Before prescribing montelukast sodium, please read the accompanying Prescribing Information.

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1 Merck & Co., Inc. U.S. Human Health P.O. Box 1000 North Wales, PA Dear Health Care Professional: Thank you for your interest in the enclosed attachment, Stepwise Approach for Managing, excerpted from the full Expert Panel Report 3: Guidelines for the Diagnosis and Management of. Please note that montelukast sodium is indicated for prophylaxis and chronic treatment of asthma in patients aged 12 months and older. Safety and effectiveness of montelukast sodium in patients younger than 12 months have not been established. sodium should not be used as rescue medication to treat acute asthma episodes. Patients should be advised to have appropriate rescue medication available. Use of montelukast sodium may not eliminate the need for inhaled or systemic s. Patients should not decrease the dose or stop taking any other anti-asthma medications unless instructed by a physician. Phenylketonuric patients should be informed that the 4-mg and 5-mg chewable tablets contain phenylalanine, a component of aspartame. The enclosed tables may contain information about certain products and uses that are not approved by the US Food and Drug Administration. For more details, please consult the individual product s prescribing information. The enclosed information is intended to serve as a guideline for the treatment of asthma. It does not represent a comprehensive review of the subject nor does it replace the assessment and clinical judgment based on sound medical expertise of a physician with an individual patient. Before prescribing montelukast sodium, please read the accompanying Prescribing Information. Sincerely, Bram Greenberg, MD, FAAP Executive Director, Medical Services (1)-11/07-HMS Printed in USA Minimum 10% Recycled Paper

2 Stepwise Approach for Managing : National Heart, Lung, and Blood Institute National Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Excerpts From Full Report 2007

3 STEPWISE APPROACH FOR MANAGING ASTHMA IN CHILDREN 0 4 YEARS OF AGE Consult with asthma specialist if step 3 care or higher is required. Consider consultation at step 2. Cromolyn or Oral systemic s inhaler technique, and ) Patient Education and Environmental Control at Each Step at least 3 months) SABA as for symptoms. Intensity of treatment depends on severity of symptoms. With viral respiratory infection: SABA q 4 6 hours up to 24 hours (longer with physician consult). Consider short course of oral systemic s if exacerbation is severe or patient has history of previous severe exacerbations. Caution: Frequent use of SABA may indicate the need to step up treatment. See text for recommendations on initiating daily long-term- therapy. Key: Alphabetical order is used when more than one treatment option is listed within preferred or alternative therapy., inhaled ; LABA, inhaled long-acting beta 2 -agonist; SABA, inhaled short-acting beta 2 -agonist The stepwise approach is meant to assist, not replace, the clinical decisionmaking required to meet individual patient needs. If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. If clear benefit is not observed within 4 6 weeks and patient/family medication technique and adherence are satisfactory, consider adjusting therapy or alternative diagnosis. Studies on children 0 4 years of age are limited. preferred therapy is based on Evidence A. All other recommendations are based on expert opinion and extrapolation from studies in older children.

4 STEPWISE APPROACH FOR MANAGING ASTHMA IN CHILDREN 5 11 YEARS OF AGE Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Cromolyn, Nedocromil, or EITHER: LABA, or OR LABA LTRA or LABA LTRA or Each step: Patient education,, and management of comorbidities. Steps 2 4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma (see notes). LABA + oral systemic LTRA or + oral systemic SABA as for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals as. Short course of oral systemic s may be. Caution: Increasing use of SABA or use >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate and the need to step up treatment. inhaler technique,, and comorbid conditions) at least 3 months) Key: Alphabetical order is used when more than one treatment option is listed within preferred or alternative therapy., inhaled ; LABA, inhaled long-acting beta 2 -agonist, leukotriene receptor antagonist; SABA, inhaled short-acting beta 2 -agonist The stepwise approach is meant to assist, not replace, the clinical decisionmaking required to meet individual patient needs. If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. is a less desirable alternative due to the need to monitor serum concentration levels. and step 2 medications are based on Evidence A. adjunctive therapy and are based on Evidence B for efficacy of each treatment and extrapolation from comparator trials in older children and adults comparator trials are not available for this age group; steps 4 6 are based on expert opinion and extrapolation from studies in older children and adults. Immunotherapy for steps 2 4 is based on Evidence B for house-dust mites, animal danders, and pollens; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens. The role of allergy in asthma is greater in children than in adults. Clinicians who administer immunotherapy should be prepared and equipped to identify and treat anaphylaxis that may occur.

5 STEPWISE APPROACH FOR MANAGING ASTHMA IN YOUTHS 12 YEARS OF AGE AND ADULTS Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Cromolyn, Nedocromil, or LABA OR, or Zileuton LABA LTRA, or Zileuton LABA AND Consider Omalizumab for patients who have allergies Each step: Patient education,, and management of comorbidities. Steps 2 4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma (see notes). + LABA + oral AND Consider Omalizumab for patients who have allergies SABA as for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals as. Short course of oral systemic s may be. Use of SABA >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate and the need to step up treatment., and comorbid conditions) at least 3 months) Key: Alphabetical order is used when more than one treatment option is listed within preferred or alternative therapy. EIB, exercise-induced bronchospasm;, inhaled ; LABA, long-acting inhaled beta 2 -agonist; leukotriene receptor antagonist; SABA, inhaled short-acting beta 2 -agonist The stepwise approach is meant to assist, not replace, the clinical decisionmaking required to meet individual patient needs. If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. Zileuton is a less desirable alternative due to limited studies as adjunctive therapy and the need to monitor liver function. requires monitoring of serum concentration levels. In step 6, before oral systemic s are introduced, a trial of high-dose LABA + theophylline, or zileuton may be considered, although this approach has not been studied in clinical trials., 2, and 3 preferred therapies are based on Evidence A; step 3 alternative therapy is based on Evidence A for Evidence B for theophylline, and Evidence D for zileuton. preferred therapy is based on Evidence B, and alternative therapy is based on Evidence B for LTRA and theophylline and Evidence D for zileuton. preferred therapy is based on Evidence B. preferred therapy is based on (EPR ) and Evidence B for omalizumab. Immunotherapy for steps 2 4 is based on Evidence B for house-dust mites, animal danders, and pollens; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens. The role of allergy in asthma is greater in children than in adults. Clinicians who administer immunotherapy or omalizumab should be prepared and equipped to identify and treat anaphylaxis that may occur.

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