Fricel (Tablets) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

R06AX27 (Desloratadine)

Active Substance

Desloratadine (Rec.INN WHO registered)

Dosage Form

Fricel

Film-coated tablets 5 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

10 pcs. – blister packs – cardboard packs (10 pcs.) – Over-the-Counter
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – Over-the-Counter
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
15 pcs. – blister packs (2 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Systemic antihistamines; other systemic antihistamines

Pharmacological Action

Desloratadine is a long-acting histamine H₁-receptor blocker. It is the primary active metabolite of loratadine.

It inhibits the release of histamine and leukotriene C₄ from mast cells. It prevents the development and alleviates the course of allergic reactions.

It has antiallergic, antipruritic, and anti-exudative effects. It reduces capillary permeability, prevents the development of tissue edema, and relieves smooth muscle spasm.

It has practically no sedative effect and, when taken at a dose of 7.5 mg, does not affect the speed of psychomotor reactions.

In comparative studies of desloratadine and loratadine, no qualitative or quantitative differences in the toxicity of the two drugs at comparable doses (taking into account the concentration of desloratadine) were identified.

Pharmacokinetics

After oral administration, it begins to be detected in plasma within 30 minutes. Food does not affect distribution.

Bioavailability is proportional to the dose in the range from 5 mg to 20 mg. Plasma protein binding is 83-87%.

After a single dose of 5 mg or 7.5 mg, C_max is reached in 2-6 hours (on average in 3 hours). It does not penetrate the blood-brain barrier.

It is intensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, conjugated with glucuronide.

Only a small part of the orally administered dose is excreted by the kidneys (<2%) and with feces (<7%). T_1/2 is 20-30 hours (on average – 27 hours).

When using desloratadine at a dose of 5 mg to 20 mg once a day for 14 days, no signs of clinically significant accumulation were detected.

Indications

Seasonal allergic rhinitis, chronic idiopathic urticaria.

ICD codes

Dosage Regimen

Administer orally once daily. Take with or without food.

For adults and adolescents (12 years and older), the dose is 5 mg (one tablet).

For children aged 6 to 11 years, the dose is 2.5 mg (one-half tablet).

For children aged 1 to 5 years, the dose is 1.25 mg (one-quarter tablet).

Do not use in children under 1 year of age.

For pediatric dosing, use a tablet that can be accurately split to the required fraction.

In patients with severe renal impairment, use this medication with caution.

The duration of treatment depends on the indication. For seasonal allergic rhinitis, continue throughout the exposure period. For chronic idiopathic urticaria, continue as directed by a physician.

Adverse Reactions

Nervous system disorders: headache, hallucinations, psychomotor hyperactivity, seizures.

Gastrointestinal disorders: dry mouth, hepatitis.

Other: photosensitivity, myalgia, dyspnea, feeling of fatigue.

Contraindications

Phenylketonuria, pregnancy, lactation, children under 1 year of age, hypersensitivity to desloratadine.

Use in Pregnancy and Lactation

Desloratadine is contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Use in Renal Impairment

Desloratadine should be used with caution in severe renal impairment.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

Desloratadine should be used with caution in severe renal impairment.

Effect on the ability to drive vehicles and operate machinery

No adverse effects on driving a car or operating complex technical devices have been reported.

Drug Interactions

A study of interaction with ketoconazole and erythromycin did not reveal clinically significant changes.

It does not affect the effects of ethanol.

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.