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OverviewMechanism of ActionHow To UseUsesBenfitsIndicationsMethod of AdministrationDosage StrengthsDosage FormsDietary RestrictionsContraindicationsWarnings and Precautions for usingAdverse ReactionsSide EffectsOverdosage Clinical Pharmacology Clinical StudiesAuthored by Reviewed by References
Bromhexine

Bromhexine

Indications, Uses, Dosage, Drugs Interactions, Side effects
Bromhexine
Medicine Type :
Allopathy
Prescription Type:
Prescription Required
Approval :
DCGI (Drugs Controller General of India)
Schedule
Schedule H
Pharmacological Class:
Mucolytic agent,
Therapy Class:
Antioxidant,

Bromhexine is an antioxidant belonging to Mucolytic agent.

Bromhexine is a mucolytic drug used to decrease the viscosity of mucus in the airway, enhancing mucus clearance including the common cold, influenza, respiratory tract infections, or other conditions

Bromhexine is Rapidly and completely absorbed from the gastrointestinal tract. Its Bioavailability: Approx 22.2 ± 8.5% (tab); 26.8 ± 13.1% (oral solution). It Crosses blood brain-barrier; placenta (small amounts). Plasma protein binding: 95% (unchanged drug).Bromhexine is almost completely metabolised to a variety of hydroxylated metabolites, including Bromhexine and dibromanthranilic acid and Undergoes extensive hepatic first-pass metabolism. It gets excreted Via urine (approx 97.4 ± 1.9%; <1% as unchanged drug). Terminal elimination half-life: 6.6-31.4 hours (single dose).

The Tmax of Bromhexine was found within Approx 1 hour.

Bromhexine shows common side effects like Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis.

Bromhexine is available in the form of , solution, syrup, tablet.

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

Bromhexine is a mucolytic agent that acts on the mucus gland in the respiratory tract to change the structure of bronchial secretion. It enhances the transport of mucus by reducing its viscosity and increases cilia activity resulting in enhanced mucociliary clearance. This secretolytic and secretomotor effect in the bronchial tract facilitates expectoration and relieves cough.

Bromhexine is available in the form of solution, syrup and tablet.

Bromhexine is a mucolytic drug used to decrease the viscosity of mucus in the airway, enhancing mucus clearance including the common cold, influenza, respiratory tract infections, or other conditions.

Inflammation of the airways, increased mucus secretion, and altered mucociliary clearance are the hallmarks of various diseases of the respiratory tract. Mucus clearance is necessary for lung health; bromhexine aids in mucus clearance by reducing the viscosity of mucus and activating the ciliary epithelium, allowing secretions to be expelled from the respiratory tract.

Bromhexine is approved for use in the following clinical indications

  • It is Indicated to reduce mucus viscosity and clear mucus in conditions associated with mucus hypersecretion, including the common cold, influenza, respiratory tract infections, or other conditions.

Oral

Mucolytic

Adult: For the treatment of bronchopulmonary diseases or conditions associated with excessive mucous secretion: 8 mg tid as needed, may be increased to 16 mg tid for the 1st 7 days.

Child: 2-5 years 2 mg tid or 4 mg bid (Max: 8 mg daily); 6-11 years 4-8 mg tid (Max: 24 mg daily); ≥12 years Same as adult dose. 

Bromhexine is available in various strengths as 4 mg/5 mL, 8 mg/5 mL, 8 mg.

Bromhexine is available in the form of , solution, syrup, tablet.

Bromhexine is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to bromhexine hydrochloride (or any of the other ingredients in the product).

General warnings

Gastric ulceration

This medicine is not recommended for use in patients with a known history of gastric ulceration or any other gastrointestinal disorders due to the increased risk of worsening of the patient's condition. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Use in pediatrics

The tablet form of this medicine is not recommended for use in patients below 6 years of age since the safety and efficacy of use are not clinically established.

Duration of usage

This medicine is not recommended for prolonged use. If symptoms do not improve within 14 days, consult your doctor before continuing therapy with this medicine.

Liver impairment

This medicine should be used with caution in patients with a history of liver diseases due to the increased risk of worsening of the patient's condition. Close monitoring of liver function tests, appropriate dose adjustments, or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Renal impairment

This medicine should be used with caution in patients with a history of renal diseases due to the increased risk of worsening of the patient's condition. Close monitoring of kidney function, appropriate dose adjustments, or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Driving or Operating machinery

This medicine may rarely cause dizziness in some patients. It is advised that you do not perform any activities such as driving a vehicle or operating machinery if you experience dizziness during treatment with this medicine.

Pregnancy Warning

Category A: Bromhexine has been taken by a large number of pregnant women and women of child bearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.

  • Common Adverse effects

Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis.

  • Less Common Adverse effects

Diarrhoea, nausea, vomiting, upper abdominal pain.

  • Rare Adverse effects

Rash, sweating, urticaria, pruritus.

Enhances the penetration of antibiotic agents (e.g. amoxicillin, erythromycin, cefuroxime) into bronchial secretions.

The common side effects of Bromhexine include the following Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis.

The oral LD50 of bromhexine in rats is 6 g/kg. The observed symptoms of accidental overdose with bromhexine are consistent with the known adverse effects of bromhexine, including headache, nausea, and vomiting, among other symptoms. Provide symptomatic treatment and contact poison control services if an overdose is confirmed or suspected

Pharmacodynamic

Bromhexine is a mucolytic agent that acts on the mucus gland in the respiratory tract to change the structure of bronchial secretion. It enhances the transport of mucus by reducing its viscosity and increases cilia activity resulting in enhanced mucociliary clearance. This secretolytic and secretomotor effect in the bronchial tract facilitates expectoration and relieves cough.

Pharmacokinetics

  • Absorption: Rapidly and completely absorbed from the gastrointestinal tract. Bioavailability: Approx 22.2 ± 8.5% (tab); 26.8 ± 13.1% (oral solution). Time to peak plasma concentration: Approx 1 hour.
  • Distribution: Crosses blood brain-barrier; placenta (small amounts). Plasma protein binding: 95% (unchanged drug).
  • Metabolism: Almost completely metabolised to a variety of hydroxylated metabolites, including Bromhexine and dibromanthranilic acid. Undergoes extensive hepatic first-pass metabolism.
  • Excretion: Via urine (approx 97.4 ± 1.9%; <1% as unchanged drug). Terminal elimination half-life: 6.6-31.4 hours (single dose).
There are some clinical studies of the drug Bromhexine mentioned below:
  • https://clinicaltrials.gov/ct2/show/NCT04430790
  • https://clinicaltrials.gov/ct2/show/NCT02820025
  • https://pubmed.ncbi.nlm.nih.gov/27612991/
  • https://clinicaltrials.gov/ct2/show/NCT03894189
  • https://www.rxlist.com/dopram-drug.htm
  • https://www.mims.com/india/drug/info/Bromhexine ?type=full&mtype=generic
  • https://go.drugbank.com/drugs/DB00561
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7003846/
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Parthika Patel
Parthika Patel has completed her Graduated B.Pharm from SSR COLLEGE OF PHARMACY and done M.Pharm in Pharmaceutics. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
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Dr JUHI SINGLA
Dr JUHI SINGLA has completed her MBBS from Era’s Lucknow Medical college and done MD pharmacology from SGT UNIVERSITY Gurgaon. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
Published on: 3 Feb 2023 2:15 PM GMT
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