Brostin DS

• Respiratory Conditions with Viscous Mucus:
• Treatment of productive cough associated with acute and chronic bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD), and other respiratory tract disorders characterized by excessive or thick mucus.
• Mucolytic Adjunct Therapy:
• Used to facilitate expectoration by reducing mucus viscosity and improving mucociliary clearance.
• Off-label Uses:
• May be used in upper respiratory tract infections and sinusitis where mucus hypersecretion is problematic.
• Adjunct in pediatric respiratory conditions requiring mucus clearance (age-dependent).

• Adults and Adolescents (≥12 years):
• Oral tablets or syrup: 8–16 mg three times daily.
• Children (2–12 years):
• Dosage adjusted by age/weight; commonly 4–8 mg three times daily (check specific pediatric dosing guidelines).
• Elderly:
• No specific dose adjustment; start with standard dose, monitor tolerability.
• Renal or Hepatic Impairment:
• Use with caution; no formal dose adjustments but careful monitoring advised.
• Administration:
• Oral route, tablets swallowed with water or syrup given directly.
• Can be taken with or without food.
• Duration typically 5–7 days depending on clinical response.

Bromhexine hydrochloride acts as a mucolytic agent by stimulating the production of serous mucus in the respiratory tract, which decreases the viscosity and adhesiveness of phlegm. It facilitates enzymatic breakdown of mucopolysaccharide fibers in mucus, enhancing clearance through improved ciliary activity and easier expectoration. This leads to improved airway patency and respiratory function by promoting the removal of secretions.

• Absorption:
• Rapidly absorbed from the gastrointestinal tract with oral administration.
• Peak plasma concentrations reached within 1 hour post-dose.
• Distribution:
• Widely distributed in tissues, including lungs and bronchial secretions.
• Approximately 75–90% plasma protein binding.
• Metabolism:
• Extensively metabolized in the liver via demethylation and conjugation.
• Elimination:
• Mainly excreted via urine, with a small fraction unchanged.
• Half-life:
• Elimination half-life ranges from 12 to 15 hours.

• Pregnancy:
• No established FDA pregnancy category.
• Limited human data; animal studies show no significant teratogenic effects. Use only if clearly needed and after risk-benefit assessment.
• Lactation:
• Bromhexine is excreted in breast milk in small amounts. Use caution during breastfeeding; consider alternatives if possible.

• Primary Class: Mucolytic Agent
• Subclass: Respiratory Expectorant

• Known hypersensitivity to bromhexine or any formulation components.
• Severe hepatic or renal impairment (relative contraindication; use cautiously).
• Peptic ulcer disease (caution advised).

• Use cautiously in patients with gastric ulcers or gastrointestinal irritation.
• Rare risk of allergic reactions including rash or angioedema; discontinue if these occur.
• Not recommended for children under 2 years of age unless specifically prescribed.
• Caution in patients with impaired hepatic or renal function.
• Avoid use if cough is unproductive or in conditions where mucus clearance is not beneficial.

• Common:
• Gastrointestinal discomfort (nausea, vomiting, diarrhea)
• Mild abdominal pain
• Less Common:
• Hypersensitivity reactions (rash, urticaria)
• Headache
• Rare:
• Anaphylactic reactions (very rare)
• Bronchospasm (especially in asthmatic patients)

• No significant drug interactions reported.
• May enhance the absorption of certain antibiotics (e.g., amoxicillin, erythromycin) by improving mucus clearance.
• Caution when used with other mucolytics or expectorants to avoid excessive thinning of secretions.
• No known CYP450 enzyme interactions.

• Clinical guidelines continue to support bromhexine as an effective mucolytic for managing thick mucus in bronchopulmonary diseases.
• No major recent changes in indications or dosing.
• Emphasis on caution in pediatric use and avoiding in cases with dry, nonproductive cough.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep container tightly closed.
• Keep out of reach of children.