Usage
This combination medication is prescribed for the symptomatic relief of productive cough associated with various respiratory disorders. These disorders include:
- Acute bronchitis (including tracheobronchitis)
- Acute bronchitis due to respiratory viruses
- Chronic bronchitis
- COPD (Chronic Obstructive Pulmonary Disease)
- Asthmatic bronchitis
- Pneumonia
- Emphysema
- Bronchial Asthma
- Bronchiectasis
- Pulmonary Tuberculosis
- Whooping Cough
- Other Broncho-Spastic conditions
Pharmacological Classification:
This drug is a combination of a mucolytic (Bromhexine), expectorant (Guaifenesin), bronchodilator (Salbutamol), and a topical anesthetic/soothing agent (Menthol).
Mechanism of Action:
Bromhexine breaks down thick mucus, making it less viscous and easier to expectorate. Guaifenesin increases respiratory tract secretions, aiding in mucus expulsion. Salbutamol relaxes the airway muscles, relieving bronchospasms, and widening the airways. Menthol provides a cooling and soothing sensation to irritated airways.
Alternate Names
While the generic name is Bromhexine + Guaifenesin + Menthol + Salbutamol, the combination may be referred to by various regional or international names. Brand names under which this combination is marketed include Ascoril Expectorant, Shaltoux Expectorant, Saltol Expectorant, Synabron Expectorant, Okaril Expectorant, Pecof/Pecof SF, and Eascof Expectorant.
How It Works
Pharmacodynamics:
- Bromhexine: Reduces mucus viscosity by breaking down mucopolysaccharide fibers.
- Guaifenesin: Stimulates bronchial glands to increase respiratory fluid secretions, thus lubricating and thinning mucus.
- Salbutamol: A beta-2 adrenergic agonist that relaxes bronchial smooth muscle, leading to bronchodilation.
- Menthol: Activates TRPM8 receptors, producing a cooling sensation. It also acts as a weak kappa opioid receptor agonist, providing mild local anesthetic and antitussive effects.
Pharmacokinetics:
- Bromhexine: Well-absorbed orally. Metabolized in the liver and excreted primarily in the urine.
- Guaifenesin: Readily absorbed from the gastrointestinal tract. Metabolized in the liver and excreted in the urine.
- Salbutamol: Inhaled salbutamol has rapid onset of action. Oral salbutamol is absorbed from the GI tract, metabolized in the liver, and excreted in the urine and feces.
- Menthol: Absorbed through the skin and mucous membranes. Metabolized in the liver and excreted in urine.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation:
- Salbutamol: Binds to beta-2 adrenergic receptors, leading to increased intracellular cAMP, which in turn relaxes bronchial smooth muscle.
Elimination Pathways:
- Primarily renal excretion for Bromhexine, Guaifenesin, and Salbutamol.
- Hepatic metabolism and renal excretion for Menthol.
Dosage
Standard Dosage
Adults:
10 mL (2 teaspoons) three times daily. Some patients may require a higher dose for desired effects.
Children:
- 6-12 years: 5-10 mL (1-2 teaspoons) three times daily.
- 2-6 years: 5 mL (1 teaspoon) three times a day (under medical supervision).
- Under 2 years: Use only under strict medical supervision.
Special Cases:
- Elderly Patients: Initiate with lower doses and titrate based on response and tolerance.
- Patients with Renal Impairment: Dose adjustment may be necessary. Monitor renal function.
- Patients with Hepatic Dysfunction: Dose adjustment may be required. Monitor liver function tests.
- Patients with Comorbid Conditions: Use with caution in patients with diabetes, cardiovascular diseases, hypertension, hyperthyroidism, and peptic ulcer disease. Close monitoring is recommended.
Clinical Use Cases
Dosage in specific clinical scenarios such as intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be determined by the attending physician based on the patient’s individual needs and clinical status. The combination may not be specifically indicated for these cases, and alternative treatments might be more suitable.
Dosage Adjustments
Dose modification is necessary based on patient-specific factors such as renal/hepatic dysfunction, metabolic disorders, and other comorbid conditions. Genetic polymorphisms affecting drug metabolism may also necessitate dose adjustments.
Side Effects
Common Side Effects:
- Nausea, vomiting, diarrhea
- Stomach pain or discomfort
- Headache, dizziness
- Shakiness or tremor, muscle cramps
- Increased heart rate (tachycardia)
- Sleeplessness
Rare but Serious Side Effects:
- Allergic reactions (e.g., skin rash, itching, swelling)
- Paradoxical bronchospasm
- Cardiac arrhythmias
- Hypokalemia
Long-Term Effects:
Prolonged use without proper medical supervision may lead to tolerance to Salbutamol, reduced effectiveness, and potential adverse effects on cardiovascular and metabolic systems.
Adverse Drug Reactions (ADR):
Severe allergic reactions (angioedema, anaphylaxis), severe hypokalemia, and cardiac arrhythmias are serious ADRs requiring urgent medical attention.
Contraindications
- Hypersensitivity to any of the components.
- Pregnancy (generally not recommended).
- Tachyarrhythmia, myocarditis, heart defects.
- Decompensated diabetes mellitus, thyrotoxicosis.
- Glaucoma.
- Severe liver and/or kidney failure.
- Gastric and duodenal ulcers in the acute phase, gastric bleeding.
- Children under 2 years of age.
Drug Interactions
- Beta-blockers: Antagonize the bronchodilating effect of Salbutamol.
- Diuretics: May potentiate hypokalemia caused by Salbutamol.
- Digoxin: Salbutamol may increase the risk of arrhythmias in patients taking digoxin.
- Theophylline: Concurrent use may enhance theophylline’s side effects.
- MAO inhibitors and Tricyclic antidepressants: May potentiate the cardiovascular effects of Salbutamol.
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding is not fully established. Consult a doctor before using this medicine during pregnancy or while breastfeeding. Salbutamol may be used if the potential benefits outweigh the risks, but other components of the combination may not be as well-studied in these populations.
Drug Profile Summary
- Mechanism of Action: Mucolytic, expectorant, bronchodilator, and soothing effects.
- Side Effects: Nausea, vomiting, diarrhea, headache, dizziness, tremor, increased heart rate.
- Contraindications: Hypersensitivity, pregnancy, severe cardiovascular/renal/hepatic disease, glaucoma.
- Drug Interactions: Beta-blockers, diuretics, digoxin, theophylline, MAO inhibitors, tricyclic antidepressants.
- Pregnancy & Breastfeeding: Consult a doctor before use.
- Dosage: Adults: 10 mL TID. Children: As per age guidelines.
- Monitoring Parameters: Respiratory rate, heart rate, blood pressure, potassium levels, blood glucose levels (in diabetics).
Popular Combinations
This combination itself is a popular combination used clinically to address multiple aspects of respiratory disorders with cough and mucus congestion.
Precautions
- Pre-existing medical conditions: Screen patients for hypersensitivity, diabetes, cardiovascular diseases, hypertension, hyperthyroidism, and peptic ulcer disease.
- Pregnant women: Avoid use unless benefits outweigh risks.
- Breastfeeding mothers: Consult a doctor before use.
- Children and elderly: Adjust dosage as needed.
- Lifestyle: Avoid alcohol as it may worsen dizziness. Avoid driving or operating machinery if experiencing dizziness or drowsiness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Bromhexine + Guaifenesin + Menthol + Salbutamol?
A: Adults: 10 mL three times daily. Children: Dose varies according to age (see Dosage section).
Q2: Can this combination be used in patients with asthma?
A: Yes, this combination can be beneficial in asthmatic bronchitis where cough and mucus production are prominent along with bronchospasm. However, it’s crucial to consider the patient’s overall asthma management plan and adjust the dosage accordingly.
Q3: What are the common side effects?
A: Nausea, vomiting, diarrhea, headache, dizziness, tremor, and increased heart rate are common side effects.
Q4: Is this drug safe during pregnancy?
A: Safety during pregnancy is not fully established. Consult a doctor before use.
Q5: Can this combination be used in children under 2 years of age?
A: Use only under strict medical supervision in children under 2.
Q6: Are there any drug interactions I should be aware of?
A: Yes. Interactions can occur with beta-blockers, diuretics, digoxin, theophylline, MAO inhibitors, and tricyclic antidepressants.
Q7: Can I take this medication if I have diabetes?
A: Use with caution and monitor blood glucose levels closely.
Q8: What should I do if my cough persists despite taking this medicine?
A: If symptoms persist for more than 7 days or worsen, consult a physician.
Q9: How long should I take this medication?
A: Consult a doctor to determine the appropriate duration of treatment based on your condition. Do not use for prolonged periods without medical advice.
Q10: Can I operate machinery after taking this medication?
A: Avoid operating machinery or driving if you experience dizziness or drowsiness after taking this medication.