Indications

Bilastin Kids (Bilastine) is indicated for the symptomatic treatment of:

• Allergic rhinoconjunctivitis (seasonal and perennial)
• Urticaria (hives)
• Symptoms of hay fever, such as sneezing, itchy/runny/blocked nose, and watery eyes.

Pharmacology

Bilastine is a potent, non-sedating, and long-acting antihistamine. It works by selectively binding to and blocking the H1 receptor with high affinity, preventing histamine from causing allergic symptoms. It has an excellent safety profile and is not metabolized, being excreted primarily through feces and urine.

Dosage & Administration

• Adults and Adolescents ($\ge$12 years): 20 mg tablet once daily. Take with water on an empty stomach to ensure optimal absorption. Do not exceed the maximum daily dose of 20 mg.
• Children (6-11 years): 10 mg mouth-dissolving tablet once daily. The tablet dissolves rapidly in saliva and can be swallowed easily.
• Children (2-11 years): 4 ml once daily. If a dose is missed, take the next scheduled dose. Do not take an extra dose.

Interaction

• Ketoconazole, Erythromycin, Cyclosporine, or Diltiazem: Concomitant use with these drugs may increase Bilastine's concentration, but this does not appear to affect the safety profile.
• Alcohol: Bilastine does not potentiate the psychomotor effects of alcohol.
• Lorazepam: Bilastine does not potentiate the CNS depressant effects of lorazepam.

Contraindications

Bilastine is contraindicated in patients with a known hypersensitivity to the active substance or any of its excipients.

Side Effects

The most commonly reported side effects are headache, dizziness, somnolence (drowsiness), and fatigue. These occurred with a similar frequency to patients taking a placebo.

Pregnancy & Lactation

• Pregnancy: There is limited data on Bilastine use in pregnant women. As a precaution, it is preferable to avoid its use during pregnancy. Animal studies do not show direct or indirect harmful effects on reproduction.
• Lactation: It is not known if Bilastine is excreted in human milk. A decision should be made to either discontinue breastfeeding or therapy, considering the benefits for both the child and mother.

Precautions & Warnings

• Driving: Bilastine 20 mg does not typically affect driving performance. However, rare cases of drowsiness may occur.
• Elderly Patients: Clinical trials showed no difference in safety or efficacy in elderly patients compared to younger patients.
• Renal and Hepatic Impairment: No dosage adjustment is necessary for patients with renal impairment, and changes in liver function are not expected to have a clinically relevant influence as Bilastine is not metabolized.

Use in Special Populations

The efficacy and safety of Bilastin Kids have not been established in children under 2 years of age. It is not recommended for this age group.

Overdose Effects

In clinical trials, doses up to 11 times the therapeutic dose were associated with a higher frequency of side effects like dizziness, headache, and nausea, but no serious adverse events or significant cardiac issues were reported.

Therapeutic Class

Bilastin Kids is classified as a non-sedating antihistamine.

Storage Conditions

Keep below 30°C, protected from light and moisture. Keep out of the reach of children.