Simeticone

Simeticone

Clinical data
Trade names	Infacol, Wind-eze, WindSetlers, others
Other names	Simethicone [1] (USAN US)
AHFS/Drugs.com	Monograph
Pregnancy category	C
Routes of administration	Oral
ATC code	A03AX13 ( WHO )
Legal status
Legal status	US: OTC
Pharmacokinetic data
Bioavailability	None
Protein binding	0%
Metabolism	Not metabolized
Elimination half-life	N/A
Excretion	Feces
Identifiers
IUPAC name Poly(dimethylsiloxane), silicon dioxide
CAS Number	8050-81-5  Y
PubChem CID	6433516
DrugBank	DB09512  Y
ChemSpider	None
ChEMBL	ChEMBL1200838  N
CompTox Dashboard (EPA)	DTXSID00904918
ECHA InfoCard	100.107.016
Chemical and physical data
Formula	(C2H6OSi)n · (SiO2)m
Molar mass	Variable
NY  (what is this?)    (verify)

Simeticone (INN), also known as simethicone (USAN), is an anti-foaming agent used to reduce bloating, discomfort or pain caused by excessive gas.

Medical uses

Simethicone tablets

Simethicone is used to relieve the symptoms of excessive gas in the gastrointestinal tract, namely bloating, burping, and flatulence. ^{[2] [3]} While there is a lack of conclusive evidence that simethicone is effective for this use,⁣ ^{[4] [5] [ failed verification ]} studies have shown that it can relieve symptoms of functional dyspepsia ^[6] and functional bloating. ^[7]

It has not been fully established that simethicone is useful to treat colic in babies, ^[8] and it is not recommended for this purpose. ^[5] A study in the United Kingdom reported that according to parental perception simethicone helped infant colic in some cases. ^[9]

Simethicone can also be used for suspected postoperative abdominal discomfort in infants. ^[10]

Side effects

Simethicone does not have any serious side effects. ^[11] Two uncommon side effects (occurring in 1 in 100 to 1 in 1,000 patients) are constipation and nausea. ^[12]

Though poorly documented, ^[13] some studies show a possible negative interaction between simethicone and levothyroxine, meaning it can possibly bind levothyroxine in the GI tract and hence reduce its absorption leaving the patient prone to clinical manifestations of hypothyroidism. It is important to mention the long T_1/2 of levothyroxine which makes the phenomenon a matter of at least a week of using levothyroxine with simethicone. To prevent this interaction, simethicone is recommended to be taken at least 4 hours before or after levothyroxine. ^[14]

Pharmacology

Simethicone is a non-systemic surfactant which decreases the surface tension of gas bubbles in the GI tract. ^[11] This allows gas bubbles to leave the GI tract as flatulence or belching. ^[11] Simethicone does not reduce or prevent the formation of gas. ^[15] Its effectiveness has been shown in several in vitro studies. ^{[16] [17]}

Chemistry

Simethicone is a mixture of dimethicone and silicon dioxide. ^[18]

Names

The INN name is "simethicone", which was added to the INN recommended list in 1999. ^[19]

Simethicone is marketed under many brand names and in many combination drugs; it is also marketed as a veterinary drug. ^[20]

Brands

Brand names include A.F., Acid Off, Aero Red, Aero-OM, Aero-Sim, Aerocol, Aerox, Aesim, Aflat, Air-X, Anaflat, Antiflat, Baby Rest, Bicarsim, Bicarsim Forte, Blow-X, Bobotic, Bobotik, Carbogasol, Colic E, Colin, Cuplaton, Degas, Dentinox, Dermatix, Digesta, Dimetikon Meda, Disflatyl, Disolgas, Elugan N, Elzym, Endo-Paractol, Enterosilicona, Espaven Antigas, Espumisan, Espumisan L, Flacol, Flapex, Flatidyl, Flatoril, Flatulex, Flucolic, Gas X, Gas-X, Gaselab, Gaseoflat, Gaseoflatex, Gaseophar, Gaseoplus, Gaseovet, Gaservol, Gasimetin, Gasnil, Gasofilm, Gastrex, Gastrosen, Gazim X, Gazix, Geludrox-HS, Genasyme, Ilio-Funkton, Imogas, Imogaze, Imonogas, Infacalm, Infacol, Infacolic, Lefax, Lefaxin, Lefoam, Logastin, Luftal, Maxi Flat, Meteosim, Metiorisan, Metsil, Mylanta, Mylicon, Mylicongas, Mylom, Mymus, Nanog, Neodrop, Neogasol, Neolanta, Orocure, Ovol, Pedicon, Phazin, Phazyme, Polysilane Junior, Restime, Rugby Gas Relief, Sab Simplex, Salinal, Semecon, Semeth, Sicongast, Siflat, Silbione, Siligas, Silipin, Sim, Simcone, Simecon, Simecrin, Simedill, Simegut, Simet, Simethicon, Simethicone, Simetic, Simeticon, Simeticona, Simeticone, Siméticone, Simeticonum, Simetigast, Simflat, Simicol, Simicon, Wilcon, Wind-eze and WindSetlers. [20] It is also marketed as a combination drug: [20] with algeldrate as Kestomatine with aluminium or magnesium salts and in some cases both, as Alamag Plus, Almacone, Alposim, Aluphagel, Alutop, Amico-L Andursil, Axcel Eviline, Boots Wind Relief, Di-Gel, Diovol Plus, Diovol Plus AF, Gas Ban DS, Hydrosil, Iosopan Plus, Kremil, Kremil-S, Maalox Plus, Magasida, Mi-Acid, Mygel, Mylagen, Mylanta, Polysilane, Polysilane Delalande, Rumibex and Trial AG with alverine as Avarin, Meteospasmyl, Nady-Spasmyl with barium sulfate as Bario Dif with bismuth as Gastop with calcium carbonate as Flamints, Gaseoflatex Plus, Malugel, Titralac Plus with activated charcoal as Carbosylane, Clingest, Finigax. Flatuna with cinitapride as Rogastril Plus with clebopride as Flatoril with dicycloverine as Cloact, Colicspam, Colimix, Colispas, Coliza-D, Cyclopam, Fri-Spas, Meftal Spas, Respas, Simcomine, Spasact, Spasmindon DPS with domperidone as Bigetric, Dom Simecon, Doprokin-S, Glomoti, Moperidona AF, Mutecium, Praxis with hydrotalcite as Altacide and Talsil Forte with homatropine as Aero-Sim Compuesto, Asestor, Factor AG, Sedotropina Flat with lactulose as Dinolak with levonorgestrel as Jaydess with loperamide as Eldoper Plus, Imodium Duo, Imolopesim, Loperamide HCl/Dimeticon, Loperuma, Lositala, Losiwuto, Regulane AF, Stoperan Plus, Toban F Plus with magaldrate as Aci Basic, Aci-Tip, Acicone-S, Acid-Farvet, Acifin, Amalset, Antiax, Asidrat, Assis, Avicid, Banacid-s, Buenox, Cremalon, Curecid, Digax, Digeril, Endcid, Gaseovet MS, Gastrine, Gastrogel, Gastroral, Gastrorapid, Magacid, Magal-D, Magalat, Magaldrato+Simeticona, Magaldrax, Maganta Plus, Magsilon, Marlox Plus, Megacil Plus, Megalrat Plus, Minicidez, Miopan Plus, Novelta, Oxecone-MS, Riopan Plus, Rolac Plus, Sedo Mag, Simagal, Simelgat Plus, Taimacon, Zymcon with metoclopramide as Anaflat Compuesto, Di-Aero OM, Digespar, Factorine, Pangastren with mosapride as M-Pride-MPS, Moxar, Moza MPS with pancreatin as Anaflat Enzimático, Digenil, Digesflat, Enzym Lefax, Enzymet, Enzymin, fermento duodenal, Finigax Indigestion, Flaton, Flazymec, Gasflat, Gaszym, Gesdyp, Hazmolin, Komflat, MeteoZym, Pankreoflat, Tripanzym with papaverine as Espasmo Siligas with pinaverium as Alevian Duo, Pladuet, Planex with pipenzolate bromide as Cadinol, Gasorbol Gotas with phloroglucinol as Meteoxane with trimebutine as Eumotil-S, Eumotrix Plus, Libertrim SDP, Libertrim SII, Muvett S with urea as Hidribet. It is also marketed as a veterinary drug under the brands Birp and Methysilox.

References

1. "Simethicone names". Drugs.com. Retrieved 27 August 2017.
2. "Simethicone tablet". NIH DailyMed. April 2016. Retrieved 27 August 2017.
3. "Simeticone". NHS. 10 October 2019. Retrieved 30 January 2020.
4. Modi R, Clearfield HR, Levitt M (July 2013). "Belching, Bloating and Flatulence". American College of Gastroenterology.
5. "Simethicone". drugs.com. Efficacy not established for the symptomatic relief of immediate postprandial upper abdominal distress
6. Holtmann G, Gschossmann J, Mayr P, Talley NJ (September 2002). "A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia". Alimentary Pharmacology & Therapeutics. 16 (9). Wiley: 1641–8. doi:10.1046/j.1365-2036.2002.01322.x. PMID   12197843. S2CID   23286985.
7. Burta O, Iacobescu C, Mateescu RB, Nicolaie T, Tiuca N, Pop CS (25 September 2018). "Efficacy and safety of APT036 versus simethicone in the treatment of functional bloating: a multicentre, randomised, double-blind, parallel group, clinical study". Translational Gastroenterology and Hepatology. 3 (72). AME Publications: 72. doi: 10.21037/tgh.2018.09.11 . PMC   6256934 . PMID   30511026.
8. Biagioli E, Tarasco V, Lingua C, Moja L, Savino F (September 2016). "Pain-relieving agents for infantile colic". The Cochrane Database of Systematic Reviews. 2016 (9) CD009999. doi:10.1002/14651858.CD009999.pub2. PMC   6457752 . PMID   27631535.
9. Goldman M, Beaumont T (March 2017). "A real world evaluation of a treatment for infant colic based on the experience and perceptions of 4004 parents". British Journal of Nursing. 26 (5 Suppl 1): S3 –S10. doi:10.12968/bjon.2017.26.Sup5.S3. PMID   28350192. S2CID   32885530.
10. Voepel-Lewis TD, Malviya S, Burke C, D'Agostino R, Hadden SM, Siewert M, Tait AR (March 1998). "Evaluation of simethicone for the treatment of postoperative abdominal discomfort in infants". Journal of Clinical Anesthesia. 10 (2): 91–94. doi:10.1016/S0952-8180(97)00249-3. PMID   9524891.
11. Ingold CJ, Akhondi H (January 2021). "Simethicone". StatPearls [Internet]. PMID   32310457.
12. "Simethicone Side Effects in Detail". Drugs.com. Retrieved 27 August 2017.
13. Skelin, Marko; Lucijanić, Tomo; Amidžić Klarić, Daniela; Rešić, Arnes; Bakula, Miro; Liberati-Čizmek, Ana-Marija; Gharib, Hossein; Rahelić, Dario (February 2017). "Factors Affecting Gastrointestinal Absorption of Levothyroxine: A Review". Clinical Therapeutics. 39 (2): 378–403. doi:10.1016/j.clinthera.2017.01.005.
14. Balapatabendi, M.; Harris, D.; Shenoy, S. D. (2011-09-01). "Drug interaction of levothyroxine with infant colic drops". Archives of Disease in Childhood. 96 (9): 888–889. doi:10.1136/archdischild-2011-300333. ISSN   0003-9888.
15. "Treatment of Gas". International Foundation for Functional Gastrointestinal Disorders. 4 September 2015.
16. Brecević L, Bosan-Kilibarda I, Strajnar F (May 1994). "Mechanism of antifoaming action of simethicone". Journal of Applied Toxicology. 14 (3). Wiley: 207–11. doi:10.1002/jat.2550140311. PMID   8083482. S2CID   7453218 . Retrieved 30 January 2020.
17. Dittrich M, Miederer SE, Havertz B, Krastev R (12 May 2010). "Schaumzerstörung und Schaumverhinderung: Der Wirkmechanismus von Simeticon in vitro" [Defoaming and antifoaming action of simethicone in vitro](PDF). Journal für Gastroenterologische und Hepatologische Erkrankungen. (in German). 8 (3). Krause & Pachernegg: 19–25.
18. O'Neil MJ, ed. (2006). "Dimethicone". The Merck Index (14th ed.). Whitehouse Station, NJ: Merck. p. 545.
19. "Recommended INN List 42" (PDF). WHO Drug Information. 13 (3): 202. 1999.
20. "Simeticone international brands". Drugs.com. Retrieved 27 August 2017.