Bilastine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

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:
Mechanism of Action: 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

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.

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