aluminum hydroxide/magnesium hydroxide/simethicone (Mylanta, Mygel, DiGel, Gelusil, Rulox)
Classes: Antacids, Combos
Dosing and uses of Mylanta, Mygel (aluminum-hydroxide-magnesium-hydroxide-simethicone)
Adult dosage forms and 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)
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
Pediatric dosage forms and strengths
Safety & efficacy not established
Mylanta, Mygel (aluminum-hydroxide-magnesium-hydroxide-simethicone) adverse (side) 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
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
Pregnancy and 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.
Pharmacology of Mylanta, Mygel (aluminum-hydroxide-magnesium-hydroxide-simethicone)
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
