Gascon

Gascon

simeticone

Manufacturer:

Kissei

Distributor:

Hing Ah
Full Prescribing Info
Contents
Dimethicone.
Description
Each tablet contains dimethylpolysiloxane 40 mg. It has a diameter of 8.6 mm, thickness of 4.2 mm and weighs 0.22 g.
Each drop contains dimethylpolysiloxane 20 mg. It also contains the following excipients: Paraoxyethyl benzoate, dibutyl hydroxytoluene, saccharin sodium and flavor.
Dimethicone is dimethylpolysiloxane.
Dimethylpolysiloxane is a colorless, transparent, viscous liquid which is nearly odorless. It mixes with ether, hexane or tetraethoxysilane. It is practically insoluble in water or ethanol.
Action
Gastrointestinal anti-gas agent.
Pharmacology: Antifoaming Action: It has been observed in vitro that the drug breaks up small gas bubbles by lowering their surface tension and combining them into a free gas. Thus, the drug, in small quantities, has been observed to display a powerful antifoaming action.
Action on Removing Foaming Mucus Inside Stomach: In scanning electron-microscopic observations of the surface of rhesus monkey stomachs, the drug has been reported to have the effect of removing mucus attached to the inside walls of the stomachs.
Clinical Studies: Double-Blind Tests and General Clinical Trial: The following is an outline of double-blind tests (gastrointestinal symptoms eg, distention and meteorism) and of general clinical trial of 2194 patients. The total number of patients in Japan in whom it was possible to judge the effects was 2194. The drug was judged to be effective in 1849 of these, amounting to a total effective rate of 84.3%. See Table 1.

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Pharmacokinetics: Distribution: When doses of 500 mg/kg dimethylpolysiloxane were administered orally to male Wistar-type rats, only trace amounts were detected in the liver 1-3 hrs after administration and none was detected in the blood and other organs. Dimethylpolysiloxane passed rapidly through the stomach and small intestines and approximately 50% of it was excreted into the faeces within 6 hrs after administration and approximately 90% in 12-24 hrs. None was detected from the urine and almost all of it was excreted into the faeces.
Metabolism: A study of metabolites in rat faeces shows that dimethylpolysiloxane itself was contained in the faeces. It was excreted in its unmodified form.
Indications/Uses
Improvement of abdominal symptoms due to gas in the gastrointestinal tract.
Elimination of foamy mucus in the stomach prior to gastric endoscopy.
Elimination of gas in the intestine prior to abdominal x-ray examination.
Dosage/Direction for Use
Adults: Improvement of Abdominal Symptoms Due to Gas in the Gastrointestinal Tract: 120-240 mg daily divided into 3 times after or between meals by oral route.
Elimination of Foamy Mucus in the Stomach Prior to Gastric Endoscopy: 40-80 mg with about 10 mL of water at 15-40 min prior to the test by oral route.
Elimination of Gas in the Intestine Prior to Abdominal X-Ray Examination: 120-240 mg daily divided into 3 times after or between meals for 3-4 days prior to the test by oral route.
Some adjustments may be made according to the age and symptom of the patient.
Administration: Gascon Drops: Shake and then use.
Special Precautions
When Gascon tablets are combined with phenolphthalein-type drug eg, phenovalin, it will be colored pink. However, the drug efficacy is not affected.
Adverse Reactions
Adverse reactions were reported in 16 of 2546 patients (0.63%) treated with Gascon. The most frequently observed adverse reactions were soft stools in 8 patients (0.31%), gastric discomfort in 4 patients (0.16%), diarrhea in 3 patients (0.12%) and stomachache in 3 patients (0.12%). No abnormal changes were reported in laboratory tests. (At the end of the re-evaluation.) See Table 2.

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Caution For Usage
For drugs that are dispensed in a press-through package (PTP), remove the drug from the package prior to use. (It has been reported that, if the PTP sheet is swallowed by mistake, sharp corner of the sheet may puncture the esophageal mucosa, resulting in severe complication eg, mediastinitis).
Storage
Store at room temperature.
ATC Classification
A03AX13 - silicones ; Belongs to the class of other drugs used for functional bowel disorders.
Presentation/Packing
Tab 40 mg (white, marked with "K" on 1 side and "GS 40" on the other side) x 1000's. Drops (emulsion; white, turbid liqd with fragrance and a sweet taste) 20 mg/mL x 300 mL.
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