Simeticon

Structural formula
General
Non-proprietary name	Simeticon
other names	α- (trimethylsilyl) -ω-methylpoly [oxy (dimethylsilylene)] ( WHO ) ; Simeticonum ( Latin ) ; Dimeticon silicon dioxide; SIMETHICONE ( INCI ) ;
Molecular formula	(C 2 H 6 OSi) n • (SiO 2 ) m
Brief description	viscous , gray-white, opalescent liquid
External identifiers / databases
EC number	617-098-1
ECHA InfoCard	100.107.016
PubChem	6433516
Wikidata	Q419415
Drug information
ATC code	A03 AX13
Drug class	Carminativa
properties
Molar mass	variable
density	0.965-0.970 g cm -3
solubility	practically insoluble in water and methanol , very sparingly soluble to practically insoluble in absolute ethanol , partially miscible with dichloromethane , ethyl acetate , 2-butanone and toluene
safety instructions
	Please note the exemption from the labeling requirement for drugs, medical devices, cosmetics, food and animal feed
GHS hazard labeling ; no classification available
Toxicological data	900 mg kg −1 ( LD 50 , dog , iv )
	As far as possible and customary, SI units are used. Unless otherwise noted, the data given apply to standard conditions .

Simethicone (also simethicone) is a drug from the group of carminativa , the oral is taken and bloating can alleviate pain caused by too much gas in the gastrointestinal tract are triggered. In the case of poisoning with surfactants , simeticon is used as an antidote against excessive foam formation.

Clinical information

application areas

In the case of excessive gas formation and gas accumulation in the gastrointestinal area ( meteorism ) with gastrointestinal complaints such as gas , bloating and tightness in the upper abdomen, which can be caused, for example, by aerophagia (air swallowing) or by nutritional or diet errors.
The administration of simeticon in postoperative intestinal atony and Ogilvie syndrome counteracts meteorism .
For the symptomatic treatment of functional dyspepsia .
For the symptomatic treatment of infant colic ( three-month colic ).

In the case of increased gas formation after operations and Roemheld's syndrome

As an aid for diagnosis in the abdominal area to reduce gas shadows (sonography, X-ray and gastroscopy).

As an immediate measure for defoaming after oral ingestion of detergents and detergents containing surfactants. Suitable for use by laypeople in the household; especially effective when consuming large amounts of surfactant.

Contraindications

At a hypersensitivity against simethicone as well as a bowel obstruction (ileus) simethicone-containing allowed drug not be administered.

Drug interactions

Although no interactions are known to date, influences on the absorption of other medicinal substances cannot be ruled out due to the surface-active properties of the active substance. The interactions described here are individual cases.

Digoxin : increased levels of digoxin
Ribavirin : decreased levels of ribavirin - AUC = −14%
Warfarin : increased levels of warfarin
Carbamazepine : Toxicity Increase of Carbamazepine - Individual Report

Use during pregnancy and breastfeeding

Since simeticon is not absorbed by the body, the corresponding drugs can be taken during pregnancy and breastfeeding . However, the duration of use should not exceed three days during pregnancy and then a treatment-free interval of 14 days should be observed.

Pharmacological properties

Disturbed digestive processes often lead to flatulence. The increased gases are present in the gastrointestinal tract as sluggish, fine-bubble foam. This makes the normal absorption of the gases through the intestinal wall difficult or completely impossible. Simeticon is a stable, surface-active polydimethylsiloxane . It reduces the surface tension of the gas bubbles embedded in the food pulp and in the mucus of the digestive tract , which disintegrate as a result. The gases released in the process can be absorbed by the intestinal wall and eliminated by the intestinal peristalsis . Simeticon works only physically, does not take part in chemical reactions and is pharmacologically and physiologically an inert substance . At a concentration of 0.1 mg / ml, Simeticon destroys foams in 3 to 6 seconds, and foam prevention also takes place at this concentration. This lasts for about 24 hours.

After oral administration of simeticon there is no absorption; the active ingredient is excreted unchanged in the stool after gastrointestinal passage .

Chemical properties

Simeticon - α (trimethylsilyl) -ω-methylpoly [oxy (dimethylsilylene)] with silicon dioxide - is the abbreviation for dimeticon activated with 4% to 7% silicon dioxide , it contains 90.5% to 99.0% polydimethylsiloxane. The surface of the silicon dioxide is changed by the incorporation of methylsilyl groups.

Trade names

Monopreparations : Aero-OM (A, CH), Antiflat (A), Elugan (D), Endo-Paractol (D), Espumisan (D), Flatulex (CH), Lefax (D), Lefaxin (A), Sab simplex (D, A), Uluxan (CH), Air-X (TH), as well as various generics

Combination preparations: Andursil (CH), Enzym-Lefax (D), Helopanflat (A), Imodium akut complex / plus (D, A, CH), Rennie Deflatin (CH)

Brand Names: Compounds: Dow Corning Q7-2243 (CEP), Dow Corning AF M Compound (CEP) Emulsion: Dow Corning Q7-2587 Emulsion

Individual evidence

↑ Entry on SIMETHICONE in the CosIng database of the EU Commission, accessed on December 28, 2019.
↑ ^a ^b European Pharmacopoeia Commission (ed.): EUROPEAN PHARMACOPOE 5TH EDITION . tape 5.0-5.8 , 2006.
^ The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th Edition (Merck & Co., Inc.), Whitehouse Station, NJ, USA, 2006; ISBN 978-0-911910-00-1 .
↑ This substance has either not yet been classified with regard to its hazardousness or a reliable and citable source has not yet been found.
↑ Entry on Simeticon in the ChemIDplus database of the United States National Library of Medicine (NLM) .
↑ O. [ed.] HP [ed.]; Trentz R .; Bruch Berchtold: Berchtold surgery with StudentConsult access . Urban & Fischer in Elsevier, Munich 2006, ISBN 978-3-437-44480-7 .
↑ G. Holtmann et al .: A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia. In: Aliment Pharmacol Ther . Volume 16, Issue 9, 2002, pp. 1641-1648, PMID 12197843 .
↑ Simeticon is effective and tolerable for infant colic. Observation of use in: Pharmazeutische Zeitung (edition 28/2004).
↑ JC McElnay et al .: Interaction of digoxin with antacid constituents'. Br Med J. 1978 June 10; 1 (6126): 1554; PMID 656806 ; PMC 1604992 (free full text, PDF).
↑ Ozlem Guneysel et al .: Carbamazepine overdose after exposure to simethicone: a case report Journal of Medical Case Reports 2008, 2: 242 full text (PDF; 201 kB) doi: 10.1186 / 1752-1947-2-242 .
↑ ^a ^b Technical information (sample text from the BfArM for simeticon), as of December 21, 2000 ( RTF ; 33 kB).
↑ M. Dittrich, SE Miederer, B. Havertz, R. Krastev: Foam destruction and foam prevention: The mechanism of action of simeticon in vitro . (PDF) In: Journal for Gastroenterological and Hepatological Diseases . No. 8, 2010, pp. 1-7. Retrieved July 26, 2010.

Web links

MeSH simeticon

Wikibooks: Pharmacology and Toxicology: Gastrointestinal Tract: Defoamers - Learning and Teaching Materials

[CosIng-1] Entry on SIMETHICONE in the CosIng database of the EU Commission, accessed on December 28, 2019.

[Ph._Eur._5-2] European Pharmacopoeia Commission (ed.): EUROPEAN PHARMACOPOE 5TH EDITION . tape 5.0-5.8 , 2006.

[MERCK_Index-3] The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th Edition (Merck & Co., Inc.), Whitehouse Station, NJ, USA, 2006; ISBN 978-0-911910-00-1 .

[NV-4] This substance has either not yet been classified with regard to its hazardousness or a reliable and citable source has not yet been found.

[ChemIDplus-5] Entry on Simeticon in the ChemIDplus database of the United States National Library of Medicine (NLM) .

[6] O. [ed.] HP [ed.]; Trentz R .; Bruch Berchtold: Berchtold surgery with StudentConsult access . Urban & Fischer in Elsevier, Munich 2006, ISBN 978-3-437-44480-7 .

[7] G. Holtmann et al .: A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia. In: Aliment Pharmacol Ther . Volume 16, Issue 9, 2002, pp. 1641-1648, PMID 12197843 .

[8] Simeticon is effective and tolerable for infant colic. Observation of use in: Pharmazeutische Zeitung (edition 28/2004).

[9] JC McElnay et al .: Interaction of digoxin with antacid constituents'. Br Med J. 1978 June 10; 1 (6126): 1554; PMID 656806 ; PMC 1604992 (free full text, PDF).

[10] Ozlem Guneysel et al .: Carbamazepine overdose after exposure to simethicone: a case report Journal of Medical Case Reports 2008, 2: 242 full text (PDF; 201 kB) doi: 10.1186 / 1752-1947-2-242 .

[fi-11] Technical information (sample text from the BfArM for simeticon), as of December 21, 2000 ( RTF ; 33 kB).

[12] M. Dittrich, SE Miederer, B. Havertz, R. Krastev: Foam destruction and foam prevention: The mechanism of action of simeticon in vitro . (PDF) In: Journal for Gastroenterological and Hepatological Diseases . No. 8, 2010, pp. 1-7. Retrieved July 26, 2010.