What is the recommended dose and frequency of Simethicone (Dimethicone)?

From the Guidelines

Simethicone should be taken at a dose of 320 mg or higher to improve bowel preparation quality and reduce bubbles, with the timing of ingestion not significantly affecting the outcome, as evidenced by recent meta-analyses 1. When considering the optimal dose and frequency of simethicone, it is essential to prioritize the most recent and highest quality studies.

• The dose of simethicone used in various studies ranged from 200 mg to 1,200 mg, with some studies failing to report the concentration.
• A recent meta-analysis of 38 trials with 10,505 patients observed that oral simethicone use, particularly with a dose of 320 mg or higher, was associated with improved bowel preparation quality and fewer bubbles, but no improvement in adenoma detection rates (ADR) 1.
• The addition of simethicone to a PEG-based bowel preparation regimen reduces the intraprocedural use of simethicone, highlighting its potential benefits in improving bowel preparation quality 1.
• Regarding the timing of simethicone ingestion, studies have shown that it does not significantly affect the outcome, with some studies suggesting that earlier dosing may be associated with shorter cecal intubation times and higher detection of diminutive right-sided adenomas 1.
• Overall, the evidence suggests that simethicone is a useful adjunct to bowel preparation regimens, particularly when used at a dose of 320 mg or higher, and its timing of ingestion can be flexible based on individual patient needs.

From the FDA Drug Label

Directions adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician Active ingredient (per softgel) Simethicone 180 mg The recommended dose of simethicone is 1 or 2 softgels as needed, with each softgel containing 180 mg of simethicone. The recommended frequency is after meals and at bedtime, with a maximum of 2 softgels in 24 hours unless advised by a physician 2 2.

From the Research

Simethicone Dose and Frequency

• The dose and frequency of simethicone can vary depending on the specific use case and patient population.
• In a study comparing the efficacy and safety of APT036 and simethicone in treating functional bloating, simethicone was administered orally 3 times a day for 20 consecutive days 3.
• Another study assessing the efficacy and safety of simethicone with or without N-acetylcysteine before gastroscopy did not specify the exact dose and frequency of simethicone, but it was used as an oral drinking agent before gastroscopy 4.
• There is no direct information on the optimal dose and frequency of simethicone for other uses, such as preventing acute gastrointestinal bleeding or maintaining gastric pH above 3.5 in critically ill patients 5, 6, 7.

Administration and Efficacy

• Simethicone can be administered orally, and its efficacy may depend on the specific use case and patient population.
• In the study on functional bloating, both APT036 and simethicone were well tolerated, but APT036 was superior to simethicone in relieving symptoms of functional bloating 3.
• The study on gastroscopy found that simethicone plus N-acetylcysteine offered more benefit on positive findings and total mucosal visibility score compared to simethicone alone or water 4.
• The other studies did not provide direct information on the efficacy of simethicone for preventing acute gastrointestinal bleeding or maintaining gastric pH above 3.5 in critically ill patients 5, 6, 7.

Safety Profile

• Simethicone has been shown to have a good safety profile in various studies.
• In the study on functional bloating, no adverse effects were reported with simethicone 3.
• The study on gastroscopy found no significant difference in adverse events between simethicone and water groups 4.
• The other studies did not provide direct information on the safety profile of simethicone for other uses 5, 6, 7.