Pronunciation

(sye METH i kone)

Index Terms

• Activated Dimethicone
• Activated Methylpolysiloxane

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Gas Free Extra Strength: 125 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Gas Relief Extra Strength: 125 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Gas Relief Ultra Strength: 180 mg [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Gas Relief Ultra Strength: 180 mg [contains fd&c yellow #6 (sunset yellow)]

Gas-X Extra Strength: 125 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Gas-X Ultra Strength: 180 mg [contains fd&c yellow #6 (sunset yellow)]

GasAid: 125 mg [DSC]

Phazyme: 180 mg

Phazyme Maximum Strength: 250 mg [contains brilliant blue fcf (fd&c blue #1)]

Phazyme Ultra Strength: 180 mg [contains fd&c yellow #6 (sunset yellow)]

Generic: 125 mg, 180 mg

Liquid, Oral:

Gas-X Infant Drops: 20 mg/0.3 mL (30 mL) [alcohol free, no artificial color(s), no artificial flavor(s), saccharin free; contains polyethylene glycol, sodium benzoate]

Strip, Oral:

Gas-X Childrens: 40 mg (16 ea) [contains alcohol, usp, fd&c red #40; sweet cinnamon flavor]

Gas-X Extra Strength: 62.5 mg (18 ea, 30 ea) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1); peppermint flavor]

Gas-X Extra Strength: 62.5 mg (18 ea) [contains alcohol, usp, fd&c red #40]

Suspension, Oral:

Gas Relief: 20 mg/0.3 mL (30 mL) [dye free; contains sodium benzoate; fruit flavor]

Infants Gas Relief: 20 mg/0.3 mL (30 mL) [contains sodium benzoate]

Infants Simethicone: 20 mg/0.3 mL (30 mL) [alcohol free, no artificial color(s), no artificial flavor(s), saccharin free; contains polyethylene glycol, sodium benzoate]

Generic: 40 mg/0.6 mL (30 mL)

Tablet Chewable, Oral:

Gas Relief: 80 mg [lactose free]

Gas Relief Maximum Strength: 125 mg [lactose free]

Gas-X: 80 mg [DSC] [scored; cherry creme flavor]

Gas-X: 80 mg [scored; peppermint creme flavor]

Gas-X Extra Strength: 125 mg

Gas-X Extra Strength: 125 mg [scored; peppermint creme flavor]

Gas-X Extra Strength: 125 mg [contains fd&c yellow #10 aluminum lake; peppermint creme flavor]

Gas-X Extra Strength: 125 mg [contains soy protein; cherry cream flavor]

Mi-Acid Gas Relief: 80 mg

Mytab Gas: 80 mg [peppermint flavor]

Mytab Gas Maximum Strength: 125 mg [scored; peppermint flavor]

Phazyme: 125 mg [cool mint flavor]

Phazyme: 125 mg [contains aspartame; cool mint flavor]

Generic: 80 mg, 125 mg

Brand Names: U.S.

• Gas Free Extra Strength [OTC] [DSC]
• Gas Relief Extra Strength [OTC]
• Gas Relief Maximum Strength [OTC]
• Gas Relief Ultra Strength [OTC]
• Gas Relief [OTC]
• Gas-X Childrens [OTC]
• Gas-X Extra Strength [OTC]
• Gas-X Infant Drops [OTC]
• Gas-X Ultra Strength [OTC]
• Gas-X [OTC]
• GasAid [OTC] [DSC]
• Infants Gas Relief [OTC]
• Infants Simethicone [OTC]
• Mi-Acid Gas Relief [OTC]
• Mytab Gas Maximum Strength [OTC]
• Mytab Gas [OTC]
• Phazyme Maximum Strength [OTC]
• Phazyme Ultra Strength [OTC]
• Phazyme [OTC]

Pharmacologic Category

• Antiflatulent

Pharmacology

Decreases the surface tension of gas bubbles thereby disperses and prevents gas pockets in the GI system

Excretion

Feces

Use: Labeled Indications

Gas retention: Relief of pressure, bloating, fullness, and discomfort of gastrointestinal gas.

Contraindications

Hypersensitivity to simethicone or any component of the formulation

Dosing: Adult

Gas retention: Oral: Usual dose: 40 to 125 mg 4 times daily as needed after meals and at bedtime; may administer single doses of up to 160 to 500 mg after meals or at bedtime, not to exceed a maximum daily dose of 500 mg/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Gas retention: Oral:

Infants and Children <2 years or <11 kg: 20 mg 4 times daily after meals and at bedtime, as needed (maximum: 240 mg/day)

Children >2 years or >11 kg: 40 mg 4 times daily after meals and at bedtime, as needed (maximum: 480 mg/day)

Children and Adolescents >12 years: Refer to adult dosing.

Dosing: Renal Impairment

There is no dosage adjustment provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to the drug not being systemically absorbed.

Dosing: Hepatic Impairment

There is no dosage adjustment provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to the drug not being systemically absorbed.

Administration

Oral: Chewable tablet: Chew thoroughly and swallow

Oral suspension (drops): Shake well before using; may mix with 30 mL water, infant formula, or other liquids. Fill enclosed dropper to recommended dosage level and dispense slowly in mouth towards inner cheek.

Oral strips: Allow to dissolve on tongue.

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from moisture. Avoid high humidity and excessive heat.

Oral suspension: Do not freeze.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined: Gastrointestinal: Loose stools

Warnings/Precautions

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

Pregnancy Considerations

Simethicone is not absorbed systemically following oral administration. Systemic absorption would be required in order for simethicone to cross the placenta and reach the fetus (Mahadevan 2006).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.