Erolin^® (Tablets, Syrup) Instructions for Use

ATC Code

R06AX13 (Loratadine)

Active Substance

Loratadine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

H1 histamine receptor blocker

Pharmacological Action

Histamine H₁-receptor blocker. 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, is reached in approximately 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 approximately 1 hour, while 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 (range 8.8-92 hours).

Approximately 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 a glass of water.

Take on an empty stomach, at least 1 hour before or 2 hours after a meal, to ensure consistent absorption.

For adults and children over 12 years of age, and for those with a body weight over 30 kg, the standard dose is 10 mg once daily.

For children from 2 to 12 years of age with a body weight less than 30 kg, the recommended dose is 5 mg once daily.

For pediatric patients, use the syrup formulation for accurate dosing; ensure the measuring device provided is used.

Adjust the dosage regimen for patients with severe hepatic impairment or renal insufficiency (creatinine clearance less than 30 mL/min); initiate therapy at 10 mg every other day for adults or an equivalent reduced dose for children.

Do not exceed the recommended daily dose.

The duration of treatment depends on the indication and clinical response; continue use for as long as allergen exposure persists.

Discontinue use and consult a physician if symptoms worsen or do not improve.

Adverse Reactions

From the digestive system: rarely – dry mouth, nausea, vomiting, gastritis; in isolated 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 isolated 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, while administration in high doses revealed some fetotoxic effects.

Use in Hepatic Impairment

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

Use in Renal Impairment

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

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

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

Patients with impaired renal or liver function require dosage 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 the 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.