New Release: Alpha testing version has been released.

Dimeticone

A02A - Antacids ATC A02AF02 Unknown

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

Gas retention: Oral: Usual dose: 40 to 125 mg 4 times daily as needed after meals and at bedtime; may administer single doses of up to 160 to 500 mg after meals or at bedtime, not to exceed a maximum daily dose of 500 mg/day
(For additional information see "Simethicone: Pediatric drug information") Gas retention: Oral: Infants and Children Children >2 years or >11 kg: 40 mg 4 times daily after meals and at bedtime, as needed (maximum: 480 mg/day) Children and Adolescents >12 years: Refer to adult dosing.
Refer to adult dosing.
There is no dosage adjustment provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to the drug not being systemically absorbed.
There is no dosage adjustment provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to the drug not being systemically absorbed.

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)

BrandForm / strengthPackAgentCitizen (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