Usage
This combination medication is prescribed for the symptomatic relief of respiratory conditions characterized by bronchospasm (narrowing of the airways) and mucus build-up. These conditions include:
- Chronic Obstructive Pulmonary Disease (COPD)
- Asthma
- Bronchitis (chronic and acute)
- Emphysema
- Bronchiectasis
- Other respiratory tract infections
Pharmacological Classification: This is a combination drug belonging to multiple classes:
- Albuterol: Beta-2 adrenergic agonist (bronchodilator)
- Bromhexine: Mucolytic, expectorant
- Etofylline: Xanthine derivative (bronchodilator)
- Menthol: Topical anesthetic, decongestant
Mechanism of Action: This combination medication works through the synergistic action of its components:
- Albuterol relaxes the bronchial smooth muscle by stimulating beta-2 adrenergic receptors, leading to bronchodilation and increased airflow.
- Bromhexine breaks down disulfide bonds in mucus, reducing its viscosity and facilitating expectoration.
- Etofylline relaxes bronchial smooth muscle, similar to theophylline, promoting bronchodilation. It also improves diaphragmatic contractility and may have some anti-inflammatory effects.
- Menthol activates cold-sensing TRPM8 receptors, creating a cooling sensation and relieving minor throat irritation. It also acts as a mild topical anesthetic and decongestant.
Alternate Names
This combination medication doesn’t have a universally recognized international non-proprietary name (INN). It is often identified by the names of its components. Brand names vary regionally. Some common brand names include Shwas and Albutamol Plus.
How It Works
Pharmacodynamics: As described above in Mechanism of Action, the combined effects of the drug’s components lead to bronchodilation, mucus thinning, and symptomatic relief of respiratory distress.
Pharmacokinetics:
- Absorption: Albuterol is readily absorbed after oral administration but has low bioavailability. Bromhexine, etofylline, and menthol are also absorbed orally.
- Metabolism: Albuterol is primarily metabolized in the liver. Bromhexine, etofylline, and menthol also undergo hepatic metabolism.
- Elimination: Albuterol is excreted primarily in urine. Bromhexine and its metabolites are excreted in urine. Etofylline and menthol are also primarily eliminated through the kidneys.
Mode of Action: The combined effects of albuterol and etofylline relaxing the bronchial smooth muscles and bromhexine’s action of thinning mucus provide relief from bronchospasm and mucus buildup, and menthol gives symptomatic relief in sore throats and nasal congestion.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation:
- Albuterol: Binds to beta-2 adrenergic receptors.
- Bromhexine: No specific receptor binding or enzyme inhibition is known. It acts directly on mucus.
- Etofylline: Similar to theophylline, it likely inhibits phosphodiesterase enzymes, leading to increased cAMP levels and bronchodilation.
- Menthol: Activates TRPM8 receptors.
Dosage
Standard Dosage
- Syrups typically contain Albuterol 2mg, Bromhexine 4mg, Etofylline 200mg, and Menthol 1mg per 5ml. The usual adult dose is 5-10ml three to four times daily.
- Tablets may contain Albuterol 1mg/2mg, Bromhexine 8mg, and Etofylline 50mg, taken three to four times a day. One tablet 3-4 times a day.
Children: Dosing in children is typically weight-based and should be carefully determined by a physician. It is generally not recommended for children under 2 years of age.
- For children 2 to 6 years old, Albuterol dosing starts at 0.1mg/kg every 8 hours, potentially increasing to 0.2mg/kg every 8 hours. Other component dosing should be adjusted proportionally by a doctor.
- For children 6 years and older, the tablet form is often used, starting with a lower dose than adults and titrated upwards based on response and tolerability.
Special Cases:
- Elderly Patients: Dosage adjustments may be necessary due to age-related decline in renal and hepatic function. Start with a lower dose and monitor closely.
- Patients with Renal Impairment: Reduce dosage based on creatinine clearance. Close monitoring is essential.
- Patients with Hepatic Dysfunction: Use with caution and adjust dosage as needed. Monitor liver function tests.
- Patients with Comorbid Conditions: Use cautiously in patients with cardiovascular disease, hypertension, hyperthyroidism, diabetes, seizures, or peptic ulcer disease. Dosage adjustments and careful monitoring are often required.
Clinical Use Cases
The combination is generally not recommended for use in specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. In these scenarios, individual components might be used separately under strict medical supervision.
Dosage Adjustments
Dosage should be individualized based on patient response, age, weight, renal function, hepatic function, and comorbid conditions.
Side Effects
Common Side Effects:
- Nausea
- Vomiting
- Stomach discomfort/pain
- Diarrhea
- Headache
- Dizziness
- Tremors
- Restlessness
- Increased heart rate
- Palpitations
- Sweating
- Skin rash
- Muscle cramps
Rare but Serious Side Effects:
- Allergic reactions (e.g., rash, itching, swelling, severe dizziness, difficulty breathing)
- Paradoxical bronchospasm
- Cardiac arrhythmias
- Seizures
- Worsening of pre-existing conditions (e.g., peptic ulcer, hyperthyroidism)
Long-Term Effects:
- Tolerance to bronchodilator effects (with albuterol)
- Potassium depletion (with albuterol and etofylline)
- Worsening of glaucoma or urinary retention
Contraindications
- Hypersensitivity to any component of the medication
- Acute asthma attacks or status asthmaticus
- Severe cardiovascular disease (e.g., coronary artery disease, heart failure)
- Uncontrolled hypertension
- Hyperthyroidism
- Angle-closure glaucoma
- Severe hepatic impairment
- Severe renal impairment
Drug Interactions
- Beta-blockers: May antagonize the bronchodilator effects of albuterol.
- Digoxin: Etofylline may increase digoxin levels.
- Diuretics: May enhance hypokalemia caused by albuterol and etofylline.
- MAO inhibitors and tricyclic antidepressants: May potentiate the cardiovascular effects of albuterol.
- Xanthines (e.g., theophylline): May increase the risk of adverse effects.
- CYP450 interactions: Etofylline metabolism can be affected by inducers and inhibitors of CYP enzymes.
- Other sympathomimetic bronchodilators or epinephrine should not be used concomitantly with salbutamol, since their combined effect on the cardiovascular system may be deleterious to the patient.
- Concomitant use of propranolol and other beta blockers should be avoided as they reduce Salbutamol’s bronchodilating effect.
Pregnancy and Breastfeeding
Use with caution during pregnancy and breastfeeding. Albuterol crosses the placenta. While albuterol is often used to manage asthma during pregnancy, it should be used only if clearly needed and under close medical supervision. Its safety during breastfeeding is not well established. It’s essential to weigh the potential benefits against the potential risks to the fetus or nursing infant. Consult with a specialist if you have concerns. Pregnancy Category C.
Drug Profile Summary
- Mechanism of Action: Bronchodilation (albuterol, etofylline), mucolytic (bromhexine), decongestant (menthol).
- Side Effects: Nausea, vomiting, headache, dizziness, tremors, increased heart rate, palpitations. Rarely: allergic reactions, paradoxical bronchospasm, cardiac arrhythmias.
- Contraindications: Hypersensitivity, acute asthma attacks, severe cardiovascular disease, uncontrolled hypertension, hyperthyroidism, angle-closure glaucoma.
- Drug Interactions: Beta-blockers, digoxin, diuretics, MAO inhibitors, tricyclic antidepressants, xanthines, other sympathomimetic bronchodilators, epinephrine.
- Pregnancy & Breastfeeding: Use with caution during pregnancy and breastfeeding. Consult a specialist.
- Dosage: Adults: Syrup: 5-10ml TID/QID. Tablets: One tablet TID or QID. Pediatric: Weight-based dosing, consult guidelines and a physician.
- Monitoring Parameters: Respiratory rate, heart rate, blood pressure, potassium levels, pulmonary function tests.
Popular Combinations
This combination itself is a popular combination for managing respiratory conditions with bronchospasm and mucus build-up. Other medications may be added depending on the specific clinical picture, including inhaled corticosteroids, anticholinergics, or other bronchodilators.
Precautions
- General Precautions: Pre-screening for allergies, metabolic disorders (diabetes, thyroid disorders), organ dysfunction (liver/kidney disease), cardiovascular disease, and glaucoma. Monitor potassium levels, especially with long-term use.
- Pregnant Women: Consult with a specialist. Use only if clearly needed.
- Breastfeeding Mothers: Consult with a specialist regarding safety during breastfeeding. Weigh risks and benefits. Consider alternatives.
- Children & Elderly: Age-specific dosing and careful monitoring are necessary. Not recommended for children under 2.
- Lifestyle Considerations: Limit alcohol intake due to potential additive effects on dizziness and drowsiness. Avoid driving or operating heavy machinery if experiencing dizziness or tremors. Patients should be cautioned against engaging in activities requiring complete mental alertness, and motor coordination such as operating machinery until their response to the medicine is known.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Albuterol + Bromhexine + Etofylline + Menthol?
A: Adults: Syrup: 5-10 ml TID/QID. Tablets: One tablet TID/QID. Children: Weight-based dosing. Consult guidelines and a physician.
Q2: What are the common side effects?
A: Nausea, vomiting, headache, dizziness, tremors, increased heart rate, palpitations.
Q3: Can this combination be used during pregnancy?
A: Use with caution during pregnancy. Consult a specialist. Benefits must outweigh risks.
Q4: Is it safe to breastfeed while using this medication?
A: Safety during breastfeeding is not well established. Consult a specialist. Consider alternatives.
Q5: What are the contraindications?
A: Hypersensitivity, acute asthma attacks, severe cardiovascular disease, uncontrolled hypertension, hyperthyroidism, angle-closure glaucoma, severe hepatic/renal impairment.
Q6: Are there any significant drug interactions?
A: Yes, with beta-blockers, digoxin, diuretics, MAO inhibitors, tricyclic antidepressants, xanthines, other sympathomimetic bronchodilators, epinephrine.
Q7: What precautions should I take when prescribing this medicine?
A: Pre-screen for allergies, metabolic/organ dysfunction, cardiovascular disease. Monitor potassium levels. Use cautiously in elderly patients.
Q8: Can this combination be used in children?
A: It is generally not recommended in children younger than two years. Dosing in older children is weight-based, always consult a physician.
Q9: What is the mechanism of action of this combination drug?
A: Albuterol and etofylline are bronchodilators, bromhexine is a mucolytic, and menthol acts as a decongestant and topical anesthetic.
Q10: What should patients do if they experience side effects?
A: They should report any side effects to their doctor, particularly any severe or unusual reactions.
