API

Doxofylline (400mg) + Montelukast (10mg)

Drug classification

Bronchodilator (xanthine derivative) and leukotriene receptor antagonist combination for respiratory disorders.

Dosage form

Doxiflo-M Tablet SR is an oral sustained-release tablet.

API strength per dosage

Dose

Doxiflo-M Tablet SR typically contains doxofylline 400 mg and montelukast 10 mg, taken once daily for adults. Safety and dosing in children, and in patients with renal or hepatic impairment, have not been well established; use with caution and consult product-specific guidance. Dose adjustments may be necessary in hepatic impairment. Always follow prescribing information.

Mechanism of action

Doxofylline inhibits phosphodiesterase-3 (PDE3), increasing intracellular cAMP, leading to bronchial smooth muscle relaxation. Montelukast selectively blocks cysteinyl leukotriene receptor 1 (CysLT1), preventing leukotriene-mediated bronchoconstriction and inflammation. Together, they reduce airway resistance and inflammation, improving airflow in obstructive airway diseases.

Indications

Treatment and prevention of Asthma

Side effects

Nausea Vomiting Headache Abdominal pain Diarrhea Upper respiratory tract infection Rash Fever Epigastric pain Tachycardia Extrasystoles Increased respiratory rate Pharyngitis Cough Increased liver enzymes Otitis media infection of ear Influenza Runny nose Sinus inflammation

Pregnancy category

Safety in pregnancy is not well established; use only if potential benefits justify potential risks to the fetus. Consult a healthcare professional before use.

Precautions

Monitor for hypersensitivity reactions, liver function, neuropsychiatric symptoms, gastrointestinal disturbances, theophylline-like side effects, drug interactions, renal impairment, avoid in acute asthma exacerbations, caution in elderly, assess for efficacy and adverse effects regularly, counsel on adherence and symptom reporting.

Contraindications

Hypersensitivity to doxofylline, montelukast, or excipients, acute myocardial infarction, hypotension, lactating women, severe arrhythmias, status asthmaticus, severe hepatic impairment, phenylketonuria (if aspartame present), children under 6 years (montelukast).