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/

Images: Related links to external sites (from Bing)

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

Ontology: Simethicone (C0037138)

Definition (MSH) A poly(dimethylsiloxane) which is a polymer of 200-350 units of dimethylsiloxane, along with added silica gel. It is used as an antiflatulent, surfactant, and ointment base.
Definition (NCI) A mixture of polydimethylsiloxanes with antifoaming and anti-bloating effects. Simethicone reduces the surface tension of gas bubbles causing them to coalesce into larger bubbles that can be passed more easily by belching or flatulence.
Concepts Pharmacologic Substance (T121) , Biomedical or Dental Material (T122) , Organic Chemical (T109)
MSH D012841
SnomedCT 387442005, 77898008
LNC LP171639-0
English Simeticone, Simethicone, simethicone (medication), Simethicone [Chemical/Ingredient], dimethicone activated, activated dimethicone, simethicone, Activated dimethicone, Activated methylpolysiloxane, Simethicone (product), Simethicone (substance), SIMETHICONE
Swedish Simetikon
Czech simethikon
Finnish Simetikoni
Russian SIMETIKON, DIMETIKON, ДИМЕТИКОН, СИМЕТИКОН
Japanese シメチコン
Spanish dimeticona, dimeticona activada, metilpolisiloxano activado, simeticona (producto), simeticona (sustancia), simeticona, Simeticona
Polish Simeticon, Simetykon
Norwegian Simetikon
French Siméticone
German Simethicon
Italian Simeticone
Portuguese Simeticone

Ontology: Mylicon (C0721886)

Concepts Pharmacologic Substance (T121) , Organic Chemical (T109)
English Mylicon, mylicon

Ontology: Phazyme (C0722576)

Concepts Pharmacologic Substance (T121) , Organic Chemical (T109)
English Phazyme, phazyme