Cetirizine Sandoz - instructions for use, dose, side effects, contraindications

active substance: cetirizine dihydrochoride - 10 mg; Excipients: glycerol 85% - 125 mg, propylene glycol - 125 mg, sodium acetate trihydrate - 15 mg, water - 765, 6 μl.

Description:Clear, colorless solution without foreign particles.

Pharmacotherapeutic group:antiallergic agent-H1 histamine receptor blocker.

ATX: & nbsp

E.06.A.E.07 Cetirizine

Pharmacodynamics:Cetirizine - a metabolite of hydroxyzine, a selective antagonist of H1-histamine receptors, has almost no anticholinergic and antiserotonin action. Has a pronounced antiallergic effect: it prevents the development andfacilitates the course of allergic reactions. In therapeutic doses, it practically does not have a sedative effect. Has antipruritic and anti-exsudative effect. Affects the "early" histamine-dependent stage of the allergic reaction, limits the release of inflammatory mediators at the "late" stage of the allergic reaction, and also reduces the migration of eosinophils,

neutrophils and basophils, stabilizes the membranes of mast cells. 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. The therapeutic effect of the drug appears on average 60 minutes after admission. After the abolition of therapy, the effect lasts up to 3 days. Against the background of course treatment, tolerance to the antihistamine effect of cetirizine does not develop.

Pharmacokinetics:

After oral administration cetirizine quickly and completely absorbed from the gastrointestinal tract, bioavailability when taken in the form of tablets and a solution is the same.The intake of food has no effect on the amount of absorption, but reduces the rate of absorption. The maximum concentration in blood plasma is achieved after 1 ± 0.5 h and is 300 ng / ml. Connection with blood plasma proteins - 93 ± 0,3%. The pharmacokinetic parameters of cetirizine vary linearly. The volume of distribution is 0.5 l / kg. Weakly metabolized in the liver by 0-dealkylation to form a pharmacologically inactive metabolite. When cetirizine is taken in a daily dose of 10 mg for 10 days, cumulation is not observed. Penetrates into breast milk in small amounts. 2/3 of the accepted dose of cytirizine is excreted by the kidneys' in unchanged form. The half-life (T_1/2) is about 10 hours; in children aged 6-12 years - 6 hours, 2-6 years - 5 hours; from 6 months to 2 years - 3.1 hours. In elderly patients and patients with chronic liver disease T_1/2 increases by 50%, systemic clearance by 40%. In patients with moderate renal insufficiency and patients on hemodialysis (creatinine clearance (CC) less than 7 ml / min), T_1/2 increases 3-fold, the clearance decreases by 70% relative to patients with normal renal function, which requires correction of dosing. Cetirizine practically not removed from the body during hemodialysis.

Indications:Symptomatic therapy of year-round and seasonal allergic rhinitis and allergic conjunctivitis; urticaria (including chronic idiopathic), allergic dermatosis, accompanied by itching and rashes (including atopic dermatitis).

Contraindications:Hypersensitivity to cetirizine and / or other components of the drug, hydroxyzine or other piperazine derivatives; renal failure in the terminal stage (creatinine clearance less than 10 ml / min); age under 1 year (experience in children under 1 year is limited); pregnancy; lactation period.

Carefully:With caution, the drug should be used in patients with moderate and severe renal dysfunction (creatinine clearance from 11 to 49 ml / min inclusive) - correction of the dosing regimen is required (see "Method of administration and dose"); patients with epilepsy and the risk of seizures; patients with chronic diseases of the liver, as well as elderly patients (possibly reducing glomerular filtration).

Pregnancy and lactation:

The use of the drug for pregnant women is contraindicated due to the lack of reliable clinicaldata confirming the safety of cetirizine during pregnancy.

Cetirizine is excreted in small amounts with breast milk, so the drug is contraindicated for use during breastfeeding.

Dosing and Administration:

Inside, regardless of food intake, dissolving in water before taking.

Adults and adolescents over the age of 12 years: 10 mg (20 drops) once a day.

Children aged 6-12 years: 5 mg (10 drops) 2 times a day or 10 mg (20 drops) once a day.

Children aged 2-6 years: 5 mg (10 drops) 1 time per day or 2.5 mg (5 drops) 2 times a day.

Children aged 1 to 2 years: 2.5 mg (5 drops) 2 times a day.

Elderly patients with normal renal function, dose adjustment is not required. Patients with renal insufficiency dose correction should be performed depending on the amount of creatinine clearance (CC).

CK for men can be calculated from the plasma concentration of creatinine according to the formula:

KK (ml / min) = {140 - age (years)] х body weight (kg)

72 X QC_plasma (mg/ dl)

KK for women can be calculated by multiplying the obtained value by a factor of 0.85. Correction of the dose should be carried out taking into account the data of Table No. 1.

Table №1.

Renal insufficiency	Creatinine clearance (ml / min)	Dosing regimen
Norm	>80	10 mg / day
Lightweight	50-79	10 mg / day
Average	30-49	5 mg / day
Heavy	<30	5 mg every other day
Terminal - patients who are	<10	The drug is contraindicated
on dialysis	<10

Children with renal insufficiency correction of the dose is carried out individually, taking into account QA, age and body weight.

Adult patients in the presence of both renal and hepatic insufficiency correction of the dose is carried out according to the table given above.

Patients with a violation of only liver function correction of the dose is not required.

Side effects:

According to the World Health Organization (WHO) undesirable Effects are classified according to their frequency of development as follows: very often (>1/10), often (from >1/100 to <1/10), infrequently (from >1 / 1,000 to <1/100), rarely (from >1 / 10,000 to <1 / 1,000), very rarely (<1 / 10,000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the gastrointestinal tract

often: dry mouth, nausea; infrequently: diarrhea; rarely: abdominal pain.

From the immune system

rarely: reactions hypersensitivity;

rarely: anaphylactic shock.

From the nervous system

often: headache, fatigue, dizziness;

infrequently: paresthesia, agitation;

rarely: drowsiness, convulsions, aggression, depression, hallucinations, insomnia;

rarely: violation of taste, dyskinesia, dystonia, fainting, tremor, tick, confusion, excitation;

frequency is unknown: violation of memory, including amnesia, suicidal thoughts.

From the sense organs

rarely: violation of accommodation, blurred vision, nystagmus (involuntary movements eyeballs);

frequency is unknown: vertigo (dizziness).

From the side of cardiovascular systems

rarely: tachycardia.

From the side of blood and lymphatic systems

rarely: thrombocytopenia.

From the side of the liver and bile ducts

rarely: change of functional liver tests (increased activity "hepatic" transaminases, alkaline phosphatase, gamma-glutamintransferase and concentration of bilirubin).

From the skin and subcutaneous fabrics

infrequently: itching of the skin, rash;

rarely: hives;

rarely: angioedema edema, persistent erythema.

From the side of urinary systems

rarely: dysuria, enuresis;

frequency is unknown: retention of urine.

From the respiratory system

often: rhinitis, pharyngitis.

From the side of metabolism

rarely: weight gain.

Other

infrequently: asthenia, malaise;

rarely: peripheral edema;

frequency is unknown: rise appetite.

If any of the side effects instructions aggravated, or you noticed any other side effects, not specified in the instructions, please

about this doctor.

Interaction:

There are no clinically significant interactions cetirizine with the following medicinal preparations: azithromycin, pseudoephedrine, ketoconazole, erythromycin, cimetidine, glipizide, diazepam. With simultaneous application theophylline in a low dose (400 mg / day) and cetirizine there was a slight decrease in the overall clearance of the latter. This interaction is not clinically significant, however, it may be more pronounced with higher doses of theophylline.

When cetirizine is used in therapeutic doses of a clinically relevant interaction with ethanol (with ethanol in the blood 0.5 g / l) was not observed, however, one should refrain from using it during cetirizine therapy in order to avoid oppression of the centralnervous system (CNS).

Myelostatic medicines increase the manifestation of hematotoxicity of the drug. In a study with simultaneous admission ritonavir (600 mg 2 times in

day) and cetirizine (10 mg per day) It is shown that the exposure of cetirizine increased by 40%, and exposure ritonavir is insignificant changed (decreased by 11%).

Before appointment allergological tests 3 days recommended "wash-out" period, that blockers H1-gistaminovyh receptors inhibit the development of

skin allergic reactions.

Special instructions:It is not recommended simultaneous use of drugs that depress the central nervous system, alcohol.

Effect on the ability to drive transp. cf. and fur:When taking cetirizine in the recommended dose (10 mg), its negative effect on the ability to drive vehicles and other mechanisms was not revealed. Nevertheless, during the treatment with the drug should refrain from engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Drops for ingestion 10 mg / ml.

Packaging:

By 10 or 20 ml in bottles of dark glass, sealed with a stopper-drip from polyethylene

and a lid of polypropylene with the function of protection from children. One bottle together with the instructions for

application in a cardboard bundle.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years. The open vial can be used for 6 months. Do not use after

expiration date indicated on the package!

Terms of leave from pharmacies:Without recipe

Registration number:LS-001055

Date of registration:03.02.2012

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

LICHTENHELDT, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp11.10.2015

Illustrated instructions

Instructions

Cetirizine Sandoz® (Cetirizine Sandoz®)