single dose of the drug at a therapeutic dose (5 mg), Cmax in blood plasma is 270 ng / ml and is reached in 0.9 hours, after repeated use at a dose of 5 mg — 308 ng / ml. Css is reached in 2 days.

Levocetirizine is 90% bound to plasma proteins. Vd is 0.4 l/kg. Bioavailability reaches 100%.

In small amounts (less than 14%), it is metabolized in the body by N – and O-dealkylation (unlike other H1-histamine receptor antagonists, which are metabolized in the liver by the cytochrome system) to form a pharmacologically inactive metabolite.

Due to the low level of metabolism and lack of metabolic potential, the interaction of levocetirizine with other drugs seems unlikely.

In adults, T1 / 2 is (7.9±1.9) hours; in young children, T1 / 2 is shortened. In adults, the total clearance is 0.63 ml/min/kg. About 85.4% of the drug dose is excreted unchanged by the kidneys through glomerular filtration and tubular secretion; about 12.9% – through the intestines. In patients with renal insufficiency (creatinine clearance less than 40 ml/min), the drug clearance decreases, and T1 / 2 is prolonged (for example, in patients on hemodialysis, the total clearance decreases by 80%), which requires a corresponding change in the dosage regimen. Less than 10% of levocetirizine is removed during a standard 4-hour hemodialysis procedure.

Indications

• Treatment of such symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis as itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia;
• pollinosis (hay fever).
• urticaria, including chronic idiopathic urticaria, angioedema;
• other allergic dermatoses, accompanied by itching and rashes.

Contraindications

Hypersensitivity to levocetirizine or piperazine derivatives, as well as other components of the drug;

Lactose intolerance, lactase deficiency, glucose-galactose malabsorption, renal insufficiency (creatinine clearance less than 10 ml / min) and patients undergoing hemodialysis;

Pregnancy and lactation, children under 6 years of age (due to the lack of data on the effectiveness and safety of the drug).

With caution

, chronic renal failure (dosage adjustment is required); elderly age (glomerular filtration rate may decrease).

How to take, course of use and dosage

Inside, without chewing, with food or on an empty stomach, with a small amount of water. Adults and children over 6 years of age — in a daily dose of 5 mg (1 table).

Since levocetirizine is eliminated from the body by the kidneys, when prescribing the drug to patients with renal insufficiency and elderly patients, the dose should be adjusted depending on the value of creatinine clearance.

Creatinine clearance for men can be calculated based on the concentration of serum creatinine, using the following formula:

CC (ml. min) = (140 – age (years)) * body weight (kg) / 72 * KK (serum) (mg / dl)

Creatinine clearance for women can be calculated by multiplying the resulting value by a factor of 0.85.

Elderly patients with normal renal function do not need to reduce the dose; in patients with chronic renal failure, dose calculation should be carried out taking into account creatinine clearance according to the table below.

Special instructions

It is advisable to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (although no undesirable consequences were detected when taking the recommended dose of 5 mg).

Form of production

Film-coated tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C.

Shelf

life is 2 years.

Active ingredient

Levocetirizine

Dosage form

Tablets

Description

Children over 6 years old, For adults

Indications

Urticaria, Neurodermatitis, Dermatosis, Allergic Rhinitis, Pollinosis, Allergy, Allergic Conjunctivitis, Diathesis