Formulation of Bistavo Tab
Bilastine
Bistavo Tab (Bilastine) is an antihistamine medicine used widely to relieve allergic symptoms like runny nose, sneezing, redness of the nose, watery eyes, itching, and rash. It stops the action of a natural substance called histamine produced in your body during an allergic reaction. Bilastine is available as a tablet, orodispersible tablet (tablets that dissolve in the mouth) and syrup on prescription. The tablet form is used in adolescents and adults above 12 years of age, whereas orodispersible tablets and syrup are used in children aged 6 to 11 years. The common side effects of Bilastine are headache, dizziness, nausea etc. Do not drive or operate machinery that requires high mental alertness after taking this medicine. If you notice any severe side effects, consult your doctor immediately. Taking this medicine with food or juice can lower its effects. Therefore, you can take Bilastine on an empty stomach or half an hour before or two hours after a meal. Bilastine is only recommended when there are allergic symptoms, and use it only for the prescribed period. Consult your doctor if you do not see any improvement in your symptoms after treatment.
Bilastine is used for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial)
and urticaria.
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.
Bilastine is also used to associated treatment for these conditions: chronic spontaneous Urticaria, seasonal Allergic Rhinitis.
The most commonly reported side effects in clinical trial are Headache, Drowsiness, Blood tests showing changes in the way the liver is working, dizziness, stomach pain, tiredness, increased appetite, irregular heartbeat, increased weight, nausea (the feeling of being sick), anxiety, dry or uncomfortable nose, belly pain.
When not to use
Allergy
Avoid using Bilastine if you
are allergic to it. Seek an immediate medical attention if you notice any
symptoms of allergic reactions such as skin rash, itching/swelling (especially
of the face/tongue/throat), severe dizziness, breathing difficulties, etc.
Pheochromocytoma
Pheochromocytoma is a rare
tumour of the adrenal glands-small glands located above the kidneys. Adrenal
glands produce hormones that help to regulate blood pressure in your body. This
gland gets activated by Bilastine resulting in the abnormal release of
epinephrine and nor-epinephrine (hormones) which increase the blood pressure in
your body. Hence, Bilastine is not recommended for those who have
Pheochromocytoma due to the risk of high blood pressure.
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.
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.
Precaution
In patients with moderate or severe renal impairment coadministration of bilastine with P-glycoprotein inhibitors, such as e.g, ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem, may increase plasmatic levels of bilastine and therefore increase the risk of adverse effects of bilastine. Therefore, coadministration of bilastine and P-glycoprotein inhibitors should be avoided in patients with moderate or severe renal impairment
Storage Condition
Keep below 30 °C temperature, protected from light and moisture. Keep out of reach of children