Ezlor Solution Tablets (Tablets) Instructions for Use
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
ATC Code
R06AX27 (Desloratadine)
Active Substance
Desloratadine (Rec.INN WHO registered)
Dosage Forms
 |
Ezlor Solution Tablets | Dispersible tablets, 2.5 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 200 or 300 pcs. |
| Dispersible tablets, 5 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 200 or 300 pcs. |
Dosage Form, Packaging, and Composition
Dispersible tablets from white or almost white to white with a pinkish tint, round, flat-cylindrical, with a score and a bevel.
| 1 tab. | |
| Desloratadine | 2.5 mg |
Excipients: calcium hydrogen phosphate dihydrate – 85 mg, microcrystalline cellulose (MCC-102) – 25 mg, sodium carboxymethyl starch – 3 mg, aspartame – 2.5 mg, magnesium stearate – 1.2 mg, colloidal silicon dioxide – 0.8 mg.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
Dispersible tablets from white or almost white to white with a pinkish tint, oval, biconvex, with a score and a bevel.
| 1 tab. | |
| Desloratadine | 5 mg |
Excipients: calcium hydrogen phosphate dihydrate – 170 mg, microcrystalline cellulose (MCC-102) – 50 mg, sodium carboxymethyl starch – 6 mg, aspartame – 5 mg, magnesium stearate – 2.4 mg, colloidal silicon dioxide – 1.6 mg.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
20 pcs. – contour cell packaging (1) – cardboard packs.
20 pcs. – contour cell packaging (2) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
20 pcs. – contour cell packaging (4) – cardboard packs.
20 pcs. – contour cell packaging (5) – cardboard packs.
20 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (4) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
Clinical-Pharmacological Group
Histamine H1-receptor blocker. Antiallergic drug
Pharmacotherapeutic Group
Systemic antihistamines; other systemic antihistamines
Pharmacological Action
Histamine H1-receptor blocker (long-acting). 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, Cmax is reached in 2-6 hours (on average in 3 hours). It does not penetrate the BBB.
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%).
T1/2 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
| ICD-10 code | Indication |
| J30.1 | Allergic rhinitis due to pollen |
| L50.1 | Idiopathic urticaria |
| ICD-11 code | Indication |
| CA08.00 | Allergic rhinitis due to pollen |
| EB00.1 | Chronic urticaria |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer orally once daily, irrespective of food intake.
For adults and adolescents (12 years and older), the dose is 5 mg once daily.
For children aged 6 to 11 years, the dose is 2.5 mg once daily.
For children aged 1 to 5 years, the dose is 1.25 mg once daily.
Use the 2.5 mg dispersible tablet for the 2.5 mg and 1.25 mg doses.
To administer a 1.25 mg dose, break the 2.5 mg tablet along the functional score line.
Place the tablet on the tongue; it disperses immediately and can be swallowed with or without water.
The duration of treatment depends on the symptoms and their severity.
For seasonal allergic rhinitis, continue treatment throughout the exposure period.
For chronic idiopathic urticaria, use as needed based on symptom recurrence.
In patients with severe renal impairment, use desloratadine with caution.
Do not use in children under 1 year of age due to contraindication.
Avoid use in patients with phenylketonuria, as the product contains aspartame.
Adverse Reactions
From the nervous system: headache, hallucinations, psychomotor hyperactivity, seizures.
From the digestive system: dry mouth, hepatitis.
Other: photosensitivity, myalgia, dyspnea, feeling of tiredness.
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 period (breastfeeding).
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 mechanisms
No adverse effects on driving a car or operating complex machinery have been noted.
Drug Interactions
A study of interaction with ketoconazole and erythromycin did not reveal clinically significant changes.
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.
Medical Disclaimer![Ezlor Solution Tablets [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Ezlor Solution Tablets [Tablets] 2")