Cetrin tab. p / o captivity. 10 mg # 30

Release form, composition and packaging

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Film-coated tablets of white or almost white color, round, biconvex, with a line on one side.

1 tab.

cetirizine dihydrochloride 10 mg

lactose - 106.5 mg, corn starch - 65 mg, povidone K30 - 2 mg, magnesium stearate - 1.5 mg.

The composition of the film shell: hypromellose - 3.3 mg, macrogol 6000 - 0.661 mg, titanium dioxide - 0.706 mg, talc - 1.183 mg, sorbic acid - 0.05 mg, polysorbate 80 - 0.05 mg, dimethicone - 0.05 mg.

10 pieces.

- blisters (2) - cardboard packs.

10 pieces.

- blisters (3) - cardboard packs.

pharmachologic effect

Blocker of histamine H1 receptors. Cetirizine is a hydroxyzine metabolite, a competitive histamine antagonist. Prevents the development and facilitates the course of allergic reactions, has antipruritic and antiexudative action. Influences the early histamine-dependent stage of allergic reactions, limits the release of inflammatory mediators at the late stage of an allergic reaction, reduces the migration of eosinophils, neutrophils and basophils, stabilizes the membranes of mast cells. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reaction to the introduction of histamine, specific allergens, as well as cooling (with cold urticaria). Reduces histamine-induced bronchoconstriction in mild bronchial asthma.Cetirizine has no anticholinergic and antiserotonin effects. In therapeutic doses, it does not have a sedative effect. The effect after taking drops in a single dose of 10 mg develops after 20 minutes in 50% of patients and after 60 minutes in 95% of patients, lasts more than 24 hours. After taking the pill, the effect occurs after 20 minutes. Against the background of a course of treatment, tolerance to the antihistamine effect of cetirizine does not develop. After stopping treatment, the effect persists for up to 3 days.Against the background of a course of treatment, tolerance to the antihistamine effect of cetirizine does not develop. After stopping treatment, the effect persists for up to 3 days.Against the background of a course of treatment, tolerance to the antihistamine effect of cetirizine does not develop. After stopping treatment, the effect persists for up to 3 days.

Pharmacokinetics

Pharmacokinetic parameters of cetirizine change linearly when the drug is prescribed at a dose of 5-60 mg. Absorption After oral administration, cetirizine is rapidly and completely absorbed from the gastrointestinal tract. Food intake does not affect the completeness of absorption, although the rate of absorption decreases and the Cmax value decreases by 23%. In adults, after a single dose of the drug in a therapeutic dose, Cmax in blood plasma is reached after 1 В± 0.5 hours and is 300 ng / ml. Distribution Plasma protein binding is 93 В± 0.3% and does not change when cetirizine concentration is in the range of 25-1000 ng / ml. Vd is 0.5 l / kg. When taking the drug at a dose of 10 mg for 10 days, no cumulation of cetirizine is observed. Cetirizine is excreted in breast milk.Metabolism In small amounts, it is metabolized in the body by O-dealkylation (unlike other antagonists of histamine H1 receptors, which are metabolized in the liver with the participation of the cytochrome P450 system), with the formation of a pharmacologically inactive metabolite. Withdrawal In adults, T1 / 2 is approximately 10 hours. About 2/3 of the dose of the drug is excreted in the urine unchanged, 10% - in the feces. Systemic clearance - 53 ml / min. Pharmacokinetics in special groups of patients In elderly patients and patients with chronic liver disease, a single dose of the drug at a dose of 10 mg T1 / 2 increases by about 50%, and the systemic clearance decreases by 40%. T1 / 2 in children aged 6 to 12 years is 6 hours, at the age of 2 to 6 years - 5 hours, at the age of 6 months to 2 years - 3.1 hours.In patients with mild renal insufficiency (CC> 40 ml / min), pharmacokinetic parameters are similar to those in patients with normal renal function. In patients with moderate renal failure and in patients on hemodialysis (CC < 7 ml / min), when the drug is taken orally at a dose of 10 mg, T1 / 2 is 3 times longer, and the total clearance decreases by 70% (is 0.3 ml / min / kg), relative to patients with normal renal function, which requires appropriate3 ml / min / kg), relative to patients with normal renal function, which requires appropriate3 ml / min / kg), relative to patients with normal renal function, which requires appropriate

Name ENG

CETRINE

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

Cetirizine

Dosage

10mg

Structure

1 tablet contains: Active ingredients: cetirizine dihydrochloride 10 mg.

Excipients: lactose - 106.5 mg, corn starch - 65 mg, povidone (K-30) - 2 mg, magnesium stearate - 1.5 mg.

Shell composition: hypromellose - 3.3 mg, macrogol 6000 - 0.661 mg, titanium dioxide - 0.706 mg, talc - 1.183 mg, sorbic acid - 0.05 mg, polysorbate 80 - 0.05 mg, dimethicone - 0.05 mg.

Indications

Cetrin is used in adults and children over 6 years of age to relieve symptoms in:

seasonal and chronic allergic rhinitis

allergic conjunctivitis

itching of various etiologies

urticaria (including chronic idiopathic)

angioedema (angioedema).

INN / Active ingredient

cetirizine dihydrochloride

Storage conditions and periods

Storage conditions In a dry place at a temperature not exceeding 25 В° C. Keep out of the reach of children !.

Shelf life: 2 g

Contraindications

Hypersensitivity to drug components.

Pregnancy and lactation (breastfeeding).

Specifications

Category

Allergy

Scope of the medicinal product

General

Release form

Tablet

Manufacturer country

India

Package quantity, pcs

thirty

Minimum age from

6 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Dr.

Reddy's

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

R06AE07 Cetirizine

Dosage form

Film-coated tablets

Dosage (volume) of the substance in the preparation

cetirizine dihydrochloride 10 mg

The target audience

Children

Expiration date in days

730

Package weight, g

fifty

Mode of application

:

For adults and children over 6 years of age, the daily dose is 10 mg, for adults - in 1 dose, for children, the drug is prescribed 5 mg 2 times / day.

The tablets are taken with a little water.

In case of impaired renal function, a dose adjustment of the drug is required (as a rule, the dose is reduced by 2 times).

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture