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  • Singulair
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    Active Ingredient
    Montelukast Sodium 4, 5, 10 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Chewable Tablets

    28 x 4 mg

    partial basket chart 3149 19444

    Sachets

    28 x 4 mg

    partial basket chart 11252 19723

    Chewable Tablets

    28 x 5 mg

    partial basket chart 85214 19247

    Tablets

    28 x 10 mg

    partial basket chart 85215 19248

    Related information


    Dosage

    Patients should be advised to continue taking this drug while their asthma is controlled, as well as during periods of worsening asthma.
    Note: No dosage adjustment is necessary for pediatric patients, for the elderly, for patients with renal insufficiency or mild-to-moderate hepatic impairment or for patients of either gender.
    Should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualized to suit patient needs. Patients with both asthma and seasonal allergic rhinitis should take only one tablet daily in the evening.
    Adults 15 Years of Age and Older:with Asthma and/or Seasonal Allergic Rhinitis10-mg tablet daily.
    Pediatric Patients 6 to 14 Years of Age with Asthma and/or Seasonal Allergic Rhinitis: one 5-mg chewable tablet daily.
    Pediatric Patients 2 to 5 Years of Age with Asthma and/or Seasonal Allergic Rhinitis: one 4-mg chewable tablet daily or one sachet of 4-mg oral granules daily.
    Pediatric Patients 12 Months to 2 Years of Age with Asthma: one sachet of 4-mg oral granules daily.
    For full details see proscribing information.


    Indications

    For adult and pediatric patients 12 months of age and older, for the prophylaxis and treatment of chronic treatment of asthma, including prevention of daytime and nighttime symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention exercise-induced bronchoconstriction.


    Contra-Indications

    Hypersensitivity to any component of this product.


    Special Precautions

    Should not be used to treat acute asthma attacks. If added to a patient’s existing treatment regimen of inhaled corticosteroid, the dosage of the corticosteroid should be reduced gradually and under medicdbal supervision. When added to a bronchodilator therapy, the dosage of the bronchodilator can be reduced as tolerated.
    Pregnancy and lactation: Should be used during pregnancy only if clearly needed. Caution should be excercised when given to a nursing mother.
    Pediatrics: Safety and effectiveness in pediatric patients younger than 2 years of age have not been established.
    For full details see proscribing information.


    Side Effects

    SINGULAIR has been generally well tolerated. Side effects, which usually were mild, generally did not require discontinuation of therapy.
    See prescribing information for full details.


    Drug interactions

    May be administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma, and in the treatment of allergic rhinitis. Has been used concomitantly with a wide range of commonly prescribed drugs in clinical studies without evidence of clinical adverse interactions.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: This product has not been studied in pregnant women. this product should be used during pregnancy only if clearly needed. During worldwide marketing experience, congenital limb defects have been rarely reported in the offspring of women being treated during pregnancy. Most of these women were also taking other asthma medications during their pregnancy. A causal relationship between these events and this product has not been established.
    Lactation: It is not known if montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is given to a nursing mother.
    Use in Pediatrics: This product has been studied in pediatric patients 6 months to 14 years of age  Safety and effectiveness in pediatric patients younger than 6 months of age have not been studied. Studies have shown that this product does not affect the growth rate of pediatric patients.


    Overdose

    No specific information is available on the treatment of overdose with this product.In chronic asthma studies, this product has been administered at doses up to 200 mg/day to adult patients for 22 weeks and in short-term studies up to 900 mg/day to patients for approximately one week, without clinically important adverse experiences. There have been reports of acute overdose in postmarketing experience and clinical studies with this product. These include reports in adults and children with a dose as high as 1000 mg. The clinical and laboratory findings observed were consistent with the safety profile in adults and pediatric patients. There were no adverse experiences in the majority of overdose reports. The most frequently occurring adverse experiences were consistent with the safety profile of this product and included abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. It is not known whether montelukast is dialyzable by peritoneal-or hemodialysis.


    Manufacturer
    Merck Sharp & Dohme B.V., Haarlem, Holland
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