Usage
- This combination drug is primarily prescribed for respiratory conditions like asthma, chronic obstructive pulmonary disease (COPD), and bronchitis, particularly when cough with mucus is a prominent symptom. It aids in relieving bronchospasm and promoting expectoration.
- Pharmacological Classification: This is a combination of a mucolytic (bromhexine), a bronchodilator (salbutamol), and a xanthine derivative (theophylline). It can also be classified as a respiratory combination product or an anti-asthmatic.
- Mechanism of Action: Bromhexine breaks down mucus, making it easier to cough up. Salbutamol, a beta-2 adrenergic agonist, relaxes the airway muscles, opening up the airways. Theophylline also relaxes airway muscles and may have anti-inflammatory effects.
Alternate Names
- While “Bromhexine + Salbutamol + Theophylline” is the generic name, regional or international variations may exist.
- Brand names: Asmatide BR (and other brand names may be available).
How It Works
- Pharmacodynamics: Salbutamol acts on beta-2 adrenergic receptors, causing bronchodilation. Theophylline inhibits phosphodiesterase, leading to bronchodilation and some anti-inflammatory activity. Bromhexine breaks down mucopolysaccharides in the mucus.
- Pharmacokinetics: Salbutamol is readily absorbed after oral administration but has low bioavailability due to first-pass metabolism. It is metabolized in the liver and excreted primarily in urine. Theophylline is also well-absorbed orally, metabolized in the liver by CYP450 enzymes (particularly CYP1A2), and excreted renally. Bromhexine is absorbed orally, metabolized in the liver, and eliminated renally.
- Mode of Action: Salbutamol stimulates beta-2 receptors, leading to smooth muscle relaxation in the airways. Theophylline inhibits phosphodiesterase, increasing intracellular cAMP, relaxing bronchial smooth muscle, and potentially reducing inflammation. Bromhexine breaks down disulfide bonds in mucoproteins, decreasing mucus viscosity.
- Elimination Pathways: Primarily renal excretion for all three components, with hepatic metabolism involved for salbutamol, theophylline, and bromhexine.
Dosage
Standard Dosage
Adults:
- Dosage varies according to the specific product. A common adult dose is one tablet containing salbutamol 2mg, etofylline 200mg, and bromhexine 8mg, taken three times daily. The maximum dose should not be exceeded as directed by the physician.
- Dosage can also be adjusted based on clinical presentation of cough, severity of airway obstruction and individual patient response.
Children:
- Pediatric dosing is weight- or age-based and needs to be determined by a physician.
- Use in children younger than 2 years is generally not recommended as the safety and efficacy in this population have not been fully established.
Special Cases:
- Elderly Patients: Start with a lower dose and adjust as needed based on clinical response and tolerance. Consider potential drug interactions with other medications commonly used in elderly. Close monitoring of side effects is recommended, especially cardiovascular effects.
- Patients with Renal Impairment: Reduce the dose as the clearance of all three components can be affected. Monitor renal function regularly and adjust dosage accordingly.
- Patients with Hepatic Dysfunction: Careful dose adjustment is necessary due to hepatic metabolism of all three components. Consider drug interactions and closely monitor liver function tests.
- Patients with Comorbid Conditions: Patients with cardiovascular disease, diabetes, hyperthyroidism, or seizure disorders require careful monitoring. Dosage modifications might be needed based on the specific comorbid condition.
Clinical Use Cases
- Intubation, Surgical Procedures, Mechanical Ventilation, ICU Use, Emergency Situations: The use of this fixed-dose combination is not generally recommended in these acute settings. Individual components, specifically salbutamol or theophylline, may be administered via different routes (e.g., intravenous, nebulization) under close monitoring for these situations.
Dosage Adjustments
- Dosage adjustments are based on patient-specific factors like renal function, hepatic function, age, body weight, other co-administered medications, and clinical response.
Side Effects
Common Side Effects
- Nausea, vomiting, headache, dizziness, tremor, palpitations, nervousness, restlessness, dry mouth, throat irritation, stomach upset, diarrhea, skin rash, sweating, muscle cramps.
Rare but Serious Side Effects
- Severe allergic reactions (angioedema, urticaria, bronchospasm), hypotension, collapse, hypokalemia, cardiac arrhythmias, seizures.
Long-Term Effects
- Tolerance to bronchodilator effects may develop with long-term use.
- Potential for theophylline toxicity with prolonged use, especially in patients with impaired clearance.
Adverse Drug Reactions (ADR)
- Any severe or persistent side effects warrant immediate medical attention. Cardiac arrhythmias, hypokalemia, and severe allergic reactions require urgent intervention.
Contraindications
- Hypersensitivity to any component of the drug.
- Severe heart disease, pre-existing cardiac tachyarrhythmias, irregular heartbeat, severe high blood pressure, thyrotoxicosis.
- Seizure disorders.
Drug Interactions
- Beta-blockers (metoprolol, propranolol) may antagonize the bronchodilator effects of salbutamol.
- Diuretics (furosemide, hydrochlorothiazide) can increase the risk of hypokalemia with salbutamol and theophylline.
- MAOIs and tricyclic antidepressants can potentiate the cardiovascular effects of salbutamol.
- Digoxin levels can be reduced by theophylline.
- Other xanthine derivatives, corticosteroids, and some anesthetics can interact with theophylline.
Pregnancy and Breastfeeding
- This combination should be used during pregnancy only if the potential benefit clearly outweighs the risk to the fetus.
- Caution is advised during breastfeeding, as both salbutamol and theophylline are excreted in breast milk. Monitor the infant for potential side effects (irritability, sleep disturbances).
Drug Profile Summary
- Mechanism of Action: Bronchodilation (salbutamol, theophylline), mucolytic action (bromhexine).
- Side Effects: Nausea, vomiting, tremor, palpitations, headache, dizziness. Serious side effects: hypokalemia, cardiac arrhythmias, allergic reactions.
- Contraindications: Hypersensitivity, severe heart disease, thyrotoxicosis, seizure disorders.
- Drug Interactions: Beta-blockers, diuretics, MAOIs, digoxin, xanthines, corticosteroids.
- Pregnancy & Breastfeeding: Use with caution.
- Dosage: Varies with age and specific product; adjust for renal/hepatic impairment.
- Monitoring Parameters: Respiratory function (e.g., FEV1), serum theophylline levels, potassium levels, heart rate and rhythm, blood pressure.
Popular Combinations
- It’s not typically combined with other drugs in a fixed-dose combination beyond the three ingredients. However, individual components may be part of other combination products.
Precautions
- Pre-existing medical conditions (cardiovascular disease, diabetes, hyperthyroidism, renal/hepatic impairment) require careful monitoring.
- In pregnant and breastfeeding women, use only if the potential benefit outweighs the risks.
- Caution in children and elderly.
- Avoid alcohol and smoking, as these can exacerbate respiratory problems and interact with theophylline.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Bromhexine + Salbutamol + Theophylline?
A: Dosage is dependent on the patient’s age, weight, clinical condition, and the specific product being used. Always refer to the product’s prescribing information and adjust based on individual patient factors.
Q2: How should this combination be administered?
A: Oral formulations (tablets, syrup) are usually administered with food to minimize gastrointestinal upset.
Q3: What are the common side effects?
A: Common side effects include nausea, vomiting, tremor, palpitations, headache, dizziness, and gastrointestinal disturbances.
Q4: What are the serious side effects to watch for?
A: Serious side effects include hypokalemia, cardiac arrhythmias, and severe allergic reactions. Seek immediate medical attention if these occur.
Q5: Can this combination be used in pregnant or breastfeeding women?
A: Use with caution in pregnancy and breastfeeding. Consult with a physician to assess the benefits versus risks. Monitor infants for potential side effects like irritability and sleep disturbances.
Q6: What are the major drug interactions?
A: Significant interactions can occur with beta-blockers, diuretics, MAOIs, digoxin, other xanthine derivatives, and corticosteroids. Inform your physician of all medications you are currently taking.
Q7: What are the contraindications to using this combination?
A: Contraindications include hypersensitivity to any of the components, severe heart disease, thyrotoxicosis, and seizure disorders.
Q8: Are there any lifestyle modifications recommended while taking this medication?
A: Avoid smoking and alcohol consumption, as they can exacerbate respiratory issues and interact with theophylline. Maintaining a healthy diet and good hydration can also be beneficial.
Q9: What monitoring parameters are important while using this combination?
A: Regular monitoring of respiratory function (e.g., FEV1), serum theophylline levels, potassium levels, heart rate and rhythm, and blood pressure is important to ensure safety and efficacy.
Q10: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed dose.
