2010/09/17

Allertec

Composition, structure and packing

Film-coated tablets: white to cream-colored, oblong, with one-sided separation mark.

1 tab. cetirizine dihydrochloride 10 mg.

Excipients: lactose, microcrystalline cellulose, corn starch, polyvinylpyrrolidone 25 magnesium stearate, oksipropilmetiltsellyuloza, sodium gluconate starch, silica gel, sodium lauryl sulfate, polyethylene glycol 6000.

Clinico-pharmacological group: blocker histamine H1-receptors.

Antiallergic drug.

Pharmacological action

Blocker of the peripheral histamine H1-receptors. Has anti-allergic effect. Does the early stage gistaminozavisimuyu allergic reactions, reduces the migration of eosinophils, restricts the release of inflammatory mediators in late, cell stage of allergic reactions. Prevents the development and facilitates during allergic reactions, has antipruritic effect.

Almost no anticholinergic and antiserotoninovogo action. In therapeutic doses does not cause a sedative effect. The maximum therapeutic effect is achieved within 4-8 hours after drug administration and lasts up to 24 hours

Pharmacokinetics

Absorption

After oral cetirizine rapidly and well absorbed from the gastrointestinal tract. Cmax plasma levels achieved after 30-60 min. Eating has no significant effect on the magnitude of absorption, but in this case the rate of absorption slightly reduced.

Distribution

Binding to plasma proteins is 93%. Vd is about 0.5 L / kg. Do not cross the BBB and into the cell. In applying the drug at a dose of 10 mg for 10 days accumulation of the drug is not observed.

Metabolism

Cetirizine poorly metabolized in the liver with the formation of an inactive metabolite.

Withdrawal

About 70% of applied dose cetirizine kidneys derived largely unchanged. After a single dose of a single dose of T1 / 2 is about 10 hours

Pharmacokinetics in special clinical situations

In children aged 2 to 12 years T1 / 2 of 5-6 h. The renal dysfunction (QA least 11-31 ml / min) and in patients on hemodialysis (CC less than 7 ml / min), T1 / 2 increased by 3 times, clearance is reduced by 70%.

In chronic diseases and elderly patients indicate an increase in T1 / 2 by 50% and a decrease in clearance by 40%.

Statement
seasonal and perennial allergic rhinitis;
allergic conjunctivitis;
pollinosis (hay fever);
urticaria (including chronic idiopathic);
pruritic allergic dermatitis (in t.ch atopic dermatitis, atopic dermatitis);
Quincke's edema.

Dosage regimen

Adults and children over 12 years prescribed 10 mg (1 tab.) / Day.

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

In renal insufficiency the dose should be reduced in 2 times.

When violations of the liver dose picked individually, especially when simultaneous kidney failure. Elderly patients with normal renal function, dose adjustment is required. The drug can be taken irrespective of food intake, preferably in the evening.

Tablets should be swallowed whole without chewing, drinking a small amount of water.

Side effect

On the part of the digestive system: dry mouth, and in some cases - indigestion, abdominal pain, flatulence. From the side of the central nervous system: in some cases - headache, drowsiness, dizziness, agitation.

Allergic reactions: In rare cases - urticaria, angioedema, dyspnea (the patient should be warned about the need for immediate cessation of the drug).

The drug is generally well tolerated.

Contraindications
Children under 6 years
Pregnancy
Lactation (breastfeeding);
Hypersensitivity to the drug's components.

Precautions should be prescribed the drug in patients with chronic renal failure, moderate and severe (requires correction dosing regimen), as well as elderly patients (possibly reducing the glomerular filtration).

Pregnancy and lactation

Allertek not recommend use during pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.

Application for violations of liver function

Patients with severe hepatic impairment dose is reduced.

Application for violations of renal function

Patients with severe impaired renal function reduce the dose.

Cautions

Be wary prescribers elderly and patients with impaired liver function and / or kidneys. Patients should notify the need to inform your doctor about any side effects occur against a background of the drug.

Patients should notify the need to avoid the simultaneous application of Allerteka with other drugs without a prescription.

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

Use in Pediatrics

The drug should not be administered to children under 6 years.

Effects on ability to drive vehicles and management mechanisms

Be wary prescribers to patients involved in potentially hazardous activities that require attention and quickness of psychomotor reactions.

Overdose

Symptoms: drowsiness (with the single dose of the drug in doses exceeding 50 mg) in children - anxiety, irritability, possible anticholinergic effects (urinary retention, dry mouth, constipation).

Treatment: gastric lavage, activated charcoal method, with the need to spend symptomatically. Hemodialysis is ineffective.

Drug Interactions

With simultaneous application Allerteka with theophylline may increase the frequency of side effects.

Terms and Conditions of storage

The product should be stored in a dry, dark place at a temperature of 15 ° to 25 ° C. Shelf life - 4 years.