Cetirizine-Akrikhin (Tablets) Instructions for Use

Marketing Authorization Holder

Warsaw Pharmaceutical Work Polfa, S.A. (Poland)

Manufactured By

Pharmaceutical Works “Polpharma”, SA (Poland)

ATC Code

R06AE07 (Cetirizine)

Active Substance

Cetirizine (Rec.INN registered by WHO)

Dosage Form

Cetirizine-Akrikhin

Film-coated tablets, 10 mg: 7 or 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from white to white with a yellowish tint, oblong, biconvex in shape, with a score on one side.

Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, povidone K25, magnesium stearate, sodium carboxymethyl starch, colloidal anhydrous silicon dioxide, sodium lauryl sulfate.

Shell composition hypromellose, macrogol 6000.

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

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

Blocker of peripheral histamine H₁-receptors. It has an antiallergic effect. It affects the early histamine-dependent stage of allergic reactions, reduces the migration of eosinophils, and limits the release of inflammatory mediators at the late, cellular stage of allergic reactions. It prevents the development and alleviates the course of allergic reactions, and has an antipruritic effect. It has practically no anticholinergic or antiserotonin action. In therapeutic doses, it does not cause a sedative effect.

The effect of the drug appears after 20 minutes (in 50% of patients), after 60 minutes (in 95% of patients) after taking the drug and lasts up to 24 hours.

Pharmacokinetics

Absorption

After oral administration, Cetirizine is rapidly and well absorbed from the gastrointestinal tract. C_max in blood plasma is reached after 30-60 minutes. Food intake does not significantly affect the extent of absorption, but in this case, the absorption rate is slightly reduced.

Distribution

Plasma protein binding is 93%. V_d is about 0.5 l/kg. It does not penetrate the blood-brain barrier and into the cell. When using the drug at a dose of 10 mg for 10 days, no accumulation of the drug is observed.

Metabolism

Cetirizine is weakly metabolized in the liver to form an inactive metabolite.

Excretion

About 70% of the taken dose of cetirizine is excreted by the kidneys mainly unchanged. After a single dose, T_1/2 is about 10 hours.

Pharmacokinetics in special clinical cases

In children aged 2 to 12 years, T_1/2 is 5-6 hours.

In case of impaired renal function (creatinine clearance less than 11-31 ml/min) and in patients on hemodialysis (creatinine clearance less than 7 ml/min), T_1/2 increases 3 times, clearance decreases by 70%.

In chronic diseases and in elderly patients, an increase in T_1/2 by 50% and a decrease in clearance by 40% are noted.

Indications

• Seasonal and perennial allergic rhinitis;
• Allergic conjunctivitis;
• Hay fever (hay fever);
• Urticaria (including chronic idiopathic);
• Pruritic allergic dermatoses (including atopic dermatitis, neurodermatitis);
• Angioedema.

ICD codes

Dosage Regimen

Adults and children over 12 years old are prescribed 10 mg (1 tab.)/day.

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

In case of renal failure, the dose should be reduced by half.

In case of impaired liver function, the dose is selected individually, especially in case of concomitant renal failure.

Elderly patients with normal renal function do not require dose adjustment.

The drug can be taken regardless of food intake, preferably in the evening. The tablets should be swallowed whole, without chewing, with a small amount of water.

Adverse Reactions

From the digestive system dry mouth; in some cases – dyspepsia, abdominal pain, flatulence.

From the central nervous system in some cases – headache, drowsiness, dizziness, agitation.

Allergic reactions in isolated cases – urticaria, angioedema, shortness of breath (the patient should be warned about the need to immediately stop taking the drug).

The drug is generally well tolerated.

Contraindications

• Children under 6 years of age;
• Pregnancy;
• Lactation period (breastfeeding);
• Increased sensitivity to the components of the drug.

With caution, the drug should be prescribed for chronic renal failure of moderate and severe degree (dosing regimen correction is required), as well as to elderly patients (a decrease in glomerular filtration is possible).

Use in Pregnancy and Lactation

Cetirizine-Akrikhin is not recommended for use during pregnancy. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided.

Use in Hepatic Impairment

Patients with severe liver function impairment the dose of the drug should be reduced.

Use in Renal Impairment

Patients with severe renal function impairment the dose of the drug should be reduced.

Pediatric Use

Contraindicated: children under 6 years of age.

Geriatric Use

With caution, the drug should be prescribed to elderly patients (a decrease in glomerular filtration is possible).

Special Precautions

The drug should be prescribed with caution to elderly persons and patients with impaired liver and/or kidney function.

The patient should be warned about the need to inform the doctor about the occurrence of any side effects while taking the drug.

The patient should be warned about the need to avoid simultaneous use of Allerteka with other medicines without a doctor’s prescription.

To date, no data on the interaction of cetirizine with ethanol have been obtained, despite this, alcohol consumption while using the drug Cetirizine-Akrikhin is not recommended.

Use in pediatrics

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

Effect on the ability to drive vehicles and mechanisms

The drug is prescribed with caution to patients engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms drowsiness (with a single dose of the drug at a dose of more than 50 mg); in children – anxiety, increased irritability; anticholinergic effect (urinary retention, dry mouth, constipation) is possible.

Treatment gastric lavage, intake of activated charcoal; if necessary, symptomatic therapy is carried out. Hemodialysis is ineffective.

Drug Interactions

With simultaneous use of the drug Cetirizine-Akrikhin with theophylline, an increase in the frequency of side effects is possible.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

The shelf life is 4 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.