Generic Medicine Info
Indications and Dosage
Allergic rhinitis, Urticaria
Adult: 10 mg once daily.
Child: ≥12 years Same as adult dose.
Severe heart disease, history of symptomatic arrhythmias, known or suspected QT prolongation, clinically significant bradycardia, electrolyte imbalance (e.g. hypokalaemia). Severe hepatic impairment. Concomitant use with macrolide antibiotics (e.g. erythromycin), systemic imidazole antifungals (e.g. ketoconazole), other agents that may prolong the QT interval (e.g. Class I and III antiarrhythmics).
Special Precautions
Mild to moderate hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: CNS depression; QT prolongation.
Gastrointestinal disorders: Nausea, dry mouth, abdominal pain, dyspepsia, diarrhoea.
General disorders and administration site conditions: Transient asthenia.
Investigations: Increased weight.
Metabolism and nutrition disorders: Increased appetite.
Nervous system disorders: Headache, dizziness, transient drowsiness.
Patient Counseling Information
This medicine may cause drowsiness, if affected, do not drive or operate machinery.
Drug Interactions
Potentially Fatal: Increased plasma concentration with systemic imidazole antifungals (e.g. ketoconazole), and macrolide antibiotics (e.g. erythromycin). Increased risk of QT prolongation with class I and III antiarrhythmics (e.g. amiodarone).
Mechanism of Action: Mizolastine is a non-sedating antihistamine which selectively antagonises the peripheral H1 receptors. It also has mast-stabilising properties.
Onset: Within 1 hour.
Duration: 24 hours.
Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: 65%. Time to peak plasma concentration: 1.5 hours.
Distribution: Enters breast milk. Plasma protein binding: Approx 98.4%.
Metabolism: Metabolised via glucuronidation and by the CYP3A4 isoenzyme into inactive hydroxylated metabolites.
Excretion: Elimination half-life: 13 hours.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 65906, Mizolastine. https://pubchem.ncbi.nlm.nih.gov/compound/Mizolastine. Accessed Mar. 25, 2021.

Store below 25°C.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AX25 - mizolastine ; Belongs to the class of other antihistamines for systemic use.
Anon. Mizolastine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/03/2021.

Buckingham R (ed). Mizolastine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/03/2021.

Joint Formulary Committee. Mizolastine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/03/2021.

Mizollen 10 mg Modified-Release Tablets (Aventis Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2021.

Disclaimer: This information is independently developed by MIMS based on Mizolastine 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 © 2024 MIMS. All rights reserved. Powered by MIMS.com
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