Uses of Bilambic M tablet (Bilastine & Montelukast)

Bilambic - M

Composition of medicine :

Each film coated bilayered tablet contains :
Bilastine.  –––––― 20 mg
Montelukast Sodium IP
Eqv. to Montelukast―–― 10 mg
Excipient ―――― q.s.

Colour : Erythrosine Lake (In Montelukast layer)

Dosage form :
Tablets

Description :

Bilastine :
Bilastine tablet, is a second generation antihistamine medication which is used in the treatment of allergic Rhinoconjunctivitis and urticaria (hives).
It exerts it's effect as a selective histamine H1 receptor antagonist. It was developed in Spain by FAES Farma.

Bilastine is approved in the European, Union for the symptomatic treatment of allergic Rhinoconjunctivitis and urticaria, but it is not approved for any use in the United States. Bilastine meets the current European Academy of Allergy and Clinical Immunology (EAACI) and Allergic Rhinitis and its Impact of Asthma (ARIA) criteria for medications used in the treatment of allergic rhinitis.

Bilastine has been effective in the treatment of diseases of allergies, including Rhinoconjunctivitis. Additionally, bilastine has been shown to improve quality of life, and all nasal and eye symptoms related to allergic rhinitis.

Montelukast :
Montelukast tablet, is a medication used in the maintenance treatment of asthma. It is generally less preferred for this use than inhaled corticosteroid. It is not useful for acute asthma attacks. Other uses include allergic rhinitis and hives of long duration. It is taken by mouth.

Montelukast was approved for medical use in the United States in 1998. It is available as a generic medication.

INDICATION :
For the treatment of Allergic Rhinoconjunctivitis.

Dosage and Administration :
Route of Administration :
To be taken orally

USE IN SPECIAL POPULATION
Bilastine
Adults and adolescents (12 years of age and over)

20 mg bilastine (1 tablet) once daily for the relief of symptoms of allergic Rhinoconjunctivitis (SAR and PAR) and urticaria.

The tablet should be taken one hour before or two hour after intake of food or fruit juice.

Special populations
Elderly 
No dosage adjustments are required in elderly patients.

Renal impairment
No dosage adjustment is required in patients with renal impairment.

Hepatic impairment
There is no clinical experience in patients with hepatic impairment. Sincebilastine is not metabolized and renal clearance is its major elimination route, hepatic impairment is not expected to increase systemic exposure above the safety margin. Therefore, no dosage adjustment is required in patients with hepatic impairment.

Pediatric population 
There is no relevant use of bilastine in children aged 0 to 2 years for the indications of allergic rhino-conjunctivitis and urticaria. The safety and efficacy in children below 12 years have not yet been established.

Pregnancy :
There are no 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. 

Breast Feeding :
The excretion of bilastine in milk has not been studied in humans. Available pharmacokinetic data in animals have shown excretion of bilastine in milk. A decision on whether to discontinue/abstain from bilastine therapy must be made taking into account the benefit of breastfeeding for the child and the benefit of bilastine therapy for the mother.

Fertility :
There are no or limited amount of clinical data. A study in rats did not indicate any negative effect on fertility.