Dimeticone
JFDA label: Simat 40 emulsion drops
Mechanism of Action
— Unknown
Indications
Approved
- Gas retention
Contraindications
Source: Lexicomp
- Hypersensitivity to simethicone or any component of the formulation Absolute
Dosing
Source: Lexicomp
Warnings & Precautions
Source: Lexicomp
Benzyl alcohol and derivatives
Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
Pregnancy & Lactation
Pregnancy
Simethicone is not absorbed systemically following oral administration. Systemic absorption would be required in order for simethicone to cross the placenta and reach the fetus (Mahadevan 2006).
Lactation
Due to lack of systemic absorption, simethicone is not expected to be excreted in breast milk (Hagemann 1998).
Biology & Pharmacokinetics
Pharmacokinetics
Registered Products (4)
| Brand | Form / strength | Pack | Agent | Citizen (JOD) |
|---|---|---|---|---|
| Salinal Drops | Oral Drops 41.2 mg/ml | 15 ml | Professional Drug Store | 0.900 |
| Simat 40 emulsion drops | Oral Drops 40 mg/ml | 30 ml | THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY/JORDAN | 1.250 |
| Simat 40mg Chewable tablet | Chewable Tablet 40 mg | 45 tab | THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY/JORDAN | 1.250 |
| Maalox Plus Susp. | Suspension 3.65 g, 3.25 g, 0.5 mg | 200 ml | THE ARAB DRUG STORE P.S.C | 1.780 |