Ebastin
Ebastin: 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. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Ebastine
ATX code: R06AX22
Active ingredient: ebastine (Ebastine)
Producer: Micro Labs Limited (India)
Description and photo update: 2020-13-04
Ebastine is an antiallergic drug, a blocker of H 1 -histamine receptors.
Release form and composition
Dosage form - tablets, dispersible in the oral cavity: white or almost white, flat-cylindrical, round, with a bevel (7 pcs. In blisters, in a cardboard box 1 blister; 10 pcs. In blisters, in a cardboard box 1 or 3 blisters; each pack contains instructions for the use of Ebastin).
Composition for 1 tablet:
- active ingredient: ebastine - 10 mg;
- additional substances: crospovidone - 50 mg; magnesium stearate - 3 mg; aspartame - 1 mg; mannitol - 129 mg; silicon dioxide [Syloid (Syloid)] - 5 mg; peppermint flavoring - 2 mg.
Pharmacological properties
Pharmacodynamics
Ebastine is a long-acting H 1 -histamine receptor blocker.
The pronounced antiallergic effect is manifested 60 minutes after taking the drug inside and lasts at least two days. After a 5-day course of therapy, due to the action of active metabolites, antihistamine activity persists for three days.
Long-term administration of the drug ensures the maintenance of a high level of blockade of peripheral H 1 -histamine receptors without the development of tachyphylaxis.
The drug does not have a pronounced sedative and anticholinergic effect, it does not penetrate the blood-brain barrier.
The effect of the drug on the QT interval on the ECG (electrocardiogram) when taken in a dose of 100 mg exceeding the recommended daily dose (20 mg) by 5 times was not observed.
Pharmacokinetics
After oral administration, Ebastine is rapidly absorbed and almost completely metabolized in the liver to form an active metabolite - carbastine. The maximum concentration of this metabolite in the blood plasma (157 ng / ml) is observed 1-3 hours after a single dose of 10 mg of the drug.
With a daily intake of the drug in a dose of 10–20 mg, the equilibrium concentration of 130–160 ng / ml is reached after 3–5 days.
The connection with blood plasma proteins and ebastine and its active metabolite (carbastine) is more than 95%. The half-life of the latter varies within 15-19 hours. The kidneys in the form of conjugates excrete 66% of the dose taken.
Food intake does not affect the clinical effects of the drug. Pharmacokinetic parameters are not dependent on age (so no significant changes are observed in elderly patients).
In patients with renal insufficiency, the half-life increases to 23–26 hours, with hepatic insufficiency - up to 27 hours, while the concentration of Ebastine in the blood does not exceed therapeutic values.
Indications for use
Ebastin is used for allergic rhinitis of various etiologies (seasonal and / or year-round), urticaria of various etiologies, including chronic idiopathic.
Contraindications
Absolute:
- severe hepatic dysfunction (class C on the Child-Pugh scale);
- phenylketonuria;
- age under 12;
- period of pregnancy;
- breast-feeding;
- hypersensitivity to substances in the composition of the drug.
Relative (Ebastin tablets are used with caution):
- mild to moderate hepatic impairment (classes A and B on the Child-Pugh scale);
- disruption of the kidneys;
- hypokalemia;
- an increase in the QT interval on the ECG;
- combined therapy with itraconazole, ketoconazole, rifampicin and erythromycin (due to the increased risk of QT prolongation on the ECG).
Ebastin, instructions for use: method and dosage
Ebastin tablets are intended for absorption in the oral cavity. Food intake does not affect the effect of the antihistamine.
In adults and adolescents over 12 years of age, the initial dose is 10 mg (1 tablet) once a day. Insufficient effectiveness of this dose or severe symptoms of the disease are grounds for increasing the dose to 20 mg (2 tablets) 1 time per day.
The duration of the course of treatment depends on the degree of elimination of the symptoms of the disease.
In case of impaired renal function, mild and moderate hepatic failure, as well as in elderly patients, dose adjustment is not required.
Directions for use of the medicinal product:
- Carefully open the blister and remove the tablet without breaking it (remove the tablet only with dry hands).
- Put the tablet on the tongue, where it dissolves quickly (drink it with water or any other liquid is not required).
If drug therapy does not improve the condition, or the symptoms of the disease, on the contrary, are aggravated (or new symptoms appear), you should immediately consult a doctor.
It is recommended to use the drug exclusively according to the indications set forth in this manual and in accordance with the dosage regimen indicated in it.
Side effects
Adverse reactions that occur when taking Ebastine [based on observations during clinical trials and post-marketing use, classified in accordance with the frequency of development (very often - more than 1/10; often - from 1/100 to 1/10; rarely - from 1 / 10,000 to 1/1000)]:
- CNS (central and peripheral nervous system): very often - headache; often - drowsiness; rarely - dysgeusia, hypesthesia, dizziness;
- mental disorders: rarely - insomnia, nervousness;
- digestive system: often - dryness of the oral mucosa; rarely - dyspepsia, abdominal pain, nausea, vomiting;
- immune system: rarely - hypersensitivity reactions (angioedema, anaphylaxis);
- reproductive system: rarely - menstrual irregularities;
- heart and blood vessels: rarely - tachycardia, palpitations;
- skin and subcutaneous fat: rarely - dermatitis, rash, urticaria;
- liver and biliary tract: rarely - cholestasis, hepatitis, deviation of liver function tests (increased activity of gamma-glutamyltransferase, hepatic transaminases, bilirubin, alkaline phosphatase);
- general and local reactions: rarely - asthenia, edema.
The adverse reactions observed in clinical studies in adolescents over 12 years old (the number of children in the group is 460) did not differ from the reactions noted in adults.
In the presence of any of the above undesirable phenomena or their aggravation, as well as the appearance of reactions not listed in this instruction, you should immediately seek the advice of your doctor.
Overdose
Symptoms of an overdose of ebastine have not been reported.
In case of suspicion of intoxication, the stomach should be flushed. In the future, symptomatic treatment is prescribed. It is important to monitor vital body functions. There is no specific antidote for ebastine.
special instructions
When taking Ebastine, the results of allergic skin tests may be distorted. In this regard, these tests should be carried out 5-7 days after the drug was discontinued.
Influence on the ability to drive vehicles and complex mechanisms
During the period of Ebastin therapy, caution should be exercised when driving and other vehicles, as well as engaging in potentially hazardous activities that require quick psychomotor reactions and increased concentration of attention. This is due to the possible development of side effects from the central nervous system, such as dizziness, drowsiness and headache.
Application during pregnancy and lactation
Due to the lack of studies on the safety of the use of Ebastine in women during gestation, the drug is not prescribed to patients in this category.
There is no information on the excretion of Ebastine in breast milk. On this basis, the drug is contraindicated for women who are breastfeeding. If such a need during lactation is justified, consideration should be given to stopping breastfeeding.
Pediatric use
The drug is contraindicated in patients under 12 years of age.
With impaired renal function
Patients with impaired renal function should take the drug with caution. No dose adjustment is necessary.
For violations of liver function
Severe hepatic dysfunction (class C on the Child-Pugh scale) is an absolute contraindication to taking the drug.
Patients with mild to moderate hepatic impairment (classes A and B on the Child-Pugh scale) should be careful during therapy with Ebastin. No dose adjustment is necessary.
Use in the elderly
It is not required to adjust the dose of the drug in elderly patients.
Drug interactions
Simultaneous use of Ebastine with other substances / drugs:
- ketoconazole, itraconazole, erythromycin, rifampicin: an increase in the QT interval on the ECG is possible; rifampicin also helps to reduce the concentration of Ebastine in the blood plasma, thereby inhibiting its antihistamine effect;
- theophylline, indirect anticoagulants, cimetidine, diazepam, ethanol and ethanol-containing agents: no interaction with the drug was found.
When using the above or other medicines (including over-the-counter), you should get a preliminary consultation with a specialist.
Analogs
Ebastin's analogues are Kestin, Espa-Bastin, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store in a place protected from light at a temperature not exceeding 30 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Available without a prescription.
Reviews about Ebastin
On the Internet, reviews about Ebastine are extremely rare. On one of the resources, in response to the question whether the drug helped in eliminating the symptoms of the disease, four out of five respondents answered in the affirmative, especially noting the duration of the therapeutic effect of this antihistamine.
Price for Ebastin in pharmacies
It is currently impossible to determine the price for Ebastin, since the drug is not available on sale in pharmacy chains. The cost of its counterparts is: Kestin - from 471 rubles. (in the package 10 pcs. 10 mg each), from 548 rubles. (in the package 10 pcs. 20 mg); Espa-Bastin - from 237 rubles. (in the package 10 pcs. 10 mg each), from 281 rubles. (in the package 10 pcs. 20 mg each).
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, 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!
