Indications of Biltin

Bilastine is used to treat allergic rhino-conjunctivitis (seasonal and perennial) and urticaria symptomatically.

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.

Pharmacology

Bilastine is a non-sedating, long-acting histamine antagonist that has a strong affinity for peripheral H 1 receptors but no affinity for muscarinic receptors. Following a single dose of bilastine, histamine-induced wheal and flare skin reactions are inhibited for 24 hours.

Dosage and Administration

Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine.

Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.

Children between 2 to 11 years: 4 ml once daily.

Interaction of Biltin

Bilastine’s C max was enhanced when it was taken with Ketoconazole, Erythromycin, or Diltiazem. The psychomotor performance of people who drank alcohol and Bilastine at the same time was identical to that of people who drank alcohol and placebo. Bilastine and Lorazepam 3 mg used together for 8 days did not potentiate Lorazepam’s depressive CNS effects.

Contraindications

Bilastine is not recommended for people who are hypersensitive to the active ingredient or any of the tablet’s excipients.

Side effects of Biltin

Headache, dizziness, somnolence, and weariness are the most commonly reported side effects in clinical trials. Patients who received placebo had these side effects at a similar rate.

Pregnancy & Lactation

There is no or little information about Bilastine’s use in pregnant women. In terms of reproductive toxicity, parturition, or postnatal development, animal studies show no direct or indirect adverse effects. It is best to avoid using Bilastine during pregnancy as a preventative step. Bilastine excretion in milk has not been examined in humans. The benefits of breast-feeding for the infant and the benefits of Bilastine therapy for the mother must be considered while making a decision.

Precautions & Warnings

In patients with moderate or severe renal impairment, co-administration of Bilastine and P-glycoprotein inhibitors (e.g. Ketoconazole, Erythromycin, Cyclosporine, Ritonavir, or Diltiazem) should be avoided.

Therapeutic Class

Non-sedating antihistamines

Storage Conditions

Keep the temperature below 30°C and away from light and moisture. Keep out of children’s reach.

Generic Name of Biltin

Bilastine