Bilastine


Generic Medicine Info
Indications and Dosage
Oral
Allergic rhinitis
Adult: For symptomatic relief of allergic rhino-conjunctivitis (seasonal allergic rhinitis and perennial allergic rhinitis): As conventional tab: 20 mg once daily. Limit treatment to the period of exposure to allergens. Seasonal allergic rhinitis: Discontinue treatment after the symptoms have resolved, reinitiate treatment if symptoms reappear. Perennial allergic rhinitis: Treatment may be continued during allergen exposure periods.
Child: For symptomatic relief of allergic rhino-conjunctivitis (seasonal allergic rhinitis and perennial allergic rhinitis): 6-11 years weighing at least 20 kg: As orodispersible tab and oral solution: 10 mg once daily. ≥12 years Same as adult dose.

Oral
Urticaria
Adult: As conventional tab: 20 mg once daily. Treatment duration may vary depending on the type, duration, and course of the complaints.
Child: 6-11 years weighing at least 20 kg: As orodispersible tab and oral solution: 10 mg once daily. ≥12 years Same as adult dose.
Administration
Should be taken on an empty stomach. Take 1 hr before or 2 hr after intake of food or fruit juice.
Special Precautions
Concomitant use with P-glycoprotein inhibitors in patients with moderate to severe renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Cardiac disorders: Right bundle branch block, sinus arrhythmia.
Ear and labyrinth disorders: Vertigo, tinnitus.
Gastrointestinal disorders: Nausea, diarrhoea, dry mouth, thirst, dyspepsia, gastritis, upper abdominal pain, abdominal pain.
General disorders and administration site conditions: Fatigue, asthenia, pyrexia.
Infections and infestations: Oral herpes.
Investigations: Increased gamma glutamyltransferase, alanine aminotransferase, aspartate aminotransferase, blood creatinine, triglycerides, and weight.
Metabolism and nutrition disorders: Increased appetite.
Nervous system disorders: Somnolence, headache, dizziness.
Psychiatric disorders: Anxiety, insomnia.
Respiratory, thoracic and mediastinal disorders: Nasal discomfort, nasal dryness, dyspnoea.
Skin and subcutaneous tissue disorders: Pruritus.
Overdosage
Symptoms: Nausea, headache, dizziness. Management: Symptomatic and supportive treatment.
Drug Interactions
May increase the plasma concentrations and increase the risk of adverse reactions with P-glycoprotein inhibitors (e.g. ketoconazole, erythromycin, ciclosporin, ritonavir, and diltiazem).
Food Interaction
Decreased bioavailability with grapefruit juice and possibly with other fruit juices. May increase the CNS depressant effect of alcohol.
Action
Description: Bilastine is a non-sedating, long-acting antihistamine. It has no affinity for muscarinic receptors but has selective peripheral H1 receptor antagonist affinity.
Onset: 1 hour.
Duration: 26 hours.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: Approx 61%; decreased with food. Time to peak plasma concentration: 1.13 hours.
Distribution: Plasma protein binding: 84-90%.
Metabolism: Minimally metabolised.
Excretion: Via faeces (66.5% as unchanged drug); urine (28.3% as unchanged drug). Elimination half-life: Approx 14.5 hours.
Chemical Structure

Chemical Structure Image
Bilastine

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 185460, Bilastine. https://pubchem.ncbi.nlm.nih.gov/compound/Bilastine. Accessed May 26, 2022.

Storage
Store between 15-30°C.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AX29 - bilastine ; Belongs to the class of other antihistamines for systemic use.
References
Anon. Bilastine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/03/2022.

Bilaxten 10 mg Orodispersible Tablets (A. Menarini Manufacturing Logistics and Services S.r.l,). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/03/2022.

Bilaxten 2.5 mg/mL Oral Solution (Berlin-Chemia AG). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/03/2022.

Bilaxten 20 mg Tablets (A. Menarini Manufacturing Logistics and Services S.r.l,). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/03/2022.

Buckingham R (ed). Bilastine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/03/2022.

Ilaxten 10 mg Orodispersible Tablets (Menarini International Operations Luxembourg S.A.). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2022.

Ilaxten 2.5 mg/mL Oral Solution (Menarini International Operations Luxembourg S.A.). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2022.

Ilaxten 20 mg Tablets (Menarini International Operations Luxembourg S.A.). MHRA. https://products.mhra.gov.uk. Accessed 04/03/2022.

Joint Formulary Committee. Bilastine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/03/2022.

Disclaimer: This information is independently developed by MIMS based on Bilastine 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 © 2022 MIMS. All rights reserved. Powered by MIMS.com
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