1770 Gastrointestinal Drugs respectively, and other airway, eye, and skin symptoms were rel- Homoeopathy. Senna leaf has been used in homoe- NOTE. Do not confuse with Dimeticone (p.2032). atively frequent.3 opathic medicines under the following names: Senna; Compounded preparations of simeticone may be represented by A 2-year history of pruritic scaly erythematous plaques on the the following names: 4 Senna folium. palmoplantar surfaces was reported by a patient who had taken • Co-simalcite x/y (BAN)—where x and y are the strengths in a sennoside laxative for 20 years. The lesions subsided over Administration in children. In the UK, the following oral milligrams of simeticone and hydrotalcite respectively. about 6 weeks on stopping the drug, and reappeared over the doses of sennosides are licensed for use for constipation in chil- course of 8 weeks on restarting sennoside. However, patch test- dren: Pharmacopoeias. In Eur. (see p.vii) and US. Ph. Eur. 6.2 (Simeticone). It is prepared by incorporation of 4 to ing and lymphocyte stimulation tests for sennoside were nega- • aged 2 to 6 years: 3.75 to 7.5 mg once daily in the morning tive. 7% silica into poly(dimethylsiloxane) with a degree of poly- • aged 6 to 12 years: 7.5 to 15 mg once daily at night or in the 1. Helin T, Mäkinen-Kiljunen S. Occupational asthma and rhinoc- merisation between 20 and 400. It contains 90.5 to 99.0% of onjunctivitis caused by senna. Allergy 1996; 51: 181–4. morning poly(dimethylsiloxane). It is a greyish-white, opalescent, viscous 2. Baggaley P. A shared allergy. Pharm J 1997; 259: 724. • 12 years and over: 15 to 30 mg once daily, usually at bedtime liquid. Practically insoluble in water and in methyl alcohol; very 3. Marks GB, et al. Asthma and allergy associated with occupation- In addition, although not licensed for use in children under 2 slightly soluble to practically insoluble in dehydrated alcohol; al exposure to ispaghula and senna products in a pharmaceutical years, the BNFC allows for an oral dose of syrup (containing sen- partly miscible with dichloromethane, with ethyl acetate, with work force. Am Rev Respir Dis 1991; 144: 1065–9. nosides 7.5 mg per 5 mL) of 0.5 mL/kg (to a maximum of methyl ethyl ketone, and with toluene. 4. Fujita Y, et al. A case of interstitial granulomatous drug reaction 2.5 mL) once daily in those aged 1 month to 2 years. USP 31 (Simeticone). A mixture of fully methylated linear due to sennoside. Br J Dermatol 2004; 150: 1035–7. siloxane polymers containing repeating units of the formula Preparations [-(CH3)2SiO-]n, stabilised with trimethylsiloxy end-blocking Precautions BP 2008: Senna Liquid Extract; Senna Tablets; Standardised Senna Gran- units of the formula [(CH3)3SiO-], and silicon dioxide. It con- Senna should not be given to patients with nausea or ules; tains not less than 90.5% and not more than 99% of polydimeth- Ph. Eur.: Senna Leaf Dry Extract, Standardised; ylsiloxane and not less than 4% and not more than 7% of silicon vomiting, undiagnosed abdominal pain, or intestinal USP 31: Senna Fluidextract; Senna Syrup; Sennosides Tablets. obstruction; care should also be taken in patients with dioxide. A translucent, grey, viscous fluid. Insoluble in water, in Proprietary Preparations (details are given in Part 3) alcohol, and in dehydrated alcohol; the liquid phase is soluble 1 inflammatory bowel disease. Prolonged use should Arg.: Ciruela Fibra; Laxiruela; Laxiruela Ciruela Fibra; Laxuave Sen; Aus- in 10 of chloroform, of ether, and of benzene, leaving a residue generally be avoided. tral.: Bekunis Herbal Tea; Bekunis Instant; Laxettes; SennaPlus†; Sennetabs; Senokot; Austria: Bekunis; Colonorm; Darmol; Dragees Neunzehn Sen- of silicon dioxide. Store in airtight containers. Although anthraquinone derivatives may be distribut- na†; X-Prep; Belg.: Darlin; Fuca; Midro†; Prunasine; Senokot; Transix; Braz.: Senan; Sene; Canad.: Agarol Extra; Agarol with Sennosides; Ex-Lax; ed into breast milk the concentration achieved after Experience; Glysennid†; GNC Herbal Laxative†; Herbal Laxative; Laxative Profile Pills; Sennaprep; Sennatab; Senokot; X-Prep; Chile: Cholax; Naturlax; Cz.: usual maternal dosage is thought to be insufficient to Caj z Listu Senny; List Senny; Regulax†; Sennove Lusky; Sennovy List; Tisas- Simeticone is a mixture of liquid dimeticones contain- affect the nursing infant (see also below). en†; X-Prep†; Denm.: Pursennid; Fin.: Exprep; Pursennid; Sennapur; Fr.: ing finely divided silicon dioxide to enhance the de- Senokot; X-Prep; Ger.: Abfuhrtee N; Bekunis Instant; Bekunis-Krautertee N; Depuran; Heverto†; Liquidepur†; Midro Abfuhr; Midro Tee; Neda foaming properties of the silicone. It lowers surface Breast feeding. No adverse effects have been seen in breast- Fruchtewurfel; Ramend; Regulax N†; X-Prep†; Gr.: Bekunis†; Pursennid†; fed infants whose mothers were receiving senna, and the Amer- X-Prep; Hong Kong: Senokot; Hung.: Tisasen; X-Prep; India: Senade; Se- tension and when given by mouth causes bubbles of ican Academy of Pediatrics considers1 that it is therefore usually nalax; Irl.: Senokot; Israel: Bekunis; Ex-Lax; Florilax; Jungborn; Laxikal Forte; gas in the gastrointestinal tract to coalesce, thus aiding Ital.: Falquilax; Tisana Kelemata; X-Prep; Malaysia: Senokot; Mex.: Arsen; compatible with breast feeding. Bekunis; Ciruelax Comp; Ciruelax TE; Lagenbach; Sekalax†; Senokot; X- their dispersion. 1. American Academy of Pediatrics. The transfer of drugs and oth- Prep; Neth.: Bekunis Plantaardig; Bekunis Senna; Sennocol; X-Praep; er chemicals into human milk. Pediatrics 2001; 108: 776–89. Norw.: Senokot; X-Prep; NZ: Senokot; Philipp.: Senokot; Pol.: Bekunis; Simeticone is used for the relief of flatulence and ab- Correction. ibid.; 1029. Also available at: Regulax; Senalax; Senefol; X-Prep; Xenna†; Port.: Bekunis; Pursennide; Se- nolax; X-Prep; Rus.: Glaxenna (Глаксенна); S.Afr.: Black Forest; Depuran; dominal discomfort due to excess gastrointestinal gas http://aappolicy.aappublications.org/cgi/content/full/ Gal; Hamburg Tea; Sennalax; Senokot; Soflax; X-Prep; Singapore: Senokot; in disorders such as dyspepsia (p.1695) and gastro- pediatrics%3b108/3/776 (accessed 21/11/06) Spain: Diolaxil†; Justelax; Laxante Bescansa Normal; Laxante Olan; Lax- ante Salud; Takata; X-Prep; Swed.: Pursennid; Switz.: Bekunis; Darmol; De- oesophageal reflux disease (p.1696). Doses of 100 to Colonic perforation. There were early reports of colonic per- modon Neo; Fuca N; Grains de Vals Nouvelle formule; Irolax†; Kneipp foration with faecal peritonitis,1,2 in one case fatal,1 after use of a Woerisetten S†; Midro; Tisane laxative H nouvelle formulation; X-Prep; 250 mg three or four times daily have been given. For senna preparation containing total sennosides 142 mg for bowel Thai.: Senokot; Turk.: Pursennid; Roha-Lax; Senokot; X-M; UAE: Laxal; many gastrointestinal disorders, it is given with an ant- UK: Ex-Lax; Nylax with Senna; Senokot; Sure-Lax; USA: Black-Draught; preparation before barium enema. In 1985, the strength of the Dosaflex; Dr Edwards Olive; Evac-U-Gen; Ex-Lax; Fletchers Castoria; Lax acid. UK preparation was halved to contain 72 mg of total sennosides; Pills; Little Tummys Laxative; Maximum Relief Ex-Lax; Senexon; Senna it was subsequently withdrawn, although a similar preparation, at Smooth; Senna-Gen; Senokot; Senokotxtra; X-Prep; Venez.: Laxovar; Sen- Doses of about 20 to 40 mg of simeticone have been lax; Senokot. the higher strength, remains available in some countries. To re- given with feeds to relieve colic in infants (see Gas- Multi-ingredient: Arg.: Agiolax; Calculina†; Candilax; Cirulaxia; Gelax; duce the risk of colonic perforation, patients with suspected stric- Kronolax†; LX-30; Medilaxan; Prompt†; Rapilax Fibras; Austral.: Agiolax; trointestinal Spasm, p.1696). ture, inflammatory bowel disease, or impending obstruction Chemists Own Natural Laxative with Softener; Coloxyl with Senna; Com- should not receive a bowel stimulant.2 bilax; Neo-Cleanse; Peritone; Prolax†; Sennesoft; Soflax; Austria: Abfuhr- Simeticone is also used as a defoaming agent in radiog- tee St Severin; Abfuhrtee†; Agiolax; Carilax; Entschlackender Abfuhrtee EF- 1. Galloway D, et al. Faecal peritonitis after laxative preparation EM-ES; Eucarbon; Eucarbon Herbal; Frugelletten; Herbelax; Illings Bozner raphy or endoscopy of the gastrointestinal tract. for barium enema. BMJ 1982; 284: 472. Maycur-Tee†; Laxalpin; Laxolind; Mag Kottas Krauterexpress Abfuhrtee; 2. Cave-Bigley D. Faecal peritonitis after laxative preparation for Mag Kottas May-Cur-Tee; Midro Tee; Neda Fruchtewurfel; Planta Lax; ◊ A brief review of the use of simeticone for gastrointestinal barium enema. BMJ 1982; 284: 740. Pursennid; Sabatif; The Chambard-Tee; Belg.: Agiolax; Depuratif des Alpes; symptoms concluded that although it was commonly prescribed Tux†; Braz.: Agiolax; Circanetten†; Estomafitino†; Fitolax; Florlax; Fontolax; Frutalax†; Laxarine†; Laxtam; Naturetti; Plantax†; Sene Composta†; Tamar- with an antacid, there was no good evidence that this provided Pharmacokinetics il; Tamarine; Tamarix†; Varicell†; Canad.: Cholasyn II; Cholasyn†; Control; additional benefit. When used alone simeticone probably helped Doulax; Extra Strong Formula 12†; Herbal Laxative; Herbal Laxative plus to relieve minor postoperative and postprandial symptoms and There is some absorption of anthraquinone laxatives Yogurt; Herbalax†; Herbolax; Laxaco; Mucinum†; Prodiem Plus†; Senna-S; 1 Senokot-S; Thunas Laxative†; Chile: Bilaxil; Instalax; Mielax; Naturlax; Tam- was a useful aid in upper gastrointestinal endoscopy. However, after oral doses. Absorbed anthraquinones are metabo- arine; Te Laxante; Cz.: Abfuhr-Heilkrautertee†; Agiolax; Dr Theiss Rheuma some considered there was no convincing evidence that simeti- lised in the liver. Unabsorbed senna is hydrolysed in Creme†; Dr Theiss Schweden Krauter; Dr Theiss Schwedenbitter; Projima- cone, alone or with antacids, was effective for the treatment of va; Reduktan; Senalax; Denm.: Figen; Fin.: Agiolax; Fr.: Agiolax; Grains de the colon by bacteria to release the active free an- Vals; Herbesan; Herbesan Instantane†; Ideolaxyl; Mediflor Tisane Contre la eructation, flatulence, or other signs or symptoms of excess gas- Constipation Passagere No 7; Mediflor Tisane Hepatique No 5; Modane; trointestinal gas.2 thraquinones. Anthraquinones are excreted in urine Mucinum a l’Extrait de Cascara; Pursennide; Tamarine; Vegelax†; Ger.: Agi- and faeces and distributed into breast milk. olax; Alasenn; Heumann Abfurhtee Solubilax N†; Hevertolax duo†; Presse- 1. Anonymous. Dimethicone for gastrointestinal symptoms? Drug lin Stoffwechsel-Tee Hapeka 225 N†; Ramend Krauter†; Hong Kong: Agi- Ther Bull 1986; 24: 21–2. olax; Mucinum Cascara†; Hung.: Bolus Laxans; India: Pursennid-In†; Irl.: 2. Anonymous. Simethicone for gastrointestinal gas. Med Lett Pripsen†; Israel: Agiolax; Eucarbon; Jungborn; Lido Tea; Midro-Tea; Novi- Uses and Administration carbon; Ital.: Agiolax; Colax; Combilax; Confetti Lassativi CM; Cuscutine; Drugs Ther 1996; 38: 57–8. Senna is an anthraquinone stimulant laxative (p.1693) Eucarbon; Fibrolax Complex; Lactolas; Lassatina†; Midro; Ormobyl CM†; Ortisan; Pursennid; Senna-Specie Composta†; Stimolfit; Tamarine; Tisana Preparations that is used to treat constipation (p.1693) and for bowel Kelemata; Malaysia: Eucarbon†; Mex.: Agiolax; Ciruelax Jalea; Jarabe de evacuation before investigational procedures or sur- Manzanas; Laxacaps; Naturetti†; Neth.: Agiolax; Prunacolon; Prunasine; BP 2008: Simeticone for Oral Use; Simeticone Suspension for Infants; Norw.: Agiolax; Pursennid; NZ: Coloxyl with Senna; Laxsol; Philipp.: Boie USP 31: Alumina, Magnesia, and Simethicone Oral Suspension; Alumina, gery. The active anthraquinones are liberated into the Carminative (Carminasen); Castoria; Pol.: Agiolax; Laxamix; Melisana Magnesia, and Simethicone Tablets; Alumina, Magnesia, Calcium Carbonate, colon from the sennoside glycosides by colonic bacte- Klosterfrau; Senalax K; Port.: Agiolax; Bekunis; Midro†; Mucinum; Xarope and Simethicone Tablets; Calcium Carbonate, Magnesia, and Simethicone de Macas Reinetas; S.Afr.: Agiolax; Clairo; Rubilax†; Spain: Agiolax; Beku- Tablets; Magaldrate and Simethicone Oral Suspension; Magaldrate and ria and an effect usually occurs within 6 to 12 hours of nis Complex; Crislaxo; Jarabe Manceau; Laxante Sanatorium; Laxomax†; Simethicone Tablets; Simethicone Capsules; Simethicone Emulsion; Sime- Modane; Natusor Malvasen†; Pruina; Puntual; Puntualex; Pursenid; Senal- thicone Oral Suspension; Simethicone Tablets. an oral dose. sor†; Swed.: Agiolax; Switz.: Agiolax; Dragees aux figues avec du sene; Fruttasan; Lapidar 10; Linoforce; LinoMed; Phyto-Laxia; Phytolaxin; Pursen- Proprietary Preparations (details are given in Part 3) For constipation, senna is usually given as tablets, nide; Schweden-Mixtur H nouvelle formulation; Tisane laxative; Tisane Pro- vencale No 1; Valverde Constipation dragees; Valverde Constipation sirop; Arg.: Aesim; Aflat; Carbogasol; Carbogasol Forte; Espaven Antigas; Factor granules, or syrup. In some countries it is available as Thai.: Agiolax; Circanetten; Turk.: Bekunis; Eucarbon; Karboseptin; UK: AG; Metiorisan; Mylanta Gas; Simecon; Austral.: Degas; Degas Infant suppositories. In the UK, doses of senna preparations Athera; Califig; Cleansing Herbs; Dual-Lax Extra Strong; Dual-Lax Normal Drops†; Infacol; Medefoam†; Austria: Antiflat; Disflatyl; Lefaxin; SAB Sim- Strength; Fam-Lax Senna; Fibre Plus; Jacksons Herbal Laxative; Kas-Bah; Lax- plex; Braz.: Anflat†; Dimezin; Espasmo Flatol; Finigas; Flagass; Flatex; Flatol; are usually expressed in terms of total sennosides cal- ative Tablets; Lion Cleansing Herbs; Lustys Herbalene; Manevac; Modern For Gas; Freegas†; Gastroflat; Gazyme; Luftal; Luftrin†; Meticone; Mylanta culated as sennoside B. The usual adult oral dose is 15 Herbals Laxative; Modern Herbals Menopause; Natural Herb Tablets; Out- Plus; Mylicon; Nogas†; Sanagas; Silidron; Canad.: Gas-X; Ovol; Phazyme; of-Sorts; Pripsen; Rhuaka; Senokot Dual Relief; Skin Cleansing; Tabritis; Siligaz; Chile: Flapex; Gasoff; Gasorbol†; Pepsidol†; Cz.: Ceolat†; Disflatyl†; to 30 mg as a single dose at bedtime. (For doses in chil- USA: Black-Draught†; Ex-Lax Gentle Strength; Perdiem; Peri-Colace; Senna Plus; Senna Prompt; Senna-S; Senokot-S; X-Prep Bowel Evacuant Kit-1; Espumisan; Lefax; SAB Simplex; Denm.: Aeropax; Mylicon; Fin.: Cuplaton; dren see Administration in Children, below.) In the Venez.: Agiolax; Fibralax†; Rheu-Tarx 1; Senokot con Docusato; Senokot Disflatyl; Minifom; Fr.: Siligaz; Ger.: Absorber HFV†; Aegrosan†; Ceolat; El- con Fibra†. ugan; Endo-Paractol; Espumisan; Ilio-Funkton; Imogas; Kompensan Dimeti- USA, the usual adult dose is 15 to 30 mg once or twice con; Lefax; Meteosan†; SAB Simplex; Gr.: Ceolat†; Infacolic; Hong Kong: daily, expressed in terms of total sennosides. Air-X; Dentinox Colic Drops; Disflatyl; Gascon; Gasteel; Infacol; Ovol; Hung.: Espumisan; Infacol; SAB Simplex; India: Dimol; Tricaine-MPS; In- For bowel evacuation before investigational proce- don.: Aeroson; Disflatyl; Flatunic; Irl.: Infacol; Israel: Gazim X; Simicol; Ital.: Meteosim; Mylicon; Polisilon†; Simecrin; Simetic; Malaysia: Cuplaton; dures, a dose of 105 to 157.5 mg of sennosides may be Simeticone (BAN, rINN) Dentinox Colic Drops; Disflatyl; Gascoal; Gastyl; Mex.: Diflax†; Espaven given orally as a liquid preparation on the day before Pediatrico; Liberan; Neth.: Aeropax; Ceolat†; Setlers Windfree; Norw.: Activated Dimethicone; Activated Dimethylpolysiloxane; Acti- Ceolat†; Minifom; Siloxan; NZ: De-Gas; Infacol; Medefoam†; Philipp.: Dis- the procedure (but see Colonic Perforation under Pre- vated Dimeticone; Antifoam A; Antifoam AF; Simethicone (US- flatyl; Pol.: Bobotic; Espumisan; Esputicon; Gastrosil; Infacol; Manti Gastop; cautions, above). AN); Simeticona; Siméticone; Simeticonum; Simetikon; Simetiko- Simet; Port.: Aero-Om; Imogas; Rus.: Disflatyl (Дисфлатил); Espumisan (Эспумизан); SAB Simplex (САБ Симплекс); Simicol (Симикол)†; S.Afr.: The purified sennosides (sennosides A and B), and nas; Simetikoni; Szimetikon. Te l a m e n t ; Singapore: Cuplaton; Gascoal; Infacol†; RidWind; Spain: Aero their calcium salts (calcium sennoside A and calcium Симетикон Red; Enterosilicona; Swed.: Minifom; Switz.: Disflatyl; Flatulex; Lefax; Polysi- lane; Simet-AF†; Thai.: Air-X; Airrox; Babcon†; Blow-X; Disflatyl; Gas-MM; sennoside B) are used similarly to senna. CAS — 8050-81-5. Gas-X; Gassi; Gastyl; Logastin; Mylom; Ovol; Semeth; Sigas†; Simcone; Simeticone/Anhydrous Sodium Sulfate 1771 Simecon; Simetyl; Siticon; Turk.: Antiflat; Metsil; UAE: Salinal; UK: Asilone tions in the period before taking the bowel preparation. Care is Picolax; Rus.: Guttalax (Гутталакс); Laxygal (Лаксигал); Spain: Contumax; Windcheaters†; Dentinox Colic Drops; Infacol; Wind-Eze; USA: Baby Gas- needed when sodium picosulfate solutions are used in those with Evacuol; Ezor; Gutalax; Lubrilax; Skilax; Swed.: Cilaxoral; Laxoberal; Switz.: X; Colicon; Degas; Extra Strength Mintox Plus; Flatulex; Gas Relief; Gas-X; 6 Fructines; Laxoberon; UK: Dulcolax; Laxoberal; Venez.: Lasoberon. Maalox Anti-Gas†; Major-Con; Mylanta Gas; Mylicon; Phazyme; SonoRx; a low seizure threshold or potential sodium depletion. Venez.: Antifom; Flatoril; Sicon†; Silicon†. Multi-ingredient: Arg.: Agarol; Cascara Sagrada Oligoplex; Austral.: 1. McDonagh AJG, et al. Safety of Picolax (sodium picosulphate- Colonprep†; Picolax†; Picoprep; Prep Kit-C; Belg.: Pilules de Vichy; Braz.: Multi-ingredient: numerous preparations are listed in Part 3. magnesium citrate) in inflammatory bowel disease. BMJ 1989; Agarol; Forlax; Canad.: Pico-Salax; Irl.: Picolax; Malaysia: Picoprep; NZ: 299: 776–7. Picoprep; Spain: Emuliquen Laxante; Switz.: Laxasan; UK: CitraFleet; Pi- Used as an adjunct in: Austria: Prontobario; Cz.: Prontobario†; Spain: colax. Bario Dif. 2. Evans M, et al. Safety of Picolax in inflammatory bowel disease. BMJ 1989; 299: 1101–2. 3. Lewis M, et al. Bowel preparation at home in elderly people. BMJ 1997; 314: 74. Anhydrous Sodium Sulfate Smectites 4. Hanning CD. Bowel preparation at home in elderly people. BMJ Anhydrous Sodium Sulphate; Dried Sodium Sulphate; Exsiccated Смектиты 1997; 314: 74. Sodium Sulphate; Natrii Sulfas; Natrii sulfas anhydricus; Natrio ATC — A07BC05 (diosmectite). 5. Adverse Drug Reactions Advisory Committee (ADRAC). Elec- trolyte disturbances with sodium picosulphate bowel cleansing sulfatas, bevandenis; Natrium Sulfuricum Siccatum; Natriumsul- ATC Vet — QA07BC05 (diosmectite). products. Aust Adverse Drug React Bull 2002; 21: 2. Also avail- faatti, vedetön; Natriumsulfat, vattenfritt; Síran sodný; Sodium able at: http://www.tga.health.gov.au/adr/aadrb/aadr0202.pdf (sulfate de) anhydre; Sodu siarczan bezwodny; Sulfato de sodio Profile (accessed 03/07/08) Smectites are natural mineral clays composed mainly of alumin- anhidro; Vízmentes nátrium-szulfát. ium silicates and include aluminium magnesium silicate 6. Frizelle FA, et al. Hyponatremia and seizures after bowel prepa- Безводный Сульфат Натрия ration: report of three cases. Dis Colon Rectum 2005; 48: 393–6. (p.2141), bentonite (p.2141), and Fuller’s earth (p.1447). They Na SO = 142.0. have adsorbent properties and some, such as dioctahedral smec- 2 4 CAS — 7757-82-6. tite (diosmectite), have been used in the management of diar- Pharmacokinetics rhoea. They are also used as pharmaceutical excipients and in ATC — A06AD13; A12CA02. industry. Like bisacodyl (p.1710), sodium picosulfate is metab- ATC Vet — QA06AD13; QA12CA02. olised by colonic bacteria to the active compound ◊ References. Pharmacopoeias. In Chin., Eur. (see p.vii), Int., and Viet. bis(p-hydroxyphenyl)pyridyl-2-methane. Only a small US includes a single monograph for both the anhydrous form and 1. Szajewska H, et al. Meta-analysis: smectite in the treatment of amount of sodium picosulfate is absorbed after an oral acute infectious diarrhoea in children. Aliment Pharmacol Ther the decahydrate. 2006; 23: 217–27. dose; this is subsequently excreted in the urine. Ph. Eur. 6.2 (Sodium Sulphate, Anhydrous). A white or almost 2. Yen ZS, Lai MS. Smectite for acute diarrhoea in children. Emerg white, hygroscopic powder. Freely soluble in water. Store in air- Med J 2006; 23: 65–6. tight containers. Uses and Administration USP 31 (Sodium Sulfate). It contains 10 molecules of water of Preparations Sodium picosulfate is a stimulant laxative related to hydration or is anhydrous. The decahydrate loses between 51 and Proprietary Preparations (details are given in Part 3) bisacodyl (p.1710) used for the treatment of constipa- 57% of its weight on drying and the anhydrous form loses not Cz.: Smecta; Fr.: Smecta; Ger.: Colina; Gr.: Smecta; Hong Kong: Smecta; tion (p.1693) and for evacuation of the colon before in- more than 0.5% of its weight. Large, colourless, odourless, trans- Hung.: Smecta; Ital.: Diosmectal; Nodia; Malaysia: Smecta; Pol.: Smecta; parent crystals or a granular powder. It effloresces rapidly in air, Rus.: Smecta (Смекта); Singapore: Smecta; Thai.: Smecta. vestigational procedures or surgery. When taken orally liquefies in its water of hydration at about 33°, and loses all of its Multi-ingredient: Belg.: Barexal; Ger.: Colina Spezial. it is metabolised by colonic bacteria to an active form water of hydration at about 100°. Freely soluble in water; insol- that stimulates bowel movements. It is usually effec- uble in alcohol; soluble in glycerol. Store in airtight containers, tive within 6 to 12 hours although when used with preferably at a temperature not exceeding 30°. magnesium citrate for bowel evacuation an effect may Sodium Picosulfate (BAN, rINN) be seen within 3 hours. Sodium Sulfate DA-1773; LA-391; Natrii picosulfas; Natrii Picosulfas Monohydri- For constipation it is given as a single oral dose of 5 to E514; Glauber’s Salt; Natrii sulfas decahydricus; Natrii Sulphas; Natrio sulfatas dekahidratas; Natrium Sulfuricum Crystallisatum; cus; Natrio pikosulfatas; Natriumpikosulfaatti; Natriumpikosulfat; 10 mg, usually at bedtime. (For doses in children see Nátrium-pikoszulfát; Picosulfate de Sodium; Picosulfato de sodio; Natriumsulfaattidekahydraatti; Natriumsulfatdekahydrat; Nátri- Picosulphol; Pikosíran sodný monohydrát; Sodium, picosulfate below.) um-szulfát-dekahidrát; Síran sodný dekahydrát; Sodium (sulfate de; Sodium Picosulphate. Disodium 4,4′-(2-pyridylmethylene)- For bowel evacuation, a dose of sodium picosulfate de) décahydraté; Sodium Sulphate; Sodium Sulphate Decahy- drate; Sodu siarczan dziesięciowodny; Sulfato de sodio. di(phenyl sulphate). 10 mg with magnesium citrate (p.1743) is given in the Натрия Пикосульфат morning and again in the afternoon of the day before Глауберова соль; Сульфат Натрия Na SO ,10H O = 322.2. C18H13NNa2O8S2,H2O = 499.4. examination. 2 4 2 CAS — 10040-45-6. CAS — 7727-73-3 (sodium sulfate decahydrate). Administration in children. In the UK, the following oral ATC — A06AD13; A12CA02. ATC — A06AB08. doses of sodium picosulfate have been recommended for chil- ATC Vet — QA06AD13; QA12CA02. ATC Vet — QA06AB08. dren in the treatment of constipation; the dose is usually given at night: Pharmacopoeias. In Chin., Eur. (see p.vii), Int., and Viet. US includes a single monograph for both the anhydrous form and • 1 month to 4 years: 250 micrograms/kg (maximum 5 mg) the decahydrate. Ph. Eur. 6.2 (Sodium Sulphate Decahydrate; Sodium Sulphate • 4 to 10 years: 2.5 to 5 mg BP 2008). A white or almost white, crystalline powder or colour- N • over 10 years: 5 to 10 mg less, transparent crystals. Freely soluble in water; practically insoluble in alcohol. It partly dissolves in its own water of crys- Most UK licensed product information gives similar doses to tallisation at about 33°. It loses between 52.0 and 57.0% of its O O those above for bowel cleansing. Alternatively, some recom- weight on drying. -O O- Na+ S S Na+ mend that children may be given the following doses of a sachet USP 31 (Sodium Sulfate). It contains 10 molecules of water of O O containing sodium picosulfate 10 mg (with magnesium citrate): hydration or is anhydrous. The decahydrate loses between 51 and O O 57% of its weight on drying and the anhydrous form loses not •1 to 2 years: ⁄ sachet in the morning and ⁄ sachet in the after- noon more than 0.5% of its weight. Large, colourless, odourless, trans- Pharmacopoeias. In Eur. (see p.vii) and Jpn. parent crystals or a granular powder. It effloresces rapidly in air, Ph. Eur. 6.2 (Sodium Picosulfate). A white or almost white, crys- •2 to 4 years: ⁄ sachet in the morning and ⁄ sachet in the after- liquefies in its water of hydration at about 33°, and loses all of its talline powder. Freely soluble in water; slightly soluble in alco- noon water of hydration at about 100°. Freely soluble in water; insol- hol. uble in alcohol; soluble in glycerol. Store in airtight containers, • 4 to 9 years: 1 sachet in the morning and ⁄ sachet in the after- preferably at a temperature not exceeding 30°. noon Adverse Effects and Precautions Profile As for Bisacodyl, p.1710 and p.1710. • over 9 years: 1 sachet in the morning and 1 sachet in the after- Sodium sulfate has been used as an osmotic laxative (p.1693). It noon is also given in dilute solution (about 0.5%) with a high molecu- Bowel evacuation. Sodium picosulfate with magnesium cit- lar weight macrogol for prompt bowel evacuation before inves- rate was considered a safe and effective bowel cleansing agent in Preparations tigational procedures or surgery (see Macrogols, p.2336). adults1 and children2 with inflammatory bowel disease. They tol- erated the preparation as well as patients with other colonic dis- BP 2008: Compound Sodium Picosulfate Powder for Oral Solution; Sodi- Sodium sulfate is also used as an additive in foods. um Picosulfate Oral Solution. orders with no adverse effect on their disease symptoms. Patients For the general properties of sodium salts, see p.1686. should be kept well hydrated (it may be appropriate to carry out Proprietary Preparations (details are given in Part 3) Preparations bowel preparation in hospital in frail or elderly patients to avoid 3,4 Arg.: Agarol; Cirulaxia; Dagol; Dulcolax; Factor Laxante; Feen-A-Mint; the risks of over- or underhydration ), and this procedure should Gotalax; Granulax†; Kritel; Laxamin; Modaton; Modernel†; Opalino; Rapi- USP 31: Sodium Sulfate Injection. not be used in suspected toxic dilatation of the colon. lax; Rogelina†; Trali; Verilax; Yodolin; Austral.: Durolax SP; Austria: Agaffin; Proprietary Preparations (details are given in Part 3) Agiopic; Guttalax; Laxasan; Belg.: Dulcolax Picosulphate; Fructines; Guttal- In Australia, the Adverse Drug Reactions Advisory Committee ax†; Laxoberon; Picolaxine; Braz.: Cronoplex; Diltin; Guttalax; Picolax†; Austral.: Celloids SS 69. has warned that low volume sodium picosulfate solutions may Rapilax; Chile: Aguala; Cronolax; Guttalax; Laxantil; Laxoberal; Cz.: Agiolax Multi-ingredient: Arg.: Magnesia Phosphorica I Oligoplex; Austral.: cause marked dehydration, hyponatraemia, other electrolyte ab- Pico; Darmol†; Guttalax; Laxygal; Progut; Regulax Pikosulfat; Denm.: Acti- Duo Celloids SPSS; Duo Celloids SSMP; Duo Celloids SSPC; Duo Celloids normalities, and associated complications. Patients at particular lax; Laxoberal; Picolon; Fin.: Laxoberon; Fr.: Fructines; Ger.: Agiolax Pico; SSS; Iron Compound†; Liv-Detox†; Silybum Complex†; Canad.: Normo risk include infants, the elderly, the frail, and those with conges- Darmol Pico; Darmol†; Dulcolax NP; Laxans-ratiopharm Pico; Laxoberal; Gastryl; Fr.: Actisoufre; Digedryl; Hepargitol; Normogastryl†; Oxyboldine; 5 Liquidepur mit Natriumpicosulfat; Midro Pico†; Regulax Picosulfat; Gr.: Prefagyl†; Ital.: Argirofedrina†; Pol.: Sal Ems Artificiale; Sal Ems Factitium; tive heart failure or with renal impairment. Guttalax; Laxatol; Hong Kong: Sur-Lax; Hung.: Darmol; Guttalax; Laxygal; Sal Vichy Factitium; Spain: Darmen Salt; Digestovital†; Leberetic; Lebersal; A grand mal seizure in a 64-year-old female given sodium pico- India: Cremalax; Indon.: Laxoberon; Irl.: Dulcolax Perles; Laxoberal; Ital.: Salcedol; Switz.: Padma-Lax; Padmed Laxan; Thai.: Ulgastrin; USA: Tr iv; Euchessina CM; Falquigut; Gocce Lassative Aicardi; Guttalax; Jpn: Lax- Venez.: Topdent†. sulfate with magnesium citrate was assumed to have been caused oberon; Mex.: Anara; Laxoberon; Neth.: Dulcodruppels; Dulcopearls; by hyponatraemia; the patient had normal electrolyte concentra- Norw.: Laxoberal; Philipp.: Laxoberal; Port.: Fructines; Guttalax; Laxodal; The symbol † denotes a preparation no longer actively marketed The symbol ⊗ denotes a substance whose use may be restricted in certain sports (see p.vii)