- Indications and Usage Asthma: Indicated for the prophylaxis and chronic treatment of asthma, including prevention of daytime and nighttime symptoms, aspirin-sensitive asthma, and prevention of exercise-induced bronchoconstriction. Allergic Rhinitis: Indicated for the relief of nasal and non-nasal symptoms of seasonal and perennial allergic rhinitis.
- Dosage and Administration Pediatric Dosage: 4 mg once daily for 1 to 2 years (asthma only), 4 mg once daily for 2 to 14 years (asthma and/or allergic rhinitis), and 5 mg once daily for 6 to 14 years (asthma and/or allergic rhinitis). Adult and Adolescent Dosage: 10 mg once daily for patients 15 years and older. Administration Details: The oral film should be placed on the tongue and allowed to dissolve. It should not be chewed, spat out, or spoken during dissolution to ensure proper use and avoid risk of choking. Timing: Asthma patients should take the medication at bedtime. Patients with allergic rhinitis may take it as needed.
- Mechanism of Action Receptor Antagonism: Montelukast sodium is a selective leukotriene receptor antagonist. Pathway Inhibition: It binds with high affinity and selectivity to the cysteinyl leukotriene 1 (CysLT1) receptor, effectively inhibiting the physiological effects produced by LTC4, LTD4, and LTE4 binding to this receptor.
- Safety and Warnings Neuropsychiatric Events: Neuropsychiatric events have been reported, including agitation, aggressive behavior or hostility, anxiety, depression, sleep disturbances, suicidal thinking and behavior. Patients should be monitored, and the drug discontinued if such symptoms occur. Hypersensitivity: Eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy diagnosed as Churg-Strauss syndrome have been reported rarely. Not for Acute Attacks: The efficacy of the oral film in treating acute asthma exacerbations has not been established. It should not be used to replace rescue medications. Drug Substitution: It should not be used to abruptly replace or reduce the dose of inhaled or oral corticosteroids.
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: Headache, abdominal pain, thirst, fever, and cough. Clinical Research: Clinical trials have demonstrated that the oral film formulation provides effective control of asthma symptoms and allergic rhinitis manifestations with a safety profile comparable to other oral formulations.
- Drug Interactions CYP Enzymes: At recommended doses, montelukast does not have clinically significant effects on the pharmacokinetics of drugs metabolized by major cytochrome P450 enzymes (e.g., theophylline, prednisone, prednisolone, ethinyl estradiol/norethindrone, digoxin, warfarin). Phenobarbital: Concomitant use with phenobarbital may decrease montelukast exposure by approximately 40%.
- Pharmaceutical Information Chemical Composition: Active ingredient: Montelukast sodium. Appearance: Pink film-shaped oral film. Storage: Store at room temperature. Keep out of the reach of children.
Runpei Montelukast Sodium Oral Films
Brand Name: 润沛 ®（Runpei®）
Generic Name: Montelukast Sodium
Strength: 4 mg per film, 7 films per box
Manufacturer: Qilu Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Qilu Pharmaceutical Co., Ltd.
Approval Date in China: March 9, 2021
Registration Number: 国药准字H20210010
Storage: Store sealed, protected from light at temperature not exceeding 30°C, keep dry and away from moisture. Take immediately after opening the pouch. Refer to the full package insert for detailed storage specifications.
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