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

Excipients: sodium carboxymethyl starch 2.0 mg, corn starch 20.0 mg, silicon dioxide 1.2 mg, lactose monohydrate 31.0 mg, magnesium stearate 2.5 mg, sodium lauryl sulfate 0.3 mg, povidone 4.0 mg, microcrystalline cellulose 39.0 mg;

composition of the shell: hypromellose 3.4 mg, macrogol 6000 0.6 mg.

Description:The oblong, biconvex tablets are film-coated, from white to cream-colored, with a risk on one side.

Pharmacotherapeutic group:Anti-allergic agent-H1 histamine receptor blocker.

ATX: & nbsp

E.06.A.E.07 Cetirizine

Pharmacodynamics:

The drug Cetirizine-Akrihin is an effective antihistamine, an antiallergic agent. Active substance cetirizine, belongs to the group of competitive histamine antagonists, blocks H1-histamine receptors, has almost no m-holinoblokiruyuschego and antiserotoninovogo action. Prevents development and facilitates the course of allergic reactions, has anti-allergic, antipruritic, anti-exsudative action. Cetirizine affects the "early", histamine-dependent stage of allergic reactions, reduces the migration of inflammation cells, inhibits the release of mediators participating in the late allergic reaction. Reduces capillary permeability, prevents development

edema of tissues, relieves spasm of smooth muscles. In therapeutic doses, it practically does not have a sedative effect. Against the background of the course, tolerance does not develop.

The drug begins in 20 minutes (in 50% of patients), after 1 hour (95% of patients), and persists for 24 hours.

Pharmacokinetics:

Suction: after oral administration cetirizine quickly and well absorbed from the gastrointestinal tract.The maximum concentration is determined after about 30 - 60 minutes.

Eating does not have a significant effect on the amount of absorption, but in this case, the rate of absorption is slightly reduced.

Distribution: cetirizine binds to blood plasma proteins by about 93%. The volume of the distribution (Vd) low (0.5 l / kg), the drug inside the cell does not penetrate.

The drug does not penetrate the blood-brain barrier.

Metabolism: cetirizine weakly metabolized in the liver with the formation of an inactive metabolite. At 10-day application in a dose of 10 mg accumulation of the drug is not observed.

Excretion: approximately 70% of the kidneys are mostly unchanged. After a single dose of a single dose, the half-life period is about 10 hours. In children aged 2 to 12 years, the half-life is reduced to 5 to 6 hours.

If the renal function is impaired (creatinine clearance is less than 11-31 ml / min) and in hemodialysis patients (creatinine clearance less than 7 ml / min), the half-life period increases by 3 times, the clearance decreases by 70%. Against the backdrop of chronic diseases and in elderly patients there is an increase in the half-life of 50% and a decrease in clearance by 40%.

Indications:

- seasonal and year-round allergic rhinitis;

- allergic conjunctivitis;

- Pollinosis (hay fever);

- urticaria, incl. chronic idiopathic;

- itching allergic dermatoses (including atopic dermatitis, neurodermatitis);

- angioedema.

Contraindications:

- deficiency of lactase;

- lactose intolerance;

- glucose-galactose malabsorption;

- children's age till 6 years;

- pregnancy;

- lactation period;

- hypersensitivity to any of the components of the drug.

Carefully:In chronic renal failure of moderate to severe severity, correction of the dosing regimen is required.

Pregnancy and lactation:

During pregnancy, the use of Cetirizine-Acrychin is contraindicated. If it is necessary to use the drug during lactation, it is necessary to solve the problem of terminating breastfeeding.

Dosing and Administration:

Inside, regardless of food intake, without chewing and washing down with a small amount of water, preferably in the evening.

Adults and children over the age of 12: 1 tablet (10 mg) once a day.

Children at the age from 6 to 12 years: 1/2 tablet (5 mg) 2 times a day.

In renal failure, the recommended dose should be reduced by a factor of 2.

If the liver function is impaired, it is necessary to select the dose individually, especially with simultaneous renal failure.

Elderly patients with normal renal function are not required to adjust the dose.

Side effects:

From the hematopoiesis: thrombocytopenia.

From the nervous system: drowsiness, dizziness, headache, aggression, agitation, confusion, depression, hallucinations, insomnia, teak, seizures, dyskinesia, dystonia, paresthesia, fainting, tremor.

From the sense organs: violation of accommodation, visual impairment, nystagmus.

From the CAS side: tachycardia.

From the respiratory system: rhinitis, pharyngitis.

From the digestive system: dryness of the oral mucosa, nausea, abdominal pain, diarrhea; violation of liver function (increased activity of "liver" transaminases, alkaline phosphatase, gamma-glutamine transferase, bilirubin concentration).

From the genitourinary system: urination disorder, urinary incontinence.

From the skin and subcutaneous tissue: itching, rash, hives, angioedema.

Allergic reactions: hypersensitivity up to the development of anaphylactic shock.

From the side of metabolism: increase in body weight.

Other: fatigue, asthenia, malaise, swelling.

Usually, the drug Cetirizine-Acrychin is well tolerated. In some cases, side effects are possible, in which case the drug should be discontinued immediately and urgently needed to see a doctor.

Overdose:

Symptoms (when taking 50 mg): confusion, dizziness, headache, fatigue, weakness, malaise, sedation, drowsiness, stupor, mydriasis, itching, tremor, diarrhea, urinary retention. In children, an overdose of the drug may be accompanied by anxiety and increased irritability, possibly the appearance of signs of anticholinergic action in the form of urine retention, dry mouth, constipation.

Treatment: gastric lavage, provocation of vomiting; reception of activated charcoal, symptomatic and maintenance therapy. There is no specific antidote. Hemodialysis is ineffective.

Interaction:

It is not recommended without consulting a doctor to combine the use of Cetirizine-Acrychin with other medicines.

Joint application with theophylline (400 mg / day) leads to a decrease in the total clearance of cetirizine by 16% (theophylline kinetics does not change). Myelotoxic drugs increase manifestations of hematoxicity of the drug.

Special instructions:

Care should be taken when prescribing the drug to persons who perform activities requiring increased concentration, attention and speed of psychomotor reactions (for example, vehicle management, car maintenance, altitude work, etc.).

Data on the interaction of cetirizine with alcohol have not been obtained to date, despite this, the use of alcoholic beverages in the treatment with the drug Allertec® is not recommended.

Effect on the ability to drive transp. cf. and fur:If Cetirizine-Acrychin is used in the recommended doses, there is no clinically significant effect on the psychophysical condition, but caution should be exercised during vehicle management and machine maintenance and do not use doses exceeding the recommended doses.

Form release / dosage:Tablets, film-coated, 10 mg.

Packaging:At 7 or 20 tablets were placed into blisters of PVC film and aluminum foil. One blister, along with instructions for use, is placed in a cardboard box.

Storage conditions:In a dry, the dark place at a temperature of 15 to 25 ° C, Keep out of reach of children.

Shelf life:

4 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N013633 / 01-2002

Date of registration:29.10.2008

The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland

Manufacturer: & nbsp

Warsaw Pharmaceutical Factory Polfa A.O. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp12.10.2015

Illustrated instructions

Instructions

Cetirizine-Abrichin (Cetirizine-Akrikhin)