Simethicone
Berlin-Chemie / Menarini
1702 Items
2019-09-19
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Clinical Pharmacology
Drug Espumisan® baby reduces the amount of gas in the gastrointestinal tract (GIT). The active ingredient - simethicone has surface-active properties and the ability to reduce surface tension at the liquid / gas interface, which promotes the merging of gas bubbles and the destruction of foam in the intestine, as a result of which the released gas is absorbed or excreted naturally under the influence of intestinal motility. The use of simethicone in preparation for conducting diagnostic studies of the abdominal cavity prevents the appearance of image defects caused by gas bubbles.
Pharmacokinetics
Simethicone is chemically inert, after ingestion is not absorbed from the gastrointestinal tract and acts only in its lumen. Does not interact with microorganisms and enzymes and does not affect the processes of digestion. Excreted in the intestine unchanged.
Indications
- symptoms of intestinal colic in babies;
- symptoms of excessive formation and accumulation of gases in the gastrointestinal tract (including flatulence, increased gas formation in the postoperative period);
- symptoms of excessive gas formation caused by functional dyspepsia;
- preparation for diagnostic examinations of the abdominal cavity and small pelvis (ultrasound, X-ray, esophagogastroduodenoscopy, etc.), including, as an additive to contrast media suspensions for obtaining a double contrast image;
- acute poisoning with detergents containing foaming agents (detergents), as a defoamer.
Composition
In 1 ml (25 drops) of the drug contains:
Active ingredient: Simethicone - 100.00 mg
Excipients: macrogol stearate 40 - 6.17 mg, glyceryl monostearate 40-55 - 3.78 mg, carbomer - 5.98 mg, banana flavoring - 3.98 mg, potassium acesulfame - 0.30 mg, sorbitol liquid (non-crystallizing ) - 199.17 mg, sodium chloride - 0.67 mg, sodium citrate - 4.19 mg, sodium hydroxide - 0.67 mg, sorbic acid - 1.06 mg, purified water - 732.25 mg.
Simethicone is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| Espumisan | Berlin-Chemie/Menarini | Germany | drops |
| Espumisan | Berlin-Chemie/Menarini | Germany | granules |
| Sab simplex | Pfizer | USA | suspension |
| Espumisan | Berlin-Chemie/Menarini | Germany | capsules |
| Bobotik | Medana Pharma | Poland | drops |
| Espumisan L | Berlin-Chemie/Menarini | Germany | emulsion |
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Dosage and Administration
For oral use, during or after a meal (if necessary, and at night).
With flatulence and a feeling of overcrowding in the stomach for adults and children 6-14 years - 1–2 capsules or 1–2 tsp emulsion 3-5 times per day,infants and young children- 1 tsp emulsion 3-5 times per day.
To prepare for x-ray and ultrasound of the abdominal cavity 1 day before the test - 2 capsules or 2 tsp. of emulsion 3 times a day and on the morning of the study - 2 capsules or 2 tsp. of emulsion.
For a double contrast image - 20–40 ml per 1 l of contrast suspension. In case of poisoning with detergents -for adults 50–100 ml,for children- 10–50 ml depending on the severity of the poisoning. Infants and young children take the emulsion with bottle or liquid after meals.
Adverse reactions
In some cases: individual intolerance to the components of the drug.
Contraindications
Hypersensitivity to the drug; intestinal obstruction.
Drug interactions
Clinically significant interaction of the drug Espumisan® with other medicines is not established.
Pregnancy and Lactation
The drug Espumisan® can be used during pregnancy and during breastfeeding.
Special instructions
Does not contain sugar, it is possible the use of patients with diabetes and digestive disorders.
Application during the periods of pregnancy and breastfeeding is possible.
Overdosage
An overdose of the drug Espumisan® is unlikely due to the chemical and physiological inertness of the drug.
- Brand name: Espumisan
- Active ingredient: Simethicone
- Dosage form: Drops for oral administration, 100 mg / ml.
- Manufacturer: Berlin-Chemie / Menarini
- Country of Origin: Germany
Studies and clinical trials of Simethicone (Click to expand)
- Mechanism of antifoaming action of simethicone
- A RP-LC method with evaporative light scattering detection for the assay of simethicone in pharmaceutical formulations
- Randomised double-blind comparison of simethicone with cisapride in functional dyspepsia
- A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia
- Case report medication error: oral antibiotics and simethicone accidentally injected intravenously
- Efficacy and tolerability of polyethylene glycol-electrolyte lavage solution with and without simethicone in the preparation of patients with inflammatory bowel disease for colonoscopy
- Effect of small bowel preparation with simethicone on capsule endoscopy
- Effect of a simethicone-containing tablet on colonic gas elimination in breath
- Improvement of oral colonic lavage with supplemental simethicone
- Use of simethicone during colonoscopy
- Efficacy of an activated charcoal–simethicone combination in dyspeptic syndrome: Results of a placebo-controlled prospective study in general practice
- A scintigraphic study to investigate the potential for altered gut distribution of loperamide from a loperamide–simethicone formulation in man
- The effects of loperamide, or loperamide plus simethicone, on the distribution of gut water as assessed by MRI in a mannitol model of secretory diarrhoea
- An analysis of standards for antacid simethicone defoaming properties
- Simethicone—another “pill in the pocket” in paroxysmal atrial fibrillation?
- Simethicone coated cellulose as an oral contrast agent for ultrasound of the upper abdomen
- Simethicone coated cellulose as an oral contrast agent for ultrasound of the upper abdomen
- Decrease in defoaming potency of commercial simethicone antacid tablets over time
- Further analysis of standards for antacid simethicone defoaming properties
- Evaluation of Simethicone for the Treatment of Postoperative Abdominal Discomfort in Infants
- Improvements in soft gelatin capsule sample preparation for USP-based simethicone FTIR analysis
- The use of simethicone suspension as a luminal contrast agent during endoscopic ultrasound
- Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study
- The effectiveness of simethicone in improving visibility during colonoscopy when given with a sodium phosphate solution: A double-blind randomized study
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