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  • CLASSES

    Other Products for Functional Bowel Disorders

    DEA CLASS

    OTC

    DESCRIPTION

    Oral antiflatulent agent, available as a single agent or in combination with antacids or antidiarrheals. Simethicone-coated cellulose suspension (SonoRx®) is used to enhance upper GI visibility in ultrasound images and is not used as an antiflatulent.

    COMMON BRAND NAMES

    Equalizer Gas Relief, Gas Free, Gas Relief, Gas-X, Gas-X Extra Strength, Gas-X Ultra Strength, GasAid, Genasyme, Gerber Gas Relief, Infantaire, Little Remedies for Tummys, Mylanta Gas, Mylicon, Mytab Gas, PediaCare Infant's Gas Relief, Phazyme

    HOW SUPPLIED

    Equalizer Gas Relief/Gas Relief/Gas-X/Genasyme/Gerber Gas Relief/Infantaire/Little Remedies for Tummys/Mylicon/PediaCare Infant's Gas Relief/Simethicone Oral Drops: 0.3mL, 20mg
    Gas Free/Gas Relief/Gas-X/Gas-X Extra Strength/Gas-X Ultra Strength/Mylanta Gas/Phazyme/Simethicone Oral Cap: 125mg, 180mg
    Gas Relief/Gas-X/Gas-X Extra Strength/Genasyme/Mylanta Gas/Mytab Gas/Phazyme/Simethicone Oral Tab Chew: 80mg, 125mg
    Gas-X Oral Film: 62.5mg

    DOSAGE & INDICATIONS

    For the symptomatic relief of flatulence (gas), functional gastric bloating, and postoperative gas pains.
    Oral dosage
    Adults and Adolescents

    40 to 125 mg PO 4 times per day after meals and at bedtime. Higher doses have been used.

    Children 2 to 12 years

    40 to 50 mg PO 4 times per day after meals and at bedtime.

    Infants and Children < 2 years

    20 mg PO 4 times per day after meals and at bedtime. Do not exceed 12 doses per day. Efficacy for infant colic is questionable.

    For enhancing the delineation of upper abdominal anatomy in conjunction with ultrasound imaging.
    Oral dosage(simethicone-coated cellulose suspension, SonoRx ONLY)
    Adults

    400 mL (3,000 mg) PO of SonoRx administered over 15 minutes after completing at least a 4-hour fast. Begin abdominal ultrasound imaging within 10 minutes of completing the ingestion. The feces of patients may appear orange-colored for up to 48 hours after ingestion.

    For the treatment of functional dyspepsia†.
    Oral dosage
    Adults

    80 mg PO 3 times per day. Simethicone has been demonstrated more effective than cisapride in the first 2 weeks of dyspepsia treatment.

    For use prior to gastroscopy to enhance visualization and prior to gastrointestinal radiography† to reduce gas shadows.
    Oral dosage (simethicone drops)
    Adults

    67 mg dispersed in 2.5 mL of water PO. Simethicone has also been used with oral gastric lavage solutions prior to colonoscopy; it appears that approximately 100 mg of simethicone oral suspension (drops) are mixed with the lavage solution and administered PO the night prior to colonoscopy.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    500 mg/day PO. 400 ml (3000mg)/day PO (SonoRx).

    Elderly

    500 mg/day PO. 400 ml (3000mg)/day PO (SonoRx).

    Adolescents

    500 mg/day PO.

    Children

    240 mg/day PO.

    Infants

    240 mg/day PO.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Oral Administration
    Oral Solid Formulations

    Chewable tablets: Chew well before swallowing, do not swallow whole.
    Softgels: Swallow whole with water; do not chew.

    Oral Liquid Formulations

    Oral drops: Shake well prior to each administration. Measure dose with provided calibrated dropper. Administer liquid toward the inner cheek of infant. To ease administration, drops may be mixed with water, infant formula, or other liquids.
    Simethicone-coated cellulose suspension (SonoRx): Shake bottle vigorously prior to administration. To allow excess air to escape from the suspension, allow the container to stand for 2 minutes before administration.

    STORAGE

    Generic:
    - Store at room temperature (between 59 to 86 degrees F)
    Equalizer Gas Relief:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Gas Free :
    - Avoid exposure to heat
    - Do not refrigerate
    - Protect from light
    - Protect from moisture
    - Store at room temperature (between 59 to 86 degrees F)
    Gas Relief:
    - Store at room temperature (between 59 to 86 degrees F)
    GasAid:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Gas-X:
    - Store at room temperature (between 59 to 86 degrees F)
    Gas-X Extra Strength:
    - Avoid exposure to heat
    - Do not refrigerate
    - Protect from light
    - Protect from moisture
    - Store at room temperature (between 59 to 86 degrees F)
    Gas-X Ultra Strength:
    - Avoid exposure to heat
    - Protect from moisture
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Genasyme:
    - Store at room temperature (between 59 to 86 degrees F)
    Gerber Gas Relief:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Infantaire:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Little Remedies for Tummys:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Mylanta Gas:
    - Store at room temperature (between 59 to 86 degrees F)
    Mylicon:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Mytab Gas:
    - Store at room temperature (between 59 to 86 degrees F)
    PediaCare Infant's Gas Relief:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Phazyme:
    - Avoid excessive heat (above 104 degrees F)
    - Avoid excessive humidity
    - Store at room temperature (between 59 to 86 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    For all formulations of simethicone:
    Simethicone is contraindicated in patients with hypersensitivity to any component of the active or inactive ingredients.
     
    For SonoRx Ultrasound Imaging Agent (simethicone-coated cellulose suspension):
    The feces of patients receiving simethicone-coated cellulose suspension may appear orange-colored for up to 48 hours after ingestion of the product.
     
    Animal studies have noted capsular granulomatous inflammation of the spleen, liver, and kidneys after intraperitoneal injection of simethicone-coated cellulose suspension. Cellulose accumulated in areas of the kidney and spleen. The effects of simethicone-coated cellulose suspension on human peritoneal tissues are not known.
     
    Approximately 14 ounces of simethicone-coated cellulose suspension must be ingested over a period of 15 minutes prior to ultrasound. Patients who are under fluid restrictions or who cannot tolerate large fluid shifts may be at risk; use caution in these patients.

    Breast-feeding

    Studies have not been conducted to determine if simethicone is excreted in human milk. However, due to the fact that simethicone is not absorbed systemically, it seems unlikely that simethicone would be excreted in the milk of breast-feeding women. Problems in infants have not been documented.

    Pregnancy

    Simethicone-coated cellulose suspension is classified in FDA pregnancy risk category B. Conventional dosage forms of simethicone are classified in FDA pregnancy risk category C. Epidemiologic evidence during human pregnancy shows no difference in outcomes between exposed and nonexposed pregnancies, and there is a low risk for use during endoscopy because it is not systemically absorbed. In normal therapeutic doses (e.g., such as found in antacid combinations) for the treatment of occasional gas, the drug is also considered low risk.

    Phenylketonuria

    Some formulations of chewable simethicone tablets contain aspartame, a source of phenylalanine. Check inactive ingredient labels if simethicone is used in patients with phenylketonuria.

    Hypercalcemia, hypercalciuria

    Because chewable simethicone tablets contain calcium, these products should not be used in patients with preexisting hypercalcemia or hypercalciuria, especially if renal calculi are present.

    Children

    The safety and effectiveness of simethicone-coated cellulose suspension in children have not been established. Dose adjustments for the capacity of the upper GI tract are not known.

    ADVERSE REACTIONS

    Moderate

    dysphagia / Delayed / 0-0.5
    melena / Delayed / 0-0.5

    Mild

    diarrhea / Early / 5.5-5.5
    nausea / Early / 3.4-3.4
    vomiting / Early / 2.1-2.1
    abdominal pain / Early / 2.0-2.0
    headache / Early / 1.8-1.8
    eructation / Early / 1.0-1.0
    back pain / Delayed / 1.0-1.0
    xerostomia / Early / 0-0.5
    rash (unspecified) / Early / 0.5-0.5
    rhinitis / Early / 0.5-0.5
    pharyngitis / Delayed / 0.5-0.5
    stool discoloration / Delayed / Incidence not known

    DRUG INTERACTIONS

    Desiccated Thyroid: (Major) Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption. To minimize the risk of interaction, oral thyroid hormones should be administered at least 4 hours before or after the ingestion of simethicone.
    Levothyroxine: (Major) Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption. To minimize the risk of interaction, oral thyroid hormones should be administered at least 4 hours before or after the ingestion of simethicone.
    Liothyronine: (Major) Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption. To minimize the risk of interaction, oral thyroid hormones should be administered at least 4 hours before or after the ingestion of simethicone.
    Liotrix: (Major) Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption. To minimize the risk of interaction, oral thyroid hormones should be administered at least 4 hours before or after the ingestion of simethicone.
    Thyroid hormones: (Major) Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption. To minimize the risk of interaction, oral thyroid hormones should be administered at least 4 hours before or after the ingestion of simethicone.

    PREGNANCY AND LACTATION

    Pregnancy

    Simethicone-coated cellulose suspension is classified in FDA pregnancy risk category B. Conventional dosage forms of simethicone are classified in FDA pregnancy risk category C. Epidemiologic evidence during human pregnancy shows no difference in outcomes between exposed and nonexposed pregnancies, and there is a low risk for use during endoscopy because it is not systemically absorbed. In normal therapeutic doses (e.g., such as found in antacid combinations) for the treatment of occasional gas, the drug is also considered low risk.

    Studies have not been conducted to determine if simethicone is excreted in human milk. However, due to the fact that simethicone is not absorbed systemically, it seems unlikely that simethicone would be excreted in the milk of breast-feeding women. Problems in infants have not been documented.

    MECHANISM OF ACTION

    Mechanism of Action: As an antiflatulent, simethicone has been shown in vitro to disperse and prevent the formation of mucus-surrounded gas pockets in the GI tract. Changing the surface tension of the gas bubble prevents these pockets. The gas bubbles coalesce and are more quickly eliminated by flatus, belching, or absorption into the bloodstream. These actions in vivo have not been clearly established. Additionally, simethicone exhibits in vitro activity against Helicobacter pylori.A reduction in gas bubbles that obstruct the view is the mechanism for simethicone in uses such as radiography, gastroscopy, and colonoscopy. Simethicone-coated cellulose suspension (SonoRx®) acts to absorb and disperse gas within the bowel lumen resulting in reduced shadowing during ultrasound imaging.

    PHARMACOKINETICS

    Both simethicone and simethicone-coated cellulose suspension are administered orally. Simethicone is physiologically inert and not systemically absorbed. A study in volunteers measuring silicon in the blood (as the surrogate marker for simethicone) noted that blood and urine levels of silicone were similar at baseline and after receiving SonoRx or vehicle control. This suggests minimal systemic absorption of simethicone. Similarly, the body does not metabolize simethicone and cellulose. Simethicone and cellulose are both excreted unchanged in the feces. Simethicone is not known to interfere with gastric secretion or nutrient absorption; however, this medicine is usually taken after at least 4 hours of fasting. SonoRx may color the stool orange until elimination is complete, typically 24 to 48 hours.

    Oral Route

    Simethicone is physiologically inert and not systemically absorbed.