Usage
- Medical Conditions: Bromhexine is prescribed for respiratory disorders associated with productive cough, such as acute and chronic bronchitis, pneumonia, bronchiectasis, emphysema, and other conditions where mucus secretion is excessive or impaired. It is a mucolytic agent, meaning it helps to thin and loosen mucus in the airways.
- Pharmacological Classification: Mucolytic, expectorant.
- Mechanism of Action: Bromhexine works by breaking down the structure of mucopolysaccharides in the mucus, reducing its viscosity. This facilitates easier expectoration (coughing up) of phlegm and clears the airways. It may also stimulate the serous glands in the respiratory tract, increasing the volume of less viscous secretions, further aiding in mucus clearance.
Alternate Names
- International/Regional Variations: Bisolvon is a common international nonproprietary name (INN).
- Brand Names: Bisolvon is a widely recognized brand name. Other brand names may vary depending on the region.
How It Works
- Pharmacodynamics: Bromhexine reduces mucus viscosity and increases its volume, thereby promoting mucociliary clearance in the respiratory tract. This leads to easier expectoration and relief from productive cough.
- Pharmacokinetics:
- Absorption: Bromhexine is rapidly and almost completely absorbed after oral administration.
- Metabolism: It undergoes extensive first-pass metabolism in the liver, primarily to ambroxol (an active metabolite).
- Elimination: Bromhexine and its metabolites are mainly excreted in the urine. The elimination half-life can range from 6.6 to 31.4 hours.
- Mode of Action: At the molecular level, bromhexine depolymerizes mucopolysaccharide fibers in mucus, decreasing its viscosity. It does not directly bind to receptors or inhibit enzymes but alters the physical properties of mucus.
- Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: No significant receptor binding, enzyme inhibition, or neurotransmitter modulation has been observed.
- Elimination Pathways: Primarily renal excretion. It is extensively metabolized in the liver, primarily by CYP enzymes, to various metabolites, including ambroxol.
Dosage
Standard Dosage
Adults:
- Oral: 8-16 mg three to four times daily. In some cases, the dose can be increased to 16 mg three times daily, especially during the first week of treatment.
- Intravenous/Intramuscular: 4mg two to three times a day.
- Inhalation: 4mg (2ml solution), diluted approximately 2.5 times with saline and inhaled three times daily.
Children:
- Under 1 year: 2 mg twice daily.
- 1-5 years: 4 mg twice daily.
- 6-10 years: 4 mg four times daily or 2.5-5ml syrup three times a day.
- 12-14 years and patients <50kg: 24mg daily in three doses
- 12 years and older: Adult dose
Special Cases:
- Elderly Patients: Dosage adjustments may be needed, considering age-related decline in organ function. Start with a low dose and adjust as necessary.
- Patients with Renal Impairment: Dose reduction may be required for patients with severe renal dysfunction.
- Patients with Hepatic Dysfunction: Caution is advised in patients with severe liver disease. Dosage adjustments may be needed.
- Patients with Comorbid Conditions: Adjust dosage according to the specific condition, such as cardiovascular disease, diabetes, or asthma.
Clinical Use Cases:
- Intubation: May be used to facilitate airway clearance prior to or after intubation.
- Surgical Procedures: May be used to prevent or treat postoperative pulmonary complications associated with impaired mucus secretion and transport.
- Mechanical Ventilation: Can be used to thin secretions in patients on mechanical ventilation to aid in suctioning.
- Intensive Care Unit (ICU) Use: May be used for managing secretions in critically ill patients.
- Emergency Situations: Not typically indicated for emergency situations like status epilepticus or cardiac arrest.
Dosage Adjustments:
- Adjust dose based on patient-specific factors such as renal/hepatic impairment, metabolic disorders, and other relevant comorbid conditions.
- Consult with specialists for individualised dosage adjustments.
Side Effects
Common Side Effects:
- Nausea, vomiting, diarrhea, dyspepsia (indigestion).
- Headache, dizziness.
- Skin rash, sweating.
Rare but Serious Side Effects:
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
- Angioedema, anaphylaxis.
- Bronchospasm.
Long-Term Effects:
- No specific long-term effects have been commonly reported.
Adverse Drug Reactions (ADR):
- Report any severe skin reactions or signs of allergic reaction immediately and discontinue use.
- Monitor liver function tests periodically.
Contraindications
- Known hypersensitivity to bromhexine.
- Active gastric or duodenal ulcer (relative contraindication).
- Severe hepatic or renal impairment (use with caution and dose adjustment).
- Pregnancy, especially the first trimester (use only if clearly needed).
- Breastfeeding (bromhexine is excreted in breast milk).
Drug Interactions
- Antibiotics: Bromhexine may increase the concentration of antibiotics in bronchial secretions, potentially enhancing their efficacy in respiratory tract infections.
- Other Medications: No clinically significant interactions with commonly prescribed medications have been consistently reported. However, inform your healthcare provider about all concurrent medications to avoid potential interactions.
- OTC Drugs and Supplements: Consult your healthcare provider before combining bromhexine with other OTC medications or supplements, especially those with expectorant or antitussive properties.
- Food and Lifestyle Factors: No specific food or lifestyle interactions have been documented.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Limited data are available on the safety of bromhexine during pregnancy, particularly in the first trimester. Use only if potential benefits outweigh the risks.
- Fetal Risks, Teratogenicity, and Developmental Concerns: Animal studies have not shown teratogenic effects, but there is insufficient data in pregnant women to assess fetal risk.
- Drug Excretion in Breast Milk: Bromhexine is excreted in breast milk. Avoid use during breastfeeding due to the potential for adverse effects in the infant.
- Alternative Safer Options: Discuss with a physician for alternative safer mucolytics if necessary during pregnancy or lactation.
Drug Profile Summary
- Mechanism of Action: Breaks down mucopolysaccharides, reducing mucus viscosity and promoting mucociliary clearance.
- Side Effects: Nausea, vomiting, diarrhea, headache, dizziness, skin rash. Rarely: severe skin reactions, angioedema, bronchospasm.
- Contraindications: Hypersensitivity, active peptic ulcer, severe liver/kidney disease, pregnancy (especially first trimester), breastfeeding.
- Drug Interactions: May increase antibiotic concentration in bronchial secretions. Consult with a healthcare provider about other medications.
- Pregnancy & Breastfeeding: Avoid use.
- Dosage: Adults: 8-16 mg 3-4 times daily. Children: Dose varies by age, consult guidelines. Special adjustments for hepatic/renal impairment.
- Monitoring Parameters: Monitor liver function tests periodically. Observe for signs of hypersensitivity reactions.
Popular Combinations
- Bromhexine is sometimes combined with other medications like terbutaline (a bronchodilator) and guaiphenesin (an expectorant) for synergistic effects in managing cough and bronchospasm associated with respiratory conditions.
Precautions
- General Precautions: Assess for allergies and pre-existing gastrointestinal, hepatic, or renal conditions.
- Specific Populations: As described above.
- Lifestyle Considerations: No specific lifestyle restrictions are typically necessary. However, advise patients to stay hydrated to aid in mucus thinning.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Bromhexine?
A: Adults: 8-16 mg three to four times daily. Children: dosing varies by age; see the pediatric dosage section above.
Q2: How does Bromhexine differ from other mucolytics?
A: Bromhexine’s primary mechanism is breaking down mucopolysaccharide fibers. Other mucolytics might use different mechanisms, like altering disulfide bonds.
Q3: Can Bromhexine be used in asthmatic patients?
A: Use with caution in asthmatic patients, as bronchospasm has been reported as a rare side effect. Monitor patients closely.
Q4: Is Bromhexine safe for long-term use?
A: Generally safe for short-term use. Long-term use should be evaluated based on the patient’s condition and monitored for potential side effects.
Q5: Can Bromhexine be crushed or chewed?
A: Tablets should be swallowed whole. Liquid formulations are available for patients who have difficulty swallowing tablets.
Q6: What should I do if a patient misses a dose?
A: Take the missed dose as soon as remembered unless it is close to the next scheduled dose. Do not double the dose.
Q7: Are there any drug interactions I should be aware of?
A: It can potentiate the effects of certain antibiotics in bronchial secretions. Consult with the patient’s medication list.
Q8: What should I counsel patients about regarding side effects?
A: Inform patients about common gastrointestinal side effects and advise them to report any severe skin reactions or breathing difficulties immediately.
Q9: Can Bromhexine be used in patients with kidney problems?
A: Use with caution and dose adjustments are often necessary for patients with severe renal impairment. Consult specialist advice.
Q10: How should Bromhexine be administered to patients on mechanical ventilation?
A: Administering via nebulization or through the ventilator circuit can help thin secretions, but consult guidelines for appropriate dilution and administration techniques.
