Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Simethicone is an Anti-flatulent belonging to Gastrointestinal drug.
Simethicone is an anti-flatulence agent used to relieve pressure, bloating, and symptoms referred to as gas.
Simethicone not absorbed from the gastrointestinal tract. Simethicone excreted via faeces as unchanged drug.
Simethicone shows common side effects like nausea and constipation.
Simethicone is available in the form of Oral capsule, oral tablet, oral suspension, oral disintegrating strip.
Simethicone is available in India, US, Canada, Vietnam, China, Philippines, Malaysia, Australia, Singapore, Japan, and Spain.
Simethicone is a Gastrointestinal drug belonging to the class Anti-flatulent.
Simethicone is a surfactant that decreases the surface tension of gas bubbles in the gastrointestinal tract, more easily allowing gas to exit the body.
The Onset and Duration of action of Simethicone is approximately 30minutes from intake and 3-4 hours respectively.
Simethicone is available in the form of Oral capsule, oral tablet, oral suspension, oral disintegrating strip.
Simethicone capsule, tablet is taken orally usually 3 to 4 times daily. Simethicone Chewable tablet is Chew thoroughly and swallow. Simethicone Oral suspension (drops): Shake well before using; may mix with 30 mL water or other liquids. Simethicone Oral disintegrating strips place it on tongue and allow to dissolve.
Simethicone is an anti-flatulent medicine. It is used to reduce excessive gas in the stomach and relieve symptoms like stomach discomfort, abdominal pain, fullness, and bloating/flatulence (accumulation of gas in the stomach). This medicine works by reducing stomach discomfort by expelling gas.
Simethicone is an Anti-flatulent belonging to Gastrointestinal drug.
Simethicone, a surface-active substance, is a mixture of liquid dimethicones consisting of finely divided silicon dioxide to increase the defoaming effects of silicone. It lowers the surface tension of the intestinal mucous therefore, disperses and prevents gas pockets in the gastrointestinal system.
Simethicone is approved for use in the following clinical indications
- Flatulence
Simethicone is indicated for the treatment of bloating, pressure, and cramps caused by gas.
- Flatulence
Adult: 100-250 mg 3 or 4 times daily, or as directed. Dosage recommendation may vary among countries and individual products.
Child:
<2 years weighing <10.9 kg: 20 mg 4 times daily as necessary after meals and at bedtime. Max: 240 mg/24 hours.
≥2 years weighing ≥10.9 kg: 40 mg 4 times daily as necessary after meals and at bedtime. Max: 480 mg/24 hours.
Simethicone is available in various strengths as 125 mg; 60 mg; 95 mg; 40 mg/0.6 mL; 180 mg; 80 mg; 62.5 mg; 166 mg; 50 mg/5 mL; 40 mg; 150 mg; 250 mg; 62.5 mg/5 mL; 20 mg/0.3 mL.
Simethicone is available in the form of Oral capsule, oral tablet, oral suspension, oral disintegrating strip.
Avoid carbonated beverages and gas-forming foods.
Simethicone is contraindicated in patients with
- Breast-feeding
- Pregnancy
- Phenylketonuria
- Hypersensitivity
Common
Nausea, constipation, mild diarrhea, regurgitation, vomiting, heartburn. Rarely, hypersensitivity reactions (e.g. rash, facial oedema, pruritus, tongue oedema, respiratory difficulty).
Levothyroxine: (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of simethicone. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption.
Levothyroxine; Liothyronine (Porcine): (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of simethicone. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption.
Levothyroxine; Liothyronine (Synthetic): (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of simethicone. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption.
Liothyronine: (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of simethicone. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption.
Thyroid hormones: (Moderate) Oral thyroid hormones should be administered at least 4 hours before or after a dose of simethicone. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Simethicone has been reported to chelate oral levothyroxine within the GI tract when administered simultaneously, leading to decreased thyroid hormone absorption.
The common side effects of Simethicone include the following
Common side effects
Nausea, constipation, mild diarrhea, regurgitation, vomiting, heartburn. Rarely, hypersensitivity reactions (e.g. rash, facial oedema, pruritus, tongue oedema, respiratory difficulty).
- Pregnancy
Pregnancy Category C
Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
- Nursing Mothers
Simethicone is not recommended for use during breastfeeding. If you are breastfeeding, all risk shall be considered before using this medicine.
- Pediatric Use
Simethicone is not recommended for use in infants under one month of age for colic pain as the safety and efficacy of use are not clinically established.
- Pharmacodynamic
Simethicone decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion. It has a short duration of action as it is generally given as needed, and a wide therapeutic index as it is not systemically absorbed.
- Pharmacokinetics
Absorption
Simethicone not absorbed from the gastrointestinal tract.
Distribution
Information is not available.
Metabolism and Excretion
Simethicone excreted via faeces as unchanged drug.
- Burta O, Iacobescu C, Mateescu RB, Nicolaie T, Tiuca N, Pop CS. Efficacy and safety of APT036 versus simethicone in the treatment of functional bloating: a multicentre, randomised, double-blind, parallel group, clinical study. Translational Gastroenterology and Hepatology. 2018;3.
- Wu L, Cao Y, Liao C, Huang J, Gao F. Systematic review and meta-analysis of randomized controlled trials of Simethicone for gastrointestinal endoscopic visibility. Scandinavian journal of gastroenterology. 2011 Feb 1;46(2):227-35.
- Li Y, Du F, Fu D. The effect of using simethicone with or without N-acetylcysteine before gastroscopy: A meta-analysis and systemic review. Saudi journal of gastroenterology: official journal of the Saudi Gastroenterology Association. 2019 Jul;25(4):218.
- https://www.uptodate.com/contents/simethicone-drug-information?search=simethicone&source=panel_search_result&selectedTitle=1~29&usage_type=panel&kp_tab=drug_general&display_rank=1
- https://go.drugbank.com/drugs/DB09512
- https://www.drugs.com/sfx/simethicone-side-effects.html
- https://medlineplus.gov/druginfo/meds/a682683.html
- https://www.rxlist.com/simethicone/generic-drug.htm
- https://reference.medscape.com/drug/mylicon-phazyme-simethicone-342005#4
- https://www.pdr.net/drug-summary/Gas-X-simethicone-2675
