Indications

Bilista is indicated for the symptomatic treatment of:

• Allergic rhinoconjunctivitis (seasonal and perennial).
• Urticaria (hives). It is also used to relieve the symptoms of hay fever, such as sneezing, itching, runny or blocked nose, and red, watery eyes.

Pharmacology

Bilastine is a potent, non-sedating, long-acting histamine antagonist that selectively and with high affinity blocks the H1​ receptor. It has a high selectivity for the H1​ receptor and does not show affinity for other receptors like muscarinic, serotonergic, or dopaminergic receptors. Bilastine is not metabolized to be active and is primarily excreted through feces and urine.

Dosage & Administration

• Adults and adolescents (12 years and over): 20 mg tablet once daily. It should be swallowed with water on an empty stomach for optimal absorption. The maximum daily dose is 20 mg.
• Children (6 to 11 years): 10 mg mouth-dissolving tablet once daily. The tablet disperses rapidly in saliva and can be swallowed easily. The maximum daily dose is 10 mg.
• Children (2 to 11 years): 4 ml once daily.
• Missed Dose: If a dose is missed, the next scheduled dose should be taken, and an extra dose should not be taken.

Interaction

• Concomitant use with ketoconazole, erythromycin, cyclosporine, or diltiazem can increase the concentration of Bilista, but these changes do not appear to affect the safety profile.
• It does not potentiate the effects of alcohol or other depressant drugs like lorazepam on psychomotor performance or the central nervous system.

Contraindications

Bilista is contraindicated in patients with a known hypersensitivity to bilastine or any of the tablet's other components.

Side Effects

The most common side effects reported in clinical trials were headache, dizziness, somnolence (sleepiness), and fatigue. These occurred with a frequency similar to that of the placebo.

Pregnancy & Lactation

This drug should preferably be avoided during pregnancy due to limited data. Animal studies have not shown any direct or indirect harmful effects on reproduction. It is not known whether bilastine is excreted in human milk, so a decision should be made considering the benefits for both the mother and the child.

Precautions & Warnings

• Bilista does not affect driving performance, but patients should be aware that, rarely, some people may experience drowsiness, which could affect their ability to drive or use machines.
• No dosage adjustment is needed for patients with renal impairment.
• Since bilastine is not metabolized in the human body, changes in liver function are not expected to have a clinically relevant influence.

Use in Special Populations

The efficacy and safety of Bilista have not been established in children under 2 years of age. There is also limited clinical experience in children aged 2 to 5 years, so Bilista should not be used in these age groups.

Overdose Effects

In clinical trials, doses 10 to 11 times the therapeutic dose resulted in a higher frequency of side effects like dizziness, headache, and nausea, but no serious adverse events or significant cardiac effects were reported.

Therapeutic Class

Bilista belongs to the therapeutic class of non-sedating antihistamines.

Storage Conditions

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