Each ml contains: Simethicone Emulsion USP Equivalent to Simethicone 40 mg.
SIMETHICONE EMULSION 30% USP 40 mg as Anti-Flatulent.
Colour: Sunset Yellow FCF.
Excipients/Inactive Ingredients: DYSPEP also contains following inactive ingredients: Carmellose Sodium (Sodium Carboxy Methylcellulose) BP, Saccharin Sodium BP, Sodium benzoate NF, Disodium Edetate BP, Sorbitol Solution 70% (Non-Crystallising) BP, Citric Acid Monohydrate BP, Aniseed Oil Co.S.p., Colour Sunset Yellow FCF Co.Sp., Microcrystalline Cellulose & Carboxy Methyl Cellulose Sodium (AVICEL RC-591) NF, Glycerol BP, Purified Water BP.
Pharmacology: Pharmacodynamics: Mechanism of Action: SIMETHICONE is a mixture of liquid Dimethylpolysiloxanes which have Antifoaming or Antibubbling activity. SIMETHICONE acts in the stomach and intestines by altering the surface tension of gas and mucus bubbles enabling them to coalesce. Coalescence of gas bubbles accelerates the passage of gas through the intestine either through belching, passing of flatus, or increased absorption of gas into the bloodstream.
Simethicone has been shown to have activity against Helicobacter pylori. The Minimal Inhibitory Concentration (MIC) for Simethicone against H. pylori ranges from 64 to 128 mg/L which can be achieved in the stomach with therapeutic doses. Simethicone is likely to be evaluated in combination therapy for the treatment of H. pylori-associated peptic ulcer disease (Ansorg et al, 1996).
Pharmacokinetics: No Pharmacokinetic data is available.
ADME: Excretion: Breast Milk: Breastfeeding: unknown.
Other: Other Excretion: FECES, good (USPDI, 1995): SIMETHICONE is excreted unchanged in the feces (USPDI, 1995).
Toxicology: Preclinical Safety Data: Preclinical Data reveal no special hazard for humans based on conventional studies of pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
DYSPEP is indicated for the treatment of pain and pressure of excess gas in the stomach and intestines.
Posology: The usual recommended adult dose of SIMETHICONE is 40 to 125 mg four times daily after each meal and at bedtime. The pediatric dose may be administered via drops; the usual recommended dose for children over 2 years of age is 0.6 ml (40 mg) four times daily after meals and at bedtime. For infants (children under 2 years) the usual initial dose is 0.3 ml (20 mg) four times a day administered after meals and at bedtime. The dosage should not exceed 12 doses/day.
Method of Administrations: Oral Route of Administration.
Symptoms of overdose may include: severe Drowsiness and Constipation.
Hypersensitivity to Simethicone or other product components.
Effects on Ability to Drive and Use Machines: None.
U.S. Food and Drug Administration's Pregnancy Category B by one manufacturer and category C by another source (Briggs et al, 1998).
See Drug Consult reference: "PREGNANCY RISK CATEGORIES".
There have been no published reports linking Simethicone with congenital defects. However, an unpublished surveillance study of 229,101 completed pregnancies identified 248 newborns exposed to Simethicone during the first trimester, in which 14 (5.6%) major birth defects were observed and 11 were expected. Of the 6 defect categories, only the cardiovascular defects suggested possible association with Simethicone; specific data for the individual categories were as follows (observed/expected): cardiovascular 6/2; oral clefts 0/0.5; spina bifida 0/0; Polydactyly 2/1; limb reduction defects 0/0.5; and hypospadias 1/0.5 (Briggs et al, 1998).
No severe side effects have been reported with the use of Simethicone.
FOSPHENYTOIN: Summary: Fosphenytoin is a prodrug of phenytoin and the same interactions that occur with phenytoin are expected to occur with fosphenytoin. McElnay et al (1982) evaluated the effect of concomitant administration of a simethicone-containing antacid on phenytoin bioavailability. In five of six patients evaluated, an insignificant decrease in bioavailability of phenytoin was demonstrated; however, three of the five did experience a decrease of at least 30%. It is unknown to what extent simethicone contributed to this interaction, since the use of antacids as a sole entity can reduce the bioavailability of phenytoin. The authors suggest that clinicians should be aware of this potential interaction, and exercise caution when administering simethicone to patients on phenytoin maintenance therapy.
Severity: Not specified.
Onset: Not specified.
PHENYTOIN: Severity: Not specified.
Onset: Not specified.
Literature Reports: McElnay et al (1982) evaluated the effect of concomitant administration of a Simethicone-containing antacid on phenytoin bioavailability. In five of six patients evaluated, an insignificant decrease in bioavailability of phenytoin was demonstrated; however, three of the five did experience a decrease of at least 30%. It is unknown to what extent Simethicone contributed to this interaction, since the use of antacids as a sole entity can reduce the bioavailability of phenytoin.
The authors suggest that clinicians should be aware of this potential interaction, and exercise caution when administering Simethicone to patients on Phenytoin maintenance therapy.
DRUG-LAB MODIFICATIONS: CHEMICAL TEST FOR OCCULT BLOOD: Summary: In an in vitro study, Simethicone interfered with the results of guaiac tests of gastric aspirates (Gogel et al, 1989). Physicians should keep this in mind when interpreting the results of guaiac card tests.
Instruction for Use, Handling and Disposal: For Internal use only. Store in cool place.
Shake well before use.
Store in a cool place.
Shelf Life: 36 Months from the date of Manufacturing.
A03AX13 - silicones ; Belongs to the class of other drugs used for functional bowel disorders.
Oral susp 40 mg/mL (orange coloured, with a sweet and flavoured taste) x 30 mL x 1's.