Simethicone

Identification

Summary

Simethicone is an anti-flatulence agent used to relieve pressure, bloating, and symptoms referred to as gas.

Brand Names
Phazyme
Generic Name
Simethicone
DrugBank Accession Number
DB09512
Background

Simethicone is a silicon based surfactant that decreases the surface tension of gastrointestinal gas bubbles to facilitate their elimination.2 It has a favourable safety profile as it is not systemically absorbed.2

Simethicone has been in use since the 1940s1 but was granted FDA approval in 1952.2

Type
Small Molecule
Groups
Approved
Structure
Thumb
Weight
Average: 238.461
Monoisotopic: 238.051288665
Chemical Formula
C6H18O4Si3
Synonyms
  • Simeticona
  • Simeticone
  • Siméticone
  • Simeticonum

Pharmacology

Indication

Simethicone is indicated for the treatment of bloating, pressure, and cramps caused by gas.4 Simethicone is also used as part of bowel preparation for colonoscopies.3

Pharmacology
Accelerate your drug discovery research with the industry’s only fully connected ADMET dataset, ideal for:
Machine Learning
Data Science
Drug Discovery
Accelerate your drug discovery research with our fully connected ADMET dataset
Learn more
Associated Conditions
Associated Therapies
Contraindications & Blackbox Warnings
Contraindications
Contraindications & Blackbox Warnings
With our commercial data, access important information on dangerous risks, contraindications, and adverse effects.
Learn more
Our Blackbox Warnings cover Risks, Contraindications, and Adverse Effects
Learn more
Pharmacodynamics

Simethicone decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion.2 It has a short duration of action as it is generally given as needed, and a wide therapeutic index as it is not systemically absorbed.2

Mechanism of action

Simethicone is a surfactant that decreases the surface tension of gas bubbles in the gastrointestinal tract, more easily allowing gas to exit the body.2

Absorption

Simethicone is not systemically absorbed and so these data are not readily available.2

Volume of distribution

Simethicone is not systemically absorbed and so these data are not readily available.2

Protein binding

Simethicone is not systemically absorbed and so these data are not readily available.2

Metabolism

Simethicone is not systemically absorbed and so it is not metabolised by the body.2

Route of elimination

Simethicone is eliminated in the feces.2

Half-life

Simethicone is not systemically absorbed and so these data are not readily available.2

Clearance

Simethicone is not systemically absorbed and so these data are not readily available.2

Adverse Effects
Medicalerrors
Reduce medical errors
and improve treatment outcomes with our comprehensive & structured data on drug adverse effects.
Learn more
Reduce medical errors & improve treatment outcomes with our adverse effects data
Learn more
Toxicity

Data regarding overdoses with simethicone are rare due to the fact that it is not systemically absorbed.2. In the case of an overdose stop the drug2 and initiate symptomatic and supportive care.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
  • Take with or without food. Recommendations vary from product to product - consult individual product monographs for additional information.

Products

Products
Comprehensive & structured drug product info
From application numbers to product codes, connect different identifiers through our commercial datasets.
Learn more
Easily connect various identifiers back to our datasets
Learn more
Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
air-X 120 TabletTabletOralIMEKS PHARMA SDN. BHD.2020-09-08Not applicableMalaysia flag
Air-X SF TabletTabletOralIMEKS PHARMA SDN. BHD.2020-09-08Not applicableMalaysia flag
Cancap Simethicone USP 180 Mg Soft CapsulesCapsule180 mgOralCancap Pharmaceutical Ltd2014-01-302018-11-21Canada flag
Disflatyl Tablet 40mgTabletOralA. MENARINI SINGAPORE PTE. LTD.2020-09-08Not applicableMalaysia flag
Extra Strength Gas ReliefCapsule166.0 mgOralEssentia Healthcare (Canada) Limited2003-06-162004-12-09Canada flag
Extra Strength Gas Relief Liquid GelsCapsule180 mgOralCatalent Ontario LimitedNot applicableNot applicableCanada flag
Extra Strength Maalox Grf Tablets 150mgTablet150 mgOralNovartis1996-07-301998-07-08Canada flag
Gas ReliefCapsule125 mgOralBanner Pharmacaps2003-06-162014-09-10Canada flag
Gas Relief Extra StrengthCapsule125.0 mgOralApotex CorporationNot applicableNot applicableCanada flag
Gas Relief Liquid GelsCapsule125 mgOralCatalent Ontario LimitedNot applicableNot applicableCanada flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
ACED FULL SUSPENSIONSimethicone (400 mg) + Aluminum hydroxide (4 g) + Magnesium hydroxide (4 g)SuspensionOralCOASPHARMA S.A.S.2018-06-12Not applicableColombia flag
ACILAX�Simethicone (0.4 g) + Aluminum hydroxide (4 g) + Magnesium hydroxide (4 g)SuspensionOralFABRIFARMA S.A.2017-05-15Not applicableColombia flag
ACITIP SUSPENSIÓNSimethicone (600 mg) + Magaldrate (8000 mg)SuspensionOralLABORATORIOS SIEGFRIED S.A.S.2018-03-26Not applicableColombia flag
ACTAL PLUS TabletSimethicone (25 mg) + Alexitol sodium (200 mg) + Magnesium hydroxide (152 mg)TabletOralA. MENARINI SINGAPORE PTE. LTD.2020-09-08Not applicableMalaysia flag
ALEVIAN DUO � CAPSULASSimethicone (300 mg) + Pinaverium bromide (100 mg)Capsule, liquid filledOralBAXALTA COLOMBIA S.A.S.2011-05-03Not applicableColombia flag
ALLUMAG MPS TABLETSimethicone (50 mg) + Aluminum hydroxide (300 mg) + Magnesium trisilicate (100 mg)TabletOralCHULIA PHARMA SDN BHD2017-10-032019-09-11Malaysia flag
ALMECON SUSPENSIONSimethicone (20 mg) + Aluminum hydroxide (200 mg) + Magnesium hydroxide (200 mg)SuspensionOralPRIME PHARMACEUTICAL SDN. BHD.2020-09-08Not applicableMalaysia flag
ALMECON TABLETSimethicone (20 mg) + Aluminum hydroxide (200 mg) + Magnesium hydroxide (200 mg)TabletOralPRIME PHARMACEUTICAL SDN. BHD.2020-09-08Not applicableMalaysia flag
ALTEGAM� TABLETAS RECUBIERTASSimethicone (120 mg) + Trimebutine maleate (200 mg)Tablet, coatedOralCLARIPACK LTDA.2018-05-16Not applicableColombia flag
ALUCID SUSPENSIONSimethicone (50 mg) + Aluminum hydroxide (250 mg) + Magnesium hydroxide (250 mg)SuspensionOralDUOPHARMA MANUFACTURING (BANGI) SDN BHD2020-09-08Not applicableMalaysia flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
METSIL 40 MG ÇIĞNEME TABLETI, 100 ADETSimethicone (40 mg)Tablet, chewableOralHÜSNÜ ARSAN İLAÇLARI A.Ş.2020-08-14Not applicableTurkey flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
Not Available
CAS number
8050-81-5
InChI Key
AMTWCFIAVKBGOD-UHFFFAOYSA-N
InChI
InChI=1S/C6H18O2Si2.O2Si/c1-7-10(5,6)8-9(2,3)4;1-3-2/h1-6H3;
IUPAC Name
3,3,5,5-tetramethyl-2,4-dioxa-3,5-disilahexane; silanedione
SMILES
O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C

References

General References
  1. KEARNS WM, HEFKE H, MORTON SA: Ditopax; a new excretory urographic medium; a clinical report on 1280 injections. J Urol. 1946 Sep;56:392-8. doi: 10.1016/s0022-5347(17)69822-7. [Article]
  2. Ingold CJ, Akhondi H: Simethicone . [Article]
  3. Tongprasert S, Sobhonslidsuk A, Rattanasiri S: Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation. World J Gastroenterol. 2009 Jun 28;15(24):3032-7. doi: 10.3748/wjg.15.3032. [Article]
  4. FDA Approved Drug Products: Imodium Multi-Symptom Relief (Loperamide HCl, Simethicone) Oral Tablet [Link]
  5. Health Canada Approved Drug Products: Imodium Complete (Loperamide HCl, Simethicone) Oral Chewable Tablets [Link]
PubChem Substance
347910457
ChemSpider
4938661
RxNav
9796
ChEMBL
CHEMBL1200838
Wikipedia
Simeticone

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedDiagnosticBowel preparation therapy / Colonoscopy1
4CompletedDiagnosticGastric Mucosal Lesion1
4CompletedDiagnosticSmall Bowel Diseases1
4CompletedDiagnosticStomach Neoplasms1
4CompletedScreeningAdenoma Colon1
4CompletedTreatmentColonoscopy1
4CompletedTreatmentDiarrhoea2
4CompletedTreatmentIleus / Postoperative paralytic ileus1
4CompletedTreatmentInfantile Colics1
4CompletedTreatmentIrritable Bowel Syndrome (IBS)3

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Tablet; tablet, chewableOral
Capsule, liquid filledOral125 mg
Tablet, chewableOral
LiquidOral
Tablet, chewableOral
Solution / dropsOral
TabletOral
Powder
Powder, for solutionOral
EmulsionOral
SyrupOral
Capsule, liquid filledOral250 mg
SuspensionOral66.6 mg
Tablet, delayed releaseOral
TabletOral
Tablet, chewableBuccal470 mg
Tablet
EmulsionOral
CapsuleOral40 mg
EmulsionOral40 mg
CapsuleOral166.0 mg
TabletOral150 mg
SolutionOral
SuspensionOral1 g
Tablet, coatedOral
SuspensionOral66 mg
CapsuleOral125.0 mg
CapsuleOral180.0 mg
StripOral62.5 mg
CapsuleOral166 mg
CapsuleOral
SolutionOral40 mg / 0.6 mL
CapsuleOral200 mg
Tablet, sugar coatedOral
SuspensionOral40 mg / mL
SuspensionOral
Tablet, chewableOral105 mg
SuspensionOral41.2 mg
Powder, for suspensionOral
LiquidOral20 mg / 0.3 mL
SuspensionOral
Solution / dropsOral6.66 %
CapsuleOral
Capsule, liquid filledOral
Capsule, liquid filledOral60 mg
TabletOral40 MG
Solution / dropsOral40 mg / mL
TabletOral180 mg
Tablet, film coatedOral
CapsuleOral95 mg
EmulsionOral62.5 mg / 5 mL
GelOral30 %
Capsule, coatedOral
SyrupOral
Suspension
SyrupOral6.67 g
SuspensionOral69.19 mg/ml
Tablet, chewableOral69.19 mg/ml
Granule, effervescentOral
TabletOral125 MG
Tablet, chewableOral125 mg
Tablet, chewableBuccal125 mg
EmulsionOral80 MG/ML
Tablet, chewableOral120 MG
Tablet, chewableOral40 MG
Tablet, chewableOral80 MG
Tablet, chewableOral85 mg
Tablet, chewableOral180 mg
Tablet, chewableBuccal100 mg
Tablet, chewableOral42 MG
Solution / dropsOral66.6 MG/ML
Suspension / dropsOral
CapsuleOral140 mg
Tablet, film coated
SuspensionOral57.97 g
SuspensionOral41.2 mg/mL
SuspensionOral40 mg/1ml
SuspensionOral67 mg/1ml
EmulsionOral40 mg/0.6ml
CapsuleOral125 mg
CapsuleOral180 mg
SuspensionOral120 mg/15ml
CapsuleOral150 mg
Solution
TabletOral100 mg
SuspensionOral40 mg/0.6ml
TabletOral80 mg
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US6103260No2000-08-152017-07-17US flag

Properties

State
Liquid
Experimental Properties
Not Available
Predicted Properties
PropertyValueSource
Water Solubility1.71 mg/mLALOGPS
logP2.6ALOGPS
logP1.76ChemAxon
logS-2ALOGPS
pKa (Strongest Basic)-3.7ChemAxon
Physiological Charge0ChemAxon
Hydrogen Acceptor Count2ChemAxon
Hydrogen Donor Count0ChemAxon
Polar Surface Area18.46 Å2ChemAxon
Rotatable Bond Count3ChemAxon
Refractivity37.63 m3·mol-1ChemAxon
Polarizability18.48 Å3ChemAxon
Number of Rings0ChemAxon
Bioavailability1ChemAxon
Rule of FiveYesChemAxon
Ghose FilterNoChemAxon
Veber's RuleYesChemAxon
MDDR-like RuleNoChemAxon
Predicted ADMET Features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
Not Available

Drug created on November 30, 2015 19:10 / Updated on July 24, 2021 14:58