Zodac express pills 5mg, 7pcs

Composition

Active ingredient:  

levocetirizine dihydrochloride 5 mg;

Auxiliary substances:  

lactose monohydrate — 67.5 mg;

MCC-25 mg;

sodium carboxymethyl starch-1 mg;

colloidal silicon dioxide-0.5 mg;

magnesium stearate-1 mg;

Film shell:  

hypromellose 2910/5 — 3.3 mg;

macrogol 6000-0.35 mg;

talc-0.85 mg;

titanium dioxide (E 171) – 0.5 mg

Pharmacological action

of Zodak express-anti-allergic.

Pharmacodynamics

Levocetirizine, the (R)-enantiomer of cetirizine, is a peripheral H1-histamine receptor inhibitor with a 2-fold higher affinity than cetirizine. After a single dose of levocetirizine, binding of H1-histamine receptors was observed by 90% after 4 hours and by 57% after 24 hours.

Levocetirizine has an effect on the histamine-dependent stage of allergic reactions, reduces the migration of eosinophils, reduces vascular permeability, limits the release of inflammatory mediators, prevents the development and facilitates the course of allergic reactions, has an antiexudative, antipruritic effect, practically does not have an anticholinergic and antiserotonin effect, in therapeutic doses practically does not have a sedative effect.

The effect of levocetirizine begins 12 minutes after taking a single dose in 50% of patients, after 1 hour – in 95% of patients and continues for 24 hours. Levocetirizine does not affect the ECG QT interval.

Pharmacokinetics

The pharmacokinetics of levocetirizine are linear, independent of dose and time, and vary slightly from patient to patient.

After oral use, levocetirizine is rapidly and completely absorbed from the gastrointestinal tract.

Food intake does not affect the completeness of absorption, although its rate decreases.

Plasma Cmax is reached in 0.9 h (54 min) after taking the drug.

Css is installed in 2 days. Plasma Cmax after a single dose of 5 mg of levocetirizine is 270 ng / ml, and after repeated use at a dose of 5 mg-308 ng / ml.

Levocetirizine is 90% bound to plasma proteins. Vd is 0.4 l/kg. There are no data on the distribution of levocetirizine in tissues and its penetration through the BBB in humans.

Levocetirizine is metabolized in small amounts (

Due to the limited metabolism and lack of metabolic inhibitory activity, the interaction of levocetirizine at the metabolic level with other substances is unlikely. T1 / 2 in adults is 7.9±1.9 hours; in young children, T1 / 2 is shortened. The average observed total clearance was 0.63 ml / min / kg.

Levocetirizine is mainly excreted unchanged in the urine, on average, about 85.4% of the dose taken by glomerular filtration and active tubular secretion. Excretion through the intestine (with feces) is only 12.9% of the dose taken.

Patients with renal insufficiency. Total clearance of levocetirizine depends on Cl creatinine. Therefore, patients with moderate to severe renal insufficiency are recommended to increase the intervals between doses of the drug in accordance with creatinine clearance. In patients with anuria and end-stage renal failure, the total clearance of levocetirizine decreases by approximately 80% compared to healthy people. The amount of levocetirizine eliminated during a standard 4-hour hemodialysis procedure is less than 10%.

Indications

• The treatment of the symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis, such as itching, sneezing, nasal congestion, runny nose, watery eyes, redness of the conjunctiva;
• pollinosis (hay fever);
• urticaria, including chronic idiopathic urticaria;
• angioedema (as adjuvant therapy);
• other allergic dermatoses, accompanied by itching and rashes.

Contraindications

• Hypersensitivity to levocetirizine and other piperazine derivatives or to any of the auxiliary components of the drug;
• end-stage renal failure with a creatinine clearance of less than 10 ml / min;
• congenital galactose intolerance, lactase deficiency or glucose-galactose malabsorption (due to the content of lactose in the drug)
• pregnancy;
• children under 6 years of age (for this dosage form).

With caution:  concomitant use with alcohol (see “Interaction”); chronic renal failure with a creatinine clearance of more than 10 ml / min, but less than 50 ml / min (dosage adjustment is required); elderly age (glomerular filtration rate may decrease).

Side effects

From the immune system:  very rarely — hypersensitivity reactions, including anaphylactic reactions.

Nervous system disorders:  often-headache; infrequently-drowsiness; very rarely-aggression, agitation, hallucinations, depression, convulsions.

From the side of the visual organ:  very rarely — visual disorders.

From the side of the heart:  very rarely-palpitation, tachycardia.

Respiratory, thoracic and mediastinal disorders:  very rarely — shortness of breath.

From the gastrointestinal tract:  often — dryness of the oral mucosa; infrequently-abdominal pain; very rarely-nausea, diarrhea.

Liver and biliary tract disorders:  very rarely — hepatitis.

Skin and subcutaneous tissue disorders:  very rarely-angioedema, pruritus, rash, including drug rash, urticaria.

Musculoskeletal and connective tissue disorders:  very rarely — myalgia.

General violations:  often-fatigue; infrequently-asthenia.

From the side of laboratory and instrumental data:  very rarely — violation of liver function indicators, weight gain.

Interaction

The interaction of levocetirizine with other drugs, including studies with inducers of the CYP3A4 isoenzyme, has not been studied.

When studying the drug interaction of cetirizine racemate with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam, clinically significant undesirable interactions were not detected.

When co-administered with theophylline (400 mg/day), the total clearance of cetirizine decreases by 16% (theophylline kinetics does not change).

In a study with simultaneous use of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), it was shown that cetirizine exposure increased by 40%, while ritonavir exposure changed slightly (11%).

In sensitive patients, concomitant use of levocetirizine and alcohol or other substances that depress the central nervous system may increase the effect on the central nervous system, although cetirizine racemate has not been shown to increase the effect of alcohol.

How to take, course of use and dosage

Inside, without chewing and washing down with liquid, regardless of food intake. It is recommended to take the daily dose in one dose.

Adults, teenagers, and children over 6 years of age. The recommended daily dose is 5 mg (1 tablet).

Overdose

Symptoms:  possible drowsiness and agitation (in adults), as well as anxiety, followed by drowsiness (in children).

Treatment:  There are no specific levocetirizine antidotes. In case of overdose, symptomatic or supportive treatment is recommended. If a little time has passed after taking the drug, gastric lavage should be performed. Levocetirizine is practically not excreted during hemodialysis.

Special instructions

During treatment with the drug, it is not recommended to take ethanol.

Impact on the ability to drive vehicles or engage in other potentially dangerous activities. Levocetirizine, when taken at the recommended doses, does not adversely affect attention and speed of psychomotor reactions and the ability to drive vehicles. However, during the period of taking the drug, it is advisable to refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Composition

Tablet Form of production

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Levocetirizine

Dosage form

Tablets

Purpose

For adults and Children over 6 years of age

Indications

Atopic Dermatitis, Allergic Conjunctivitis, Allergic Rhinitis, Angioedema, Pollinosis, Allergy, Dermatosis, Urticaria, Pruritus, Neurodermatitis