Indications
Aeron FT is prescribed for:

• Preventing and managing chronic asthma.
• Acute prevention of exercise-induced bronchospasm (EIB).
• Easing the symptoms of allergic rhinitis (AR), including both seasonal and perennial types.
  Use as directed by a registered healthcare professional.

Pharmacology
Montelukast is an oral leukotriene receptor antagonist that selectively targets the cysteinyl leukotriene receptor (CysLT1). Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are byproducts of arachidonic acid metabolism and are released by various cells, such as mast cells and eosinophils. These leukotrienes, along with their receptor binding, play a key role in the development of asthma and allergic rhinitis by causing inflammation, airway swelling, smooth muscle contraction, and other cellular activities associated with the inflammatory response that lead to asthma symptoms.

Dosage & Administration

• For Adults and Adolescents (15 years and older) with asthma or seasonal allergic rhinitis:
  Take 10 mg (one tablet) once a day.
• For Pediatric Patients (6 to 14 years old) with asthma or seasonal allergic rhinitis:
  The prescribed dose is 5 mg (one tablet) once daily.
• For Pediatric Patients (2 to 5 years old) with asthma or seasonal allergic rhinitis:
  Take 4 mg (one tablet) once daily.
• For Children (6 months to 5 years old):
  Administer 4 mg oral granules once daily, either directly in the mouth or mixed with a small amount of cold water or soft food at room temperature.

Hepatic Insufficiency:
No dose adjustment is required for patients with mild-to-moderate liver impairment.

Renal Insufficiency:
No dosage adjustment is needed for those with renal insufficiency.

Elderly Use:
The pharmacokinetic profile and bioavailability of a 10 mg oral dose are similar in both younger and elderly adults, although the half-life may be slightly longer in older individuals. No dosage adjustment is needed in elderly patients.

Consult your healthcare provider for proper usage.

Interactions
Aeron FT has been used alongside other medications commonly prescribed for asthma without significant increases in adverse reactions. In drug interaction studies, the recommended dose of Aeron FT had no clinically meaningful effects on the pharmacokinetics of drugs like theophylline, prednisone, prednisolone, oral contraceptives (norethindrone 1mg/ethinyl estradiol 35mcg), terfenadine, digoxin, and warfarin. While no further interaction studies were conducted, clinical use alongside various other drugs (such as thyroid hormones, sedatives, NSAIDs, benzodiazepines, and decongestants) has shown no clinical adverse reactions. Phenobarbital, which induces liver enzymes, reduced the area under the curve (AUC) of Aeron FT by approximately 40%. Clinical monitoring is advisable when used with potent cytochrome P450 enzyme inducers like phenobarbital or rifampin.

Contraindications
Aeron FT should not be used by individuals who are hypersensitive to any ingredient in this product.

Side Effects
Common:

• Diarrhea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory infections.

Uncommon:

• Akathisia, anxiety, joint pain, fatigue, abnormal behavior, depression, dizziness, drowsiness, dry mouth, bleeding, irritability, malaise, muscle issues, swelling, seizures, abnormal sensations, sleep disturbances.

Rare:

• Angioedema, impaired concentration, confusion, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucinations, liver issues, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremors.

Pregnancy & Lactation
Montelukast crosses the placenta in animal studies, but its safety during pregnancy in humans has not been fully established. It should only be used during pregnancy if absolutely necessary. As Montelukast is excreted in breast milk, caution should be exercised when administering this medication to nursing mothers.

Precautions & Warnings
Aeron FT is not meant to treat acute asthma attacks or bronchospasms, such as status asthmaticus. Patients should have access to appropriate rescue medication. Aeron FT can continue to be used during asthma flare-ups, but corticosteroid doses should be reduced gradually under medical supervision. Aeron FT should never be used as a replacement for inhaled or oral corticosteroids without the doctor’s guidance. It is also not recommended as the sole treatment for exercise-induced bronchospasm. Patients with known aspirin sensitivity should avoid aspirin and non-steroidal anti-inflammatory drugs while taking Aeron FT. Though Aeron FT can help manage airway function in aspirin-sensitive asthmatics, it does not prevent the bronchoconstrictor effects of aspirin or NSAIDs in these patients.

Overdose Effects
Most overdose reports do not indicate serious adverse effects. Common symptoms include abdominal pain, drowsiness, headache, nausea, vomiting, and increased activity. In case of overdose, typical supportive care should be provided, including the removal of unabsorbed material from the gastrointestinal tract and clinical monitoring.

Therapeutic Class
Leukotriene receptor antagonists

Storage Conditions
Store in a cool, dry place below 30°C, away from light and moisture. Keep out of reach of children.