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SANDOZ MONTELUKAST is a brand name for Montelukast, supplied as a tablet. 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.
Serious Warnings and Precautions WARNING:
SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. 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 montelukast sodium use are currently not well understood (see WARNINGS AND PRECAUTIONS). Because of the risk of NP events, the benefits of montelukast sodium 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 Sandoz Montelukast 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 Sandoz Montelukast.
Discuss the benefits and risks of montelukast sodium with patients and caregivers when prescribing Sandoz Montelukast. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking Sandoz Montelukast.
If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue Sandoz Montelukast and contact a healthcare provider immediately (see WARNINGS AND PRECAUTIONS). Information to be Provided to the Patient Patients should be advised to take Sandoz Montelukast 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 Sandoz Montelukast is not for the treatment of acute asthma attacks. They should have appropriate rescue medication available. 60 mg per 4 mg and 5 mg chewable tablet. General The efficacy of oral montelukast sodium for the treatment of acute asthma attacks has not been established.
Therefore, Sandoz Montelukast 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, Sandoz Montelukast should not be abruptly substituted for inhaled or oral Sandoz Montelukast Page 6 of 35 corticosteroids.
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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When Sandoz Montelukast 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 Sandoz Montelukast.
Although montelukast sodium 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 montelukast sodium. Post-market reports with montelukast sodium 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 montelukast sodium 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 montelukast sodium treatment, but some were reported after montelukast sodium discontinuation. Based upon the available data, it is difficult to identify risk factors for or quantify the risk of neuropsychiatric events with montelukast sodium use.
Physicians should discuss the benefits and risks of montelukast sodium use with patients and caregivers when prescribing Sandoz Montelukast. Patients and/or caregivers should be advised to be alert for changes in behavior or for new neuropsychiatric symptoms when taking Sandoz Montelukast.
If changes in behavior are observed, or if new neuropsychiatric symptoms or suicidal thoughts and/or behavior occur, patients should be advised to discontinue Sandoz Montelukast and contact a healthcare provider immediately. In many cases, symptoms resolved after stopping montelukast sodium therapy; however, in some cases symptoms persisted after discontinuation of montelukast sodium.
Therefore, patients should be monitored and provided supportive care until symptoms resolve. Physicians should carefully evaluate the risks and benefits of continuing treatment with Sandoz Montelukast if such events occur. Eosinophilic Conditions In rare cases, patients with asthma on therapy with montelukast sodium 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 […]