BILAXTEN 20/MG TAB 20/TAB

Indications

Approved Uses

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

Off-Label Uses

No off-label uses identified in sources

Dosage & Administration

Dosing by Condition

Allergic rhinoconjunctivitis (≥12 years): 20 mg orally once daily; Urticaria (≥12 years): 20 mg orally once daily.

Initial Dose

20mg once daily.

Maintenance Dose

20mg once daily.

Maximum Dose

20mg once daily.

Children's Dosage

Children 6-11 years (weighing at least 20 kg): 10mg once daily. Not recommended for children under 6 years of age.

Dose Adjustment Notes

No dose adjustment is required in renal or hepatic impairment.

How to Take

Swallow the tablet whole with water. Take on an empty stomach, either 1 hour before or 2 hours after food or fruit juice.

Side Effects

Common Side Effects

Headache, somnolence/drowsiness, dizziness, fatigue.

Side Effect Frequency

Common: headache (up to 12%), somnolence (up to 3.9%), fatigue (up to 2.6%). Uncommon: dizziness. QT prolongation not reported as adverse event.

Safety & Warnings

Contraindications

Hypersensitivity to bilastine or to any excipients (product ingredients).

Warnings & Precautions

Use caution in moderate-severe renal impairment, particularly with concomitant P-glycoprotein inhibitors; QT prolongation risk is low.

Age Restriction

Bilastine 20 mg tablet is indicated for adults and adolescents ≥12 years; not recommended/approved for children <12 years for this strength/formulation.

Driving Warning

No impairment of driving performance

Drug Interactions

Drug Interactions

Avoid fruit juices (e.g., grapefruit/orange/apple) around dosing as they reduce absorption; bilastine exposure increases with P-glycoprotein inhibitors (e.g., ketoconazole, erythromycin, cyclosporine, diltiazem, ritonavir), and may decrease with strong inducers (e.g., rifampicin).

Interaction Severity

MODERATE: Strong P-gp inhibitors (e.g., ketoconazole, erythromycin, cyclosporine, ritonavir) may increase bilastine exposure; P-gp inducers (e.g., rifampicin) may decrease exposure. MINOR: Fruit juices/food reduce absorption.

Food Interaction

Take on an empty stomach: at least 1 hour before or 2 hours after food or fruit juice (e.g., grapefruit/orange/apple), as they reduce bilastine bioavailability (about 30%).

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Children 6-11 years (weighing at least 20 kg): 10mg once daily. Not recommended for children under 6 years of age.

Kidney Impairment

No routine dose adjustment is required; in severe renal impairment, avoid/ use caution if co-administered with P-glycoprotein inhibitors (risk of increased exposure).

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Overdose

Expected symptoms include headache, dizziness, somnolence and nausea; management is symptomatic/supportive.

Patient Counseling

Take 1 tablet (20 mg) once daily on an empty stomach: at least 1 hour before or 2 hours after food or fruit juice (avoid taking with fruit juices such as grapefruit, orange, or apple as they reduce absorption). Swallow with water. It is generally non-sedating, but drowsiness can occur in some people-use caution with driving/operating machinery until you know your response. Avoid alcohol if it makes you sleepy. Seek urgent medical help for signs of serious allergy (e.g., facial/lip/tongue swelling, difficulty breathing). Prescription-only; do not share. Store below 30°C.

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

Selective peripheral histamine H1-receptor antagonist that competitively blocks H1 receptors, reducing histamine-mediated symptoms of allergic rhinoconjunctivitis and urticaria with minimal CNS effects.

Onset of Action

Within about 1 hour.

Duration of Effect

Approximately 24 hours.

Half-Life

Approximately 14.5 hours.

Bioavailability

Approximately 61% (and it is significantly reduced by food and fruit juices).

Metabolism

Minimal metabolism; not significantly metabolized by CYP450 and is eliminated largely unchanged (low CYP-mediated interaction potential).

Protein Binding

84-90%.

Product Information

Available Dosage Forms

Tablet (this SFDA-registered product: 20 mg oral tablet; blister pack of 20).

Composition per Dose

Each tablet: 20mg bilastine

OTC Alternatives

OTC alternatives in many markets include cetirizine 10 mg, loratadine 10 mg, and fexofenadine (e.g., 120 mg once daily), subject to local regulatory status.

Symptom Target

Allergy, Runny Nose

Sedating

No

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