Edition 38
TH
The NEW Martindale NEW The
INTERNATIONAL
OBJECTIVE & UNBIASED & OBJECTIVE
WIDE REACHING WIDE AUTHORITATIVE
Since its very first edition, Martindale: The Complete Drug Reference has been relied upon by pharmacists for information on drugs and medicines. Now, this completely revised and updated 38TH edition once again sets a new standard for the breadth and volume of content on offer in a single resource. What makes the 38TH edition so special? • The new Martindale has been redesigned to make it easier to access information, with greater emphasis on uses and administration. So, when you have a query, you’ll get to the right answer quickly. • The content has been expanded, with over 200 new monographs and increased global coverage of proprietary preparations. • Underpinning Martindale is the same stringent, independent and objective editorial process that has made Martindale indispensable to pharmacists across the globe.
• The 38TH edition contains : - Over 6,000 drug monographs including over 200 new to this edition - Information on over 180,000 drug preparations - Over 54,000 reference citations - Details of almost 20,000 drug manufacturers and distributors - Information on proprietary drug preparations from 43 countries and regions • As well as drugs and medicines, Martindale includes over 700 disease reviews and information on herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins and poisons.
Preparations ...... (details are given in Volume B) Proprietary Preparations duration of action of bambuterol of at least 24 hours. USA: Tornalate†. Hydrolysis of bambuterol is catalysed by plasma cholin- Single-ingredient Preparations. Bambuterol Hydrochloride esterase; however, bambuterol also inhibits plasma cholin- : esterase and therefore partly inhibits its own metabolism. (BANM, rINNM) For the metabolism and excretion of terbutaline, see Bufylline (BAN) p. 1229.1. Bambutérol, Chlorhydrate de; Bambuterol, hidrocloruro de; Ambuphylline (USAN); Bufilina; Theophylline-aminoisobuta- Clin Pharmacokinet . Bambuterol-hidroklorid; Bambuterolhydrochlorid;rolhydroklorid; Bambuteroli Bambu- References. nol; Буфиллин 1. Sitar DS. Clinical pharmacokinetics of bambuterol. Br J terol-hydrochlorid; Bambute 1996; 31: 246–56. 2-Amino-2-methylpropan-1-ol theophyllinate. . Pharmacokinetics of bambuterol in healthy subjects. =269.3 hydrochloridum; Bambuterolihydrokloridi; Bambuterolio et al C H19N5O3 2. Nyberg L, 1998; 45: 471–8. 11 Clin Pharmacol 1998; — 5634-34-4. hidrochloridas; Hidrocloruro de. bambuterol; KWD-2183; . Pharmacokinetics of bambuterol in subjectsBr J Clin Pharmacol homozygous CAS -phenylene bis 3. Bang U, et al Бамбутерола Гидрохлорид m ATC — R03DA10. tert-Butylamino-1-hydroxyethyl)- for the atypical gene for plasma cholinesterase. QR03DA10. (RS)-5-(2- 45: 479–84. 48: 299– ATC Vet — et al . Pharmacokinetics of bambuterol during1999; oral (dimethylcarbamate) hydrochloride. 4. Ahlstro ¨ m H, Br J Clin Pharmacol UNII — VOU5V0B772. administration to asthmatic children. H29N3O5,HCl=403.9 C18 308. Br J Clin — 81732-65-2 (bambuterol); 81732-46-9 (bambuterol et al . Pharmacokinetics of bambuterol during oral CAS 5. Rosenborg J, Profile administration of plain tablets and solution to healthy adults...... monohydrochloride). 2000; 49: 199–206. ATC — R03CC12. Pharmacol Bufylline is a theophylline derivative (p. 1229.3) that has ATC Vet — QR03CC12. been used for its bronchodilator effects as an ingredient of — 786Q84QZ3F. Preparations preparations promoted for coughs and other respiratory- Drug UNII ...... Eur. (see p. vii). (details are given in Volume B) tract disorders. The ethiodide has also been used. In Proprietary Preparations Braz.: Bam- Pharmacopoeias. Austria: Bambec; 帮备); The new layout and (Bambuterol Hydrochloride). A white or almost 利); Bambec ( Ph. Eur. 8: Single-ingredient Preparations. 奥多 Preparations nomenclature China: Ao Duo Li ( 汇杰); Li Ke ...... white crystalline powder. It exhibits polymorphism. Freely bair; Bambec; 贝合健); Hui Jie ( 祝龙); (details are given in Volume B) 邦顺); Bei He Jian ( 罗利); Zhu Long ( Proprietary Preparations soluble in water; soluble in alcohol. BangShun ( 洛希); LuoLi ( : Abel; Braz.: EMS Expectorante; Revenil S. 可菲); Luo Xi ( : Bambec; India design of Martindale Fei ( 立 Fr.: Oxeol; Ger. NZ: Multi-ingredient Preparations. highlighted for Norw.: Bambec; Uses and Administration Denm.: Bambec; Oxeol; Singapore: Dospan; Revenil Expectorante; Revenil; Xpe Expectorante; ...... Asthafree; Bambudil; Bemlo; Betaday; UK: Afr.: Nethaprin Dospan†; Nethaprin Expectorant†. TH Philipp.: Bambec; Bambutec; Pulmitac;Thai.: Bambec; Bambuterol is an inactive prodrug of terbutaline Bambec; Swed.: Bambec; 38 edition make clarity 2 Spain: Bambec; (p. 1228.1), a direct-acting sympathomimetic with mainly Bambec; New typography beta-adrenergic activity and a selective action on beta Bambec. (BAN) 2 agonist). It has similar actions to those of India: Montair Plus; Monway Caffeine receptors (a beta it even easier for salbutamol (p. 1220.2) except that it has a more prolonged Multi-ingredient Preparations. Anhydrous Caffeine; Cafeína; Cafeína anhidra; Caféine; makes Martindale Plus; Odimont Plus. duration of action (at least 24 hours). Bambuterol Coffein; Coffeinum; Guaranina; Guaranine; Kofeiini; Kofein; hydrochloride is used as a long-acting bronchodilator for Kofeina; Kofeinas; Koffein;Кофеин Methyltheobromine;. Metilteobro- easier to use you to find the persistent reversible airways obstruction in conditions such mina; Teína; Théine; H,1H)-dione; 1,3,7-Trimethyl- as asthma (p. 1195.2). The usual dose is 10 to 20 mg orally Bamifylline Hydrochloride 1,3,7-Trimethylpurine-2,6(3 once daily at bedtime. Doses may need to be reduced in (BANM, USAN, rINNM) xanthine; 7-Methyltheophylline. renal impairment (see below). N O2=194.2 Licensed product AC-3810; Bamifilina, hidrocloruro de; Bamifylline, Chlorhy- C8H10 4 reliable, unbiased drate de; Bamifyllini Hydrochloridum; BAX-2739Z;Бамифиллина 8102-CB; CAS — 58-08-2. Administration in renal impairment. ATC — N06BC01. information recommends that the initial dose of bambu- CB-8102; Hidrocloruro de bamifilina; . ATC Vet — QN06BC01. Uses and terol hydrochloride should be halved in patients with Гидрохлорид N-2-hydroxyethylamino)ethyl]theo- drugs and medicines N-ethyl- UNII — 3G6A5W338E. renal impairment (glomerular filtration rate less than 8-Benzyl-7-[2-( 50 mL/minute). Further doses should be adjusted accord- phylline hydrochloride. NOTE. Compounded preparations of caffeine may be N O3,HCl=421.9 Administration ing to response. C20H27 5 represented by the followingPEN)—butalbital, names: paracetamol, and — 2016-63-9 (bamifylline); 20684-06-4 (bamifylline Co-bucafAPAP ( information you CAS . Viet. References. caffeine. , Jpn, US, and Clearer text Asthma. et al . Therapeutic equivalence between bambuterol, hydrochloride). (see p. vii), Int. now located at 1. Fugleholm AM, R03DA08. In Eur. 1993; 6: 1474–8. ATC — Pharmacopoeias. 10 mg once daily, and terbutalineEur Respir controlled J release, 5 mg twice daily, in QR03DA08. mild to moderate asthma. ATC Vet — Some pharmacopoeias include caffeine and caffeine hydrate need and can depend . Comparison of the efficacy, tolerability and patient et al — 66466QLM3S. structure makes the start of each 2. Gunn SD, Eur J Clin Pharmacol UNII under one monograph. acceptability of once-daily bambuterol tablets against twice-daily (Caffeine). A white or almost white, crystalline controlled release salbutamol in nocturnal asthma. Ph. Eur. 8: 1995; 48: 23–8. powder or silky white or almost white crystals. It sublimes each entry easier upon. It is published et al . The Bambuterol Multicentre Study Group. One-year 29: monograph 3. Zarkovic JP, 2000; Profile readily. Sparingly soluble in water; freely soluble in boiling Pediatr Pulmonol ...... safety study with bambuterol once daily and terbutaline three times daily in 2-12-year-old children with asthma. Bamifylline hydrochloride is a theophylline derivative water; slightly soluble in dehydrated alcohol. It dissolves in (p. 1229.3) that is used for its bronchodilator properties in concentrated solutions of alkali benzoates or salicylates. to find 424–9. in print as a practical, reversible airways obstruction. It is not converted to USP 36: (Caffeine). It is anhydrous or contains one Adverse Effects and Precautions theophylline in the body. It is given in usual oral doses of molecule of water of hydration. An odourless white powder ...... 600 or 900 mg daily in 2 or 3 divided doses. It is also given or white, glistening needles, usually matted together. The two-volume set. As for Salbutamol, p. 1221.3. Bambuterol is not rectally as suppositories, and by slow intravenous infusion. hydrate is efflorescent in air. The hydrate is soluble 1 in 50 of recommended for patients with severe hepatic impairment water, 1 in 75 of alcohol, 1 in 6 of chloroform, and 1 in 600 as its metabolism would be unpredictable. The dose of Preparations of ether. The hydrate should be stored in airtight containers. bambuterol should be reduced in renal impairment (see ...... (details are given in Volume B) Proprietary Preparations Fr.: Trentadil; (BANM) above). It is unsuitable for the relief of acute bronchospasm Braz.: Bamifix; Caffeine Citrate or in patients with unstable respiratory disease. Single-ingredient Preparations. Cafeína, citrato de; Citrated Caffeine; Coffeinum Citricum; A prescription event monitoring Ital.: Bamifix; Briofil. . Effects on the heart. Кофеина Цитрат ,C6H8O7=386.3 study found an excess risk of non-fatal heart failure in : C8H10N4O2 elderly patients receiving bambuterol,1 See also particularly under Salbutamol, in the (BANM, rINNM) — 69-22-7. Bitolterol Mesilate CAS first month of treatment. ATC — N06BC01. p. 1222.1. — QN06BC01. 53: 558–62. Bitoltérol, Mésilate de; Bitolterol, mesilato de; Bitolterol ATC Vet et al . Risk of non-fatal cardiacThorax failure1998; and ischaemic heart 1. Martin RM, β2 agonists. Mesylate (USAN); Bitolteroli Mesilas; Mesilato. de bitolterol; -tol- UNII — U26EO4675Q. disease with long acting Win-32784; Битолтерола Мезилат o-phenylene di-p 4-[2-(tert-Butylamino)-1-hydroxyethyl]- (BANM) Porphyria. The Drug Database for Acute Porphyria, com- uate methanesulphonate. Caffeine Hydrate piled by the Norwegian Porphyria Centre (NAPOS) and S=557.7 NO5,CH4O3 the Porphyria Centre Sweden, classifies bambuterol as C28H31 Cafeína monohidrato; Caféine monohydratée; Caffeine 1 — 30392-40-6 (bitolterol); 30392-41-7 (bitolterol mesilate). probably not porphyrinogenic; it may be used as a drug of CAS Monohydrate; Coffein-Monohydrat; Coffeinum Monohydri- first choice and no precautions are needed. ATC — R03AC17. cum; Kofeiinimonohydraatti; Kofein monohydrát; Kofeinas — QR03AC17. 1. The Drug Database for Acute Porphyria. Available at: http://www. ATC Vet monohidratas; Koffein-monohidrát;. Koffeinmonohydrat; FOR THE MOST UP-TO-DATEdrugs-porphyria.org (accessed 17/10/11) UNIIINFORMATION— 4E53T3611U. Кофеин Моногидрат ON ,H2O=212.2 C8H10N4O2 Interactions CAS — 5743-12-4...... Profile ATC — N06BC01. As for Salbutamol, p. 1223.1. Bambuterol inhibits plasma ...... ATC Vet — QN06BC01. cholinesterases and can prolong the action of drugs such as Bitolterol is an inactive prodrug that is hydrolysed in the body to colterol, a direct-acting sympathomimetic with UNII — 9T65I06326. Int., Jpn, US, and DRUGS AND MEDICINESsuxamethonium (see Sympathomimetics, ORDER under Suxa- MARTINDALE NOW, Eur. (see p. vii), mainly beta-adrenergic activityagonist). and It ahas selective similar action properties on to In Chin. methonium, p. 2040.1) that are inactivated by these receptors (a beta 2 Pharmacopoeias. enzymes. beta2 Some pharmacopoeias include caffeine and caffeine those of salbutamol (p. 1220.2), and has been used as a Viet. bronchodilator in the management of diseases with hydrate under one monograph. Pharmacokinetics (Caffeine Monohydrate; Caffeine Hydrate BP ...... reversible airways obstruction such as asthma (p. 1195.2) Ph. Eur. 8: Martindale: View aNearly sample 20% of a dose of bambuterol chapter is absorbed from the at:or in somewww.pharmpress.com/martindale2014 patients with chronic obstructive pulmonary 2014). A white or almost white, crystalline powder or silky gastrointestinal tract after oral doses. It is slowly metabolised disease (p. 1199.1); inhalation results in the rapid onset of white or almost white crystals. It sublimes readily. Sparingly in the body to its active metabolite, terbutaline; peak bronchodilatation (2 to 4 minutes) with a duration of action The Complete Drug terbutaline concentrations are reported to occur about 4 to 7 of 5 or more hours. : denotes a substance whose use may be restricted in certain sports (see p. viii) hours after a dose of bambuterol as tablets. The slow rate at The symbol TO ORDER:which metabolism occurs determines the prolonged Reference { denotes a preparation no longer actively marketed The symbol 38TH Edition Online: www.pharmpress.com/martindale2014 EDITED BY Tel: +44 (0)1256 302 699 Email: [email protected] Alison Brayfield Royal Pharmaceutical Society, For discounts on bulk orders please contact: London, UK Tel: +44 (0)20 7572 2266 Email: [email protected] Hardback 276 x 219mm (4688pp) £459.00 Online subscription: ISSN 0263-5364 • ISBN 978 0 85711 139 5 Access and search all the Martindale content online via MedicinesComplete, the online service that provides you with access to world-leading drug and healthcare resources, www.medicinescomplete.com Why have the world’s pharmacists relied on Martindale for more than 130 years?
Martindale is AUTHORITATIVE Martindale: the Complete Drug Reference is created by pharmacists, for pharmacists. Recognised as being accurate, reliable and extensively referenced, Martindale provides you with an unrivalled breadth and depth of information on drugs and medicines. It is backed by the expertise of a respected and international editorial team. In addition to landmark updates in print, Martindale is updated quarterly online and accessed via a subscription to MedicinesComplete.com
Martindale is OBJECTIVE The content of Martindale is entirely unbiased and independent of the pharmaceutical industry. It contains over 54,000 reference citations and links to published information. Having undergone extensive rigorous editorial processes, only the most clinically relevant data are selected for inclusion and re-checked. Martindale quickly delivers trustworthy, accurate information in a single resource for pharmacists across healthcare, industry and academia.
Martindale is INTERNATIONAL Martindale is respected around the world for the rigour of its editorial process and the quality of its content. It is a truly international resource, including proprietary preparations from 43 countries and regions, and alternative international drug names and brand names. This global perspective is unchallenged by other resources, making Martindale the international choice of pharmacists.