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Simethicone is a nonabsorbed antifoaming agent for gas that compounding pharmacies prepare in oral forms by prescription.
Simethicone is a silicone-based antiflatulent made mostly of polydimethylsiloxane with finely dispersed silica. It acts inside the gut by lowering the surface tension of gas bubbles, so small bubbles join into larger ones that are easier to pass by belching or flatus. It does not change how much gas the body makes and is not absorbed into the bloodstream. Simethicone is sold over the counter under the FDA antiflatulent monograph, which allows it for relief of pressure, bloating and fullness commonly referred to as gas. Manufactured forms include softgels such as Gas-X, chewable tablets and infant drops, and it is combined with antacids in some products. A prescriber might order it compounded in a dye-free or allergen-free vehicle, a liquid in a strength not sold over the counter, or a combination. Compounded preparations are not FDA-approved and require a prescription.
Simethicone has no boxed warning. Because it is not absorbed, StatPearls reports no serious adverse effects; mild diarrhea and nausea have been reported but appear tied to the underlying condition. The OTC monograph requires the warning to keep it out of the reach of children, and infant drop labels add that you should get medical help or call Poison Control right away after an overdose. Do not use it if you are allergic to simethicone. Liquid forms that contain benzyl alcohol should be avoided or used with caution in newborns. Isolated case reports describe changes in how other oral drugs are absorbed, including levothyroxine and carbamazepine, so tell your prescriber about medicines with narrow safety margins. LactMed notes simethicone cannot pass into breast milk because it is not absorbed and needs no special precautions. If gas symptoms persist or are severe, talk to your prescriber or pharmacist.
Simethicone is an inert, nonabsorbable antifoaming agent that coalesces gas bubbles in the gastrointestinal tract; it is excreted unchanged in the feces and does not alter gas production, absorption or motility. Under 21 CFR Part 332 it is the sole OTC antiflatulent active ingredient, may be combined with a monograph antacid only for gas associated with heartburn, sour stomach or acid indigestion, and may carry professional labeling for postoperative gas pain and use in endoscopic examination. StatPearls describes use for functional dyspepsia symptoms, as premedication before upper endoscopy and as an adjunct in bowel preparation before colonoscopy, where the US Multi-Society Task Force on Colorectal Cancer has recommended adjunctive oral simethicone. Reviews found no support for use in infantile colic, and a randomized trial in postoperative ileus after colorectal surgery found no difference from placebo. It should not be given parenterally or by inhalation. Dosing is per prescriber. No routine laboratory monitoring is required; consider monitoring narrow therapeutic index drugs such as carbamazepine when starting or stopping simethicone. No hepatic or renal adjustment is expected. Simethicone is not a controlled substance.
Compounded at Bayview
Patient guides for the preparations we make most often. Each one is compounded to order and requires a prescription.
We do not have a patient page for this ingredient yet. That does not mean we cannot make it. Bayview compounds this ingredient to a prescriber's order, and our full compounding formulary lists every preparation we make. Viewing the formulary requires a prescriber account.
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Every preparation in our formulary that contains this ingredient. Strength, base and dose form are set by the prescription.
Other salt forms of this molecule, and ingredients commonly compounded alongside it.
This page describes an active pharmaceutical ingredient, not a finished drug product. Bayview Pharmacy compounds preparations containing it only on a prescriber's order for an individual patient.
Compounded preparations are not FDA-approved, and the FDA has not evaluated them for safety, effectiveness, or manufacturing quality. Nothing on this page is a claim that any preparation is effective for any condition.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Our pharmacists work with prescribers to build preparations around a patient's dose, form and tolerances. Ask us what is possible with this ingredient.
