Product Description

Acebrophylline 200 mg Sustained Release & Montelukast 10 mg Tablets IP is a combination of a mucoactive bronchodilator and a leukotriene receptor antagonist, used for the maintenance treatment of chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis (sneezing, runny nose, itching due to allergies). 

Acebrophylline (theophylline-7-acetate + ambroxol) provides prolonged bronchodilation and mucus clearance via sustained release, while montelukast reduces airway inflammation. 

It is not for acute attacks (use rescue inhalers like salbutamol). Suitable for adults; requires prescription due to potential cardiac/neuropsychiatric risks.

Avoid if you have hypersensitivity to xanthines, leukotriene antagonists, or acute severe asthma. Baseline LFTs and ECGs are recommended for at-risk patients.

Uses

Acebrophylline 200 mg SR & Montelukast 10 mg Tablets IP are indicated for:

• Maintenance therapy in mild-moderate persistent asthma (to reduce exacerbations and symptoms like wheezing, cough)

• Management of stable COPD or chronic bronchitis (improves airflow and mucus clearance)

• Prevention and treatment of allergic rhinitis symptoms (seasonal/perennial: sneezing, rhinorrhea, nasal congestion)

• Adjunctive use in exercise-induced bronchoconstriction or aspirin-sensitive asthma

Not for acute bronchospasm, status asthmaticus, or monotherapy in severe disease (combine with ICS/LABA per GINA/GOLD). Long-term use with periodic review (e.g., every 3–6 months).

How it works:

Acebrophylline 200 mg Sustained Release & Montelukast 10 mg Tablets combine complementary actions for airway protection:

• Acebrophylline (200 mg SR): A prodrug hydrolyzing to theophylline (bronchodilator) and ambroxol (mucolytic). Theophylline inhibits phosphodiesterase (PDE) IV, increasing cAMP to relax bronchial smooth muscles and widen airways; it also antagonizes adenosine receptors. Ambroxol enhances mucociliary clearance by stimulating surfactant, reducing mucus viscosity, and providing mild anti-inflammatory effects. Sustained release ensures steady levels over 12–24 hours, minimizing peaks/troughs.

• Montelukast (10 mg): A selective cysteinyl leukotriene receptor 1 (CysLT1) antagonist that blocks leukotrienes (inflammatory mediators from mast cells/eosinophils), reducing bronchoconstriction, mucus production, edema, and eosinophil recruitment in airways and nasal mucosa.

Together, they provide synergistic relief: acebrophylline improves airflow and clearance, while montelukast targets allergic/inflammatory pathways, reducing symptoms in asthma/COPD/allergies without steroid side effects.

Benefits

Acebrophylline 200 mg SR & Montelukast 10 mg Tablets offer sustained symptom control in chronic asthma, COPD, and allergic rhinitis by relaxing airways, thinning mucus, and blocking inflammation, leading to fewer exacerbations (20–30% reduction per trials), better lung function (e.g., FEV1 improvement), and enhanced quality of life (less wheezing, cough, shortness of breath). 

The once-daily SR formulation improves adherence compared to multiple dosing, and the combination is effective as an add-on to inhaled therapies, with lower cardiac risk than plain theophylline.

How to use

The tablets are designed to be swallowed whole with water. They should not be crushed, chewed, or broken. This is because altering the tablet can affect how the sustained-release acebrophylline component works.

Side Effects

Most side effects are mild and transient, often from individual components. Common side effects (affecting 1–10% of patients) include:

• Nausea, vomiting, upset stomach, diarrhea, or heartburn (GI from acebrophylline)

• Headache

• Sore throat, cough, or nasal congestion (upper respiratory from montelukast)

• Drowsiness, dizziness, or fatigue

Less common but notable side effects:

• Abdominal pain or dyspepsia

• Mild skin rash, itching, or hives

• Flu-like symptoms (e.g., fever, malaise)

Safety Advice

• Alcohol: Avoid or limit, as alcohol may enhance CNS effects (drowsiness, dizziness) or GI irritation from acebrophylline; it can also unpredictably alter theophylline metabolism.

• Pregnancy: Montelukast Category B (no teratogenicity in animal/human studies; safe per registries); acebrophylline Category C (limited data—theophylline crosses placenta, potential fetal tachycardia). Use only if benefits outweigh risks (e.g., uncontrolled asthma); preferred alternatives like inhaled therapies. Consult your doctor; monitor fetal growth.

• Breastfeeding: Montelukast compatible (low milk levels <1%); acebrophylline caution (theophylline/ambroxol pass into milk—infant irritability possible). Avoid or use with monitoring; pump/discard if needed.

• Driving/Operating Machinery: May cause drowsiness or dizziness (especially initially); avoid until effects are known. Do not drive if impaired.

Storage Conditions

• Store at a temperature below 30°C (86°F), in a cool, dry place away from direct sunlight, heat, and excessive moisture.

FAQs

Is this medication for acute asthma attacks?

No, this medication manages and prevents chronic respiratory conditions long-term. It is not a rescue inhaler and should not treat a sudden, acute asthma attack. A separate fast-acting inhaler will be prescribed for acute symptoms.

Can this tablet be stopped if I'm feeling better?

No, do not stop taking this medication abruptly, even if symptoms improve, unless a doctor advises otherwise. Stopping prematurely can cause symptoms to return or worsen.

Can this tablet be given to children?

This medication is generally not recommended for young children. Use in children should only be under a doctor's supervision, and the dosage may need adjustment based on the child's age and condition.

Does it cause drowsiness?

Yes, this tablet can cause drowsiness or dizziness. Do not drive or operate heavy machinery if experiencing these side effects until you know how the medication affects you.

Are there any mood-related side effects?

Yes, Montelukast, a component of this tablet, has been linked to mood and behavioral changes, such as agitation, anxiety, depression, and irritability. The FDA has issued a warning regarding these potential neuropsychiatric side effects. Contact a doctor immediately if experiencing any unusual mood or behavior changes.