Ebastine


Generic Medicine Info
Indications and Dosage
Oral
Allergic conditions
Adult: Usual dose: 10-20 mg once daily.
Child: >12 years Same as adult dose.

Oral
Chronic idiopathic urticaria
Adult: 10 mg once daily.
Child: >12 years Same as adult dose.
Hepatic Impairment
Severe: Max: 10 mg daily.
Administration
May be taken with or without food.
Special Precautions
Patient with cardiac risks (e.g. long QT syndrome, hypokalaemia, treatment with agents known to increase QT interval). Concomitant use with CYP3A4 inhibitors. Severe hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Cardiac disorders: Rarely, palpitation, tachycardia.
Gastrointestinal disorders: Dry mouth. Rarely, dysgeusia, abdominal pain, nausea, dyspepsia, vomiting.
General disorders and administration site conditions: Asthenia.
Hepatobiliary disorders: Rarely, hepatitis, cholestasis.
Immune system disorders: Rarely, hypersensitivity reactions (e.g. angioedema, anaphylaxis).
Investigations: Rarely, abnormal LFTs.
Nervous system disorders: Headache, drowsiness. Rarely, dizziness, hypoesthesia.
Psychiatric disorders: Rarely, nervousness, insomnia.
Reproductive system and breast disorders: Rarely, menstrual disorders.
Respiratory, thoracic and mediastinal disorders: Pharyngitis, sinusitis, epistaxis.
Patient Counseling Information
This drug may cause drowsiness or sometimes dizziness; if affected, do not drive or operate machinery.
Drug Interactions
Increased plasma levels and risk of QTc interval prolongation with ketoconazole, itraconazole and erythromycin. Plasma concentrations and antihistamine effects may be decreased by rifampicin.
Food Interaction
Plasma levels of carebastine may be increased by 1.5-2 fold with food.
Lab Interference
May interfere with allergy skin test results.
Action
Description: Ebastine, a piperidine derivative, is a long-acting, non-sedating antihistamine that selectively binds to histamine H1 receptors to inhibit the effects of histamines.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Food may increase the plasma levels of carebastine (active metabolite). Time to peak plasma concentration: Approx 2-4 hours (carebastine).
Distribution: Plasma protein binding: >95%.
Metabolism: Almost completely metabolised primarily by CYP3A4 isoenzyme into carebastine; undergoes extensive hepatic and intestinal first-pass metabolism.
Excretion: Via urine (66%, primarily as conjugated metabolites). Elimination half-life: 15-19 hours (carebastine).
Chemical Structure

Chemical Structure Image
Ebastine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3191, Ebastine. https://pubchem.ncbi.nlm.nih.gov/compound/Ebastine. Accessed Nov. 24, 2020.

Storage
Store below 30°C.
ATC Classification
R06AX22 - ebastine ; Belongs to the class of other antihistamines for systemic use.
References
Anon. Ebastine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/09/2020.

Buckingham R (ed). Ebastine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/09/2020.

Ebast-DT 5 mg Dispersible Tablet (Brown & Burk Philippines, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 01/09/2020.

Kestine 10 mg Film-Coated Tablet (Zuellig Pharma Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 17/11/2020.

Disclaimer: This information is independently developed by MIMS based on Ebastine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
  • Kestine
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