Usage
Ambroxol is prescribed for respiratory diseases associated with viscous or excessive mucus. It is classified as a mucolytic and expectorant. Ambroxol’s mechanism of action involves:
- Mucolytic Action: Reduces the viscosity of mucus by breaking down mucopolysaccharide fibers.
- Expectorant Action: Increases serous secretions in the bronchial glands, which helps thin the mucus and makes it easier to cough up. It also stimulates the ciliary activity of the respiratory epithelium, further aiding in mucus clearance.
Alternate Names
Ambroxol hydrochloride is the chemical name. Brand names vary regionally but include Mucosolvan, Lasolvan, and Mucoangin.
How It Works
Pharmacodynamics: Ambroxol stimulates the serous cells of bronchial glands, increasing the production of watery mucus, which reduces the viscosity of existing phlegm. It demonstrates some local anesthetic properties that provide relief for a sore throat. Ambroxol also has antioxidant and anti-inflammatory properties that could offer benefits in respiratory conditions.
Pharmacokinetics:
- Absorption: Rapidly absorbed after oral administration. Peak plasma concentration is reached in approximately 2 hours. Bioavailability is around 73% after oral administration.
- Metabolism: Extensively metabolized in the liver, mainly via glucuronidation. Bromhexine is a significant metabolite.
- Elimination: Excreted primarily in the urine, with a biphasic half-life of approximately 1-9 hours. The initial (alpha) phase is about 1.3 hours, and the terminal (beta) phase is about 8.8 hours.
Mode of Action: Ambroxol’s mucolytic action is mainly due to the depolymerization of mucopolysaccharides, reducing sputum viscosity. It also enhances the activity of surfactant, a substance that helps to keep the air sacs (alveoli) open.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: There’s evidence suggesting sodium channel blocking activity in neurons by ambroxol, but the clinical relevance isn’t fully understood.
Elimination Pathways: Primarily eliminated by renal excretion, with minimal hepatic excretion.
Dosage
Standard Dosage
Adults:
Standard oral dose: 30-120 mg daily, divided into 2-3 doses. Extended-release capsules: 75 mg once daily. Lozenges (15 mg): Suck up to 6 lozenges daily (maximum 2 lozenges per dose).
Children:
- Below 6 months: 0.5 mL syrup every 12 hours
- 7-12 months: 1 mL syrup every 12 hours
- 1-2 years: 1.25 mL syrup every 12 hours.
- 2-5 years: Half a teaspoonful of syrup 2-3 times daily
- Over 5 years: One teaspoonful of syrup 2-3 times daily
Pediatric safety considerations: Carefully monitor children for potential gastrointestinal adverse effects. Adjust dosage as needed according to weight and age.
Special Cases:
- Elderly Patients: Initiate therapy at the lower end of the dosing range and adjust cautiously based on renal and hepatic function.
- Patients with Renal Impairment: Dose reduction may be necessary.
- Patients with Hepatic Dysfunction: Monitor closely for adverse effects. Dose adjustments may be needed.
- Patients with Comorbid Conditions: Individualize dosage based on specific conditions like diabetes and cardiovascular disease.
Clinical Use Cases
- Intubation: Data suggests large doses of intravenous ambroxol might be beneficial in the perioperative setting, specifically in high-risk patients, to reduce pulmonary complications.
- Surgical Procedures: For patients with chronic obstructive pulmonary disease undergoing cardiac or upper abdominal surgery, perioperative ambroxol administration may reduce postoperative pulmonary complications. Studies have shown high doses (1000 mg/day for 3 days) to be beneficial.
- Mechanical Ventilation: Large dose ambroxol has been investigated for reducing ventilator-associated pneumonia, particularly in the elderly.
- Intensive Care Unit (ICU) Use: Ambroxol has been explored in ICU settings for the treatment of acute respiratory distress syndrome (ARDS), but evidence regarding its efficacy is mixed. High-dose oral ambroxol (40 mg/kg/day in four divided doses) has been studied in ventilated pediatric ARDS patients, but results did not show significant improvements in outcomes.
- Emergency Situations: There is no established use in emergency situations like status epilepticus or cardiac arrest.
Dosage Adjustments
Renal or hepatic impairment requires cautious dose adjustment. Metabolic disorders and genetic polymorphisms affecting drug metabolism necessitate careful consideration for dosage. Patients with Gaucher’s disease and myoclonic epilepsy have been given ambroxol with increased doses up to 30 mg/kg/day.
Side Effects
Common Side Effects
Nausea, vomiting, diarrhea, skin rash, itching, dizziness, weakness, dry mouth, indigestion, altered taste, throat and mouth numbness, upset stomach.
Rare but Serious Side Effects
Severe allergic reactions (anaphylaxis), including difficulty breathing, swelling of the face, lips, tongue, or throat.
Long-Term Effects
No long-term adverse effects have been consistently reported.
Adverse Drug Reactions (ADR)
Anaphylaxis and Stevens-Johnson Syndrome are potential ADRs requiring immediate attention.
Contraindications
Known hypersensitivity to ambroxol or bromhexine. Use cautiously in patients with gastric ulcers. First trimester of pregnancy.
Drug Interactions
Ambroxol may interact with certain medications like antibiotics and some cough suppressants. Consider potential drug interactions when co-prescribing.
Pregnancy and Breastfeeding
Ambroxol should not be used during the first trimester of pregnancy. Its use during the second and third trimesters requires careful consideration of potential risks and benefits. Ambroxol may be present in breast milk; hence, its use during breastfeeding is not recommended.
Drug Profile Summary
- Mechanism of Action: Mucolytic and expectorant, decreases mucus viscosity.
- Side Effects: Nausea, vomiting, diarrhea, rash, itching, dizziness.
- Contraindications: Hypersensitivity, gastric ulcer, first trimester of pregnancy.
- Drug Interactions: Limited interactions; caution with certain antibiotics and other cough suppressants.
- Pregnancy & Breastfeeding: Avoid in first trimester; caution in later pregnancy and avoid during breastfeeding.
- Dosage: Adults: 30-120 mg/day divided; children: dose adjusted by age/weight.
- Monitoring Parameters: Respiratory rate, oxygen saturation, lung sounds, cough frequency and severity.
Popular Combinations
Ambroxol is often combined with bronchodilators (e.g., salbutamol) or antitussives depending on the clinical context.
Precautions
Pre-screen for allergies and hepatic/renal dysfunction. Careful consideration in pregnant women.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol?
A: Adults: 30-120 mg/day divided into 2-3 doses. Children: Dosage depends on age, typically given as a syrup. Specific dosages should be consulted from pediatric guidelines.
Q2: How long can a patient take Ambroxol?
A: For acute conditions, usually 5-10 days. For chronic conditions, treatment may be longer as directed by the physician. Do not use for more than 7 days without consulting a physician.
Q3: Is Ambroxol safe for children and infants?
A: Yes, when administered at the correct dosage, it is generally considered safe. Consult pediatric guidelines for specific dosing recommendations.
Q4: What are the main contraindications of using Ambroxol?
A: Hypersensitivity to ambroxol or bromhexine, gastric ulcer, and first trimester of pregnancy.
Q5: How does Ambroxol interact with other drugs?
A: While it has limited interactions, caution should be exercised when combining with certain antibiotics and cough suppressants.
Q6: Can Ambroxol be used during pregnancy and breastfeeding?
A: It’s contraindicated in the first trimester of pregnancy. Its use in later pregnancy and during breastfeeding should be determined following a careful assessment of risks and benefits.
Q7: What are the common side effects of Ambroxol?
A: Common side effects include nausea, vomiting, diarrhea, rash, itching, and dizziness.
Q8: What should I do if a patient misses a dose of Ambroxol?
A: If a dose is missed, take it as soon as remembered. Do not double the dose. If it’s close to the next scheduled dose, skip the missed dose and continue the regular schedule.
Q9: How is Ambroxol administered?
A: Ambroxol is available in various forms, including tablets, syrups, solutions for inhalation, and lozenges. The appropriate route of administration will depend on the patient’s age and the specific clinical situation.
Q10: Does ambroxol have a role in intensive care settings?
A: It has been investigated for ARDS in ICU settings, but the evidence is not conclusive. High doses of ambroxol are being considered for potential use in reducing pulmonary complications after surgery, particularly in high-risk patients. More research is needed to fully determine the best way to use it in the ICU.
