Levocetirizine Montelukast Syrup

Indications:- Anti–Allergic, Cough & Cold

APPROVED NAME:
LEVOCETIRIZINE HCL + MONTELUKAST


(PRESENTATION: Levocetirizine HCl 2.5 mg + Montelukast 4 mg
syrup per 5 ml in a Amber Bottle )

Montelukast: Leukotriene receptor antagonists. (is used for maintenance treatment of asthma and to relive symptoms of seasonal allergies) It is a selective and orally active leukotrien antagonist that inhibits the cysteinyl leukotrien CysLT1 receptor.
Levocetirizine: Third – generation non – sedative antihistamine. (is prevents the release of other allergy chemicals and increased blood supply to the area, and provides relief from the typical symptoms of hay fever). Levocetirizine, the R – entaiomer of Cetirizine, is a potent and selective antagonist of peripheral H1 – receptors.
It has been demonstrated by recent studies concomitant administration of an antileukotrien (montelukast) and an antihistamine (levocetirizine), shows significantly better symptoms relief compared with the modest improvement of rhinitis symptomatology with each of the treatments alone.

License

Montelukast: Add – on therapy for the treatment of patients, 6 years old or older, with mild to moderate asthma in adequately controlled on ‘as required’ short – acting ß – agonist and inhaled corticosteroids. Monteluakst may offer an alternative to Theophylline as add – on therapy is asthma poorly controlled by short acting ß – agonist and inhaled corticosteroids.
Levocetirizine: All form of skin allergy like food and drug allergy or atopic dermatitis, chronic idiopathic urticaria. Levocetirizine has an affinity 2 – fold higher than that of Cetirizine.

Proplylactic treatment of asthma. Chronic treatment of asthma associated with allergy. Seasonal and perennial rhinitis.

Parental dosage:

6 to 14 years----1 tsp. once a daily (at evening)
2 to 05 years ---- ½ tsp. once a daily (at evening)

No dose adjustment is necessary for 2 – 5 yr patients, if taken in conjunction with food; doses should be taken 1 hr before or 2 hr before.
or
Doctor may determine this dose for pediatric should be used depending on the symptoms and severity of child’s conditions.

Asthma and Allergic Rhinitis in Patients 12 Months of Age and Older:

Patients with both asthma and allergic rhinitis should take only ½ tsp daily in the evening.

BEFORE TAKING THIS MEDICINE TELL THE DOCTOR ABOUT ANY MEDICAL PROBLEMS AN ALLERGIES THAT CHILD HAS NOW OR HAS HAD.

Some medicines may affect how patient’s works, or other medicine work. If anyone is taking or has recently taken other medicines, including those obtained without a prescription. Such as:

  • Phenobarbital: Used for treatment of epilepsy
  • Pheytoin : Used for treatment of epilepsy
  • Rifampicin : Used for treatment of Tuberculosis and some other interactions.

THEOPHYLLINE, PREDISOLONE, ORAL CONTRACEPTIVES, TERFENADINE, DIGOXIN, WARAFIN, THYROID HORMONES & SEDATIVE HYPNOTICS.

  • Thirst was the only adverse experience commonly reported as drug related in 2 – 5 yr olds. Cough was reported as frequently (>1/10) occurring in trials regardless of causalty.
  • In older (6 – 14 yr), headache was the most commonly reported drug – related adverse – effect.
  • The most commonly reported adverse reactions were headache, asthma and upper respiratory tract infections; however none were significantly different in frequency between the groups.

Hypersensitivity, pregnant patients, patients with blood and lymphatic system disorder and psychiatric disorder.

This subsection is not applicable since they are intended for use in children 6 month to 5 years of age; however the following information is relevant to the active ingredients, Montelukast& Levocetirizine.

This medicine is not expected to affect your ability to drive a car or operate machinery Individual response to medication may vary, contain side effects (such as dizziness and drowsiness) that have been reported very rarely with the medicine may affect some patients ability to drive or operate machinery.

From the above discussion, it can be concluded that this medicine could improve the quality of life of children with allergic rhinitis as well as asthma in addition to being efficacious as immunotherapy in seasonal allergic rhinitis in children aged 2-5 years.

Moreover it has a considerable safety profile, with persistent results.

Oral doses of this medicine has shown efficacy as a preventive treatment for asthma during clinical trials in children aged 2 – 14 years. This combination offers as effective, well tolerated and convient treatment option for children with asthma and allergies.

  • " For Us Quality Means Doing It Right When No One Is Looking"

  • "Wherever the art of Medicine is love, there is also a love of Humanity "