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PMS-MONTELUKAST 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.
Serious Warnings and Precautions WARNING:
SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of montelukast. 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 use are currently not well understood (see WARNINGS AND PRECAUTIONS). Because of the risk of NP events, the benefits of pms-MONTELUKAST FC or pms-MONTELUKAST 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 pms-MONTELUKAST FC or pms-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 pms-MONTELUKAST FC or pms-MONTELUKAST.
Discuss the benefits and risks of montelukast with patients and caregivers when prescribing pms-MONTELUKAST FC or pms-MONTELUKAST. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking pms-MONTELUKAST FC or pms-MONTELUKAST.
If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue pms-MONTELUKAST FC or pms-MONTELUKAST and contact a healthcare provider immediately (see WARNINGS AND PRECAUTIONS).
Information to be Provided to the Patient Patients should be advised to take pms-MONTELUKAST FC or pms-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 montelukast is not for the treatment of acute asthma attacks. They should have appropriate rescue medication available. Chewable Tablets Phenylketonurics Phenylalanine is a component of aspartame. 50 mg of aspartame, respectively.
General The efficacy of oral montelukast for the treatment of acute asthma attacks has not been established. Therefore, montelukast should not be used to treat acute asthma attacks. Patients should be advised to have appropriate rescue medication available.
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.
pms-MONTELUKAST FC & pms-MONTELUKAST Product Monograph Page 6 of 34 While the dose of concomitant inhaled corticosteroid may be reduced gradually under medical supervision, montelukast should not be abruptly substituted for inhaled or oral corticosteroids.
When 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 montelukast.
Although montelukast 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. Post-market reports with montelukast 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 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 treatment, but some were reported after montelukast discontinuation. Based upon the available data, it is difficult to identify risk factors for or quantify the risk of neuropsychiatric events with montelukast use.
Physicians should discuss the benefits and risks of montelukast use with patients and caregivers when prescribing pms-MONTELUKAST FC or pms-MONTELUKAST. Patients and/or caregivers should be advised to be alert for changes in behavior or for new neuropsychiatric symptoms when taking pms-MONTELUKAST FC or pms-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 pms-MONTELUKAST FC or pms-MONTELUKAST and contact a healthcare provider immediately.
In many cases, symptoms resolved after stopping montelukast therapy; however, in some cases symptoms persisted after discontinuation of montelukast. Therefore, patients should be monitored and provided supportive care until symptoms resolve.
Physicians should carefully evaluate the risks and benefits of continuing treatment with pms-MONTELUKAST FC or pms-MONTELUKAST if such events occur. Eosinophilic Conditions In rare cases, patients with asthma on therapy with montelukast 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 […]