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SINGULAIR is a brand name for Montelukast. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE SINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). Relief of symptoms of allergic…
Verbatim from this product's FDA label. Tap a section to expand.
1 ). 2 ). 3 ). 3 ). Dosage (by age): 15 years and older: one 10-mg tablet ( 2 ). 6 to 14 years: one 5-mg chewable tablet ( 2 ). 2 to 5 years: one 4-mg chewable tablet or one packet of 4-mg oral granules ( 2 ). 6 to 23 months: one packet of 4-mg oral granules ( 2 ).
4 ). 5 ). 1 Asthma For asthma, administer SINGULAIR orally once daily in the evening, with or without food. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing.
The following doses are recommended:
Table 1: Recommended Dosage in Asthma Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age one 4 mg chewable tablet or one packet of oral granules Pediatric patients 12 to 23 months of age Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
one packet 4 mg oral granules Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. 2 Exercise-Induced Bronchoconstriction (EIB) For prevention of EIB, administer a single dose of SINGULAIR orally at least 2 hours, before exercise.
The following doses are recommended:
Table 2: Recommended Dosage in Exercise-Induced Bronchoconstriction (EIB) Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age Safety and effectiveness in patients younger than 6 years of age have not been established.
one 5 mg chewable tablet An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose. Patients already taking SINGULAIR daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB.
All patients should have available for rescue a short-acting β-agonist. Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB. 3 Allergic Rhinitis For allergic rhinitis, administer SINGULAIR orally once daily without regard to time of food ingestion.
Time of administration in patients with allergic rhinitis can be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: Table 3: Recommended Dosage in Seasonal Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
1 ). gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the following description of clinical trials experience, adverse reactions are listed regardless of causality assessment. The most common adverse reactions (incidence ≥5% and greater than placebo; listed in descending order of frequency) in controlled clinical trials were: upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis.
Adults and Adolescents 15 Years of Age and Older with Asthma SINGULAIR has been evaluated for safety in approximately 2950 adult and adolescent patients 15 years of age and older in clinical trials. 2 Laboratory Adverse Reactions Number of patients tested (SINGULAIR and placebo, respectively): ALT and AST, 1935, 1170; pyuria, 1924, 1159.
9 The frequency of less common adverse reactions was comparable between SINGULAIR and placebo. The safety profile of SINGULAIR, when administered as a single dose for prevention of EIB in adult and adolescent patients 15 years of age and older, was consistent with the safety profile previously described for SINGULAIR.
Cumulatively, 569 patients were treated with SINGULAIR for at least 6 months, 480 for one year, and 49 for two years in clinical trials. With prolonged treatment, the adverse reaction profile did not significantly change. Pediatric Patients 6 to 14 Years of Age with Asthma SINGULAIR has been evaluated for safety in 476 pediatric patients 6 to 14 years of age.
Cumulatively, 289 pediatric patients were treated with SINGULAIR for at least 6 months, and 241 for one year or longer in clinical trials. The safety profile of SINGULAIR in the 8-week, double-blind, pediatric efficacy trial was generally similar to the adult safety profile.
2 ). 2 ). Inhaled corticosteroid may be reduced gradually. 3 ). 4 ). Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, has been reported. 2 ). 6 ). 1 Neuropsychiatric Events Serious neuropsychiatric (NP) events have been reported with use of SINGULAIR.
These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), tic, and tremor.
NP events have been reported in adult, adolescent, and pediatric patients with and without a previous history of psychiatric disorder. NP events have been reported mostly during SINGULAIR treatment, but some were reported after SINGULAIR discontinuation.
3) ] ; however, the mechanisms underlying SINGULAIR-associated NP events are currently not well understood. Based upon the available data, it is difficult to identify risk factors for or quantify the risk of NP events with SINGULAIR use.
Because of the risk of NP events, the benefits of SINGULAIR may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. 3) ] . In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing SINGULAIR.
Discuss the benefits and risks of SINGULAIR use with patients and caregivers when prescribing SINGULAIR. Advise patients and/or caregivers to be alert for changes in behavior or for new NP symptoms when taking SINGULAIR. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue SINGULAIR and contact a healthcare provider immediately.
4 CONTRAINDICATIONS SINGULAIR is contraindicated in patients with hypersensitivity to any of its components. Hypersensitivity to any component of SINGULAIR ( 4 ).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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one 4 mg chewable tablet or one packet of 4 mg oral granules The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended: Table 4: Recommended Dosage in Perennial Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age one 4 mg chewable tablet or one packet of 4 mg oral granules Pediatric patients 6 to 23 months of age Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
one packet of 4 mg oral granules Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. 4 Asthma and Allergic Rhinitis For patients with both asthma and allergic rhinitis, administer only one SINGULAIR dose orally once daily in the evening.
Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. 5 Instructions for Administration of Oral Granules SINGULAIR 4-mg oral granules can be administered either directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature soft foods; based on stability studies, only applesauce, carrots, rice, or ice cream should be used.
The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food) must be administered within 15 minutes. If mixed with baby formula, breast milk, or food, SINGULAIR oral granules must not be stored for future use.
Discard any unused portion. SINGULAIR oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration. SINGULAIR oral granules can be administered without regard to the time of meals.
In pediatric patients 6 to 14 years of age receiving SINGULAIR, the following reactions occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: pharyngitis, influenza, fever, sinusitis, nausea, diarrhea, dyspepsia, otitis, viral infection, and laryngitis.
The frequency of less common adverse reactions was comparable between SINGULAIR and placebo. With prolonged treatment, the adverse reaction profile did not significantly change. The safety profile of SINGULAIR, when administered as a single dose for prevention of EIB in pediatric patients 6 years of age and older, was consistent with the safety profile previously described for SINGULAIR.
In studies evaluating growth rate, the safety profile in these pediatric patients was consistent with the safety profile previously described for SINGULAIR. In a 56-week, double-blind study evaluating growth rate in pediatric patients 6 to 8 years of age receiving SINGULAIR, the following reactions not previously observed with the use of SINGULAIR in this age group occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: headache, rhinitis (infective), varicella, gastroenteritis, atopic dermatitis, acute bronchitis, tooth infection, skin infection, and myopia.
Pediatric Patients 2 to 5 Years of Age with Asthma SINGULAIR has been evaluated for safety in 573 pediatric patients 2 to 5 years of age in single- and multiple-dose studies. Cumulatively, 426 pediatric patients 2 to 5 years of age were treated with SINGULAIR for at least 3 months, 230 for 6 months or longer, and 63 patients for one year or longer in clinical trials.
In pediatric patients 2 to 5 years of age receiving SINGULAIR, the following reactions occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: fever, cough, abdominal pain, diarrhea, headache, rhinorrhea, sinusitis, otitis, influenza, rash, ear pain, gastroenteritis, eczema, urticaria, varicella, pneumonia, dermatitis, and conjunctivitis.
Pediatric Patients 6 to 23 Months of Age with Asthma Safety and effectiveness in pediatric patients younger than 12 months of age with asthma have not been established. SINGULAIR has been evaluated for safety in 175 pediatric patients 6 to 23 months of age.
The safety profile of SINGULAIR in a 6-week, double-blind, placebo-controlled clinical study was generally similar to the safety profile in adults and pediatric patients 2 to 14 years of age. In pediatric patients 6 to 23 months of age receiving SINGULAIR, the following reactions occurred with a frequency ≥2% and more frequently than in pediatric patients who received placebo: upper respiratory infection, wheezing; otitis media; pharyngitis, tonsillitis, cough; and rhinitis.
The frequency of less common adverse reactions was comparable between SINGULAIR and placebo. Adults and Adolescents 15 Years of Age and Older with Seasonal Allergic Rhinitis SINGULAIR has been evaluated for safety in 2199 adult and adolescent patients 15 years of age and older in clinical trials.
SINGULAIR administered once daily in the morning or in the evening had a safety profile similar to that of placebo. 9% of patients receiving SINGULAIR vs. 5% of patients receiving placebo. In a 4-week, placebo-controlled clinical study, the safety profile was consistent with that observed in 2-week studies.
The incidence of somnolence was similar to that of placebo in all studies. Pediatric Patients 2 to 14 Years of Age with Seasonal Allergic Rhinitis SINGULAIR has been evaluated in 280 pediatric patients 2 to 14 years of age in a 2-week, multicenter, double-blind, placebo-controlled, parallel-group safety study.
SINGULAIR administered once daily in the evening had a safety profile similar to that of placebo. In this study, the following reactions occurred with a frequency ≥2% and at an incidence greater than placebo: headache, otitis media, pharyngitis, and upper respiratory infection.
Adults and Adolescents 15 Years of Age and Older with Perennial Allergic Rhinitis SINGULAIR has been evaluated for safety in 3357 adult and adolescent patients 15 years of age and older with perennial allergic rhinitis of whom 1632 received SINGULAIR in two, 6-week, clinical studies.
SINGULAIR administered once daily had a safety profile consistent with that observed in patients with seasonal allergic rhinitis and similar to that of placebo. In these two studies, the following reactions were reported with SINGULAIR with a frequency ≥1% and at an incidence greater than placebo: sinusitis, upper respiratory infection, sinus headache, cough, epistaxis, and increased ALT.
The incidence of somnolence was similar to that of placebo. Pediatric Patients 6 Months to 14 Years of Age with Perennial Allergic Rhinitis The safety in patients 2 to 14 years of age with perennial allergic rhinitis is supported by the safety in patients 2 to 14 years of age with seasonal allergic rhinitis.
The safety in patients 6 to 23 months of age is supported by data from pharmacokinetic and safety and efficacy studies in asthma in this pediatric population and from adult pharmacokinetic studies. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of SINGULAIR.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 1) ] Nervous system disorders drowsiness, paraesthesia/hypoesthesia, seizures Cardiac disorders palpitations Respiratory, thoracic and mediastinal disorders epistaxis, pulmonary eosinophilia Gastrointestinal disorders diarrhea, dyspepsia, nausea, pancreatitis, vomiting Hepatobiliary disorders Cases of cholestatic hepatitis, hepatocellular liver-injury, and mixed-pattern liver injury have been reported in patients treated with SINGULAIR.
Most of these occurred in combination with other confounding factors, such as use of other medications, or when SINGULAIR was administered to patients who had underlying potential for liver disease such as alcohol use or other forms of hepatitis.
Skin and subcutaneous tissue disorders angioedema, bruising, erythema multiforme, erythema nodosum, pruritus, Stevens-Johnson syndrome/toxic epidermal necrolysis, urticaria Musculoskeletal and connective tissue disorders arthralgia, myalgia including muscle cramps Renal and urinary disorders enuresis in children General disorders and administration site conditions edema Patients with asthma on therapy with SINGULAIR may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
These reactions have been sometimes associated with the reduction of oral corticosteroid therapy. 5) ].
In many cases, symptoms resolved after stopping SINGULAIR therapy; however, in some cases symptoms persisted after discontinuation of SINGULAIR. Therefore, continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with SINGULAIR if such events occur.
2 Acute Asthma SINGULAIR is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Therapy with SINGULAIR can be continued during acute exacerbations of asthma.
Patients who have exacerbations of asthma after exercise should have available for rescue a short-acting inhaled β-agonist. 3 Concomitant Corticosteroid Use While the dose of inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR should not be abruptly substituted for inhaled or oral corticosteroids.
4 Aspirin Sensitivity Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR. 1) ] . 5 Eosinophilic Conditions Patients with asthma on therapy with SINGULAIR may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
These events have been sometimes associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
2) ]. 6 Risk in Patients with Phenylketonuria SINGULAIR contains aspartame, a source of phenylalanine. Phenylalanine can be harmful to patients with phenylketonuria (PKU). 842 mg of phenylalanine, respectively. Before prescribing SINGULAIR to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including SINGULAIR.