Finished product reference

Bilastine

Tablet · Oral · 20 mg

List code
53442
Pharmacologic class
Second-generation (non-sedating) H1-antihistamine

What it is and how it works

Bilastine is a selective peripheral H1-receptor inverse agonist with minimal penetration of the central nervous system and negligible affinity for muscarinic receptors. It is not significantly metabolised and is eliminated largely unchanged.

Indications

Symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria.

Dosage and administration (summary)

Adults and adolescents 12 years and over: 20 mg once daily by mouth. Children 6–11 years (body weight at least 20 kg): 10 mg once daily (oral solution or orodispersible tablet). Take 1 hour before or 2 hours after food or fruit juice.

Contraindications

Hypersensitivity to bilastine or any excipient.

Warnings and precautions

Food and grapefruit or other fruit juices reduce absorption. Co-administration with P-glycoprotein inhibitors should be avoided in moderate or severe renal impairment. Headache and somnolence may occur, although sedation is uncommon.

Pregnancy

Avoid in pregnancy as a precaution, owing to limited data.

Storage and supply

No special temperature requirements; store in the original package (oral solution: use within the in-use period after opening).

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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