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Simeticone


Drug Nomenclature

Synonyms: Activated Dimethicone; Activated Dimethylpolysiloxane; Activated Dimeticone; Antifoam A; Antifoam AF; Simethicone; Simeticona; Simeticonum; Simetikon; Simetikonas; Simetikoni; Szimetikon
BAN: Simeticone
USAN: Simethicone
INN: Simeticone [rINN (en)]
INN: Simeticona [rINN (es)]
INN: Siméticone [rINN (fr)]
INN: Simeticonum [rINN (la)]
INN: Симетикон [rINN (ru)]
CAS: 8050-81-5

Note. Do not confuse with Dimeticone. Compounded preparations of simeticone may be represented by the following names:

• Co-simalcite x/y (BAN) — where x and y are the strengths in milligrams of simeticone and hydrotalcite respectively.

Pharmacopoeias. In Europe and US.

European Pharmacopoeia, 6th ed. (Simeticone). It is prepared by incorporation of 4 to 7% silica into poly(dimethylsiloxane) with a degree of polymerisation between 20 and 400. It contains 90.5 to 99.0% of poly(dimethylsiloxane). It is a greyish-white, opalescent, viscous liquid. Practically insoluble in water and in methyl alcohol very slightly soluble to practically insoluble in dehydrated alcohol partly miscible with dichloromethane, with ethyl acetate, with methyl ethyl ketone, and with toluene.

The United States Pharmacopeia 31, 2008 (Simeticone). A mixture of fully methylated linear siloxane polymers containing repeating units of the formula [-(CH3)2SiO-]n, stabilised with trimethylsiloxy end-blocking units of the formula [(CH3)3SiO-], and silicon dioxide. It contains not less than 90.5% and not more than 99% of polydimethylsiloxane and not less than 4% and not more than 7% of silicon dioxide. A translucent, grey, viscous fluid. Insoluble in water, in alcohol, and in dehydrated alcohol the liquid phase is soluble 1 in 10 of chloroform, of ether, and of benzene, leaving a residue of silicon dioxide. Store in airtight containers.

Profile

Simeticone is a mixture of liquid dimeticones containing finely divided silicon dioxide to enhance the defoaming properties of the silicone. It lowers surface tension and when given by mouth causes bubbles of gas in the gastrointestinal tract to coalesce, thus aiding their dispersion.

Simeticone is used for the relief of flatulence and abdominal discomfort due to excess gastrointestinal gas in disorders such as dyspepsia and gastrooesophageal reflux disease. Doses of 100 to 250 mg three or four times daily have been given. For many gastrointestinal disorders, it is given with an antacid.

Doses of about 20 to 40 mg of simeticone have been given with feeds to relieve colic in infants (see Gastrointestinal Spasm).

Simeticone is also used as a defoaming agent in radiography or endoscopy of the gastrointestinal tract.

A brief review of the use of simeticone for gastrointestinal symptoms concluded that although it was commonly prescribed with an antacid, there was no good evidence that this provided additional benefit. When used alone simeticone probably helped to relieve minor postoperative and postprandial symptoms and was a useful aid in upper gastrointestinal endoscopy. However, some considered there was no convincing evidence that simeticone, alone or with antacids, was effective for the treatment of eructation, flatulence, or other signs or symptoms of excess gastrointestinal gas.

Preparations

BP 2008: Simeticone for Oral Use Simeticone Suspension for Infants

The United States Pharmacopeia 31, 2008: Alumina, Magnesia, and Simethicone Oral Suspension; Alumina, Magnesia, and Simethicone Tablets; Alumina, Magnesia, Calcium Carbonate, and Simethicone Tablets; Calcium Carbonate, Magnesia, and Simethicone Tablets; Magaldrate and Simethicone Oral Suspension; Magaldrate and Simethicone Tablets; Simethicone Capsules; Simethicone Emulsion; Simethicone Oral Suspension Simethicone Tablets.

Single-ingredient Preparations

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

Argentina: Aesim; Aflat; Carbogasol Forte; Carbogasol; Espaven Antigas; Factor AG; Mylanta Gas; Simecon; Australia: Degas Infant Drops¤; Degas; Infacol; Medefoam; Mylicon¤; Phazyme¤; Austria: Disflatyl; Lefaxin; SAB Simplex; Setlers¤; Belgium: Polysilon¤; Brazil: Anflat; Dimezin; Finigas; Flagass; Flatex; Flatol; For Gas; Freegas; Gastroflat; Gazyme; Luftal; Luftrin; Meticone; Mylanta Plus; Mylicon; Nogas; Sanagas; Silidron; Canada: Babys Own Infant Drops¤; Gas-X; Maalox GRF¤; Ovol; Phazyme; Siligaz; Chile: Flapex; Gasorbol¤; Pepsidol¤; Czech Republic: Ceolat; Disflatyl; Espumisan; Lefax; SAB Simplex; Denmark: Aeropax; Ceolat¤; Minifom¤; Mylicon; Finland: Ceolat¤; Cuplaton; Disflatyl; Minifom; France: Polysilane¤; Siligaz; Germany: Absorber HFV¤; Aegrosan; Busala¤; Ceolat; Dremisan¤; Elugan; Endo-Paractol; Espumisan; Ilio-Funkton; Kompensan Dimeticon; Kramik¤; Lefax; Meteosan; SAB Simplex; Greece: Ceolat¤; Hong Kong: Air-X; Dentinox Colic Drops; Disflatyl; Gasteel; Infacol; Ovol; Hungary: Espumisan; Infacol; SAB Simplex; India: Dimol; Tricaine-MPS; Ireland: Infacol; Israel: Simicol; Italy: Meteosim; Mylicon; Polisilon¤; Simecrin; Simetic; Malaysia: Cuplaton; Dentinox Colic Drops; Disflatyl; Gascoal; Gastyl; Mexico: Diflax; Espaven Pediatrico; Liberan¤; Netherlands: Aeropax; Carboticon¤; Ceolat¤; Polysilane¤; Setlers Windfree; Norway: Ceolat¤; Minifom; Siloxan; New Zealand: De-Gas; Infacol; Medefoam; Portugal: Aero-Om; Russia: Disflatyl (Дисфлатил); Espumisan (Еспумизан); SAB Simplex (САБ Симплекс); Simicol (Симикол); South Africa: Telament; Singapore: Cuplaton; Gascoal¤; Infacol; RidWind; Spain: Aero Red; Disflatyl¤; Enterosilicona; Pergastric¤; Phazyme¤; Sweden: Abulen¤; Ceolat¤; Minifom; Switzerland: Aeropax¤; Disflatyl; Flatulex; Lefax; Polysilane; SAB Simplex¤; Sili-Met-San¤; Simet-AF¤; Thailand: Air-X; Airrox; Babcon¤; Disflatyl; Gas-MM; Gas-X; Gassi; Gastyl; Logastin; Margel; Mylom; Ovol; Semeth; Sigas; Simcone; Simecon; Simetyl; United Arab Emirates: Salinal; United Kingdom: Asilone Windcheaters¤; Dentinox Colic Drops; Infacol; Phazyme¤; Wind-Eze; Woodwards Colic Drops¤; United States: Colicon; Degas; Extra Strength Mintox Plus; Flatulex; Gas Relief; Gas-X; Maalox Anti-Gas¤; Major-Con; Mylanta Gas; Mylicon; Phazyme; SonoRx; Venezuela: Antifom; Sicon; Silicon;

Multi-ingredient Preparations

Argentina: Aci Tip; Aci-Tip; Alplax Net; Aludrox II; Ansielix Digest; Asestor; Bigetric; Bil 13 Enzimatico; Bilagol; Biletan Enzimatico; Biluen Enzimatico; Carbogasol Antiacido¤; Carbogasol Digestivo; Carbogasol; Cistoquine Plus; Dafne; Digenorflat; Digenormotil Plus; Digesplen; Ditopax¤; Ditopax; Dom-Polienzim; Estreptocarbocaftiazol; Euciton Stress; Eudon; Faboacid; Facilgest; Factor AG Antiacido; Factor AG Antiespasmodico; Factor Bioenterico; Factorine; Faelac¤; Faradil Enzimatico; Faradil Novo; Faradil; Gastop; Gastridin-E; Gastrimet Enzimatico; Gastrimet; Gastroge; Gastron Fuerte¤; Genolaxante; Hepadigenor; Laxicona; Moperidona AF; Moperidona Enzimatica; Mosar Enzimatico; Mosar Plus; Mucalan; Mylanta II; Mylanta Max; Mylanta Plus; Novodig; Pankreoflat Sedante; Pankreoflat; Pankreon Total; Pepsamar Duo; Polienzim; Praxis; Pulsar Enzimatico; Pulsar Plus; Regulane AF; Sidomal; Simecon Antiacido; Somasedan; Suspension Antiacida con Simeticona; Tensium Gastric; Vacuobil Plus; Vegestabil Digest; Australia: Alucone¤; Degas Extra; Dexsal; Diaguard Forte¤; Diaguard¤; Diareze; Gastreze¤; Gastrogel; Gelusil; Imodium Advanced; Infacol-C¤; LoAsid¤; Mucaine 2 in 1¤; Mylanta; No Gas; Sigma Liquid Antacid; Simeco¤; Sodexol¤; Titralac-Sil¤; Austria: CO2 Granulat; Duplotrast Weinsaure; Duplotrast Z; Duplotrast¤; Enzyflat; Gallo Merz¤; Helopanflat; Imodium Plus; Laxbene; Pankreoflat; Purgazen; SAB¤; Sabatif; Silkonol¤; Belgium: Gastrobul¤; Gelusil ML¤; Gelusil Simethicone; Kestomatine Baby; Kestomatine; Mylanta¤; Sili-Met-San; Zoru¤; Brazil: Acidex¤; Aclorisan; Alca-Luftal; Alcalone Plus; Algedrox; Alkagel; Anacidron¤; Andursil; Asilone¤; Asilone; Azime¤; Digecap-Zimatico; Digeplus; Digesnorma¤; Digest¤; Elozima¤; Espasmacid; Espasmo Colic; Espasmo Luftal; Espasmo Novozyme¤; Espasmo Silidron; Essen; Estomagel; Eufermen¤; Flagass Baby; Gamalat¤; Gascol; Gastran; Gastricin¤; Gastrobene; Gastrobene; Gastrobion; Gastrogel¤; Gastrol TC; Gastromag¤; Gastroplus; Gelusil M; Hidroxid¤; Hidroxogel; Imodium Plus¤; Kolampept; Kolantyl DMP; Luftgaz¤; Maalox Plus; Magnesin; Milax; Milgex; Neutraforte¤; Normopride Enzimatico¤; Nutrizim¤; Pankreoflat; Pepsaplus; Pepsogel; Plasil Enzimatico; Primeral; Riopan Plus; Siligel¤; Siludrox; Simeco Plus; Sintozima; Vonil Enzimatico¤; Canada: Almagel Plus; Amphojel Plus¤; Antacid Liquid¤; Antacid Plus Antiflatulant; Antacid Tablet; Antacide Suspension avec Antiflatulent; Centra Acid Plus¤; Di-Gel¤; Diovol Plus AF; Diovol Plus; Diovol Plus; E-Z-Gas II¤; Gastrinol¤; Gastrocalm; Gastrocalm; Imodium Advanced; Maalox Plus; Maalox Quick Dissolve with Antigas; Mylanta; Riopan Plus; Spasmo Nil¤; Stomaax Plus; Thunas Hyperacidity Tablets¤; Chile: Aci-Tip¤; Aeroflat¤; Aerogastrol; Antiax; Digenil; Digespar; Disfrutab; Ditopax; Ditopax; Flapex E; Garceptol; Gaseofin; Gasopax; Gasorbol Plus¤; Gasorbol; Maalox Plus; Mylanta; No-Ref; Nogastra; Nogastra; Nutrizima; Onoton¤; Pangastren; Peptinal Forte; Peptinal; Peptinal; Simeco Plus; Czech Republic: CO2 Granulat; E-Z-Gas; Meteospasmyl; Denmark: Alkasid¤; Imodium med Simethicon; France: Aerocid¤; Carbosylane; Carbosymag; Contracide; Dimalan¤; Gastralgine¤; Gastrobul¤; Gastrovison¤; Gelosedine¤; Imosselduo; Maalox Ballonnements; Meteospasmyl; Meteoxane; Pepp¤; Pepsane; Pereflat¤; Polysilane Delalande; Polysilane Joullie¤; Polysilane Reglisse¤; Primperoxane¤; Rennie Deflatine; Spasmenzyme¤; Zymoplex¤; Germany: Adsorgan¤; Andursil¤; Barilux Brausetabletten; Ceolat compositum¤; CO2 Granulat¤; Digest-Merz¤; Elzym N¤; Enzym-Kugeletten¤; Enzym-Lefax; Enzym-Paractol¤; Esberizym N¤; Euflat I¤; Gallo Merz N; Gallo Merz Spasmolyticum¤; Gastrovison¤; Gillazym¤; Helopanflat N¤; Hevert Enzym Novo¤; Hevert-Enzym Plus; Imodium Plus; Jasicholin N¤; Kompensan-S forte¤; Kompensan-S¤; Meteophyt-V¤; Meteozym; Pankreoflat; Paractol; Paractol; Rennie Defarin; Spasmo-Canulase N¤; Tri Viaben¤; Unibaryt¤; Wismut comp¤; Greece: Carbosylane; Gastrovison¤; Maalox Plus; Simeco; Hong Kong: Actal Plus; Colimix; Crema-U¤; Dicymine Co; Diovol Plus; Diovol Plus; Disflatyl; Enzyplex; Fedra-Gel-S; Gastrogel; Gelusil Plus; Hydrosil; Imodium Plus; Lantacid; Lederscon¤; Maalox Plus; Magsil¤; Meteospasmyl¤; Mylanta; Mytancid; Nilcid-MPS¤; Pankreoflat; Polysilane¤; Silox-50; Simeco¤; Simegel; Topase¤; Triloxane; Veragel; Vida Flatugel; Hungary: Gastrobul; Imodium Komplett; Meteospasmyl; Pankreoflat; India: Acidin; Alucinol; Aristogyl Plus; Aristogyl-F; Bestozyme; Colimex; Colirid; Cyclopam; Digene; Digeplex-T; Diovol Forte DGL; Diovol Forte; Diovol; Disogel; Distenil; Entasid; Entasid; Gastro MPS; Gelusil MPS¤; Logascid; Maglid; Maylox; Molzyme¤; Neopeptine; Pankreoflat; Paractol; Paractol; Pepticaine; PFT; pH4; Polycrol; Rolac Plus; Sanzyme-DS; Siloxogene; Simeco; Solacid; Spasmonil; Ulgel¤; Unienzyme; Visco; Ireland: Altacite Plus¤; Andursil¤; Asilone¤; Bisodol Extra¤; Carbex¤; Kolanticon¤; Maalox Plus; Polycrol¤; Rennie Deflatine; Israel: Carbosylane; Dentinox; Liquid Antacid Plus Simethicon¤; Maalox Plus; Pankreoflat; Silain; Italy: Aerofagil; Anacidol; Anti-Acido; Belsar¤; Canulase¤; Carbosylane Bi-Attivo¤; Carboyoghurt; Contracide; Debridat Enzimatico¤; Digestum¤; Duogas; Ede 6¤; Ede¤; Enterocantril¤; Essen¤; Eugastran¤; Gastrotuss; Gastrovison¤; Geffer; Maalox Plus; Mylanta¤; No-Gas; Nuleron; Onoton¤; Pancreoflat; Pancresil¤; Plasil Enzimatico¤; Prandium¤; Quanto¤; Selg-Esse; Silisan; Trimalcina¤; Malaysia: Actal Plus; Alucid; Belcid; Colimix; Enzyplex; Gelusil Forte¤; Gelusil Plus; Gerskin; Maalox Plus; Macgel; Meteospasmyl; Mylanta¤; Polysilane; Simagel; Titralac-Sil¤; Uphacol; Zellox-II; Mexico: Alkagel Complex; Cidetox; Difarben; Digenor Plus; Dirfaben¤; Ditopax-F; Ditopax; Ditopax; Dixiflen; Espasal; Espasin; Espaven Alcalino; Espaven Enzimatico; Espaven MD; Espaven; Espraden; Farcolan; Farmeban; Finprob; Gelan Plus; Gelar; Geldrox Plus; Gelpex; Imodium Plus; Melox Plus¤; Meteospasmyl; Mylanta Plus; Neo-Panlacticos Plus; Nilcid¤; Noax 3; Normex Plus; Ochozim; Onoton; Pankreoflat; Pepsane; Plasil Enzimatico; Plusgel; Pramigel; Primpesasy; Riopan; Segel; Selecto-D; Ulgel; Wingel; Zimeton; Netherlands: Diacure Plus¤; Maalox Plus; Mylanta-II¤; Polysilane Comp¤; Rennie Deflatine; Zoru¤; New Zealand: Gastrogel¤; Imodium Advanced; Mylanta; Titralac-Sil¤; Portugal: Di-Gel Forte¤; Di-Gel¤; Espasmo Canulase; Fermetone Composto; Helopanflat; Kompensan-S; Maalox Plus; Modulanzime; Nutrizym¤; Pankreoflat; Vingel; Russia: Almagel Neo (Алмагель Нео); Gestid (Гестид); Meteospasmyl (Метеоспазмил); Pankreoflat (Панкреофлат); Pepfiz (Пепфиз); South Africa: Asilone¤; Docgel¤; Gel-S¤; Gelusil S; Imodium Plus; Lo-Acid; Maalox Plus; Medigel¤; Merasyn; Microgel¤; Microgel; Pankreoflat; Pedimed; pH 550¤; Polycrol¤; Propan Gel-S; Rubragel-D¤; Rubragel¤; Spasmo-Canulase; Telament¤; Viscalox¤; Singapore: Actal Plus; Almac¤; Alusorb¤; Colimix; Dentinox; Disflatyl; Enzyplex; Gelusil Plus; Gerskin¤; Gestid¤; Hydrosil¤; Macgel¤; Meclosil; Meteospasmyl; Mylanta¤; Polysilane¤; Polysilic III; Simeco¤; Titralac-Sil¤; Tocid¤; Veragel DMS; Zellox-II; Spain: Aci Kestomal¤; Acidac¤; Acidion¤; Acidrina¤; Aero Plus; Aero Red Antiacido; Aero Red Complex; Aeroflat; Aerogel; Aligest Plus¤; Aligest¤; Alucol Silicona; Alucol¤; Clanzoflat; Edym Sedante¤; Espasmo Canulasa¤; Estopec¤; Flatoril; Flavigel¤; Gastro Gobens¤; Gastro Red Antiacido¤; Gastro Red¤; Gastroalgine; Gastrosindrom¤; Geloalumin; Imodium Plus; Jorkil¤; Lactored¤; Lidobama Complex¤; Lidobama Plus¤; Lupidon; Meteoril; Mosil Complex¤; Novo Aerofil Sedante¤; Pankreoflat Sedante¤; Pankreoflat; Parkelanta¤; Polidasa¤; Polisilan Gel¤; Primperan Complex¤; Rabro¤; Silargin¤; Surifarm¤; Suxidina; Takadispep Complex¤; Timulcer¤; Tornacin¤; Trizima¤; Ulpi
r Gastro¤; Sweden: Gastroluft¤; Switzerland: Alucol-S¤; Andursil¤; Andursil; Carboticon; Combacid N; Drofaron; E-Z-Gas II; Elzym¤; Fermento duodenal; Flatulex; Gastroluft¤; Gillazyme plus¤; Gillazyme¤; Globase¤; Helopanflat¤; Imodium Plus; Kestomatine Bebe; Kestomatine¤; Macosil¤; Pankreoflat¤; Pepsane¤; Polysilane Midy¤; Primoxan¤; Rennie Deflatine; Rivogel + Dimethicone¤; Sili-Met-San; Spasmo-Canulase; Zymoplex¤; Thailand: Admag¤; Almaxane¤; Alutop; Amacone; Amco; Amico-L; Antacia; Antacil; Belcid; Berclomine; Bowa; Calthicon; Cymine; Defomag; Defomil; Diovol; Diovol; Droxyl¤; Elzym¤; Enzymet; Enzyplex; Gasteel¤; Gaszym; Gelusil MPS; Kremil-S; Kremil; Maccrol; Machto; Mag 77; Magcol; Malugel; Mano; Mar¤; Meteospasmyl; Pepfiz; Polyenzyme-I; Polyenzyme-N; Polysilane; Simagel¤; Simeco¤; Simeco; Spasticone; Stomac; Ulcegel; V Day Milk¤; Veragel; Ziga-Gel; United Arab Emirates: Alkasid; Moxal Plus; United Kingdom: Actonorm; Altacite Plus; Andursil¤; Asilone; Asilone; Bioglan Effervescent Tablets¤; Bisodol Wind Relief; Boots Wind Relief; Carbex; Diovol¤; Imodium Plus; Indigestion Relief Liquid¤; Indigestion Relief Tablets¤; Kolanticon; LoAsid¤; Maalox Plus; Novasil Plus¤; Piptalin¤; Polycrol¤; Remegel Wind Relief; Rennie Deflatine; Siloxyl¤; Simeco¤; Simeco; Sovol¤; Unigest¤; United States: Advanced Formula Di-Gel; Alamag Plus; Almacone; Aludrox; Anti-Gas Antacid¤; Baby Orajel Tooth and Gum Cleanser; Baros; Di-Gel; Extra Strength Maalox Antacid/Anti-Gas¤; Fast-Acting Mylanta¤; Flatulex; Gas Ban DS; Gas Ban; Gas-X with Maalox; Gaviscon Extra Strength Relief Formula; Gelusil; Imodium Advanced; Iosopan Plus; Kudrox Double Strength¤; Lowsium Plus; Maalox Anti-Gas Extra Strength¤; Maalox Max; Maalox Plus¤; Maalox Regular Strength; Magalan¤; Magalox Plus¤; Medazyme¤; Mi-Acid; Mintox Plus; Mygel; Mylagen; Mylanta; Phazyme-PB¤; Riopan Plus; Rolaids Multi-Symptom; RuLox Plus; Simaal Gel 2; Sparkles; Tempo; Titralac Plus; Trial AG; Tums Plus; Venezuela: Almag; Carbargal con Atropina; Carbargal; Cremalon; Ditosil Plus; Ditosil; Ditosil; Elzym; Maalox Plus; Mylanta; Mylantados; Mylantamil; Nutizym Compositum; Stamyl; Valmecon;

Adjuvant to Preparations

Austria: Prontobario; Brazil: Telebar¤; Canada: Polibar Liquid¤; Polibar Plus¤; Czech Republic: Prontobario; Spain: Barigraf Tac¤; Bario Dif; Bario Faes¤

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