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'''Simethicone,''' is an [[Wiktionary:oral|oral]] [[anti-foaming agent]] used to reduce [[bloating]], discomfort and pain caused by excess gas in the stomach or intestinal tract. It is a mixture of [[polydimethylsiloxane]] and [[silica gel]].
{{DrugProjectFormSinglePage
|authorTag={{AJ}}
|OTC=Yes
|genericName=Simethicone
|aOrAn=a
|drugClass=[[antiflatulent]], [[diagnostic]] and [[gastrointestinal]] agent
|indicationType=treatment
|indication=excessive upper [[gastrointestinal]] [[gas]]
|adverseReactions=darrhea, [[nausea]], [[regurgitation]] and [[vomiting]]
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult=* Relieves pressure and bloating commonly referred to as gas.
* Ultrasonography


==Chemical action==
====Dosing Information====


Simethicone is an anti-foaming agent that reduces the [[surface tension]] of gas [[bubble]]s, causing them to combine into larger bubbles in the [[stomach]] that can be passed more easily by [[burping]]. Simethicone does not reduce the quantity of gas in the [[Gastrointestinal tract|digestive tract]], it only increases the rate at which it exits the body, and is ineffective in the [[intestine]].<ref>{{Citation  | last =Norton  | first =William  | title =Controlling Intestinal Gas  | date =2005-01-09  | year =2005  | url =http://www.iffgd.org/store/viewproduct/155  | accessdate =2007-07-31}}</ref> Simethicone is not absorbed by the body into the bloodstream, and is therefore considered relatively safe, with sources reporting the worst side effects as bloating, constipation, diarrhea, gas and heartburn. Simethicone solutions of differing concentration also have industrial applications for reducing foaming in certain chemical processes.
* Chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. Do not exceed 6 tablets per day unless directed by a physician.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Simethicone in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Simethicone in adult patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Simethicone in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Simethicone in pediatric patients.
|contraindications=There is limited information regarding <i>Contraindication</i> of Simethicone
|warnings=* When using this product • do not take more than directed, except under the advice of a doctor


== Dosage ==
* If [[pregnant]] or [[breast feeding]], ask a health professional before use.
Simethicone comes in many different oral forms, which have differing usual [[Effective dose|dosages]].  Though there are standard dosages for adults and teens, dosages for children should be determined by a doctor.


* Capsules or tablets:
* Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
:: Adults and teenagers: 60 to 125 milligrams (mg) four times a day, after meals and at bedtime. No more than 500 mg should be taken in twenty-four hours.  


* Chewable tablets:
* Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
::Adults and teenagers: 40 to 125 mg four times a day, after meals and at bedtime or the dose may be 150 mg three times a day, after meals.  No more than 500 mg should be taken in twenty-four hours.  
|clinicalTrials=There is limited information regarding <i>Adverse Reactions</i> of Simethicone.
|postmarketing=There is limited information regarding <i>Adverse Reactions reported from Post Experience</i> of Simethicone.
|drugInteractions=There is limited information regarding <i>Drug Interactions</i> of Simethicone.
|administration=* Oral
|drugBox={{Drugbox2
| Verifiedfields = changed
| verifiedrevid = 417768970
| IUPAC_name = Poly(dimethylsiloxane), silicon dioxide
| image = Simethicone structure.png


* Suspension:
<!--Clinical data-->
::Adults and teenagers: 40 to 95 mg four times a day, after meals and at bedtime. No more than 500 mg should be taken in twenty-four hours.  
| tradename = 
| Drugs.com = {{drugs.com|monograph|simethicone}}
| [[Pregnancy Category]] = A
| legal_US = OTC
| routes_of_administration = Oral


* Dissolving membrane:
<!--Pharmacokinetic data-->
::A thin dissolving membrane dose that is placed on the tongue and dissolves with [[saliva]]
| bioavailability = not absorbed from the gut
| protein_bound = N/A
| metabolism = N/A
| elimination_half-life = N/A
| excretion = N/A


== Availability ==
<!--Identifiers-->
'''Simethicone''' is generally available over the counter under many trade names in varying dosage sizes, including:
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 8050-81-5
| ATC_prefix = A03
| ATC_suffix = AX13
| PubChem = 6433516
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = NA
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1200838


* Air-X (Thailand)
<!--Chemical data-->
* Baby's Own Infant Drops
| chemical_formula = (C<sub>2</sub>H<sub>6</sub>OSi)<sub>n</sub> · (SiO<sub>2</sub>)<sub>m</sub>
* De-Gas
 
* Espumisan
| molecular_weight = variable
* Flatulex
}}
* Gas Relief
|PD=There is limited information regarding <i>Pharmacodynamics</i> of Simethicone
* Gas-X
|PK=There is limited information regarding <i>Pharmacokinetics</i> of Simethicone
* GasAid
|nonClinToxic=There is limited information regarding <i>nonclinical toxicology</i> of Simethicone
* Gasvan (Serbia)
|clinicalStudies=There is limited information regarding <i>clinical studies </i> of Simethicone
* Genasyme
|storage=* Store at room temperature, 15°C - 30°C (59˚F - 86˚F)
* Imodium Advanced
* Package not child resistant
* lnfacol
|packLabel=====PACKAGE LABEL====
* lnfacon
 
* Kremil-S
GERICARE
* Lefax (Germany)
 
* Little Tummies
NDC 57896-791-01
* [[Maalox]] Anti-Gas
 
* Maalox Max
CHEWABLE
* Minifom (Norway, Sweden)
 
* My Baby Gas Relief Drops
 
* [[Mylanta]] Gas
SIMETHICONE
* Mylanta Gas Relief
* Mylicon Drops
* Ovol
* Phazyme
* Simeco
* Triaerom (Peru)
* WindEze (UK)


== Other uses ==
TABLETS USP, 80mg
While not indicated on the label, it has been reported that simethicone is sometimes used by patients before a [[gastroscopy]] or a [[radiography of the bowel]].  Simethicone is also used in some [[detergent]]s when foaming is unwanted.


Despite being useful in the treatment of gas, simethicone does not appear to be useful in the treatment of infant [[Baby colic|colic]].<ref>[http://www.med.umich.edu/pediatrics/ebm/cats/colic.htm University of Michigan clinical trial for simethicone used for colic]</ref>
FOR GAS DISTRESS


== References ==
MINT FLAVOR
<references/>
* {{cite web | title=Jackson Gastroenterology - Patient Education - Simethicone | url=http://www.gicare.com/pated/simethicone.htm| accessmonthday=July 30 | accessyear=2005 }}
* {{cite web | title=Medline Plus - Simethicone | url=http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682683.html | accessmonthday=April 16 | accessyear=2007 }}


[[Category:Antiflatulents]]
100 Tablets
[[Category:Food additives]]
[[Category:Silicones]]


{{Pharma-stub}}
80 mg each


[[de:Simeticon]]
[[File:Simethicone drug label01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[fr:Siméticone]]
|alcohol=Alcohol-Simethicone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
{{WikiDoc Sources}}
|brandNames=* Mylicon
* Gas-X
* Maalox Anti-Gas
* Mylanta Gas
* Genasyme
* Mytab Gas
* Phazyme
* Alka-Seltzer Anti-Gas
}}

Latest revision as of 18:50, 2 April 2015

Simethicone
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Simethicone is a antiflatulent, diagnostic and gastrointestinal agent that is FDA approved for the treatment of excessive upper gastrointestinal gas. Common adverse reactions include darrhea, nausea, regurgitation and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Relieves pressure and bloating commonly referred to as gas.
  • Ultrasonography

Dosing Information

  • Chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. Do not exceed 6 tablets per day unless directed by a physician.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Simethicone in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Simethicone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Simethicone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Simethicone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Simethicone in pediatric patients.

Contraindications

There is limited information regarding Contraindication of Simethicone

Warnings

  • When using this product • do not take more than directed, except under the advice of a doctor
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Adverse Reactions of Simethicone.

Postmarketing Experience

There is limited information regarding Adverse Reactions reported from Post Experience of Simethicone.

Drug Interactions

There is limited information regarding Drug Interactions of Simethicone.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Simethicone in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Simethicone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Simethicone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Simethicone in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Simethicone in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Simethicone in geriatric settings.

Gender

There is no FDA guidance on the use of Simethicone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Simethicone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Simethicone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Simethicone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Simethicone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Simethicone in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Simethicone Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Simethicone and IV administrations.

Overdosage

There is limited information regarding Simethicone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Template:Px
Simethicone
Systematic (IUPAC) name
Poly(dimethylsiloxane), silicon dioxide
Identifiers
CAS number 8050-81-5
ATC code A03AX13
PubChem 6433516
Chemical data
Formula (C2H6OSi)n · (SiO2)m
Mol. mass variable
Pharmacokinetic data
Bioavailability not absorbed from the gut
Protein binding N/A
Metabolism N/A
Half life N/A
Excretion N/A
Therapeutic considerations
Pregnancy cat.

?

Legal status

OTC(US)

Routes Oral

Mechanism of Action

There is limited information regarding Simethicone Mechanism of Action in the drug label.

Structure

There is limited information regarding Simethicone Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Simethicone

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Simethicone

Nonclinical Toxicology

There is limited information regarding nonclinical toxicology of Simethicone

Clinical Studies

There is limited information regarding clinical studies of Simethicone

How Supplied

There is limited information regarding Simethicone How Supplied in the drug label.

Storage

  • Store at room temperature, 15°C - 30°C (59˚F - 86˚F)
  • Package not child resistant

Images

Drug Images

{{#ask: Page Name::Simethicone |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PACKAGE LABEL

GERICARE

NDC 57896-791-01

CHEWABLE


SIMETHICONE

TABLETS USP, 80mg

FOR GAS DISTRESS

MINT FLAVOR

100 Tablets

80 mg each

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Simethicone |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Simethicone Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Simethicone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Mylicon
  • Gas-X
  • Maalox Anti-Gas
  • Mylanta Gas
  • Genasyme
  • Mytab Gas
  • Phazyme
  • Alka-Seltzer Anti-Gas

Look-Alike Drug Names

There is limited information regarding Simethicone Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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