Simethicone

Identification

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Name
Simethicone
Accession Number
DB09512
Type
Small Molecule
Groups
Approved
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.

Structure
Thumb
Synonyms
  • Simeticona
  • Simeticone
Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Cancap Simethicone USP 180 Mg Soft CapsulesCapsule180 mgOralCancap Pharmaceutical Ltd2014-01-30Not applicableCanada
Extra Strength Gas ReliefCapsule166.0 mgOralEssentia Healthcare (Canada) Limited2003-06-16Not applicableCanada
Extra Strength Maalox Grf Tablets 150mgTablet150 mgOralNovartis1996-07-301998-07-08Canada
Gas ReliefCapsule125 mgOralBanner Pharmacaps2003-06-162014-09-10Canada
Gas Relief Extra StrengthCapsule125.0 mgOralApotex CorporationNot applicableNot applicableCanada
Gas Relief TabletsTablet, chewable125 mgOralGuardian Drug Company2010-03-25Not applicableCanada
Gas Relief Ultra StrengthCapsule180.0 mgOralApotex CorporationNot applicableNot applicableCanada
Gas X Thin Strips 62.5mg SimethiconeStrip62.5 mgOralGlaxosmithkline Inc2006-04-03Not applicableCanada
Gas X Ultra StrengthCapsule180 mgOralGlaxosmithkline Inc2008-02-22Not applicableCanada
Gas-X Extra StrengthTablet, chewable125 mgOralGlaxosmithkline Inc1991-12-31Not applicableCanada
Additional Data Available
  • Application Number
    Application Number

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

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  • 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 End
Antacid & AntigasSimethicone (20.00 mg) + Aluminum hydroxide (153.000 mg) + Magnesium hydroxide (200.00 mg)SuspensionOralGericare PharmaceuticalsNot applicableNot applicableCanada
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
Antacid Plus Extra StrengthSimethicone (40 mg) + Aluminum hydroxide (306 mg) + Aluminum hydroxide (400 mg)LiquidOralJamp Pharma Corporation2006-02-16Not applicableCanada
Antacid Regular With Anti-gasSimethicone (20 mg) + Aluminum hydroxide (200 mg) + Magnesium hydroxide (200 mg)LiquidOralJamp Pharma Corporation2006-02-16Not applicableCanada
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
Antacid With Anti-gas Liquid Extra Strength Mint FlavourSimethicone (40 mg) + Aluminum hydroxide (306 mg) + Magnesium hydroxide (400 mg)LiquidOralPharmetics (2011) Inc.Not applicableNot applicableCanada
Diovol Plus AFSimethicone (25 mg) + Calcium Carbonate (200 mg) + Magnesium hydroxide (200 mg)Tablet, chewableOralChurch & Dwight Company, Inc.1995-12-31Not applicableCanada
Diovol Plus AF-suspensionSimethicone (25 mg) + Calcium Carbonate (200 mg) + Magnesium hydroxide (200 mg)SuspensionOralChurch & Dwight Company, Inc.1995-12-31Not applicableCanada
Diovol Plus SuspensionSimethicone (25 mg) + Aluminum hydroxide (165 mg) + Magnesium hydroxide (200 mg)SuspensionOralChurch & Dwight Company, Inc.1963-12-31Not applicableCanada
Diovol Plus TabletsSimethicone (25 mg) + Aluminum hydroxide (300 mg) + Magnesium hydroxide (100 mg)TabletOralChurch & Dwight Company, Inc.1963-12-31Not applicableCanada
Categories
UNII
Not Available
CAS number
8050-81-5
Weight
Average: 238.461
Monoisotopic: 238.051288665
Chemical Formula
C6H18O4Si3
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

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
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.

Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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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.

Toxicity

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

Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
Not Available
Food Interactions
Not Available

References

General References
  1. MSDS [Link]
  2. product info [Link]
  3. wikipedia [Link]
External Links
PubChem Substance
347910457
ChemSpider
4938661
ChEMBL
CHEMBL1200838
Wikipedia
Simeticone
AHFS Codes
  • 56:10.00 — Antiflatulents

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedDiagnosticHemorrhage, Gastrointestinal1
1WithdrawnTreatmentFunctional Abdominal Pain / Functional Dyspepsia / Irritable Bowel Syndrome (IBS)1
2CompletedTreatmentNegative Middle Ear Pressure / Otitis Media (OM)1
2RecruitingDiagnosticStomach Diseases1
2RecruitingTreatmentInfantile Colics1
2, 3CompletedNot AvailableLesion of Stomach1
3CompletedDiagnosticColonoscopy1
3CompletedTreatmentOccasional Constipation1
3RecruitingPreventionBenign Gynecologic Neoplasm1
3RecruitingTreatmentIndigestion1
3RecruitingTreatmentSterility, Postpartum1
4CompletedDiagnosticGastric Mucosal Lesion1
4CompletedDiagnosticStomach Neoplasms1
4CompletedScreeningAdenoma Colon1
4CompletedTreatmentColonoscopy1
4CompletedTreatmentIleus / Postoperative paralytic ileus1
4CompletedTreatmentInfantile Colics1
4CompletedTreatmentSimethicone1
4TerminatedTreatmentRelapsing Remitting Multiple Sclerosis (RRMS)1
Not AvailableCompletedDiagnosticNeoplasms, Colorectal1
Not AvailableCompletedHealth Services ResearchCapsule Endoscopy / Pediatric Disorder1
Not AvailableCompletedOtherBubbles in Colon at Time of Colonoscopy1
Not AvailableNot Yet RecruitingDiagnosticColo-rectal Cancer / Colonic Neoplasms1
Not AvailableRecruitingDiagnosticLooking Into Image Quality of Video Capsule Endoscopy After Simethicone Ingestion / Video Capsule Endoscopy1
Not AvailableWithdrawnScreeningColorectal Cancers1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
SuspensionOral
CapsuleOral166.0 mg
TabletOral150 mg
CapsuleOral125.0 mg
Tablet, chewableOral125 mg
CapsuleOral180.0 mg
StripOral62.5 mg
CapsuleOral166 mg
Tablet, chewableOral42 mg
SolutionOral40 mg
TabletOral
SuspensionOral40 mg
LiquidOral20 mg
Tablet, chewableOral
TabletOral80 mg
Solution / dropsOral40 mg
TabletOral180 mg
CapsuleOral125 mg
CapsuleOral95 mg
EmulsionOral62.5 mg
Tablet, chewableOral180 mg
Tablet, chewableOral80 mg
LiquidOral
CapsuleOral180 mg
TabletOral125 mg
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US6103260No2000-08-152017-07-17Us
Additional Data Available
  • Filed On
    Filed On

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

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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

Taxonomy

Classification
Not classified

Drug created on November 30, 2015 12:10 / Updated on July 21, 2019 06:37