Klarifer (Tablets) Instructions for Use

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

ATC Code

R06AX13 (Loratadine)

Active Substance

Loratadine (Rec.INN registered by WHO)

Dosage Form

Klarifer

Tablets 10 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

H1 histamine receptor blocker

Pharmacological Action

It is a blocker of histamine H₁-receptors. It has antiallergic, antipruritic, and antiexudative effects.

It reduces capillary permeability, prevents the development of tissue edema, and reduces the increased contractile activity of smooth muscles caused by the action of histamine.

Pharmacokinetics

When taken orally at a therapeutic dose, Loratadine is rapidly absorbed from the gastrointestinal tract and is almost completely metabolized in the body.

The C_max of loratadine in plasma is reached within 1-1.3 hours, and that of the main active metabolite, descarboethoxyloratadine, in about 2.5 hours.

When taken with food, the bioavailability of loratadine and descarboethoxyloratadine increases by approximately 40% and 15%, respectively, the time to reach C_max increased by about 1 hour, but its values for these substances remained unchanged.

Plasma protein binding of loratadine is high – about 98%, while that of the active metabolite is less pronounced.

The average T_1/2 of loratadine is 8.4 hours, and that of descarboethoxyloratadine is 28 hours (8.8-92 hours).

About 80% of loratadine is excreted as metabolites in urine and feces in equal proportions over 10 days, with about 27% excreted in urine within the first 24 hours.

Indications

Seasonal and perennial allergic rhinitis, conjunctivitis, acute urticaria and angioedema, symptoms of histaminergy caused by the use of histamine liberators (pseudoallergic syndromes), allergic reactions to insect bites, complex treatment of pruritic dermatoses (contact allergic dermatitis, chronic eczema).

ICD codes

Dosage Regimen

Administer orally with water, irrespective of meals.

For adults and children over 12 years of age, the standard dose is 10 mg once daily.

For children from 2 to 12 years, base the dose on body weight.

Administer 5 mg once daily to children weighing less than 30 kg.

Administer the adult dose of 10 mg once daily to children weighing more than 30 kg.

Adjust the dosage regimen for patients with severe hepatic impairment or chronic renal failure.

For these patients, administer 10 mg every other day as a starting dose.

Do not exceed the recommended daily dose.

Discontinue use and consult a physician if symptoms persist or worsen.

Adverse Reactions

From the digestive system rarely – dry mouth, nausea, vomiting, gastritis; in some cases – impaired liver function.

From the central nervous system rarely – increased fatigue, headache, excitability (in children).

From the cardiovascular system rarely – tachycardia.

Allergic reactions rarely – skin rash; in isolated cases – anaphylactic reactions.

Dermatological reactions in some cases – alopecia.

Contraindications

Pregnancy, lactation, children under 2 years of age, hypersensitivity to loratadine.

Use in Pregnancy and Lactation

Loratadine should not be used during pregnancy and lactation.

In experimental studies on animals, Loratadine in medium doses did not have a negative effect on the fetus; when administered in high doses, some fetotoxic effects were observed.

Use in Hepatic Impairment

Patients with impaired renal or liver function require dose regimen adjustment.

Use in Renal Impairment

Patients with impaired renal or liver function require dose regimen adjustment.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

The development of seizures cannot be completely ruled out when using loratadine, especially in predisposed patients.

Patients with impaired renal or liver function require dose regimen adjustment.

Drug Interactions

With the simultaneous use of loratadine with drugs that inhibit the CYP3A4 and CYP2D6 isoenzymes or are metabolized in the liver with their participation (including cimetidine, erythromycin, ketoconazole, quinidine, fluconazole, fluoxetine), a change in the plasma concentration of loratadine and/or these drugs is possible.

Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) reduce effectiveness.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.