Simethicone

Pronunciation

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

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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: 40a –250c 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

Actions

  • 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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Gas-X Extra Strength 125MG Chewable Tablets (NOVARTIS): 18/$17.59 or 36/$21.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 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.

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