Brand names: Alka-Seltzer Gas Relief, Flatulex, GasAid, Gas-X, Genasyme, ... show all 9 brands Maalox Anti-Gas, Mylanta Gas Relief, Mylicon, Phazyme
Drug class: Antiflatulents
VA class: GA900
CAS number: 8050-81-5

Introduction

Antiflatulent; antifoaming agent.

Uses for Simethicone

Flatulence, Functional Gastric Bloating, and Postoperative Gas Pains

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

Self-medication as an antiflatulent to relieve symptoms of gas (e.g., upper GI bloating, pressure, fullness, stuffed feeling).

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

Infant Colic

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

Immediate Postprandial Upper Abdominal Distress

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

Intestinal Distress

Efficacy not established for symptomatic relief of intestinal distress; no conclusive evidence that gas causes intestinal distress symptoms.

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.

Chewable Tablets

Chew thoroughly before swallowing.

Oral Suspension

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

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

Orally Dissolving Strips

Place strips on tongue to dissolve.

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.

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.

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.

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

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.

Self-medication: 40 –250 mg as needed after meals and at bedtime; do not exceed 500 mg daily.

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.

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.

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

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

Adults

Flatulence, Functional Gastric Bloating, and Postoperative Gas Pain

Oral

Self-medication: Maximum 500 mg daily.

Special Populations

No special population dosage recommendations at this time.

Cautions for Simethicone

Warnings/Precautions

General Precautions

Simethicone is apparently nontoxic; no adverse effects reported.

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.

Lactation

Distribution into milk not expected; simethicone not orally absorbed.

Pediatric Use

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

Simethicone Pharmacokinetics

Absorption

Bioavailability

Not absorbed following oral administration.

Food

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

Elimination

Elimination Route

Excreted unchanged in feces.

Stability

Storage

Oral

Capsules, Liquid-filled

20–25°C; avoid temperatures >40°C. Protect from moisture.

Strips, Orally Dissolving

20–25°C. Protect from moisture.

Tablets and Chewable Tablets

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

Suspension

Tight, light resistant containers at <40°C; preferably 15–30°C. Avoid freezing.

Actions

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

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

Advice to Patients

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

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

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

• Importance of not chewing liquid-filled capsules.

• 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

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

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