Ambroxol

Ambroxol is an antioxidant belonging to Mucolytic agent.

Ambroxol is indicated for airway secretion clearance therapy.

Ambroxol is Rapidly and completely absorbed from the gastrointestinal tract (immediate-release). Bioavailability: 79% (immediate-release); 95% (slow-release).It has Rapid and pronounced distribution into blood, tissues and lungs. Crosses the placenta and enters breast milk. Volume of distribution: Approx 552 L. Plasma protein binding: Approx 90%.

and get Mainly metabolised in the liver via glucuronidation by CYP3A4 and some cleavage into dibromanthranilic acid (approx 10%) and minor metabolites. Undergoes first-pass metabolism (approx 30%). It get excretedVia urine.

The Tmax of Ambroxol was found within 1-2.5 hours.

Ambroxol shows common side effects like Nausea, vomiting, diarrhoea, abdominal distress, heartburn

Ambroxol is available in the form of capsules, solution, syrup, tablet.

Ambroxol is available in India, Germany, Canada, Italy.

Ambroxol is a mucolytic agent that increases respiratory tract secretion by enhancing the production of pulmonary surfactants and stimulating the ciliary activity. This activity results in the improvement of mucociliary clearance and enhancement of fluid secretion which facilitates expectoration and eases cough.

Ambroxol is indicated for airway secretion clearance therapy.

Ambroxol is a mucolytic agent. Excessive Nitric oxide (NO) is associated with inflammatory and some other disturbances of airways function. NO enhances the activation of soluble guanylate cyclase and cGMP accumulation. Ambroxol has been shown to inhibit the NO-dependent activation of soluble guanylate cyclase. It is also possible that the inhibition of NO-dependent activation of soluble guanylate cyclase can suppress the excessive mucus secretion, therefore it lowers the phlegm viscosity and improves the mucociliary transport of bronchial secretions.

Ambroxol is approved for use in the following clinical indications

Secretolytic therapy in bronchopulmonary disease with abnormal mucus secretion and transport.

Oral

As a mucolytic

Adult:

As tab:

Usual dose: 30 mg bid or tid, may be increased to 60 mg bid if necessary. Max: 120 mg daily.

As 30 mg/5 mL syr:

Usual dose: 30 mg bid or tid, or 60 mg bid. As 15 mg/5 mL syr: Usual dose: 30 mg bid or tid.

As 15 mg loz:

Dissolve 2 loz slowly in the mouth tid.

As sustained-release or retard cap:

75 mg once daily. Seek medical advice if symptoms persist for more than 14 days.

Child:

• As 6 mg/mL drops: ≤6 months Usual dose: 3 mg bid;
• 7 months to <1 year Usual dose: 6 mg bid;
• 1-2 years Usual dose: 7.5 mg bid. As 7.5 mg/mL drops: <2 years Usual dose: 7.5 mg bid;
• 2-5 years Usual dose: 7.5 mg tid. As 15 mg/5 mL or 30 mg/5 mL syr: <2 years Usual dose: 7.5 mg bid;
• 2-5 years Usual dose: 7.5 mg tid;
• 6-11 years Usual dose: 15 mg bid or tid;
• ≥12 years Same as adult dose.
• As 15 mg loz: 6-12 years Dissolve 1 loz tid. As tab: 6-11 years Usual dose: 15 mg tid;
• ≥12 years Same as adult dose.

Renal impairment:

Dose reduction may be necessary.

Oral

Sore throat

Adult: As 20 mg loz: Dissolve 1 loz slowly in the mouth as necessary. Max: 6 loz daily. Seek medical advice if symptoms persist for more than 3 days.

Child: ≥12 years Same as adult dose..

Ambroxol is available in various strengths as 75 mg, 20 mg, 7.5 mg/ml,3 g/ml, 30 mg.

Ambroxol is available in the form of capsules, solution, syrup, tablet.

Ambroxol is a Category C pregnancy drug and is not recommended for pregnant women especially in the first 3 months as it may cause harm to the unborn baby.

Breast-feeding

Ambroxol is not recommended while breastfeeding due to limited information on its use. Consult your doctor to understand all risks and benefits associated with it before taking this medicine.

General warnings

Other medicines

Ambroxol may interact with many other medicines and cause severe side effects. Hence, inform your doctor about all your current medicines including herbs and supplements before beginning treatment with this medicine.

Kidney diseases

Ambroxol should be used with caution if you have kidney problems. Impaired kidney function may lead to the accumulation of this medicine in your body and increase the risk of side effects. Your doctor may suggest another suitable medicine or adjust the dose accordingly based on your condition.

Liver dieases

Ambroxol should be used with caution if you have liver problems as this medicine is broken down in your liver. Impaired liver function may lead to the accumulation of this medicine and increase the risk of side effects. Frequent monitoring of liver functions and/or dose adjustments may be necessary based on your condition.

Use in children

Ambroxol should be used in children under doctor's supervision. Tablet form (30mg) is not recommended in children under 6 years of age and syrup form (15mg/5ml) and oral drops is not recommended in children under 2 years of age.

High-fat meal may decrease the rate but not the extent of absorption. Management: May administer with meals.

May increase the concentrations of antibiotics (e.g. cefuroxime, doxycycline, erythromycin, amoxicillin) in the lung tissue.

Pharmacodynamic

Ambroxol is a mucolytic agent that increases respiratory tract secretion by enhancing the production of pulmonary surfactants and stimulating the ciliary activity. This activity results in the improvement of mucociliary clearance and enhancement of fluid secretion which facilitates expectoration and eases cough.

Pharmacokinetics

• Absorption: Rapidly and completely absorbed from the gastrointestinal tract (immediate-release). Bioavailability: 79% (immediate-release); 95% (slow-release). Time to peak plasma concentration: 1-2.5 hours (immediate-release); 6.5 (slow-release).
• Distribution: Rapid and pronounced distribution into blood, tissues and lungs. Crosses the placenta and enters breast milk. Volume of distribution: Approx 552 L. Plasma protein binding: Approx 90%.
• Metabolism: Mainly metabolised in the liver via glucuronidation by CYP3A4 and some cleavage into dibromanthranilic acid (approx 10%) and minor metabolites. Undergoes first-pass metabolism (approx 30%).
• Excretion: Via urine. Terminal elimination half-life: Approx 10 hours.

• https://www.rxlist.com/dopram-drug.htm
• https://www.mims.com/india/drug/info/Ambroxol?type=full&mtype=generic
• https://go.drugbank.com/drugs/DB00561
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7003846/