ALLERTEK

Active material: Cetirizine
When ATH: R06AE07
CCF: Gistaminovыh blocker H1-receptors. Allergy medication
ICD-10 codes (testimony): H10.1, J30.1, J30.3, L20.8, L23, L24, L28.0, L29, L30.0, L50, T78.3
When CSF: 13.01.01.02
Manufacturer: WARSAW PHARMACEUTICAL WORK POLFA S.A. (Poland)

Pharmaceutical form, composition and packaging

Pills, coated white to cream color, oblong, with unilateral break line.

1 tab.
cetirizine digidrohlorid10 mg

Excipients: lactose, microcrystalline cellulose, corn starch, polyvinylpyrrolidone 25, magnesium stearate, sodium starch gluconate, silica gel, sodium lauryl.

The composition of the shell: hydroxypropylmethylcellulose, polyethylene glycol 6000.

7 PC. – blisters (1) – packs cardboard.
20 PC. – blisters (1) – packs cardboard.

 

Pharmacological action

Blocker peripheral histamine H1-receptors. It has anti-allergic effect. It affects gistaminozavisimuyu early stage of allergic reactions, reduces the migration of eosinophils, limits the release of inflammatory mediators in the late, cell stage allergic reactions. It prevents the development and facilitates the allergic reactions, It has antipruritic effect. Virtually no anticholinergic action and antiserotoninovogo. At therapeutic doses do not cause sedation.

Effect of the drug is manifested through 20 m (in 50% patients), through 60 m (in 95% patients) after ingestion and lasts up 24 no.

 

Pharmacokinetics

Absorption

After oral cetirizine is rapidly and well absorbed from the gastrointestinal tract. Cmax plasma levels achieved after 30-60 m. Food intake has no significant effect on the value of removals, however, in this case, the rate of absorption is reduced insignificantly.

Distribution

Plasma protein binding is 93%. Vd is about 0.5 l / kg. It does not cross the blood-brain barrier and into the cell. In applying the drug in a dose 10 mg for 10 days of drug accumulation is not observed.

Metabolism

Cetirizine poorly metabolized in the liver with the formation of active metabolites.

Deduction

About 70% the dose of cetirizine are mainly excreted by the kidneys in unchanged form. After a single administration of a single dose of T1/2 is about 10 no.

Pharmacokinetics in special clinical situations

Children between the ages of 2 to 12 T years1/2 is 5-6 no.

If the kidney function (CC less than 11-31 ml / min) and patients, hemodialysis (CC less than 7 ml / min), T1/2 increases 3 times, ground clearance is reduced by 70%.

In chronic diseases and elderly patients noted an increase in T1/2 on 50% and a decrease in the clearance 40%.

 

Testimony

- Seasonal and perennial allergic rhinitis;

- Allergic conjunctivitis;

- Hay fever (hay fever);

- Urticaria (incl. chronic idiopathic);

- Itchy allergic dermatitis (including atopicheskiy dermatitis, neurodermatitis);

- Angioedema.

 

Dosage regimen

Adults and children over 12 years appointed 10 mg (1 tab.)/d.

Children aged 6 to 12 years the drug is prescribed for 5 mg (1/2 tab.) 2 times / day, morning and evening or 10 mg (1 tab.) 1 time / day.

At renal failure the dose should be reduced 2 times.

At hepatic dysfunction Dose picked individually, especially when simultaneous renal failure.

Elderly patients with normal renal function dose adjustment is required.

The drug can be taken without regard to meals, preferably in the evening. The tablets should be swallowed whole, without chewing, with a little water.

 

Side effect

From the digestive system: dry mouth; in some cases – dyspepsia, stomach ache, flatulence.

CNS: in some cases – headache, drowsiness, dizziness, excitation.

Allergic reactions: in a few cases – hives, angioedema, breathlessness (the patient must be advised of the need for immediate discontinuation).

The drug is generally well tolerated.

 

Contraindications

- Children up to age 6 years;

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

FROM caution should be prescribed to patients with chronic renal failure, moderate to severe (requires correction mode), and elderly patients (may decrease glomerular filtration rate).

 

Pregnancy and lactation

Allertek® not recommended for use during pregnancy. If necessary, use during lactation should decide the issue of termination of breastfeeding.

 

Cautions

With care prescribe a drug to the elderly and patients with impaired liver and / or kidney.

Patients should be warned of the need to inform your doctor about any side effects occur in patients receiving the drug.

Patients should be warned of the need to avoid the simultaneous use Allerteka® with other drugs without a prescription.

Data on the interaction of cetirizine with ethanol has not yet been received, Despite this use of alcohol during treatment with the drug Allertek® not recommended.

Use in Pediatrics

The drug is not prescribed children under the age of 6 years.

Effects on ability to drive vehicles and management mechanisms

With care prescribe a drug to patients, engaged in potentially hazardous activities, require increased attention and psychomotor speed reactions.

 

Overdose

Symptoms: drowsiness (when a single dose of the drug in a dose of more than 50 mg); children – anxiety, irritability; possible anticholinergic effects (urinary retention, dry mouth, constipation).

Treatment: gastric lavage, administration of activated charcoal; if necessary, symptomatic therapy. Hemodialysis nyeeffyektivyen.

 

Drug Interactions

In an application Allerteka® with theophylline may increase the frequency of side effects.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

Conditions and terms

The drug should be stored in a dry, dark place at a temperature of 15 ° to 25 ° C. Shelf life – 4 year.

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