Montecare

Serious Warnings

• Black Box Warning: The US FDA has issued a Boxed Warning for Montelukast due to the risk of serious neuropsychiatric events. These include, but are not limited to, agitation, aggression, depression, sleep disturbances, hallucinations, tremors, suicidal thoughts and behavior. Patients and caregivers should be advised to be alert for the emergence or worsening of any neuropsychiatric symptoms and to seek medical advice immediately if these changes occur.
• Patients and caregivers should be advised to be alert for the emergence or worsening of any neuropsychiatric symptoms and to seek medical advice immediately if these changes occur.
• Montelukast is not indicated for the reversal of bronchospasm in acute asthma attacks and should not be used as a rescue medication.
• Patients should be advised to have appropriate rescue medication available.
• Do not abruptly substitute montelukast for oral or inhaled corticosteroid therapy.
• Dosage reduction of systemic corticosteroids should be gradual and under medical supervision.
• Systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss Syndrome, has been reported.
• These events are sometimes associated with the reduction of oral corticosteroid therapy.
• Discontinue montelukast if symptoms of Churg-Strauss Syndrome appear.
• Use with caution in patients with liver disease.
• Regular liver function tests may be required during treatment.
• Inform your doctor about any history of liver disease.
• Severe allergic reactions, including anaphylaxis, angioedema, and hives, can occur.
• Seek immediate medical attention if you experience symptoms such as difficulty breathing or swelling of the face, lips, tongue, or throat.
• While montelukast is not known to cause lung infections, people with asthma are at an increased risk of developing respiratory infections, including pneumonia, bronchitis, or tuberculosis.
• Seek medical attention if symptoms such as fever, cough, or difficulty breathing develop.
• Montelukast is not a substitute for non-steroidal anti-inflammatory drugs (NSAIDs) for individuals with aspirin-sensitive asthma.
• Chewable tablets may contain aspartame, a source of phenylalanine.
• Patients with phenylketonuria should inform their doctor prior to use.
• The effects of montelukast during pregnancy and breastfeeding are undetermined, and caution is advised.
• It should be used only if the potential benefits outweigh the potential risks.
• Montelukast may pass into breast milk, so breastfed infants should be monitored for potential side effects.
• Consult a healthcare provider before use if pregnant or breastfeeding.
• Montelukast may interact with other medications, including certain antibiotics, antifungal medications, and HIV medications, as well as over-the-counter medications and herbal supplements.
• Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
• Montelukast may cause dizziness or drowsiness; therefore, avoid driving or operating machinery immediately after taking this medicine until you know how it affects you.
• Alcohol consumption should be avoided.
• There is no evidence to suggest a significant impact on fertility in men or women.
• However, consult your healthcare provider if you are planning to conceive or have concerns about fertility.
• Store at room temperature, away from excess heat, moisture, and direct sunlight.
• Keep out of reach of children and pets.
• Do not use after the expiration date.
• It is important to follow the dosage instructions provided by your healthcare provider.
• Do not take more or less than recommended.
• Do not stop taking the medication without consulting your healthcare provider, even if you feel better.
• Consult your healthcare provider before starting or stopping any medications.