II. Indications

  1. Excessive Gas (Eructation, Flatulence, Bloating)
  2. Infantile Colic (off-label)
    1. Not recommended (no benefit over Placebo)

III. Dose

  1. Adult (and age >=12 years): 40-125 mg orally after meals and at bedtime as needed (max 500 mg/day)
  2. Child (age 2 to 12 years): 40 mg orally four times daily as needed (max 480 mg/day)
  3. Infant (age <2 years): 20 mg orally four times daily as needed (max 240 mg/day)

IV. Mechanism

  1. Silicone-based drug used for Flatulence and bloating
  2. Acts as a local gastrointestinal surfactant
    1. Reduces gastrointestinal gas bubble surface tension
    2. Allows gas bubbles to coalesce together and to be expelled from the Gastrointestinal Tract via Flatulence or Eructation
  3. Simethicone does NOT modify gastrointestinal gas production
    1. Does not reduce gas production due to food intolerance (e.g. Lactose Intolerance, FODMAP) or medications

V. Pharmacokinetics

  1. Not absorbed
  2. Excreted in the stool

VI. Efficacy

  1. Infantile Colic
    1. Several controlled clinical trials have been performed
    2. No evidence that Simethicone is better than Placebo in Infantile Colic
    3. Lucassen (1998) BMJ 316(7144):1563-9 [PubMed]

VII. Safety

  1. Pregnancy Category C (but not absorbed)
  2. Unknown safety in Lactation (but not absorbed)

IX. References

  1. Hamilton (2020) Tarascon Pocket Pharmacopoeia
  2. Ingold (2023) Simethicone, StatPearls, Treasure Island, Florida
    1. https://www.ncbi.nlm.nih.gov/books/NBK555997/

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Related Studies

Cost: Medications

simethicone (on 12/21/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
SIMETHICONE 125 MG TAB CHEW Generic OTC $0.10 each
SIMETHICONE 180 MG SOFTGEL Generic OTC $0.06 each
SIMETHICONE 80 MG TAB CHEW Generic OTC $0.03 each