Bromhexine

Bromhexine

Drug Nomenclature

Date of monograph revision: 13-Oct-1997; 23-Jun-1998; 07-Apr-2000; 01-Nov-2001; 01-Jul-2004; 05-Jul-2006; (last modified: 24-Jul-2006)
Synonyms: Bromexina; Bromhexin; Bromhexina; Bromhexinum; Bromiheksiini
BAN: Bromhexine
INN: Bromhexine [rINN (en)]
INN: Bromhexina [rINN (es)]
INN: Bromhexine [rINN (fr)]
INN: Bromhexinum [rINN (la)]
INN: Бромгексин [rINN (ru)]
Chemical name: 2-Amino-3,5-dibromobenzyl(cyclohexyl)methylamine
Molecular formula: C14H20Br2N2 =376.1
CAS: 3572-43-8
ATC code: R05CB02
Chemical Structure of Bromhexine

Chemical Structure of Bromhexine

Bromhexine Hydrochloride

Drug Nomenclature

Date of monograph revision: 13-Oct-1997; 23-Jun-1998; 07-Apr-2000; 01-Nov-2001; 01-Jul-2004; 05-Jul-2006; (last modified: 24-Jul-2006)
Synonyms: Brómhexin-hidroklorid; Bromheksino hidrochloridas; Bromhexin-hydrochlorid; Bromhexina, hidrocloruro de; Bromhexinhydroklorid; Bromhexini Hydrochloridum; Bromiheksiinihydrokloridi; Cloridrato de Bromexina; NA-274
BAN: Bromhexine Hydrochloride [BANM]
USAN: Bromhexine Hydrochloride
INN: Bromhexine Hydrochloride [rINNM (en)]
INN: Hidrocloruro de bromhexina [rINNM (es)]
INN: Bromhexine, Chlorhydrate de [rINNM (fr)]
INN: Bromhexini Hydrochloridum [rINNM (la)]
INN: Бромгексина Гидрохлорид [rINNM (ru)]
Molecular formula: C14H20Br2N2,HCl =412.6
CAS: 611-75-6
ATC code: R05CB02
Read code: y00DD
Pharmacopoeias:

In Chin., Eur. (see Go to European Pharmacopoeia Convention Signatories), Jpn, and Pol.

Ph. Eur. 5.5 (Bromhexine Hydrochloride). A white or almost white crystalline powder. It exhibits polymorphism. Very slightly soluble in water; slightly soluble in alcohol and in dichloromethane. Protect from light.

Adverse Effects

Gastrointestinal adverse effects may occur occasionally with bromhexine and a transient rise in serum aminotransferase values has been reported. Other reported adverse effects include headache, dizziness, sweating, and skin rashes. Inhalation of bromhexine has occasionally produced cough or bronchospasm in susceptible subjects.

Precautions

Since mucolytics may disrupt the gastric mucosal barrier bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic or renal impairment.

Pharmacokinetics

Bromhexine hydrochloride is rapidly absorbed from the gastrointestinal tract and undergoes extensive first-pass metabolism in the liver: its oral bioavailability is stated to be only about 20%. It is widely distributed to body tissues. About 85 to 90% of a dose is excreted in the urine mainly as metabolites. Ambroxol (Go to Ambroxol Hydrochloride) is a metabolite of bromhexine. Bromhexine is highly bound to plasma proteins. It has a terminal elimination half-life of up to about 12 hours. Bromhexine crosses the blood-brain barrier and small amounts cross the placenta.

Bromhexine hydrochloride given by mouth to healthy subjects produced peak plasma concentrations after about 1 hour.1 Only small amounts were excreted unchanged in the urine with a half-life of about 6.5 hours.

  1. 1. Bechgaard E, Nielsen A. Bioavailability of bromhexine tablets and preliminary pharmacokinetics in humans. Biopharm Drug Dispos 1982; 3: 337–44. PubMed

Uses and Administration

Bromhexine is a mucolytic used in the treatment of respiratory disorders associated with productive cough (Go to Cough). Bromhexine is usually given by mouth in a dose of 8 to 16 mg of the hydrochloride three times daily. It has also been given by deep intramuscular or slow intravenous injection or inhaled as an aerosol solution.

Bromhexine has also been used orally and topically in the treatment of dry eye associated with abnormal mucus production (see Go to Dry eye.).

Dry eye.

Bromhexine has been used orally in the treatment of dry eye (Go to Dry eye) in Sjögren's syndrome but results have been conflicting,1-3 and it appears to have no effect on tear secretion in healthy subjects.4 It has also been tried topically.

  1. 1. Frost-Larsen K, et al. Sjögren's syndrome treated with bromhexine: a randomised clinical study. BMJ 1978; 1: 1579–81. PubMed
  2. 2. Tapper-Jones LM, et al. Sjögren's syndrome treated with bromhexine: a reassessment. BMJ 1980; 280: 1356. PubMed
  3. 3. Prause JU, et al. Lacrimal and salivary secretion in Sjögren's syndrome: the effect of systemic treatment with bromhexine. Acta Ophthalmol (Copenh) 1984; 62: 489–97. PubMed
  4. 4. Avisar R, et al. Oral bromhexine has no effect on tear secretion in healthy subjects. Ann Pharmacother 1996; 30: 1498. PubMed

Respiratory-tract infection.

Use with an antibacterial.

Bromhexine has been shown to enhance the penetration of erythromycin into bronchial secretions.1 Although bromhexine is used as an adjuvant in the treatment of respiratory infections, few controlled studies appear to have been conducted to determine if any additional benefit is obtained. However, some studies have found improved responses with cefalexin2 and amoxicillin.3

  1. 1. Bergogne-Berezin E, et al. Etude de l'influence d'un agent mucolytique (bromhexine) sur le passage de l'érythromycine dans les sécrétions bronchiques. Therapie 1979; 34: 705–11. PubMed
  2. 2. Boraldi F, Palmieri B. Antibiotic and mucolytic therapy in elderly patients with different cases of bronchopulmonary diseases. Curr Ther Res 1983; 33: 686–91.
  3. 3. Roa CC, Dantes RB. Clinical effectiveness of a combination of bromhexine and amoxicillin in lower respiratory tract infection: a randomized controlled trial. Arzneimittelforschung 1995; 45: 267–72. PubMed

Preparations

Single-ingredient Preparations

The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.

Argentina: Amiorel; Aseptobron Expectorante; Balsasulf; Bisolvon; Bromexidryl; Broncocalmine; Brondilax; Bronquisedan Elixir; Bronquisedan Paediatrico; Catarrosine¤; Expectosan Extra Forte; Funciobron B; Jarabe Medex; Lisi-Tos; Lorbi-Bis; Lorbi; Namir; Nastizol Expectorante; No-Tos Mucolitico; Pectoral Pagliano; Pulmosan; Qura Plus; Toscalmin; Tostop; Australia: Bisolvon Chesty; Dur-Elix¤; Duro-Tuss Mucolytic Cough Liquid; Austria: Bisolvon; Belgium: Bisolvon; Bromex; Bronchi-Mereprine; Brazil: Bisolvon; Clarus; Chile: Bisolvon; Flumed; Czech Republic: Bisolvon; Flegamina; Paxirasol; Denmark: Bisolvon; Viscolyt¤; Finland: Bisolvon; Medipekt; Mucovin; France: Bisolvon; Germany: Aparsonin N; Auxit¤; Bisolvon F¤; Bisolvon; Dakryo Biciron¤; Hustentabs; Lubrirhin¤; Omniapharm; Ophtosol¤; Greece: Bisolvon; Bolisegna¤; Bromiramin¤; Bronchotussine; Hong Kong: Asthmaxine; Bisolvon; Bromoson; Bromxine; Duro-Tuss Mucolytic; Exolit; Mucolix¤; Vasican; Hungary: Paxirasol; India: Bromex; Ireland: Bisolvon; Israel: Movex; Solvex; Italy: Bisolvon; Broncokin; Japan: Bisolvon; Malaysia: Beacolytic; Bislan; Bisolvon; Bromxine; Ekxine¤; Hexolvon¤; Vasican; Mexico: Bisolvon; Bromicof; Dibroxin¤; Dizolvin; Nastizol Ex; Normoflex; Tesacof; Toridran-N; Netherlands: Bisolvon; Darolan Slijmplossende; Famel Broomhexine¤; Norway: Bisolvon; New Zealand: Bisolvon Chesty; Duro-Tuss Mucolytic¤; Portugal: Bisolvon; Lisomucin; Tosseque¤; Russia: Flegamin (Флегамин); South Africa: Bisolvon; Bronkese; Dur-Elix¤; Singapore: Bislan¤; Bisolvon; Bromxine; Broxine¤; Duro-Tuss Mucolytic; Exolit¤; Mucosol¤; Vasican; Spain: Bisolvon; Sweden: Bisolvon; Switzerland: Bisolvon; Broncodil¤; Hustosol¤; Metasolvens¤; Solvolin¤; Thailand: Asovon; Axistal; Behexine; Bislan¤; Bisoltab; Bisolvon; Bomexin¤; Bromex¤; Bromoson; Bromso; Bromxin; Bromxine; Bronclear; Disol; Dutross; Exolit; Ida; Manovon; Mihexine; Mucine; Mucola¤; Mucoxin; Ohexine; Romulin; Tromadil; United Arab Emirates: Mucolyte; Venezuela: Bexilon; Bisectron; Bisolvon; Bromedrina; Brometix; Bromox; Bronacim; Drometox; Inquixol; Kecnitril; Lisomucin; Mucobrol; Reosil; Tolmix;

Multi-ingredient Preparations

The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.

Argentina: Agrip; Amiorel Compuesto DM; Amox-G Bronquial; Amplibenzatin Bronquial; Aseptobron Bromexina; Bio Grip Classic; Bisolvon Compositum NF; Cofron; Cor-Tagrip; Dosulfin Bronquial; Duflegrip; Eritrobron; Espectocural; Factor Antigripal; Frenotos Muc; Grinsil Respiratorio; Nastizol Compositum; Neo-Tosel; Neumobacticel; Nexogrip; Notozen; Panotos NF; Panotos; Pantomucol; Pectoral Hebert NF; Pulmocler; Qura; Refrianex Compuesto; Refrianex; Rondec Compositum¤; Selectus FN; Selectus; Termogrip; Toxam; Australia: Benadryl for the Family Chesty Forte¤; Bisolvon Sinus; Chemists Own Chesty Cough¤; Chemists Own Chesty Mucus Cough¤; Dimetapp Chesty Cough; Dur-Elix Plus¤; Duro-Tuss Expectorant; Duro-Tuss Sinus; Logicin Expectorant; Ordov Chesty Cough; Robitussin ME; Tussinol Expectorant¤; Austria: Asthma-Bisolvon¤; Bisolvomycin¤; Bisolvonamid¤; Bisolvotin¤; Brazil: Amoxifar Balsamico¤; Baknyl¤; Bisolvon Complex¤; Broncatar; Bronco Cilimox¤; Bronco-Amoxil¤; Bronco-Polimoxil; Bronkotrat¤; Novocilin Balsamico¤; Chile: Bauxol; Brontal; Cofron¤; Diadicon; Mucobrol; Czech Republic: Bronchosan; France: Bisolvomycine¤; Germany: Abiadin¤; Asthma-Bisolvon¤; Berotec solvens¤; Bisolvomed mit Codein¤; Bisolvomed¤; Bisolvomycin¤; Bisolvon Gribletten¤; Bisolvonamid¤; Bisolvonat¤; Broncho-Noleptan¤; Codicaps B¤; Codyl cum expectorans¤; Customed¤; Muco Panoral¤; Synergomycin¤; Tetra-Abiadin¤; Hong Kong: Bromhexine Compound; DF Multi-Symptom; Duro-Tuss Expectorant; Methor-Co; Metoplex; Robitussin ME; Vida Cough; Vidatapp; Hungary: Nasopax; India: Albutamol; Alpha-Zedex¤; Ascoril +; Ascoril +; Asmotone Plus; Bro-Zedex; Bromolin; Bronchosolvin; Cheston DT; Cheston; Cof Q; Cof QX; Cofdex Forte; Cofdex P; Cofdex; Cofvyn; Coscopin BR; Deletus P; Gocold; Grilinctus-BM; Mucolinc; Mucosol; Okaril Plus; Okaril; Pulmo-Rest Expectorant; Pulmo-Rest; Respimox; Sedosolvin; Siokof-P; Solvin; Suprivent; Terpect; Terphylate; Toscof; Tuspel Plus; Zedex-P; Zedex; Zeecof; Zeet Expectorant; Zeet Expectorant; Ireland: Alupent Expectorant; Italy: Bertabronc¤; Bisolpent¤; Bisolvomicin¤; Desalfa¤; Solvelin¤; Tauglicolo; Mexico: Ambrexin; Amoxibron; Berosolvon; Bisolpent Ex; Bromixen; Bromoxil; Brupen Compuesto; Duracef Expec; Eriwest; Fluxedan; Hidramox-M¤; Isobutil; Lumoxbron S; Mucocef; Mucoxina; Pantobron; Penamox M; Pentibrom; Pentrexyl Expec; Quimobrom; New Zealand: Benadryl Chesty Forte; Bisolvon Sinus; Duro-Tuss Expectorant; Robitussin ME; Russia: Ascoril Expectorant (Аскорил Експекторант); Zedex (Зедекс); South Africa: Adco-Linctopent; Benylin Chesty; Bisolpent¤; Bisolvomycin¤; Bisolvon Linctus DA; Bronkese Compound; Flemeze; Singapore: Duro-Tuss Expectorant; Spain: Agerpen Mucolitico¤; Aletor Compositum¤; Alibron¤; Alongamicina Balsa¤; Amo Resan¤; Amoxi Gobens Mucol; Ampiciliber Bronquial¤; Ampilevel; Ardine Bronquial; Argemox Mucolitico¤; Bactopumon; Bactosone¤; Balsoprim; Bequipecto¤; Bimoxi Mucolitico¤; Bio Espectrum¤; Bisolvon Amoxycilina¤; Bisolvon Ampicil Retard¤; Bisolvon Ampicilina¤; Bisolvon Ciclina¤; Bisolvon Compositum; Brisantin¤; Brolimine Antibiotico¤; Bronco Aseptilex Fuerte; Bronco Aseptilex Tetra¤; Bronco Bactifor¤; Bronco Pensusan¤; Bronco Quintoxil¤; Bronco Sergo¤; Bronco Tonic; Broncobacter¤; Broncolitic¤; Bronconovag¤; Broncosolvente Mucolitic¤; Broncotyfen¤; Bronquidiazina CR; Bronquinflamatoria¤; Bronquium Amoxicilina¤; Bronquium¤; Broxamox¤; Cilinvita Bronquial¤; Clamoxyl Mucolitico; Combitorax¤; Complexobiotico Bals¤; Dalux Bronquial¤; Damoxicil Mucolitico¤; Disneumon Mucolitico¤; Edoxil Mucolitico¤; Espectona Compositum¤; Espectrosira; Hortemox¤; Hosboral Bronquial¤; Inexbron Mucolitico¤; Kefloridina Mucolitico¤; Libetusin¤; Metabacter Bronquial¤; Metalcor Bronquial¤; Metifarma Mucolit¤; Miliken Mucol Med Retard¤; Miliken Mucol Retard¤; Miliken Mucolitico¤; Mitibron¤; Moxipin Mucolitico¤; Mucobiotina¤; Neumobac¤; Neumobronquial¤; Neumotrim¤; Pectomox¤; Penisintex Bronquial¤; Precopen Mucolitico¤; Prindex Mucolitico¤; Prosbis¤; Pulminflamatoria¤; Pulmo Borbalan; Pulmo Menal¤; Pulmo Vinco¤; Pulmosterin Duo; Pulmosterin Meta¤; Rea Amoxicilina¤; Rea Tos Amoxicilina¤; Rea Tos¤; Remisan Mucolitico; Resan Mucolitico¤; Resan Retard¤; Resisten Retard¤; Retarpen Mucolitico¤; Salvapen Mucolitico; Sinus¤; Superpeni Mucolitico¤; Tresium¤; Xibornol Prodes¤; Sweden: Mollipect; Switzerland: Bisolvon Linctus; Bisolvon Pilules antigrippales¤; Thailand: Bisolvon EX; Bromso-Ex; Bronchoprex Expectorant; Dutross-P200; Ida-D; Kupa; Med-Mucolo¤; Nasorest¤; Presco; Tauglicolo; Tusno; Venezuela: Berosolvon; Bisolpent; Broxamel; Broxodin; Opilina Compuesta; Oxolavin Compuesto; Salbomex; Tolmex;



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