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aluminum hydroxide/magnesium hydroxide/simethicone (OTC)Brand and Other Names:Mylanta, Mygel, more...DiGel, Gelusil, Rulox

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

aluminum hydroxide/magnesium hydroxide/simethicone

liquid

  • (200mg/200mg/20mg)/5mL
  • (400mg/400mg/40mg)/5mL

suspension

  • (225mg/200mg/25mg)/5mL

tablet, chewable

  • 200mg/200mg/25mg (Gelusil)
more...

Dyspepsia, Abdominal Bloating

10-20 mL PO q4-6hr taken 1 hour before or 3 hours after meals, OR

Chew 2-4 tablets q4-6hr; not to exceed 12 tablets/24 hr

Safety & efficacy not established

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Interactions

Interaction Checker

aluminum hydroxide/magnesium hydroxide/simethicone and

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Aluminum hydroxide

            • Chalky taste
            • Constipation
            • Fecal impaction
            • Stomach cramps
            • Nausea
            • Vomiting
            • Rebound hyperacidity
            • Aluminum intoxication
            • Hypophosphatemia
            • Milk-alkali syndrome
            • Osteomalacia

            Magnesium hydroxide

            • Diarrhea
            • Hypermagnesemia

            Simethicone

            • Loose stools
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            Warnings

            Contraindications

            Hypersensitivity to any component of the formulation

            Cautions

            Caution in renal failure

            May increase or decrease rate &/or degree of absorption of concomitantly administered oral drugs by changing GI transit time or by binding the drug

            Mg-restricted diet

            Similar Trade Names may have different compositions

            Do not use combination product for hyperphosphatemia

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: excretion in milk unknown

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Aluminum hydroxide: Neutralizes stomach hydrocloride to form AlCl3 salt plus water; increases gastric pH

            Magnesium hydroxide: Promotes bowel evacuation by causing osmotic retention of fluid, which causes the colon to distend with increased peristaltic activity; forms magnesium chloride when reacts with hydrochloric acid

            Simethicone: Disperses and prevents gas pockets in the GI system by decreasing surface tension of gas bubles

            Elimination

            Excretion

            • Aluminium hydroxide: Absorbed Al ions are eliminated in the urine (0.1-0.5 mg of Al in aluminum-containing antacid is absorbed from standard daily doses of antacid), Insoluble or poorly absorbed Al salts in the intestines are excreted in feces
            • Magnesium hydroxide: absorbed Mg ions (up to 30%) are eliminated in urine, unabsorbed drug is excreted in feces
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