Usage
Acebrophylline + Acetylcysteine is prescribed for respiratory conditions characterized by thick mucus secretions and airway obstruction. It is primarily indicated for chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It can also be used in asthma, bronchiectasis, and pulmonary complications of cystic fibrosis.
This combination belongs to the pharmacological classifications of mucolytics (Acetylcysteine), bronchodilators (Acebrophylline), and expectorants (Acebrophylline).
Acebrophylline, a derivative of theophylline, acts as a bronchodilator by relaxing the smooth muscles in the airways. Additionally, it exhibits mucoregulatory and anti-inflammatory effects. Acetylcysteine works by breaking down disulfide bonds in mucus, reducing its viscosity and making it easier to expectorate. It also possesses antioxidant properties.
Alternate Names
While “Acebrophylline + Acetylcysteine” is the generic name, various brand names exist depending on the manufacturer and region. Some examples include Thiotrac N, Respronoc, Aphyren N, Brophyle N, and Mucomix Ace.
How It Works
Pharmacodynamics: Acebrophylline relaxes bronchial smooth muscle, leading to bronchodilation. It also exerts anti-inflammatory effects. Acetylcysteine reduces mucus viscosity by breaking down disulfide bonds. It also acts as a direct and indirect antioxidant, potentially protecting lung tissue from oxidative damage.
Pharmacokinetics: Both drugs are absorbed orally. Acebrophylline is metabolized in the liver, while Acetylcysteine is rapidly metabolized, primarily in the liver and kidneys. Elimination pathways include renal and hepatic excretion.
Dosage
Standard Dosage
Adults: One tablet (Acebrophylline 100mg + Acetylcysteine 600mg) twice daily is a common dosage regimen.
Children: Use in children under 12 years is generally not recommended. For children older than 6, dosing should be carefully determined by a healthcare professional and is usually lower than adult doses.
Special Cases:
- Elderly Patients: Use with caution. Dosage adjustments may be necessary.
- Patients with Renal Impairment: Use with caution and consider dosage adjustments.
- Patients with Hepatic Dysfunction: Use with caution and consider dosage adjustments.
- Patients with Comorbid Conditions (e.g. heart failure, hyperthyroidism, peptic ulcers): Careful monitoring and potential dosage adjustments are necessary.
Clinical Use Cases
Dosage in specific clinical settings should be determined by the physician based on individual patient needs.
Dosage Adjustments
Dose modifications should be considered in patients with renal or hepatic impairment, other comorbid conditions, and those using interacting medications.
Side Effects
Common Side Effects
Nausea, vomiting, diarrhea, heartburn, stomach discomfort, dizziness, headache, and skin rash.
Rare but Serious Side Effects
Severe allergic reactions (anaphylaxis), bronchospasm (especially in asthmatics), Stevens-Johnson syndrome, toxic epidermal necrolysis, and liver damage.
Long-Term Effects
Chronic use can potentially lead to liver or kidney issues.
Adverse Drug Reactions (ADR)
ADRs requiring immediate attention include severe allergic reactions, bronchospasm, and serious skin reactions.
Contraindications
Hypersensitivity to acebrophylline, acetylcysteine, theophylline, or any component of the formulation; acute myocardial infarction; severe hypotension; hemodynamic instability; arrhythmias; acute porphyria; severe liver and kidney dysfunction are contraindications.
Drug Interactions
Acebrophylline + Acetylcysteine can interact with several drugs, including certain antibiotics, antihypertensives, diuretics, antacids, anticoagulants, and some over-the-counter medications. Notably, interactions may occur with theophylline and other xanthine derivatives. Alcohol may enhance drowsiness. Histamine-rich foods may exacerbate allergic reactions in susceptible individuals.
Pregnancy and Breastfeeding
Acebrophylline + Acetylcysteine is generally not recommended during pregnancy and breastfeeding due to potential risks to the fetus or neonate. Safer alternatives should be considered.
Drug Profile Summary
- Mechanism of Action: Acebrophylline: Bronchodilator, mucoregulator, anti-inflammatory. Acetylcysteine: Mucolytic, antioxidant.
- Side Effects: Nausea, vomiting, diarrhea, dizziness, headache, skin rash; rarely, severe allergic reactions, bronchospasm, liver damage.
- Contraindications: Hypersensitivity, acute MI, severe hypotension, arrhythmias, acute porphyria, severe liver/kidney dysfunction.
- Drug Interactions: Numerous drug interactions exist, particularly with theophylline, antibiotics, and certain other medications.
- Pregnancy & Breastfeeding: Not recommended.
- Dosage: Adults: 1 tablet (100mg/600mg) twice daily. Pediatric use restricted.
- Monitoring Parameters: Liver and kidney function, potassium levels, and respiratory status.
Popular Combinations
Often used alone. Specific combinations should be guided by clinical needs and under the supervision of a physician.
Precautions
Pre-existing medical conditions like heart failure, hyperthyroidism, peptic ulcer disease, and kidney or liver dysfunction require careful monitoring. Caution in elderly patients and children. Avoid alcohol. Monitor potassium levels.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Acebrophylline + Acetylcysteine?
A: The usual adult dose is one tablet (100mg Acebrophylline / 600mg Acetylcysteine) twice daily. Pediatric use is restricted, and dosages should be individualized by a physician.
Q2: What are the primary uses of this combination?
A: Mainly used to manage COPD (chronic bronchitis and emphysema), as well as asthma, bronchiectasis, and cystic fibrosis pulmonary complications.
Q3: How does this drug combination work?
A: Acebrophylline dilates airways and has anti-inflammatory action, while Acetylcysteine thins and loosens mucus.
Q4: What are the common side effects?
A: Nausea, vomiting, diarrhea, stomach upset, dizziness, headache, and skin rash are commonly reported.
Q5: Are there any serious side effects I should be aware of?
A: Rare but serious side effects include severe allergic reactions, bronchospasm, and serious skin reactions. Liver or kidney damage is also possible.
Q6: What are the contraindications for this medication?
A: Patients with hypersensitivity to the components, acute MI, severe hypotension, arrhythmias, acute porphyria, and severe liver/kidney dysfunction should not use this medication.
Q7: Can this medication be used during pregnancy or breastfeeding?
A: Generally, it’s not recommended due to potential fetal/neonatal risks. Discuss alternatives with your physician.
Q8: Does this medication interact with other drugs?
A: Yes, it can interact with numerous medications, including certain antibiotics, antihypertensives, and others. Inform your doctor about all other medications you are taking.
Q9: What precautions should be taken when prescribing this combination?
A: Exercise caution in patients with pre-existing heart, liver, or kidney conditions, as well as the elderly and children. Monitor potassium levels. Alcohol should be avoided.
