MAALOX Aluminum Hydroxide / Magnesium Hydroxide 225mg / 200mg per 5mL Suspension 180mL
NONRXDRUG-DRHR-698
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Chewable tab: As an antacid for the relief of gastric hyperacidity and heartburn.
Oral susp: As an antacid for the symptomatic relief of hyperacidity in general.
Oral susp: As an antacid for the symptomatic relief of hyperacidity in general.
Dosage/Direction for Use
Chewable tab: Two to four tablets, well chewed, four times a day, taken twenty minutes to one hour after meals and at bedtime, or as directed by a physician. May be taken with water or milk.
Oral susp: Administered orally.
Two to four teaspoonfuls (10-20 mL) four times a day taken 20 minute to 1 hour after meals and at bedtime or as directed by the physician. May be followed with milk or water.
Oral susp: Administered orally.
Two to four teaspoonfuls (10-20 mL) four times a day taken 20 minute to 1 hour after meals and at bedtime or as directed by the physician. May be followed with milk or water.
Overdosage
Chewable tab: Signs and Symptoms: Reported symptoms of acute overdose with aluminum hydroxide and magnesium salts combination include diarrhea, abdominal pain, vomiting.
Large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at risk (see Warnings).
Management: Aluminum and magnesium are eliminated through urinary route; treatment of acute overdose consists of rehydration, forced diuresis. In case of renal function deficiency, haemodialysis or peritoneal dialysis is necessary.
Oral susp: Serious symptoms are unlikely following overdosage.
Large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at risk (see Warnings).
Management: Aluminum and magnesium are eliminated through urinary route; treatment of acute overdose consists of rehydration, forced diuresis. In case of renal function deficiency, haemodialysis or peritoneal dialysis is necessary.
Oral susp: Serious symptoms are unlikely following overdosage.
Administration
Should be taken with food: Take 20 min-1 hr after meals & at bedtime. May be followed w/ milk or water.
Contraindications
Chewable tab: Severe renal failure.
Hypersensitivity to the active ingredients or to any of the excipients.
Oral susp: Use in severely debilitated patients or in those suffering from kidney failure.
Hypersensitivity to the active ingredients or to any of the excipients.
Oral susp: Use in severely debilitated patients or in those suffering from kidney failure.
Warnings
Chewable tab: Aluminum hydroxide may cause constipation and magensium salts overdose may cause hypomotility of the bowel; large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at higher risk such as those with renal impairment, infants less than 2 years, or the elderly.
Aluminum hydroxide is not well absorbed from the gastrointestinal tract, and systemic effects are therefore rare in patients with normal renal function. However, excessive doses or long-term use, or even normal doses in patients with low-phosphorus diets or in infants less than 2 years, may lead to phosphate depletion (due to aluminum-phosphate binding) accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia. Medical advice is recommended in case of long-term use or in patients at risk of phosphate depletion.
In patients with renal impairment, plasma levels of both aluminum and magnesium increase. In these patients, a long-term exposure to high doses of aluminum and magnesium salts may lead to encephalopathy, dementia, microcytic anemia, or worsen dialysis-induced osteomalacia.
Aluminum hydroxide may be unsafe in patients with porphyria undergoing hemodialysis.
Oral susp: Do not take more than 16 teaspoonful (80 mL) in a 24-hour period or use the maximum dosage for more than two weeks. Do not use if you have kidney disease except under the advise and supervision of a physician.
Aluminum hydroxide is not well absorbed from the gastrointestinal tract, and systemic effects are therefore rare in patients with normal renal function. However, excessive doses or long-term use, or even normal doses in patients with low-phosphorus diets or in infants less than 2 years, may lead to phosphate depletion (due to aluminum-phosphate binding) accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia. Medical advice is recommended in case of long-term use or in patients at risk of phosphate depletion.
In patients with renal impairment, plasma levels of both aluminum and magnesium increase. In these patients, a long-term exposure to high doses of aluminum and magnesium salts may lead to encephalopathy, dementia, microcytic anemia, or worsen dialysis-induced osteomalacia.
Aluminum hydroxide may be unsafe in patients with porphyria undergoing hemodialysis.
Oral susp: Do not take more than 16 teaspoonful (80 mL) in a 24-hour period or use the maximum dosage for more than two weeks. Do not use if you have kidney disease except under the advise and supervision of a physician.
Special Precautions
Chewable tab: The prolonged use of antacids in patients with renal failure should be avoided.
Care should be observed if used by diabetics because of the sugar content in the tablet.
Oral susp: Aluminum hydroxide may cause constipation due to its astringent action, this effect may be balanced by the cathartic effect of the magnesium salts.
Aluminum hydroxide may lead to a phosphate depletion syndrome, particularly in patients on a low phosphate diet eg, malnutrition.
Magnesium salts may cause central nervous depression in the presence of renal insufficiency and should be used with caution in patients with advance renal disease.
In patients with renal impairment, plasma levels of both aluminum and magnesium increase. In these patients, a long-term exposure to high doses of aluminum and magnesium salts may lead to encephalopathy or worsen dialysis osteomalacia.
The prolonged use of antacids in patients with renal failure should be avoided.
Effects on the Ability to Drive or Operate Machinery: None.
Use in pregnancy: Maalox should not be used during pregnancy unless considered essential by the physician.
Care should be observed if used by diabetics because of the sugar content in the tablet.
Oral susp: Aluminum hydroxide may cause constipation due to its astringent action, this effect may be balanced by the cathartic effect of the magnesium salts.
Aluminum hydroxide may lead to a phosphate depletion syndrome, particularly in patients on a low phosphate diet eg, malnutrition.
Magnesium salts may cause central nervous depression in the presence of renal insufficiency and should be used with caution in patients with advance renal disease.
In patients with renal impairment, plasma levels of both aluminum and magnesium increase. In these patients, a long-term exposure to high doses of aluminum and magnesium salts may lead to encephalopathy or worsen dialysis osteomalacia.
The prolonged use of antacids in patients with renal failure should be avoided.
Effects on the Ability to Drive or Operate Machinery: None.
Use in pregnancy: Maalox should not be used during pregnancy unless considered essential by the physician.
Use In Pregnancy & Lactation
Chewable tab: Because of the limited maternal absorption when used as recommended, aluminum hydroxide and magnesium salts combinations are considered as compatible with lactation.
Oral susp: Use in pregnancy: Maalox should not be used during pregnancy unless considered essential by the physician.
Oral susp: Use in pregnancy: Maalox should not be used during pregnancy unless considered essential by the physician.
Adverse Reactions
Chewable tab: The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%, Unknown (cannot be estimated from available data).
Side effects are uncommon at recommended doses.
Immune system disorders: Frequency unknown: hypersensitivity reactions, such as pruritus, urticaria, angioedema and anaphylactic reactions.
Gastrointestinal disorders: Uncommon: diarrhea or constipation (see Warnings).
Metabolism and nutrition disorders: Frequency unknown: hypermagnesemia, hyperaluminemia, hypophosphatemia, in prolonged use or at high doses or even normal doses of the product in patients with low-phosphorus diets or in infants less than 2 years, which may result in increased bone resorption, hypercalciuria, osteomalacia (see Warnings).
Oral susp: Gastrointestinal side effects are uncommon.
Occasionally, high doses of antacids may cause diarrhea or constipation.
Side effects are uncommon at recommended doses.
Immune system disorders: Frequency unknown: hypersensitivity reactions, such as pruritus, urticaria, angioedema and anaphylactic reactions.
Gastrointestinal disorders: Uncommon: diarrhea or constipation (see Warnings).
Metabolism and nutrition disorders: Frequency unknown: hypermagnesemia, hyperaluminemia, hypophosphatemia, in prolonged use or at high doses or even normal doses of the product in patients with low-phosphorus diets or in infants less than 2 years, which may result in increased bone resorption, hypercalciuria, osteomalacia (see Warnings).
Oral susp: Gastrointestinal side effects are uncommon.
Occasionally, high doses of antacids may cause diarrhea or constipation.
Caution For Usage
Oral susp: Instructions for Use/Handling: No special requirements.
Incompatibilities: Not applicable.
Incompatibilities: Not applicable.
Storage
Store at temperatures not exceeding 30°C.
Oral susp: Once opened, use within 28 days of opening.
Shelf-Life: 2 years.
Oral susp: Once opened, use within 28 days of opening.
Shelf-Life: 2 years.
Action
Oral susp: Pharmacology: ATC code: A02A B10 (Antacids: Aluminum compounds; combination).
Pharmacodynamics: Maalox is a balanced mixture of 2 antacids: Aluminum hydroxide is a slow-acting antacid and magnesium hydroxide is fast acting. The 2 are frequently combined in antacid mixtures. Aluminum hydroxide on its own is astringent and may cause constipation. This effect is balanced by the effect of magnesium hydroxide, which, in common with other magnesium salts, may cause diarrhea.
Pharmacokinetics: The absorption of aluminium and magnesium from antacids is small. Aluminum hydroxide is slowly converted to aluminium chloride in the stomach. Some absorption of soluble aluminium salts occur in the gastrointestinal tract with urinary excretion. Any absorbed magnesium is likewise excreted in the urine.
Toxicology: Preclinical Safety Data: Not relevant.
Pharmacodynamics: Maalox is a balanced mixture of 2 antacids: Aluminum hydroxide is a slow-acting antacid and magnesium hydroxide is fast acting. The 2 are frequently combined in antacid mixtures. Aluminum hydroxide on its own is astringent and may cause constipation. This effect is balanced by the effect of magnesium hydroxide, which, in common with other magnesium salts, may cause diarrhea.
Pharmacokinetics: The absorption of aluminium and magnesium from antacids is small. Aluminum hydroxide is slowly converted to aluminium chloride in the stomach. Some absorption of soluble aluminium salts occur in the gastrointestinal tract with urinary excretion. Any absorbed magnesium is likewise excreted in the urine.
Toxicology: Preclinical Safety Data: Not relevant.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
Features
Brand
Maalox
Full Details
Dosage Strength
225mg / 200mg / 5ml
Drug Ingredients
- Aluminum
- Magnesium
Drug Packaging
Suspension 180ml
Generic Name
Aluminum Hydroxide / Magnesium Hydroxide
Dosage Form
Suspension
Registration Number
DRHR-698
Drug Classification
Over-The-Counter (OTC)
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