Full Prescribing Info
Contents
Aluminum hydroxide, magnesium hydroxide.
Description
Chewable tab: Each chewable tablet contains: Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg.
One chewable tablet is approximately equivalent to one teaspoonful (5 mL) of Maalox Suspension.
Oral susp: Each 5 mL suspension contains magnesium hydroxide (as magnesium hydroxide paste) 200 mg and aluminum hydroxide (as aluminum hydroxide gel) 225 mg.
Maalox also contains methylparahydroxybenzoate E218, propylparahydroxybenzoate E216, anhydrous citric acid, sodium saccharin, crystallizing liquid sorbitol E420, mannitol powder E421, hydrogen peroxide, peppermint oil, concentrated HCl and purified water as excipients.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Drug Interactions
Chewable tab: Concomitant use with quinidines may increase the serum levels of quinidine and lead to quinidine overdosage.
Aluminum-containing antacids may prevent the proper absorption of drugs such as H2 antagonists, atenolol, cefdinir, cefpodoxime, chloroquine, cyclines, diflunisal, digoxin, bisphosphonates, ethambutol, fluoroquinolones, sodium fluorure, glucocorticoids, indomethacin, isoniazid, ketoconazole, levothyroxine, lincosamides, metoprolol, phenothiazine, neuroleptics, penicillamine, propranolol, rosuvastatin, iron salts. Staggering the administration times of the interacting drug and the antacid by at least 2 hours (4 hours for the fluoroquinolones) will often help avoid undesirable drug interactions.
Polystyrene sulfonate (Kayexalate): Caution is advised when used concomitantly with polystyrene sulfonate (Kayexelate) due to the potential risks of reduced effectiveness of the resin in binding potassium, of metabolic alkalosis in patients with renal failure (reported with aluminum hydroxide and magnesium hydroxide), and of intestinal obstruction (reported with aluminum hydroxide).
Aluminum hydroxide and citrates may result in increased aluminum levels, especially in patients with renal impairment.
Oral susp: Aluminium hydroxide may form complexes with certain drugs eg, tetracyclines, digoxin and vitamins, resulting in decreased absorption. This should be borne in mind when concomitant administration is considered.
Concomitant use with quinidines may increase the serum levels of quinidine and lead to quinidine overdosage.
Aluminium-containing antacids may prevent the proper absorption of H2-antagonists, atenolol, chloroquine, cyclines, diflunisal, digoxin, diphosphonates, ethambutol, fluoroquinolones, sodium fluorine, glucocorticoids, indomethacin, isoniazid, kayexalate, ketoconazole, lincosamides, metoprolol, neuroleptics, phenothiazines, penicillamine, propranolol, iron salts.
Staggering the administration times of the interacting drug and the antacid by at least 2 hrs (4 hrs for the fluoroquinolones) will often help avoid undesirable drug interactions.
Caution For Usage
Oral susp: Instructions for Use/Handling: No special requirements.
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.
ATC Classification
A02AD01 - ordinary salt combinations ; Belongs to the class of combinations and complexes of aluminium, calcium and magnesium-containing antacids.
Presentation/Packing
Chewable tab 500's. Oral susp 180 mL.
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