Blogir-3® (Tablets, Solution) Instructions for Use
ATC Code
R06AX27 (Desloratadine)
Active Substance
Desloratadine (Rec.INN registered by WHO)
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 extensively 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 in feces (<7%). T1/2 is 20-30 hours (on average – 27 hours).
When desloratadine was used at doses from 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, with or without food.
For adults and adolescents (12 years and older), the recommended dose is 5 mg.
For pediatric patients, base the dose on age.
For children 6 to 11 years, administer 2.5 mg once daily.
For children 1 to 5 years, administer 1.25 mg once daily.
Do not use in children under 1 year of age.
In patients with severe renal impairment, use with caution.
No dosage adjustment is required for elderly patients.
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 lactation (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 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.
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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Orally disintegrating tablets, 5 mg: 5, 10, 20, or 30 pcs.
Marketing Authorization Holder
Belupo, Pharmaceuticals & Cosmetics d.d. (Croatia)
Manufactured By
Genepharm, S.A. (Greece)
Quality Control Release
BELUPO, Pharmaceuticals & Cosmetics, d.d. (Croatia)
Dosage Form
 |
Blogir-3® | Orally disintegrating tablets, 5 mg: 5, 10, 20, or 30 pcs. |
Dosage Form, Packaging, and Composition
Orally disintegrating tablets pink, round, flat, with inclusions of a darker color, with beveled edges and an embossed “5” on one side.
| 1 tab. | |
| Desloratadine | 5 mg |
Excipients: mannitol – 133.5 mg, microcrystalline cellulose – 15 mg, croscarmellose sodium – 6 mg, polacrilin potassium – 5 mg, aspartame – 3 mg, magnesium stearate – 1.7 mg, “tutti-frutti” flavor (flavoring substances, maltodextrin, propylene glycol (E1520), modified starch (E1450)) – 0.75 mg, red iron oxide dye – 0.7 mg, citric acid monohydrate – q.s.
5 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
Oral solution 0.5 mg/1 ml: 60 ml or 120 ml bottle with dosing spoon
Marketing Authorization Holder
Belupo, Pharmaceuticals & Cosmetics d.d. (Croatia)
Manufactured By
Famar, A.V.E. (Greece)
Labeled By
FAMAR, A.V.E. (Greece)
Or
BELUPO, Pharmaceuticals & Cosmetics, d.d. (Croatia)
Quality Control Release
BELUPO, Pharmaceuticals & Cosmetics, d.d. (Croatia)
Dosage Form
|
Blogir-3® | Oral solution 0.5 mg/1 ml: 60 ml or 120 ml bottle with dosing spoon |
Dosage Form, Packaging, and Composition
Oral solution transparent, colorless.
| 1 ml | |
| Desloratadine | 0.5 mg |
Excipients: propylene glycol – 150 mg, sorbitol – 150 mg, hypromellose – 3.5 mg, sucralose – 2 mg, sodium citrate – 1.26 mg, tutti-frutti flavor (flavoring substances, propylene glycol (E1520)) – 0.75 mg, citric acid – 0.5 mg, water – q.s.
60 ml – dark glass bottles (1) complete with a dosing spoon graduated at 2.5 ml and 5 ml – cardboard packs.
120 ml – dark glass bottles (1) complete with a dosing spoon graduated at 2.5 ml and 5 ml – cardboard packs.
![Blogir-3® [Tablets, Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Blogir-3® [Tablets, Solution] 2")