Simethicone

Identification

Name
Simethicone
Accession Number
DB09512
Description

Simethicone is an orally administered antifoaming agent. It is mainly used to reduce gas from the gastrointestinal tract (GIT) in patients complaining from recurrent flatulence. Simethicone is a mixture of polydimethylsiloxane and hydrated silica gel. It exerts its action locally in the GIT, it is not absorbed into the blood stream. The main side effects of simethicone are GIT related including: mild diarrhea, nausea and vomiting.

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

Pharmacology

Indication
  1. To relieve pain and discomfort caused by excess gas in the intestine and stomach in cases such as flatulence and post operative gaseous distention.
  2. It could be used also prior to an endoscopy to eliminate foam, gas and air from the gastrointestinal tract to reduce gas shadow which will result in better visualization.
Associated Conditions
Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
Learn More
Pharmacodynamics

Simethicone acts by decreasing the surface tension of gas bubbles, thus facilitating their coalescence and expulsion as flatus or belching. It also prevents the formation and accumulation of mucus-enclosed pockets of gas in digestive tract. Simethicone also facilitates the passage of gas through bowel lumen and allows patients to excrete a greater volume of gas at one time, thereby reducing the number of flatus events.

Mechanism of action

Decreases the surface tension of gas bubbles thereby disperses and prevents gas pockets in the GI system.

Absorption

Not absorbed following oral administration.

Volume of distribution

Simethicone is pharmacologically inert and is not absorbed from the gastrointestinal tract.

Protein binding

Simethicone is pharmacologically inert and is not absorbed from the gastrointestinal tract.

Metabolism

The drug is not absorbed and it is excreted in the feces unchanged.

Route of elimination

Excreted unchanged in feces.

Half-life

The drug is not absorbed.

Clearance

Excreted unchanged in feces.

Adverse Effects
Learn about our commercial Adverse Effects data.
Learn More
Toxicity

LD50 (oral, rat): 4070 mg/Kg.

Affected organisms
Not Available
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

Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Cancap Simethicone USP 180 Mg Soft CapsulesCapsuleOralCancap Pharmaceutical Ltd2014-01-302018-11-21Canada flag
Extra Strength Gas ReliefCapsule166.0 mgOralEssentia Healthcare (Canada) Limited2003-06-162004-12-09Canada flag
Extra Strength Gas Relief Liquid GelsCapsuleOralCatalent Ontario LimitedNot applicableNot applicableCanada flag
Extra Strength Maalox Grf Tablets 150mgTabletOralNovartis1996-07-301998-07-08Canada flag
Gas ReliefCapsule125 mgOralBanner Pharmacaps2003-06-162014-09-10Canada flag
Gas Relief Extra StrengthCapsule125.0 mgOralApotex CorporationNot applicableNot applicableCanada flag
Gas Relief Liquid GelsCapsuleOralCatalent Ontario LimitedNot applicableNot applicableCanada flag
Gas Relief TabletsTablet, chewableOralGuardian Drug Company2010-03-25Not applicableCanada flag
Gas Relief Ultra StrengthCapsule180.0 mgOralApotex CorporationNot applicableNot applicableCanada flag
Gas X Thin Strips 62.5mg SimethiconeStripOralGlaxosmithkline Inc2006-04-032016-07-19Canada flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

    Learn more
  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Antacid & AntigasSimethicone (20.00 mg) + Aluminum hydroxide (153.000 mg) + Magnesium hydroxide (200.00 mg)SuspensionOralGericare PharmaceuticalsNot applicableNot applicableCanada flag
Antacid Plus Antiflatulent - Alumina, Magnesia & Simethicone Oral SuspensionSimethicone (25 mg) + Aluminum hydroxide (225 mg) + Magnesium hydroxide (200 mg)SuspensionOralD.C. Labs Limited1993-12-312005-07-19Canada flag
Antacid Plus Extra StrengthSimethicone (40 mg) + Aluminum hydroxide (306 mg) + Aluminum hydroxide (400 mg)LiquidOralJamp Pharma Corporation2006-02-16Not applicableCanada flag
Antacid Regular With Anti-gasSimethicone (20 mg) + Aluminum hydroxide (200 mg) + Magnesium hydroxide (200 mg)LiquidOralJamp Pharma Corporation2006-02-16Not applicableCanada flag
Antacid With Alumina, Magnesia Plus Simethicone Oral Suspension USPSimethicone (25 mg) + Aluminum hydroxide (174 mg) + Magnesium hydroxide (200 mg)SuspensionOralJamp Pharma Corporation1995-08-21Not applicableCanada flag
Antacid With Anti-gas Liquid Extra Strength Mint FlavourSimethicone (40 mg) + Aluminum hydroxide (306 mg) + Magnesium hydroxide (400 mg)SolutionOralCellchem Pharmaceuticals Inc.Not applicableNot applicableCanada flag
Diovol Plus Aluminum FreeSimethicone (25 mg) + Calcium carbonate (200 mg) + Magnesium hydroxide (200 mg)Tablet, chewableOralChurch & Dwight Canada Corp1995-12-31Not applicableCanada flag
Diovol Plus Aluminum Free SuspensionSimethicone (25 mg) + Calcium carbonate (200 mg) + Magnesium hydroxide (200 mg)SuspensionOralChurch & Dwight Canada Corp1995-12-31Not applicableCanada flag
Diovol Plus SuspensionSimethicone (25 mg) + Aluminum hydroxide (165 mg) + Magnesium hydroxide (200 mg)SuspensionOralChurch & Dwight Canada Corp1963-12-31Not applicableCanada flag
Diovol Plus TabletsSimethicone (25 mg) + Aluminum hydroxide (300 mg) + Magnesium hydroxide (100 mg)TabletOralChurch & Dwight Canada Corp1963-12-31Not applicableCanada flag

Categories

Drug Categories
Classification
Not classified

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. MSDS [Link]
  2. product info [Link]
PubChem Substance
347910457
ChemSpider
4938661
RxNav
9796
ChEMBL
CHEMBL1200838
Wikipedia
Simeticone
AHFS Codes
  • 56:10.00 — Antiflatulents

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedDiagnosticBowel preparation therapy / Colonoscopy1
4CompletedDiagnosticGastric Mucosal Lesion1
4CompletedDiagnosticSmall Bowel Diseases1
4CompletedDiagnosticStomach Neoplasms1
4CompletedScreeningAdenoma Colon1
4CompletedTreatmentColonoscopy1
4CompletedTreatmentDiarrhea2
4CompletedTreatmentIleus / Postoperative paralytic ileus1
4CompletedTreatmentInfantile Colics1
4CompletedTreatmentIrritable Bowel Syndrome (IBS)3

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Tablet, chewableOral120 mg
Solution / dropsOral40 mg/0.6mL
Capsule, liquid filledOral100 mg
SuspensionOral102 mg/5mL
Tablet250 mg
SuspensionOral112.2 mg/5mL
SuspensionOral153 mg/5mL
Tablet, chewableOral350 mg
LiquidOral
SolutionOral
SuspensionOral320 mg/5mL
Capsule, liquid filledOral200 mg
SuspensionOral540 mg/5ml
Tablet, chewableOral480 mg
Suspension40 mg/5ml
Tablet, chewableOral1080 mg
EmulsionOral2 g/100mL
SuspensionOral306 mg/5mL
Tablet, chewableOral30 mg
Tablet, coatedOral5 mg
Tablet500 mg
SuspensionOral83.4 mg
SuspensionOral100 mg
TabletOral10 mg
Emulsion
Tablet, chewableOral250 mg
Capsule125 mg
Capsule180 mg
Tablet350 mg
SuspensionOral32.501 g
Tablet, coatedOral100 mg
Capsule, liquid filledOral250 mg
SuspensionOral66.6 mg
Tablet, delayed releaseOral25 mg
EmulsionOral40 mg/1mL
Tablet
Capsule, coatedOral100 mg
Tablet, chewableBuccal470 mg
Tablet40 mg
EmulsionOral5 mg
Tablet, coatedOral6 mg
CapsuleOral40 mg
EmulsionOral40 mg
Tablet, chewableOral230.77 mg
Capsule, liquid filledOral125 mg
CapsuleOral166.0 mg
Tablet, chewableOral100 mg
Tablet, chewableOral20 mg
Tablet, chewableOral125 mg
TabletOral
Tablet, coatedOral3150 FIP
SuspensionOral4 g
CapsuleOral125 mg
CapsuleOral125.0 mg
CapsuleOral180.0 mg
StripOral
Capsule200 mg
Suspension / dropsOral40 mg/0.6mL
SuspensionOral5 g
SuspensionOral0.4 g
SuspensionOral4000 mg
Suspension / dropsOral40 mg
Tablet, coatedOral200 mg
Gel
SolutionOral
Tablet2 mg
SuspensionOral
Tablet, chewableOral42 mg
Tablet, chewableOral105 mg
SuspensionOral41.2 mg
Tablet, coatedOral75 mg
LiquidOral
SuspensionOral
Tablet, chewableOral
SuspensionOral76.67 mg/5mL
SuspensionOral400 mg/5mL
SuspensionOral225 mg/5mL
Capsule60 mg
Capsule, liquid filledOral60 mg
Capsule, coatedOral250 mg
Capsule140 mg
Capsule40 mg
Suspension69.19 mg/ml
Tablet, chewableOral40 mg
SuspensionOral40 mg/5ml
Solution / dropsOral66.6 mg/ml
Tablet, chewableOral80 mg
Solution / drops50 ml
Suspension150 ml
SuspensionOral8 g
SuspensionOral204 mg/5mL
SuspensionOral2.5 g
Suspension / dropsOral40 mg/1mL
Solution / dropsOral
CapsuleOral
Tablet, coatedOral170 mg
Tablet, film coatedOral170 mg
Tablet300 mg
SuspensionOral0.6 g
EmulsionOral
Tablet, coatedOral40 mg
Tablet, coatedOral400 mg
SuspensionOral4.5 g
Tablet, coatedOral25 mg
Tablet, chewableOral800 mg
SuspensionOral10 mg
TabletOral1 mg
Tablet, chewableOral1 mg
SuspensionOral69.19 mg/ml
Tablet, chewableOral69.19 mg/ml
Suspension30 ml
Granule, effervescentOral2830 mg
SuspensionOral66 mg
SuspensionOral1 g
Suspension / dropsOral67 mg/1mL
Suspension
Tablet, chewableOral
Suspension83.35 mg
Suspension540 mg/5ml
Tablet, chewableOral85 mg
Capsule, liquid filledOral10 mg
Tablet, film coated40 mg
SuspensionOral220 mg/5mL
SuspensionOral200 mg/5mL
SuspensionOral57.97 g
SuspensionOral86.67 mg/5mL
Tablet, coatedOral120 mg
SuspensionOral172.33 mg/5mL
CapsuleOral180 mg
Capsule150 mg
SuspensionOral41.2 mg/mL
SuspensionOral40 mg/0.6mL
TabletOral
SuspensionOral600 mg/5mL
SuspensionOral300 mg/5mL
Tablet, chewableOral200 mg
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US6103260No2000-08-152017-07-17US flag
Additional Data Available
  • Filed On
    Filed On

    The date on which a patent was filed with the relevant government.

    Learn more

Properties

State
Not Available
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 12:10 / Updated on October 25, 2020 09:16

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