Biltin Tablet 20mg

Indications

Biltin is indicated for the symptomatic treatment of-

Allergic rhino conjunctivitis (seasonal and perennial) and

Urticaria

Biltin is also used to relieve the symptoms of hay fever (sneezing, itchy, runny, blocked-nose and red and watery eyes).

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Pharmacology

Bilastine is a potent, effective, non-sedating, long-acting histamine antagonist with selective & high affinity to H1 receptor (3 times higher than Cetirizine and 5 times higher than Fexofenadine). Even at a high concentration, Bilastine does not show affinity for the 30 other receptors including muscarinic, serotonergic, dopaminergic and noradrenergic receptors, for the other histamine receptor subtypes (H2, H3 and H4). It shows excellent safety profile and very favorable pharmacokinetic characteristics. Bilastine doesn’t undergo any metabolism to be active. Bilastine is excreted by feces (non -systemic) & urine (systemic) approximately 66.35% & 28.31% respectively.

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.

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Interaction

Concomitant use of Biltin with ketoconazole, erythromycin, cyclosporine or diltiazem increases the concentration of Biltin. But these changes do not appear to affect the safety profile of any of the drugs. Intake of alcohol and 20 mg Biltin shows same psychomotor performance similar to that of alcohol and placebo. Concomitant intake of Biltin 20 mg 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

Treatment with Biltin 20 mg does not affect the driving performance. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines. In clinical trials elderly patients (≥65 years) showed no difference in effcacy or safety with respect to younger patients. The maximum plasma concentration of Biltin after administration of 20 mg in patients with severe renal impairment is below the safety threshold of most common adverse e?ects and cardiac or CNS safety. No dosage adjustment is necessary in patients with renal impairment. Biltin is not metabolized in human. Since renal elimination is the major excretion, biliary excretion is expected to be only marginally involved in the elimination of Biltin. Changes in liver function are not expected to have a clinically relevant influence.

Use in Special Populations

Efficacy and safety of Biltin 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 Biltin should not be used in these age groups.

Overdose Effects

In clinical trials, after administration of Biltin 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.

Chemical Structure

Molecular Formula : C28H37N3O3

Chemical Structure : Chemical Structure of Bilastine

Common Questions about Biltin 20 mg Tablet

What is Biltin 20 mg Tablet?

Biltin 20 mg Tablet is H1 receptor antagnist. It is commonly used to treat Allergic rhino conjunctivitis (seasonal and perennial) and Urticaria.

Are there any pregnancy warnings of Biltin 20 mg Tablet?

Limited information is available. Biltin 20 mg Tablet is recommended to be used only after consulting a doctor for pregnant women.

Are there any breast-feeding warnings of Biltin 20 mg Tablet?

It is advised to consult your doctor before taking Biltin 20 mg Tablet if you are breast feeding a baby as relevant information is not available.

Does Biltin 20 mg Tablet safe with alcohol?

Excessive intake of alcohol should be avoided during the course of medication as it can increase sleepiness.

Does Biltin 20 mg Tablet affect kidney function?

It is important to consult a doctor to know the dose adjustment for patients suffering from kidney diseases.

Does Biltin 20 mg Tablet affect liver function?

Relevant information is not available. Please consult to know if any dose adjustment is needed in patients with liver impairment.

Quick Tips

Your doctor has prescribed Biltin 20 mg Tablet to help relieve allergy symptoms such as itching, swelling, and rashes.

As compared to other similar medications, it is much less likely to make you feel sleepy.

Be cautious while driving or doing anything that requires concentration as it can cause dizziness and sleepiness.

Do not drink alcohol while taking this medication as it may cause increased sleepiness.

Stop taking Biltin 20 mg Tablet at least three days before taking an allergy test as it can affect the test results.

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