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
Structure for Simethicone (DB09512)
- 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
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
- Abdominal Cramping
- Abdominal Pain
- Bloating
- Colic
- Diarrhea
- Distension
- Distention
- Dyspepsia
- Flatulence
- Gastric Ulcer
- Gastritis
- Heartburn
- Hiatus Hernia
- Hyperacidity
- Pain
- Pancreatic Insufficiency
- Peptic Esophagitis
- Peptic Ulcer
- Reflux Acid
- Stomach ache
- Gastrointestinal cramping
- Gastrointestinal cramps caused by Gas
- Gastrointestinal spasms
- Stomach cramps
- Associated Therapies
- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- 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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- 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
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Over the Counter Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image air-X 120 Tablet Tablet Oral IMEKS PHARMA SDN. BHD. 2020-09-08 Not applicable Malaysia 
Air-X SF Tablet Tablet Oral IMEKS PHARMA SDN. BHD. 2020-09-08 Not applicable Malaysia Cancap Simethicone USP 180 Mg Soft Capsules Capsule 180 mg Oral Cancap Pharmaceutical Ltd 2014-01-30 2018-11-21 Canada 
Disflatyl Tablet 40mg Tablet 40 mg Oral A. MENARINI SINGAPORE PTE. LTD. 2020-09-08 2022-03-03 Malaysia Extra Strength Gas Relief Capsule 166.0 mg Oral Essentia Healthcare (Canada) Limited 2003-06-16 2004-12-09 Canada Extra Strength Gas Relief Liquid Gels Capsule 180 mg Oral Catalent Ontario Limited Not applicable Not applicable Canada Extra Strength Maalox Grf Tablets 150mg Tablet 150 mg Oral Novartis 1996-07-30 1998-07-08 Canada Gas Relief Capsule 125 mg Oral Banner Pharmacaps 2003-06-16 2014-09-10 Canada Gas Relief Extra Strength Capsule 125.0 mg Oral Apotex Corporation Not applicable Not applicable Canada Gas Relief Liquid Gels Capsule 125 mg Oral Catalent Ontario Limited Not applicable Not applicable Canada - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image ACED FULL SUSPENSION Simethicone (400 mg) + Aluminum hydroxide (4 g) + Magnesium hydroxide (4 g) Suspension Oral COASPHARMA S.A.S. 2018-06-12 Not applicable Colombia 
ACILAX® Simethicone (0.4 g) + Aluminum hydroxide (4 g) + Magnesium hydroxide (4 g) Suspension Oral FABRIFARMA S.A. 2017-05-15 Not applicable Colombia ACITIP SUSPENSIÓN Simethicone (600 mg) + Magaldrate (8000 mg) Suspension Oral LABORATORIOS SIEGFRIED S.A.S. 2018-03-26 Not applicable Colombia ACOLIC SYRUP Simethicone (50 mg/5ml) + Dicyclomine hydrochloride (5 mg/5ml) Syrup Oral GOLDPLUS UNIVERSAL PTE LTD 1998-04-11 Not applicable Singapore ACTAL PLUS TABLET Simethicone (25 mg) + Alexitol sodium (200 mg) + Magnesium hydroxide (152 mg) Tablet Oral A. MENARINI SINGAPORE PTE. LTD. 1993-03-29 Not applicable Singapore ACTAL PLUS Tablet Simethicone (25 mg) + Alexitol sodium (200 mg) + Magnesium hydroxide (152 mg) Tablet Oral A. MENARINI SINGAPORE PTE. LTD. 2020-09-08 Not applicable Malaysia ALLUMAG MPS TABLET Simethicone (50 mg) + Aluminum hydroxide (300 mg) + Magnesium trisilicate (100 mg) Tablet Oral CHULIA PHARMA SDN BHD 2017-10-03 2019-09-11 Malaysia ALLUMAG MPS TABLET Simethicone (50 mg) + Aluminum hydroxide (300 mg) + Magnesium trisilicate (100 mg) Tablet Oral PHARMATECH RESOURCES (FE) PTE. LTD. 1997-09-22 Not applicable Singapore ALMECON SUSPENSION Simethicone (20 mg) + Aluminum hydroxide (200 mg) + Magnesium hydroxide (200 mg) Suspension Oral PRIME PHARMACEUTICAL SDN. BHD. 2020-09-08 Not applicable Malaysia ALMECON TABLET Simethicone (20 mg) + Aluminum hydroxide (200 mg) + Magnesium hydroxide (200 mg) Tablet Oral PRIME PHARMACEUTICAL SDN. BHD. 2020-09-08 Not applicable Malaysia
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
- 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]
- Ingold CJ, Akhondi H: Simethicone . [Article]
- 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]
- FDA Approved Drug Products: Imodium Multi-Symptom Relief (Loperamide HCl, Simethicone) Oral Tablet [Link]
- Health Canada Approved Drug Products: Imodium Complete (Loperamide HCl, Simethicone) Oral Chewable Tablets [Link]
- External Links
- PubChem Substance
- 347910457
- ChemSpider
- 4938661
- 9796
- ChEMBL
- CHEMBL1200838
- Wikipedia
- Simeticone
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Diagnostic Bowel preparation therapy / Colonoscopy 1 4 Completed Diagnostic Gastric Mucosal Lesion 1 4 Completed Diagnostic Neoplasm of Stomach 1 4 Completed Diagnostic Small Bowel Diseases 1 4 Completed Screening Colon Adenomas 1 4 Completed Screening Colonoscopy 1 4 Completed Treatment Colonoscopy 1 4 Completed Treatment Diarrhea 2 4 Completed Treatment Ileus / Postoperative paralytic ileus 1 4 Completed Treatment Infantile Colics 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Tablet; tablet, chewable Oral Tablet Oral 152 mg Capsule, liquid filled Oral 125 mg Tablet Oral 300 mg Tablet, chewable Oral Solution / drops Oral 41.2 mg/ml Tablet Oral 200 mg Powder Powder, for solution Oral Emulsion Oral Syrup Oral Syrup Oral 5 mg/5ml Capsule, liquid filled Oral 250 mg Suspension Oral 66.6 mg Tablet, delayed release Oral Tablet, chewable Buccal 470 mg Granule Oral Emulsion Oral Capsule Oral 40 mg Emulsion Oral 40 mg Capsule Oral 166.0 mg Tablet Oral 150 mg Solution Oral Suspension Oral 1 g Capsule, coated Oral Capsule Oral Suspension Oral 66 mg Capsule Oral 125.0 mg Capsule Oral 180.0 mg Strip Oral 62.5 mg Capsule Oral 166 mg Capsule Oral 140 mg Tablet Oral Tablet, film coated Oral Liquid Oral Solution Oral 40 mg / 0.6 mL Capsule Oral 200 mg Capsule, liquid filled Oral 200 mg Tablet, sugar coated Oral Suspension Oral 40 mg / mL Suspension Oral Tablet, chewable Oral Tablet, chewable Oral 105 mg Suspension Oral 41.2 mg Tablet, coated Oral 25 mg Powder, for suspension Oral Liquid Oral 20 mg / 0.3 mL Capsule Oral Capsule, liquid filled Oral Suspension Oral 40 mg/5ml Tablet, coated Oral Suspension Oral 400 mg/5ml Solution / drops Oral Solution / drops Oral 6.66 % Tablet Oral 40 MG Tablet, chewable Oral 40 MG Solution Oral 40 mg/0.6ml Solution / drops Oral 40 mg / mL Tablet Oral 180 mg Capsule Oral 95 mg Emulsion Oral 62.5 mg / 5 mL Gel Oral 30 % Suspension Oral Syrup Oral Tablet Oral Suspension Syrup Oral 6.67 g Emulsion Oral 100 mg/ml Suspension Oral 69.19 mg/ml Tablet, chewable Oral 69.19 mg/ml Solution / drops Oral 69.19 mg/ml Suspension Oral 30 ml Granule, effervescent Oral Tablet Oral 125 MG Tablet, chewable Oral 125 mg Tablet, chewable Buccal 125 mg Emulsion Oral 80 mg/ml Tablet, chewable Oral 85 mg Tablet, chewable Oral 180 mg Tablet, chewable Oral 80 MG Tablet, chewable Buccal 100 mg Tablet, chewable Oral 42 MG Solution / drops Oral 66.6 MG/ML Tablet, chewable Oral 120 MG Suspension / drops Oral Tablet, film coated Suspension Oral 57.97 g Suspension Oral 41.2 mg/mL Tablet Oral 250 mg Suspension Oral 40 mg/1ml Suspension Oral 67 mg/1ml Tablet Emulsion Oral 40 mg/0.6ml Capsule Oral 125 mg Capsule Oral 180 mg Suspension Oral 120 mg/15ml Capsule Oral 150 mg Solution Tablet Oral 100 mg Suspension Oral 40 mg/0.6ml Tablet Oral 80 mg - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US6103260 No 2000-08-15 2017-07-17 US 
Properties
- State
- Liquid
- Experimental Properties
- Not Available
- Predicted Properties
Property Value Source Water Solubility 1.71 mg/mL ALOGPS logP 2.6 ALOGPS logP 1.76 Chemaxon logS -2 ALOGPS pKa (Strongest Basic) -3.7 Chemaxon Physiological Charge 0 Chemaxon Hydrogen Acceptor Count 2 Chemaxon Hydrogen Donor Count 0 Chemaxon Polar Surface Area 18.46 Å2 Chemaxon Rotatable Bond Count 3 Chemaxon Refractivity 37.63 m3·mol-1 Chemaxon Polarizability 18.48 Å3 Chemaxon Number of Rings 0 Chemaxon Bioavailability 1 Chemaxon Rule of Five Yes Chemaxon Ghose Filter No Chemaxon Veber's Rule Yes Chemaxon MDDR-like Rule No Chemaxon - Predicted ADMET Features
- Not Available
Spectra
- Mass Spec (NIST)
- Not Available
- Spectra
- Not Available
Drug created at November 30, 2015 19:10 / Updated at March 21, 2023 17:58