Klarfast (Tablets) Instructions for Use

Marketing Authorization Holder

Cadila Pharmaceuticals Ltd. (India)

ATC Code

R06AX13 (Loratadine)

Active Substance

Loratadine (Rec.INN registered by WHO)

Dosage Form

Klarfast

Tablets 10 mg: 20 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, flat, white in color, with beveled edges, with a score on one side and the marking “LFT” on the other.

10 pcs. – blisters (2) – cardboard packs.
50 pcs. – blisters (2) – cardboard packs.

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.

C_max of loratadine in plasma is reached in 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, while its values for these substances remained unchanged.

Plasma protein binding of loratadine is high – about 98%, and 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 during 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 itchy dermatoses (contact allergic dermatitis, chronic eczema).

ICD codes

Dosage Regimen

Administer orally with water.

For adults and children over 12 years of age: take 10 mg (one tablet) once daily.

For children from 2 to 12 years of age: base the dose on body weight. For children weighing more than 30 kg, administer 10 mg once daily. For children weighing 30 kg or less, administer 5 mg (half a tablet) once daily.

Take the tablet on an empty stomach, at least 1 hour before a meal.

For patients with severe hepatic impairment or chronic renal failure (creatinine clearance less than 30 ml/min), adjust the dosing interval. Administer 10 mg every other day.

The duration of treatment depends on the indication. For seasonal allergic rhinitis, continue treatment throughout the exposure period. For chronic idiopathic urticaria, continue use as long as clinically necessary.

Do not exceed the recommended daily dose.

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.