Aspira Special Precautions

The efficacy of oral montelukast for the treatment of acute asthma attacks has not been established. Therefore, oral 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, montelukast should not be abruptly substituted for inhaled or oral corticosteroids. Neuropsychiatric events [eg, agitation, aggression, anxiousness, dream abnormalities, hallucinations, depression, disorientation, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), tremor] have occurred. Since other factors may have contributed to these events, it is not known if they are related to montelukast. Physicians should discuss these adverse experiences with their patients and/or caregivers. Patients and/or caregivers should be instructed to notify their physicians if these changes occur.
The reduction in systemic corticosteroids dose in patients receiving antiasthma agents including leukotriene receptor antagonists has been followed in rare cases by the occurrence of ≥1 of the following: Eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy sometimes diagnosed as Churg-Strauss syndrome, a systemic eosinophilic vasculitis.
Although a casual relationship with leukotriene receptor antagonism has not been established, caution and appropriate clinical monitoring are recommended when systemic corticosteroid reduction is considered in patients receiving montelukast.
Patients with known aspirin sensitivity should continue avoidance of aspirin or nonsteroidal anti-inflammatory agents while taking montelukast.
Although montelukast is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other documented aspirin sensitivity.
Effects on the Ability to Drive or Operate Machinery: Montelukast is not expected to affect a patient's ability to drive a car or operate machinery. However, in very rare cases, individuals have reported drowsiness or dizziness.
Use in pregnancy: The safety and efficacy of montelukast have not been determined in pregnant women. Rarely, congenital limb defects have been reported during post-marketing surveillance; however, causality has not been established. Due to the lack of human safety information, montelukast should be used in pregnant women only if the potential benefit outweighs the potential risk to the fetus.
Use in lactation: Lactation studies with montelukast in humans have not been conducted. Montelukast is excreted into the milk of lactating rats. Until further data are available, caution is advised if montelukast is used in nursing women. Available evidence and/or expert consensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding. Weigh the potential benefits of drug treatment against potential risks before prescribing Aspira during breastfeeding.