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SINGULAIR is a brand name for Montelukast, supplied as a tablet (chewable). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Information to be Provided to the Patient Patients should be advised to take SINGULAIR® daily as prescribed, even when they are asymptomatic as well as during periods of asthma worsening, and to contact their physicians if their asthma is not well-controlled.
Patients should be advised that SINGULAIR® is not for the treatment of acute asthma attacks. They should have appropriate rescue medication available. 842 mg per 4 mg and 5 mg chewable tablet. General The efficacy of oral SINGULAIR® for the treatment of acute asthma attacks has not been established.
Therefore, SINGULAIR® should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available. While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, SINGULAIR® should not be abruptly substituted for inhaled or oral corticosteroids.
Serious Warnings and Precautions WARNING:
SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR®. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide).
The mechanisms underlying NP events associated with SINGULAIR® use are currently not well understood (see WARNINGS AND PRECAUTIONS). 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 (see INDICATIONS AND CLINICAL USE).
Reserve use of SINGULAIR® for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing SINGULAIR®.
Discuss the benefits and risks of SINGULAIR® with patients and caregivers when prescribing SINGULAIR®. Advise patients and/or caregivers to be alert for changes in behavior or 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 (see WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Montelukast in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
SINGULAIR® (montelukast sodium) Page 6 of 33 When SINGULAIR® is prescribed for the prevention of exercise-induced bronchoconstriction, patients should be advised to always have readily available appropriate rescue medication. Patients with known acetylsalicylic acid (ASA) sensitivity should continue avoidance of ASA or non-steroidal anti-inflammatory agents while taking SINGULAIR®.
Although SINGULAIR® is effective in improving airway function in asthmatic patients with documented ASA sensitivity, it has not been shown to truncate bronchoconstrictor response to ASA and other non-steroidal anti-inflammatory drugs in ASA-sensitive asthmatic patients.
Neuropsychiatric post-marketing events Serious neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking SINGULAIR®. Post-market reports with SINGULAIR® use include 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 thinking and behavior (including suicide), tic and tremor.
The clinical details of some post-marketing reports involving SINGULAIR® appear consistent with a drug-induced effect. These neuropsychiatric events have been reported in patients with and without a previous history of psychiatric disorder.
Neuropsychiatric events have been reported mostly during SINGULAIR® treatment, but some were reported after SINGULAIR® discontinuation. Based upon the available data, it is difficult to identify risk factors for or quantify the risk of neuropsychiatric events with SINGULAIR® use.
Physicians should discuss the benefits and risks of SINGULAIR® use with patients and caregivers when prescribing SINGULAIR®. Patients and/or caregivers should be advised to be alert for changes in behavior or for new neuropsychiatric symptoms when taking SINGULAIR®.
If changes in behavior are observed, or if new neuropsychiatric symptoms or suicidal thoughts and/or behavior occur, patients should be advised to discontinue SINGULAIR® and contact a healthcare provider immediately. In many cases, symptoms resolved after stopping SINGULAIR therapy; however, in some cases symptoms persisted after discontinuation of SINGULAIR®.
Therefore, patients should be monitored and provided supportive care until symptoms resolve. Physicians should carefully evaluate the risks and benefits of continuing treatment with SINGULAIR® if such events occur. SINGULAIR® (montelukast sodium) Page 7 of 33 Eosinophilic Conditions In rare cases, patients with asthma on therapy with SINGULAIR® may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.
These events have been reported as occurring both with and without steroid withdrawal or reduction. Physicians should be alert to eosinophilia, vasculitic rash, arthralgia, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients (see ADVERSE REACTIONS).
A causal association between SINGULAIR® and these underlying conditions has not been established.
Hepatic/Biliary Hepatic Insufficiency:
Patients with mild-to-moderate hepatic insufficiency and […]