Bromhexine: Safety in Special Population

Availability

• Tab Bromhexine HCl 8mg
• Syrup Bromhexine HCl 4mg/5ml

Pharmacokinetic

• Metabolism: Extensive hepatic first-pass metabolism
• Excretion: Via urine (approx 85-90%, mainly as metabolites)

Liver Impairment

• There is no pharmacokinetic data available in the elderly or in patients with renal or liver insufficiency.
• Extensive clinical experience did not give rise to relevant safety concerns in these populations.
• However, reduced clearance of bromhexine parent substance may be expected in the case of severe liver disease
• A transient rise in serum aminotransferase values was seen

Renal Impairment

• In the case of severe renal insufficiency, accumulation of metabolites cannot be ruled out

Pregnancy

• Category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
• Bromhexine crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
• Clinical experience to date has shown no evidence of harmful effects on the fetus during pregnancy. Nonetheless, the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during the first trimester, the use of BISOLVON is not recommended.

Lactation

• Bromhexine is excreted in breast milk. Although unfavourable effects on breastfed infants would not be expected, BISOLVON CHESTY is not recommended for use in breastfeeding mothers.

References:

1. Bisolvan Product Information Leaflet
2. MIMS
3. NPRA- Package Insert Template