Monograph
R05CB02 - Bromhexine |
Propably not porphyrinogenic |
PNP |
Rationale
Bromhexine is almost completely metabolized and is a Cyp3A4 substrate. It is not listed as an inducer or MBI of CYPs and in therapeutic use no drug-drug interactions involving CYP enzymes has been observed.
Therapeutic characteristics
Bromhexine is indicated for respiratory disorders with viscous mucus.
Metabolism and pharmacokinetics
Bromhexine is almost completely metabolized. The half-life elimination is 1 hour. Ambroxol is a metabolite of bromhexine and in vitro studies have shown that it is metabolized by CYP3A4 (Ischiguro 2000). In vitro studies have also shown that ambroxol is a weak inhibitor (Ischiguro 2000), which indicates that the potential for drug-drug interactions is low (Ischiguro 2000 and Malerba 2008). The Summary of Product Characteristics also states that interactions with CYP2C9 and CYP3A4 are unlikely and in pharmacotherapeutic use no clinically significant DDIs has been observed (DRUID, Interaktionsdatabasen). This indicates that bromhexine or its metabolites do not act as inducers or inhibitors of CYP enzymes in vivo.
IPNet drug reports
Uneventful use reported in 9 patients with acute porphyria.
Similar drugs
References
| # | Citation details | PMID |
|---|---|---|
| * | Scientific articles | |
| 1. | Identification of CYP3A4 as the predominant isoform responsible for the metabolism of ambroxol in human liver microsomes.
Ishiguro N, Senda C, et al. Xenobiotica. 2000 Jan;30(1):71-80. |
|
| 2. | Ambroxol in the 21st century: pharmacological and clinical update.
Malerba M, Ragnoli B. Expert Opin Drug Metab Toxicol. 2008 Aug;4(8):1119-29. |
18680446 |
| * | Drug interaction databases | |
| 3. | DRUID bromhexin
|
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| 4. | Interaktionsdatabasen bromhexin
|
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| * | Summary of Product Characteristics | |
| 5. | Norwegian medicines agency. Summary of Product Characteristics (SPC). Bromhexin.
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Tradenames
This list comprises raw data collected from different countries.
In some cases, a more comprehensive list of available drug packages is included.
Consequently, very similar terms may therefore appear multiple times.
Bold names are the searchable terms, while the gray names that follow are all mapped to the bolded term.
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Albert Heijn Broomhexine HCl hoesttabletten 8 mg, tabletten · Albert Heijn Hoestdrank Broomhexine HCl 4 mg/5 ml, drank · Albert Heijn Hoestdrank Broomhexine HCl 8 mg/5 ml, drank · Bisolvon drank voor kinderen met aardbeiensmaak, 4 mg/5 ml · Bisolvon drank, 8 mg/5 ml · Bisolvon tabletten, 8 mg · Broomhexine HCI 8 mg Sameko, tabletten · Broomhexine HCl 8 mg, tabletten · Broomhexine HCl CF 4 mg/ 5 ml, drank · Broomhexine HCl CF 8 mg/5 ml, drank · Broomhexine HCl hoestdrank extra sterk suikervrij Sanias 8 mg/5 ml, drank · Broomhexine HCl hoestdrank suikervrij Sanias 4 mg/5 ml, drank · Broomhexine HCl hoesttabletten Sanias 8 mg, tabletten · Broomhexine HCl Linn 8 mg hoesttabletten · Broomhexine HCl Linn 8 mg/5 ml hoestdrank suikervrij, drank · Broomhexine HCl SAM 4 mg/5 ml, drank · Broomhexine HCl SAM 8 mg/5 ml, drank · Broomhexine HCl Teva 4 mg/5 ml, drank · Broomhexine HCl Teva 8 mg/5 ml, drank · DA Hoestdrank Broomhexine HCl 4 mg/5 ml, drank · DA Hoestdrank Broomhexine HCl 8 mg/5 ml, drank · Etos Hoestdrank Broomhexine HCl 4 mg/5 ml, drank · Etos Hoestdrank Broomhexine HCl 8 mg/5 ml, drank · Etos Hoesttabletten Broomhexine HCI 8 mg, tabletten · Hoestdrank HTP Broomhexine HCl 4 mg/5 ml, drank · Hoestdrank HTP Broomhexine HCl 8 mg/5 ml, drank · JUMBO Broomhexine HCl 4 mg/5 ml Hoestdrank, suikervrij, drank · JUMBO Broomhexine HCl 8 mg/5 ml Hoestdrank extra sterk, suikervrij, drank · JUMBO hoesttabletten broomhexine HCl 8 mg, tabletten · Kruidvat broomhexine HCl hoestdrank 4 mg/5 ml suikervrij, drank · Kruidvat broomhexine HCl hoestdrank 8 mg/5 ml extra sterk suikervrij, drank · Kruidvat hoesttabletten broomhexine HCl 8 mg, tabletten · Leidapharm Hoestdrank Broomhexine HCl 4 mg/5 ml, suikervrij, drank · Leidapharm Hoestdrank Broomhexine HCl 8 mg/5 ml, suikervrij, drank · Leidapharm Hoesttabletten Broomhexine HCl 8 mg, tabletten · Livsane Hoestdrank Broomhexine HCl 8 mg/5 ml, drank · Natterman Hoestdrank Broomhexine HCl 4mg/5ml suikervrij, drank · Natterman Hoestdrank Extra Sterk Broomhexine HCl 8mg/5ml suikervrij, drank · RXT broomhexine HCl 8 mg hoesttabletten, tabletten · Trekpleister broomhexine HCl hoestdrank 4 mg/5 ml suikervrij, drank · Trekpleister broomhexine HCl hoestdrank 8 mg/5 ml extra sterk suikervrij, drank · Trekpleister hoesttabletten broomhexine HCl 8 mg, tabletten · Xelf Broomhexine HCl 4 mg/5 ml, drank · Xelf Broomhexine HCl 8 mg/5 ml, drank 
Bisolvon · Bisolvon Slijmhoest 0.2 % sol. inhal. n?bul. · Bisolvon Slijmhoest 8 mg comp. · Bisolvon Slijmhoest 8 mg/5 ml sirop · Bromhexine EG 8 mg comp. · Toularynx Bromhexine 5 mg/5 ml sirop 
BISOLVON MUCOLITICO 1,6 mg/ ml JARABE · BISOLVON MUCOLITICO 8 mg COMPRIMIDOS SOLUBLES · Bisolvon Mucolitico Infantil 0,8 mg/ml Jarabe · PECTODIL 2 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION · PECTODIL 2 mg/ml SOLUCION ORAL/CONCENTRADO PARA SOLUCION PARA INHALACION POR NEBULIZADOR 
BROMFLUEX 12 mg · BROMFLUEX 8 mg · BROMHEXIN ARENA 12 mg · BROMHEXIN ARENA 8 mg · BROMHEXIN LABORMED 8 mg · Bromhexin - t · BROMHEXIN ATB 8 mg · BROMHEXIN FARMACOM 8 mg · BROMHEXIN HELCOR 8 mg · BROMHEXIN LAROPHARM 12 mg · BROMHEXIN MCC 8 mg · BROMHEXIN ROMPHARM 2mg/ml · BROMHEXIN SLAVIA 8 mg · BRONHOSOLV 10 mg/5 ml · BRONHOSOLV 8 mg · TUSEXIN 12 mg 
Bisolvon Chesty 
Bisolvon · Bromhexin DAK 
Bisolvon · Bromheksin Norfri 
Flegafortan · Flegamina Baby · Flegamina Classic · Flegamina Classic Junior o smaku truskawkowym · Flegamina Classic o smaku malinowym · Flegamina Classic o smaku mietowym bez cukru · Flegamina Fast · Flegamina Fast Junior · Flegtac Kaszel · Flegtac ORO 
BISOLVON Toux grasse · Toularynx Bromhexine 
S?nex · Sínex 
Bisolvon · Bisolvon Strong · Medipekt 
Bromhexin Sopharma · Bromhexine-Grindeks 
Bisolvon®
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