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Simethicone (Oral-Local)


VA CLASSIFICATION
Primary: GA900
Secondary: DX900

Commonly used brand name(s): Baby's Own Infant Drops; Degas; Extra Strength Maalox Anti-Gas; Extra Strength Maalox GRF Gas Relief Formula; Flatulex; Gas Relief; Gas-X; Gas-X Extra Strength; Genasyme; Maalox Anti-Gas; Maalox GRF Gas Relief Formula; Maximum Strength Gas Relief; Maximum Strength Mylanta Gas Relief; Maximum Strength Phazyme; My Baby Gas Relief Drops; Mylanta Gas; Mylanta Gas Relief; Mylicon Drops; Ovol; Ovol-160; Ovol-40; Ovol-80; Phazyme; Phazyme Drops; Phazyme-125; Phazyme-95.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiflatulent—

diagnostic aid (gastroscopy; radiography of the bowel)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Gas, gastrointestinal (treatment)—Simethicone's clinical use is based on its antifoam properties demonstrated in vitro . It is indicated in the treatment of functional conditions in which the retention of gas may be a problem. {01} {08}

[Gastroscopy adjunct]1 and
[Radiography, bowel, adjunct]1—Simethicone is used as an antifoaming agent during gastroscopy to enhance visualization and prior to radiography of the bowel to reduce gas shadows. {03} {05} {07}

Unaccepted
The clinical effectiveness of simethicone in such conditions as aerophagia, functional dyspepsia, peptic ulcer, spastic or irritable colon, or diverticulitis, beyond that of placebo, has not been established. {02} {03}

Simethicone is not recommended for use in infant colic. {03}

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Acts in vitro to lower the surface tension of gas bubbles. {04} Its relevance to action in vivo is not clearly established.

Elimination:
    Fecal, as unchanged drug.


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of simethicone in children.


Geriatrics


No information is available on the relationship of age to the effects of simethicone in geriatric patients.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to simethicone


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Simethicone (Oral).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to simethicone




Importance of proper diet and exercise to prevent gas problem

Proper use of this medication
Following physician's or manufacturer's instructions

» Taking after meals and at bedtime for best results

For chewable tablet dosage form
Chewing tablets thoroughly for faster and more complete results

For oral suspension dosage form
Proper use of dropper bottle or measuring spoon

» Proper dosing
Missed dose: If on regular dosing schedule—Taking as soon as possible; not taking if almost time for next dose; not doubling doses

» Proper storage


General Dosing Information
Dosage or frequency of administration may be doubled with the advice of a physician.

Pediatric dosage should be based on the severity of the condition and the surface area of the patient rather than on body weight.


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of uses and/or indications that are not included in the U.S. product labeling.

SIMETHICONE CAPSULES USP

Usual adult and adolescent dose
Antiflatulent
Oral, 95 or 125 mg four times a day {13}, after meals and at bedtime, or as needed.


Note: For OTC use, it is recommended that no more than 500 mg be taken in each twenty-four-hour period.


Usual pediatric dose
Dosage must be individualized by physician.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


125 mg (OTC) [Gas-X Extra Strength] [Maximum Strength Phazyme]

Canada—


95 mg (OTC) [Phazyme-95]


125 mg (OTC) [Phazyme-125]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container.


SIMETHICONE ORAL SUSPENSION USP

Usual adult and adolescent dose
Antiflatulent
Oral, 40 to 95 mg four times a day {13}, after meals and at bedtime, or as needed.

[Diagnostic aid (gastroscopy; radiography of the bowel)]1
Oral, 67 mg in 2.5 mL of water, as a single dose.


Note: For OTC use, it is recommended that no more than 500 mg be taken in each twenty-four-hour period.


Usual pediatric dose
Dosage must be individualized by physician.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—
{11}

40 mg per 0.6 mL (OTC) [Flatulex] [Gas Relief] [My Baby Gas Relief Drops] [Mylicon Drops] [Phazyme][Generic]

Canada—
{12}{13}

40 mg per 0.6 mL (OTC) [Baby's Own Infant Drops] [Phazyme Drops]


40 mg per mL (OTC) [Ovol]


95 mg per 1.425 mL (OTC) [Phazyme-95]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.

Auxiliary labeling:
   • Shake well. {11}

Note: Dispense in dropper bottle or with measuring spoon.



SIMETHICONE TABLETS USP

Usual adult and adolescent dose
Antiflatulent
Oral, 60 to 95 mg four times a day, after meals and at bedtime, or as needed. {06}


Note: For OTC use, it is recommended that no more than 500 mg be taken in each twenty-four-hour period.


Usual pediatric dose
Dosage must be individualized by physician.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


60 mg (OTC) [Phazyme (sugar-coated)]


80 mg (OTC) [Flatulex] [Genasyme (scored)][Generic]


95 mg (OTC) [Phazyme-95]

Canada—
{13}Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container.


SIMETHICONE TABLETS (CHEWABLE) USP

Usual adult and adolescent dose
Antiflatulent
Oral, 40 to 125 mg four times a day, after meals and at bedtime, or as needed {06} {08} {10} {12}; or, 150 mg three times a day, after meals {08}, or as needed.


Note: For OTC use, it is recommended that no more than 500 mg be taken in each twenty-four-hour period. {10}


Usual pediatric dose
Dosage must be individualized by physician.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—
{09}{10}

40 mg (OTC) [Mylanta Gas]


80 mg (OTC) [Degas] [Gas Relief] [Gas-X (scored)] [Maalox Anti-Gas] [Mylanta Gas Relief][Generic]


125 mg (OTC) [Maximum Strength Gas Relief] [Maximum Strength Mylanta Gas Relief] [Maximum Strength Phazyme]


150 mg (OTC) [Extra Strength Maalox Anti-Gas]

Canada—
{08}{12}

40 mg (OTC) [Ovol-40 (scored)]


80 mg (OTC) [Maalox GRF Gas Relief Formula] [Ovol-80 (scored)]


150 mg (OTC) [Extra Strength Maalox GRF Gas Relief Formula]


160 mg (OTC) [Ovol-160]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container.

Auxiliary labeling:
   • Chew tablets well before swallowing.



Revised: 08/14/1998



References
  1. Phazyme (Reed & Carnrick). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 26th ed. Ottawa: Canadian Pharmaceutical Association, 1991.
  1. McEvoy G, editor. AHFS Drug Information 89. Bethesda, MD: American Society of Hospital Pharmacists, 1989.
  1. Panel comments.
  1. Feldman EG, Blockstein WL, editors. Handbook of nonprescription drugs. 9th ed. Washington, DC: American Pharmaceutical Association, 1990.
  1. McNally P, Maydonovitch C, Wong R. The effect of simethicone on colonic visibility after night-prior colonic lavage. J Clin Gastroenterol 1989; 11(6): 650-2.
  1. Mylanta Gas product information (Johnson & Johnson, Merck—US), Rec 12/88.
  1. Drug evaluations subscription. Chicago: American Medical Association, 1992.
  1. Maalox GRF Gas Relief Formula product information (Rhône-Poulenc Rorer—Canada), Rec 1/12/95.
  1. Maalox Anti-Gas product information (CIBA—US), Rec 1/26/95.
  1. Mylanta Gas Relief product information (Johnson & Johnson, Merck—US), Rec 1/26/95.
  1. Mylicon Drops product information (Johnson & Johnson, Merck—US), Rec 1/26/95.
  1. Ovol (Horner). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 972.
  1. Phazyme (Reed & Carnrick). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 1016.
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