Desloratadine-Teva
Desloratadin-Teva: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Desloratadine-Teva
ATX code: R06AX27
Active ingredient: desloratadine (Desloratadine)
Manufacturer: Pharmaceuticals Inc. (Pharmascience, Inc.) (Canada); TEVA Pharmaceutical Works Private, Ltd. Co. (Hungary)
Description and photo update: 2019-11-07
Desloratadine-Teva is a long-acting antiallergic drug.
Release form and composition
Dosage form - tablets, film-coated: blue, biconvex round, engraved "D" on one side (7 or 10 pcs. In blisters, in a cardboard box 1-3 blisters and instructions for use of Desloratadine-Teva).
Composition of 1 tablet:
- active substance: desloratadine - 5 mg;
- additional substances: zinc stearate - 1 mg; microcrystalline cellulose - 65.8 mg; pregelatinized starch - 4.75 mg; magnesium oxide - 2.25 mg; hapromellose-4000 - 1.7 mg; lactose - 4.5 mg;
- shell: Opadry blue 03В90819 (hypromellose - 60%; macrogol-400 - 8%; titanium dioxide - 27.21%; indigo carmine - 4.79%) - 2.975 mg.
Pharmacological properties
Pharmacodynamics
Desloratadine is a long-acting antihistamine based on blocking H 1 -histamine peripheral receptors. Desloratadine is the primary active metabolite of loratadine, the action of which is aimed at inhibiting the cascade of reactions of allergic inflammation and includes the release of pro-inflammatory cytokines (including interleukins IL-4, IL-6, IL-8, IL-13). Also effect caused release of proinflammatory chemokines, production of superoxide anion by activated polymorphonuclear neutrophils adhesion and chemotaxis eosinophils release of adhesion molecules (such as P-selectin), IgE-mediated release of histamine, leukotriene C 4 and prostaglandin D 2 (where IgE - immunoglobulin E total).
The use of the drug prevents the occurrence of allergic reactions and facilitates their course. Desloratadine-Teva has an antipruritic and antiexudative effect, reduces capillary permeability, prevents the appearance of tissue edema and smooth muscle spasms.
The development of the action of desloratadine is noted within 30 minutes after oral administration, the effect lasts 24 hours.
Desloratadine does not affect the speed of psychomotor reactions, has practically no sedative effect, does not affect the central nervous system, and does not lead to an increase in the QT interval on the electrocardiogram.
Pharmacokinetics
After oral administration, desloratadine is well absorbed from the gastrointestinal tract, the determined plasma concentrations of the substance in the blood are reached within 30 minutes, the time to reach C max (maximum concentration) in plasma is about three hours. Eating food or alcohol has practically no effect on the pharmacological properties of the drug.
Desloratadine binds to plasma proteins at a level of 83–87%. No clinically significant cumulation was found when applied in a daily dose of 5–20 mg for a course of 14 days. Eating food or grapefruit juice does not affect the distribution of the substance (when taken in a daily dose of 7.5 mg). Desloratadine does not penetrate the blood-brain barrier.
The substance undergoes intensive metabolism by hydroxylation, resulting in the formation of 3-OH-desloratadine, combined with glucuronide. Desloratadine is not an inhibitor / substrate of P-glycoprotein and an inhibitor of CYP3A4 and CYP2D6 isoenzymes.
The drug is excreted from the body in the form of a glucuronide compound, a small part of the dose is excreted as an unchanged substance. A small amount is excreted with feces and kidneys (7 and 2%, respectively). The half-life is in the range from 20 to 30 hours, the average value of this indicator is 27 hours.
Indications for use
- allergic rhinitis: year-round and seasonal (hay fever), the use of Desloratadine-Teva allows you to eliminate or relieve sneezing, nasal congestion, nasal mucus discharge, itching in the nose / palate, redness and itching of the eyes, watery eyes;
- chronic idiopathic urticaria: as a result of the use of the drug, itching and rash are reduced / eliminated.
Contraindications
Absolute:
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- age up to 12 years;
- pregnancy and the period of breastfeeding;
- hypersensitivity to desloratadine and the additional components of Desloratadine-Teva.
Patients with severe renal impairment should undergo therapy under the supervision of a physician.
Desloratadin-Teva, instructions for use: method and dosage
Desloratadine-Teva is taken orally, at the same time of day, regardless of the meal. The tablet should be swallowed whole, without breaking / chewing, and washed down with a little water.
The recommended dosage regimen for children and adolescents over 12 years old, and adult patients: 1 tablet (5 mg) once a day.
Duration of therapy:
- intermittent (seasonal) allergic rhinitis, the symptoms of which appear less than four days a week or less than four weeks a year: an assessment of the course of the disease is required, if the symptoms pass, the drug is stopped, the reappearance of symptoms requires the resumption of the antihistamine;
- persistent (perennial) allergic rhinitis, symptoms of which occur more than four days a week or more than four weeks a year: Desloratadine-Teva is taken at all times of exposure to the allergen.
Side effects
The use of Desloratadine-Teva can lead to the development of the following side effects [> 10% - very often; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; <0.01% - very rare]:
- digestive system: infrequently - xerostomia; very rarely - vomiting, nausea, dyspepsia, abdominal pain, diarrhea;
- nervous system: infrequently - headache; very rarely - hallucinations, drowsiness, dizziness, psychomotor hyperactivity, insomnia, convulsions; with an unknown frequency - lengthening of the QT interval;
- immune system: very rarely - rash (including urticaria), dyspnea, angioedema, anaphylactic shock;
- cardiovascular system: very rarely - palpitations, tachycardia;
- musculoskeletal system: very rarely - myalgia;
- skin: with an unknown frequency - photosensitivity;
- hepatobiliary system: very rarely - hepatitis, increased concentration of bilirubin, increased activity of liver enzymes;
- others: often - increased fatigue; very rarely - shortness of breath.
In children in the post-registration period, the following adverse events (with an unknown frequency) were recorded - arrhythmia, prolongation of the QT interval, bradycardia.
Overdose
Taking Desloratadine-Teva at a dose 5 times higher than the recommended dose did not lead to any adverse reactions. In clinical trials, the daily use of desloratadine in adults and adolescents at a dose of up to 20 mg for 14 days was studied for the effect on the cardiovascular system. At the same time, clinically or statistically significant changes were not registered. Also, the prolongation of the QT interval and the appearance of serious adverse events were not recorded during the clinical and pharmacological study of therapy with desloratadine at a daily dose of 45 mg for 10 days.
Therapy: gastric lavage is indicated, the use of activated carbon; if necessary, symptomatic treatment is carried out. Desloratadine is not excreted during hemodialysis, the effectiveness of peritoneal dialysis in case of overdose has not been established.
special instructions
The effectiveness of desloratadine for the treatment of rhinitis of infectious etiology has not been studied.
It is recommended to store blisters in a cardboard box (to protect the tablets from light).
Influence on the ability to drive vehicles and complex mechanisms
In case of adverse reactions from the nervous system (drowsiness, dizziness, hallucinations), it is recommended to refuse to drive vehicles.
Application during pregnancy and lactation
The safety profile of Desloratadine-Teva in pregnant / lactating women has not been studied, therefore, the use of the drug in this group of patients is contraindicated.
Pediatric use
Patients under 12 years of age are not prescribed Desloratadine-Teva tablets.
With impaired renal function
In patients with severe renal insufficiency, therapy should be carried out under the supervision of a physician.
Drug interactions
No clinically significant drug interactions of desloratadine with azithromycin, ketoconazole, cimetidine, fluoxetine, erythromycin and other substances / drugs have been identified.
Desloratadine does not aggravate the effect of alcohol on the central nervous system, despite this, episodes of alcohol intolerance and alcohol intoxication have been reported with post-registration use of the drug. As a result, desloratadine should be taken with caution along with ethanol.
Diet and diet do not affect the effectiveness of Desloratadine-Teva.
Analogs
Analogs of Desloratadine-Teva are: Desal, Alestamine, Blogir-3, Desloratadin Canon, Desloratadine, Lordestin, Ezlor, Delorsin, Eliza, Nalorius, Erius, etc.
Terms and conditions of storage
Store at temperatures up to 25 ° C in a place protected from light. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Available without a prescription.
Reviews about Desloratadine-Teva
Patients leave mostly positive reviews about Desloratadine-Teva, noting that the drug has a quick effect, does not cause weakness and drowsiness. The cost is estimated from affordable to overpriced.
The price of Desloratadin-Teva in pharmacies
The approximate price for Desloratadine-Teva, film-coated tablets, 5 mg, is: 7 pcs. in the package - 334 rubles; 10 pcs. in the package - 474 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
