Simethicone

Class: Antiflatulents
VA Class: GA900
CAS Number: 8050-81-5
Brands: Alka-Seltzer Gas Relief, Flatulex, GasAid, Gas-X, Genasyme, Imodium Advanced, Maalox Anti-Gas, Mylanta Gas Relief, Mylicon, Phazyme

Introduction

Antiflatulent; antifoaming agent.^a

Uses for Simethicone

Flatulence, Functional Gastric Bloating, and Postoperative Gas Pains

Adjunct for symptomatic treatment of flatulence, functional gastric bloating, and postoperative gas pain.^a

Self-medication as an antiflatulent to relieve symptoms of gas (e.g., upper GI bloating, pressure, fullness, stuffed feeling).^{102 103 104 105}

Has been used prior to gastroscopy to enhance visualization and prior to radiography of the intestine to reduce gas shadows.^a

Infant Colic

Not recommended for treatment of infant colic.^a (See Pediatric Use under Cautions.)

Immediate Postprandial Upper Abdominal Distress

Efficacy not established for the symptomatic relief of immediate postprandial upper abdominal distress (IPPUAD);^{101 102} no conclusive evidence that excessive gas causes IPPUAD.^{100 101}

Intestinal Distress

Efficacy not established for symptomatic relief of intestinal distress; ^{100 101} no conclusive evidence that gas causes intestinal distress symptoms.^{100 101}

Simethicone Dosage and Administration

Administration

Oral Administration

Administer orally after meals and at bedtime, usually in up to 4 divided doses daily; infant drops (oral suspension) can be administered in up to 12 doses daily.^{a b}

Chewable Tablets

Chew thoroughly before swallowing.^a

Oral Suspension

Generally used in infants.^b Shake drops well before use; use dosing device provided by manufacturer for measurement of the dose.^b

Dose may be mixed with 1 ounce cool water, infant formula, or other suitable liquids prior to administration.^b

Orally Dissolving Strips

Place strips on tongue to dissolve.^g

Dosage

Pediatric Patients

Flatulence, Functional Gastric Bloating, and Postoperative Gas Pain

Oral

Usual dosage in children >12 years of age: 40–125 mg 4 times daily as needed after meals and at bedtime.^a

Self-medication in children <2 years of age (<10.9 kg): 20 mg (0.3 mL) as needed after meals and at bedtime as oral drops; do not exceed 12 doses (i.e., 240 mg) daily.^b

Self-medication in children 2–12 years of age (>10.9 kg): 40 mg as needed after meals and at bedtime; do not exceed 12 doses (i.e., 480 mg) daily.^b

Self-medication in children >12 years of age: 40–125 mg as needed after meals and at bedtime; do not exceed 500 mg daily.^a

Adults

Flatulence, Functional Gastric Bloating, and Postoperative Gas Pain

Oral

Usual dosage: 40–125 mg 4 times daily as needed after meals and at bedtime.^a

Self-medication: 40^a –250^c mg as needed after meals and at bedtime; do not exceed 500 mg daily.^{a 105}

Diagnostic Aid Prior to Gastroscopy or Radiography of the Intestine

Oral

67 mg as a single dose of oral suspension, in 2.5 mL of water.^a

Prescribing Limits

Pediatric Patients

Flatulence, Functional Gastric Bloating, and Postoperative Gas Pain

Oral

Self-medication in children <2 years of age (weight <10.9 kg): Maximum 12 doses (i.e., 240 mg) daily.^b

Self-medication in children 2–12 years of age (weight >10.9 kg): Maximum 12 doses (i.e., 480 mg) daily.^b

Self-medication in children >12 years of age: Maximum 500 mg daily.^a

Adults

Flatulence, Functional Gastric Bloating, and Postoperative Gas Pain

Oral

Self-medication: Maximum 500 mg daily.^{a 105}

Special Populations

No special population dosage recommendations at this time.^a

Cautions for Simethicone

Warnings/Precautions

General Precautions

Simethicone is apparently nontoxic; no adverse effects reported.^a

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C.^d

Lactation

Distribution into milk not expected; simethicone not orally absorbed.^d

Pediatric Use

Safety information in infants and children limited; not recommended for treatment of infant colic.^a

Simethicone Pharmacokinetics

Absorption

Bioavailability

Not absorbed following oral administration.^a

Food

Does not interfere with the absorption of nutrients or with gastric secretion.^a

Elimination

Elimination Route

Excreted unchanged in feces.^a

Stability

Storage

Oral

Capsules, Liquid-filled

20–25°C; avoid temperatures >40°C.^{e f} Protect from moisture.^f

Strips, Orally Dissolving

20–25°C.^g Protect from moisture.^g

Tablets and Chewable Tablets

Tight, well-closed containers at <40°C; preferably 15–30°C.^a Avoid high humidity.^c

Suspension

Tight, light resistant containers at <40°C; preferably 15–30°C.^a Avoid freezing.^{a b}

ActionsActions

• 
  

  Silicone antifoams spread on the surface of aqueous liquids, forming a low surface tension film and causing collapse of foam bubbles.^a

  
  


• 
  

  May allow mucus-surrounded gas bubbles in the GI tract to coalesce and be expelled.^a

  
  

Advice to Patients

• 
  

  Importance of not exceeding recommended self-medication dosage, unless otherwise instructed by a clinician.^b

  
  


• 
  

  Advise patients to dispense recommended dose of infant drops (oral suspension) slowly into the infant's mouth with enclosed dropper, toward the inner cheek.^b

  
  


• 
  

  Advise patients that oral suspension may be mixed with 1 ounce cool water, infant formula, or other suitable liquids.^b

  
  


• 
  

  Importance of not chewing liquid-filled capsules.^a

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Simethicone

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules, liquid-filled	125 mg	Alka-Seltzer Gas Relief Maximum Strength Softgels	Bayer
			GasAid Maximum Strength Softgels	McNeil
			Gas-X Extra Strength Softgels	Novartis
			Mylanta Gas Maximum Strength Softgels	J&J-Merck
		180 mg	Phazyme-Ultra Strength Gas Relief Softgels	GlaxoSmithKline
	Strips, orally dissolving	62.5 mg	Gas-X Thin Strips	Novartis
	Suspension	40 mg/0.6 mL*	Baby Gas-X Infant Drops	Novartis
			Flatulex Drops	Dayton
			Genasyme Drops	Teva
			Mylicon Infant’s Drops	J&J-Merck
	Tablets, chewable	80 mg*	Gas-X (scored)	Novartis
			Genasyme	Teva
			Maalox Anti-Gas Regular Strength	Novartis
		125 mg	Gas-X Extra Strength (scored)	Novartis
			Mylanta Gas Relief Maximum Strength (scored)	J&J-Merck
			Simethicone Tablets	Rugby
		150 mg	Maalox Anti-Gas Extra Strength	Novartis

Simethicone is also commercially available in combination with antacids, antispasmodics, and digestants.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Simethicone Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	125 mg with Loperamide Hydrochloride 2 mg	Imodium Advanced Caplets	McNeil
	Tablets, chewable	125 mg with Loperamide Hydrochloride 2 mg*	Imodium Advanced Chewable Tablets	McNeil

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Food and Drug Administration. Digestive aid products for over-the-counter human use; establishment of a monograph. [21 CFR Part 357; Docket No. 81N-0106] Fed Regist. 1982; 47:454-87.

101. Food and Drug Administration. Digestive aid products for over-the-counter human use; tentative final monograph. [21 CFR Part 357; Docket No. 81N-0106] Fed Regist. 1988; 53:2706-14. (IDIS 240339)

102. Food and Drug Administration. Antiflatulent drug products for over-the-counter human use; proposed amendment of monograph. [21 CFR Part 332; Docket No. 87N-0053] Fed Regist. 1988; 53:2716-7. (IDIS 240340)

103. Food and Drug Administration. Over-the-counter drugs: proposal establishing a monograph for antacid products. [21 CFR Part 130] Fed Regist. 1973; 38:8714-24.

104. Food and Drug Administration. Over-the-counter drugs generally recognized as safe and effective and not misbranded: tentative final order for antacid products. [21 CFR Part 130] Fed Regist. 1973; 38:31258-69.

105. Food and Drug Administration. Antacid products for over-the-counter (OTC) human use. Antiflatulent products for over-the-counter (OTC) human use. Final order for antacid and antiflatulent products generally recognized as safe and effective and not misbranded. [21 CFR Parts 331 and 332] Fed Regist. 1974; 39:19862-77.

a. AHFS drug information 2007. McEvoy GK, ed. Simethicone. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2918-9.

b. Johnson & Johnson. Infants' Mylicon Drops (simethicone) product information. 2006 June. From Mylicon webiste.

c. Johnson & Johnson. Mylanta Gas Maximum Strength Chewable Tablets (simethicone) product information. 2006 June. From Mylanta website.

d. Simethicone. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. 7th ed. Philadelphia: Lippincott Williams & Wilkins; 2005:1469.

e. Bayer Consumer Care. Alka-Seltzer Gas Relief (simethicone) Liquid Softgels product information. Undated. From product website. Accessed 2007 Jul 12.

f. Novartis Consumer Health. Gas-X (simethicone) Maximum Strength Softgels product information. Undated. From product website. Accessed 2007 Jul 12.

g. Novartis Consumer Health. Gas-X (simethicone) Thin Strips product information. Undated. From product website. Accessed 2007 Jul 12.

More Simethicone resources

• Simethicone Use in Pregnancy & Breastfeeding
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• Genasyme Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Simethicone with other medications

• Endoscopy or Radiology Premedication
• Functional Gastric Disorder
• Gas
• Postoperative Gas Pains