Bilastine
Indications
Bilastine is indicated for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.
Pharmacology
Bilastine is a non-sedating, long-acting
histamine antagonist with selective peripheral H 1 receptor antagonist
affinity and no affinity for muscarinic receptors. Bilastine inhibits
histamine-induced wheal and flare skin reactions for 24 hours following
single doses.
Dosage & 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.
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
Concomitant intake of Bilastine and
Ketoconazole or Erythromycin or Diltiazem increased C max of Bilastine.
The psychomotor performance after concomitant intake of alcohol and
Bilastine was similar to that observed after intake of alcohol and
placebo. Concomitant intake of Bilastine and Lorazepam 3 mg for 8 days
did not potentiate the depressant CNS effects of Lorazepam.
Contraindications
Bilastine is contraindicated in patients
with hypersensitivity to the active substance or to any of the
excipients of the tablet.
Side Effects
The most commonly reported side effects in
clinical trial are headache, dizziness, somnolence and fatigue. These
adverse events occurred with a comparable frequency in patients
receiving placebo.
Pregnancy & Lactation
There are no or limited amount of data from
the use of Bilastine in pregnant women. Animal studies do not indicate
direct or indirect harmful effects with respect to reproductive
toxicity, parturition or postnatal development. As a precautionary
measure, it is preferable to avoid the use of Bilastine during
pregnancy. The excretion of Bilastine in milk has not been studied in
humans. A decision must be made taking into account the benefit of
breast-feeding for the child and the benefit of Bilastine therapy for
the mother.
Precautions & Warnings
Co-administration of Bilastine and
P-glycoprotein inhibitors (e.g. Ketoconazole, Erythromycin,
Cyclosporine, Ritonavir or Diltiazem) should be avoided in patients with
moderate or severe renal impairment.
Use in Special Populations
Efficacy and safety of Bilastine in
children under 2 years of age have not been established and there is
little clinical experience in children aged 2 to 5 years, therefore
Bilastine should not be used in these age groups.
Overdose Effects
In clinical trials, after administration of
Bilastine at doses 10 to 11 times the therapeutic dose (220 mg as
single dose; or 200 mg/day for 7 days) frequency of treatment-emergent
adverse events was two times higher than with placebo. The adverse
reactions most frequently reported were dizziness, headache and nausea.
No serious adverse events and no significant prolongation in the QTc
interval were reported.
Therapeutic Class
Non-sedating antihistamines
Storage Conditions
Keep below 30°C temperature, protected from light and moisture. Keep out of reach of children.
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