Product Description

Acebrophylline 100 mg Capsules IP is a mucoactive agent with bronchodilator properties, used for the maintenance treatment and prevention of symptoms in chronic respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and bronchitis.

It may also provide supportive relief in pulmonary complications of cystic fibrosis by improving mucus clearance.

Acebrophylline combines the bronchodilating effects of a xanthine derivative (theophylline-7-acetate) with the mucolytic action of ambroxol, relaxing airway smooth muscles, thinning mucus, and reducing inflammation to ease breathing. It is not for acute bronchospasm (use short-acting beta-agonists) or monotherapy in severe cases. Suitable for adults; evidence supports its role as an add-on therapy in stable disease.

Avoid it if you have hypersensitivity to xanthines, active peptic ulcers, or cardiac arrhythmias. Baseline cardiac and hepatic function assessment is recommended.

Uses

Acebrophylline 100 mg Capsules IP are indicated for:

• Maintenance treatment of moderate persistent asthma (as an adjunct to inhaled corticosteroids)

• Management of stable chronic obstructive pulmonary disease (COPD) to reduce exacerbations and improve lung function

• Symptomatic relief in acute or chronic bronchitis with excessive mucus

• Supportive therapy for pulmonary complications in cystic fibrosis (e.g., improved clearance in bronchiectasis)

Not for acute asthma attacks, status asthmaticus, or primary treatment of infections ( combined with antibiotics if needed). Typical duration: long-term for chronic conditions, with periodic review.

How it works

Acebrophylline 100 mg Capsules contain acebrophylline, a prodrug that hydrolyzes to theophylline and ambroxol:

• Bronchodilator Action (Theophylline Component): Inhibits phosphodiesterase (PDE) enzymes, increasing intracellular cAMP levels, and antagonizes adenosine receptors, leading to relaxation of bronchial smooth muscles. This widens airways, reduces airway resistance, and improves ventilation.

• Mucolytic Action (Ambroxol Component): Stimulates surfactant production, enhances ciliary activity, and breaks down mucus glycoproteins, thinning and loosening phlegm for easier expectoration. It also has mild anti-inflammatory effects by modulating cytokine release.

Together, these actions alleviate bronchoconstriction, facilitate mucus clearance, and reduce symptoms like wheezing, cough, and dyspnea in obstructive diseases.

Benefits

Acebrophylline 100 mg Capsules provide sustained relief in COPD, asthma, and bronchitis by relaxing airways, thinning mucus, and decreasing inflammation, which reduces cough frequency, shortness of breath, and exacerbation risk. It improves lung function (e.g., FEV1 increase by 10–20% in trials) and quality of life, allowing better daily activities and sleep. As an oral option, it is convenient for patients intolerant to inhalers, offering additive benefits to standard therapies like bronchodilators or ICS/LABA combinations, with a lower cardiac risk profile than plain theophylline.

How to use

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush, or break it. Acebrophylline 100mg Capsules IP may be taken with or without food, but it is better to take it at a fixed time.

Side Effects

Most side effects are mild and transient, related to xanthine activity. Common side effects (affecting 1–10% of patients) include:

• Nausea or vomiting

• Headache

• Dizziness

• Abdominal pain or gastroesophageal reflux

• Insomnia or restlessness

Less common but notable side effects:

• Tremor or palpitations

• Dry mouth

Safety Advice

• Alcohol: Avoid alcohol, as it may enhance CNS stimulation (e.g., headache, insomnia) or increase GI irritation; additive effects could lead to toxicity.

• Pregnancy: Category C (limited human data; animal studies show no teratogenicity, but theophylline crosses the placenta—increased fetal heart rate risk). Use only if benefits outweigh risks (e.g., severe uncontrolled COPD); safer alternatives like inhaled therapies are preferred. Consult your doctor; folic acid supplementation is advised.

• Breastfeeding: Theophylline and ambroxol pass into breast milk (up to 1–2% of the dose); may cause infant irritability or tachycardia. Use with caution or avoid; monitor the baby and consider pumping/discarding milk.

• Driving/Operating Machinery: May cause dizziness, tremor, or drowsiness; avoid until effects are known, especially when starting treatment.

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 it safe to take Acetylcysteine tablets?

Yes, it is generally safe for most patients, though some may experience side effects. Consult your doctor for advice.

What are the recommended storage conditions for Acebrophylline 100mg?

Store according to instructions on the pack or label in a clean, dry place, out of reach of children.

How should acetylcysteine and acebrophylline tablets be used?

Follow your doctor's advice and take it with food to avoid an upset stomach.