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Maalox TC (Aluminum Hydroxide Magnesium Hydroxide)

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Pharmacology
Aluminum hydroxide and magnesium hydroxide act as antacids. Antacids react chemically to neutralize or buffer existing quantities of stomach acid but have no direct effect on its output. Antacid-induced increases in gastric pH provide relief of hyperacidity symptoms and inhibit the proteolytic action of pepsin. Aluminum hydroxide has a slow onset of action and a prolonged duration of action. Magnesium hydroxide has a fast onset of action and short duration of action.

The defoaming action of simethicone relieves flatulence by dispersing and preventing the formation of mucus-surrounded gas pockets in the gastrointestinal tract. In the stomach and intestines, it changes the surface tension of gas bubbles, enabling them to coalesce. Gas is thus more easily eliminated.

Indications
Aluminum Hydroxide And Magnesium Hydroxide Act As Antacids. Antacids React Chemically To Neutralize Or Buffer Existing Quantities Of Stomach Acid But Have No Direct Effect On Its Output. Antacid-induced Increases In Gastric PH Provide Relief Of Hyperacidity Symptoms And Inhibit The Proteolytic Action Of Pepsin. Aluminum Hydroxide Has A Slow Onset Of Action And A Prolonged Duration Of Action. Magnesium Hydroxide Has A Fast Onset Of Action And Short Duration Of Action.

The Defoaming Action Of Simethicone Relieves Flatulence By Dispersing And Preventing The Formation Of Mucus-surrounded Gas Pockets In The Gastrointestinal Tract. In The Stomach And Intestines, It Changes The Surface Tension Of Gas Bubbles, Enabling Them To Coalesce. Gas Is Thus More Easily Eliminated.

Contraindications
ypersensitivity to any of the individual ingredients of the formulations.

These products should not be given to patients who are severely debilitated or suffering from renal failure, alkalosis or hypermagnesemia.

Children: These products are contraindicated in very young children because of the risk of hypermagnesemia and aluminum toxicity, especially in infants and children with renal failure or dehydration.

Safety Information / Warning
Keep out of reach of children.

Do not take these products for more than 2weeks, or if symptoms recur, unless directed by a physician.

Do not take these products within 2hours of another medication because the effectiveness of the other medication may be altered.

Individuals with intestinal obstruction or kidney disease should not take these products except on the advice of a physician.

In patients with severe renal impairment, hypermagnesemia characterized by hypotension, nausea, vomiting, ECG changes, respiratory or mental depression and coma, has occurred after administration of magnesium-containing antacids.

Aluminum salts may cause phosphorus depletion with prolonged administration or large doses, especially in patients with inadequate dietary intake of phosphorus.

Precautions
These products should be used with caution in patients with symptoms of appendicitis, undiagnosed gastrointestinal or rectal bleeding, constipation, fecal impaction, chronic diarrhea, gastric outlet obstruction, hemorrhoids, ileostomy and Alzheimer's disease.

Aluminum salts tend to cause constipation. Magnesium salts tend to cause loose stools. The combination of aluminum and magnesium hydroxides may offer the advantage of balancing the constipating qualities of aluminum and the laxative qualities of magnesium.

Significant Drug Interactions :  Do not take these products within 2hours of another medication because the effectiveness of the other medication may be altered (see Warnings). Antacids may interfere with other drugs by increasing the gastric pH, by adsorbing or binding drugs to their surface or by increasing urinary pH.

Oral Tetracyclines: Antacids should not be taken within 3to 4hours of tetracyclines.

Oral Iron Preparations: Antacid doses should be spaced as far apart as possible from doses of oral iron preparations.

Fluoroquinolones: Concurrent use of aluminum and magnesium-containing antacids and fluoroquinolones is not recommended because the absorption of the fluoroquinolones may be reduced. When antacids are used concurrently with ciprofloxacin or norfloxacin, patients should be observed for signs of crystalluria and nephrotoxicity.

Ketoconazole: Patients should be advised to take antacids at least 3hours after ketoconazole.

Mecamylamine, Methenamine, Sodium Polystyrene Sulfonate Resin: Concurrent use is not recommended.

Laboratory Value Alterations: Gastric acid secretion test: Administration of antacids on the morning of the test is not recommended.

Pregnancy  and Lactation : Pregnant and nursing women should consult their physician before taking these products.

Children: Antacids should not be given to children unless prescribed by a physician. Since children are not usually able to describe their symptoms precisely, proper diagnosis should precede the use of an antacid. This will avoid the complication of an existing condition (e.g., appendicitis) or the appearance of severe adverse effects.

Geriatrics: Metabolic bone disease, commonly seen in the elderly, may be aggravated by the phosphorus depletion, hypercalciuria and inhibition of absorption of intestinal fluoride caused by the chronic use of aluminum-containing antacids. Elderly patients are also more likely to have age-related renal function impairment, which may lead to aluminum retention.

Side Effects / Adverse Effects
 Allergic reaction (e.g.: rash or itching), chalky taste, constipation, diarrhea, nausea or vomiting, whitish discoloration of stools and stomach cramps.


Overdose
Overdose:  In the case of accidental overdosage, contact a physician or Poison Control Centre immediately, even in the absence of symptoms.



Symptoms:
  Diarrhea is the only symptom of overdosage to be expected in the normal patient. In the presence of marked renal insufficiency, the possibility of magnesium intoxication exists. This would be manifested by dryness of mouth, drowsiness, stupor and respiratory depression.



Treatment:  Massive overdosage shoud be treated by gastric lavage and by catharsis with castor oil or other laxatives not containing magnesium. Should symptoms of magnesium intoxication be present, calcium gluconate should be administered i.v.

Recommended Dosage
Suspensions: Shake well before using.  Adults: 2to 4teaspoonfuls, 4times a day, taken 20minutes to 1hour after meals and at bedtime, or as directed by a physician. May be mixed with water or milk. In gastritis, however, undiluted administration is recommended. Do not take more than 16 teaspoonfuls in a 24-hour period.

Maalox TC Suspension: Shake well before using.  Adults: 1to 2teaspoonfuls as needed between meals and at bedtime, or as directed by a physician. Do not take more than 8 teaspoonfuls in a 24-hour period. Higher dosage regimens may be employed under the direct supervision of a physician in the treatment of active peptic ulcer disease.

Maalox TC Chewable Tablets:  Adults: Chew 1to 2 tablets, 4 times daily, 20 minutes to 1hour after meals and at bedtime, or as directed by a physician. Do not take more than 8 tablets in a 24-hour period. Higher dosage regimens may be employed under the direct supervision of a physician in the treatment of active peptic ulcer disease.

Maalox Plus Suspensions: Shake well before using.  Adults: 2to 4 teaspoonfuls, 4 times a day, taken 20 minutes to 1hour after meals and at bedtime, or as directed by a physician. Do not take more than 16 teaspoonfuls in a 24-hour period. May be mixed with milk or water except in gastritis, when undiluted administration is recommended.

Maalox Plus Extra Strength Suspensions: Shake well before using.  Adults: 2to 4 teaspoonfuls, 4 times a day, taken 20minutes to 1hour after meals and at bedtime, or as directed by a physician. Do not take more than 12 teaspoonfuls in a 24-hour period. May be mixed with milk or water except in gastritis, when undiluted administration is recommended.

Supplied / Packaging
Maalox TC: Suspension Mint:  Each 5 mL contains: magnesium hydroxide 300 mg and aluminum hydroxide dried gel USP 600mg (equivalent to 459 mg aluminum hydroxide). Nonmedicinal ingredients: flavor, guar gum, methylparaben, propylparaben, sorbitol and water. Sucrose- and tartrazine-free. Energy: 18.01 kJ (4.29 kcal)/5mL. Sodium: <1 mmol (1mg)/5 mL. Bottles of 350 mL. Protect from freezing.

Chewable Tablets Mint:  Each tablet contains: magnesium hydroxide 300mg and aluminum hydroxide dried gel USP 600mg (equivalent to 459 mg aluminum hydroxide). Nonmedicinal ingredients: flavors, glycerin, light mineral oil, magnesium stearate, mannitol, sorbitol, sucrose and talc. Tartrazine-free. Energy: 14.11kJ (3.36kcal)/tablet. Sodium: <1 mmol (1.25 mg)/tablet. Bottles of40.

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