Maalox/Maalox Plus

Maalox/Maalox Plus

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Contents
Maalox: Magnesium hydroxide, aluminum hydroxide. Maalox Plus: Magnesium hydroxide, aluminum hydroxide, simethicone.
Description
Maalox: Each oral suspension contains aluminum oxide 230 mg as hydrated aluminum oxide 460 mg and magnesium hydroxide 400 mg.
Each 4.3-mL sachet is equivalent to 6-g suspension.
Maalox Plus: Each tablet contains magnesium hydroxide 200 mg, dried aluminum hydroxide gel 200 mg and simethicone 26.25 mg.
Each 5-mL suspension contains magnesium hydroxide 200 mg, aluminum hydroxide 175 mg and simethicone 25 mg.
Action
Maalox: Pharmacotherapeutic Group: Antacid (A: Alimentary tract and metabolism).
Pharmacology: Pharmacodynamics: The antacid activity is carried out in the stomach where, at suitable doses, the magnesium hydroxide and aluminium hydroxide neutralize the production of gastric acid. The constipating effect of aluminium hydroxide is counteracted by the laxative effect of the magnesium hydroxide.
Maalox oral suspension protects the esophageal-gastroduodenal mucosa. It is transparent to x-rays. The antacid capacity is H+ 20 mEq/sachet (in vitro study of a unit dose as per the Rosset-Rice method).
Pharmacokinetics: Magnesium and aluminum hydroxides are considered local, non-systemic antacids, the absorption of which is negligible under normal conditions of use.
Maalox Plus:
Nonconstipating antacid-antiflatulent. Simethicone is a chemically, inert, non-systemic gastric defoaming agent
Indications/Uses
As an antacid for symptomatic relief of hyperacidity associated with the diagnosis of peptic ulcer, gastritis, peptic esophagitis, gastric hyperacidity, heartburn or hiatal hernia.
Maalox Plus: Also as an antiflatulent to alleviate the symptoms of gas, including postoperative gas pain.
Dosage/Direction for Use
Maalox: Adults >15 years: 1-2 sachets/intake when heartburn or acid regurgitation occur.
Maximum of 6 doses daily. No more than 12 sachets should be taken daily.
Maalox Plus:
Tablet: 2-4 tabs, well chewed, 4 times daily.
Suspension: 2-4 tsp, 4 times a daily.
Do not prescribe >16 tsp or 16 tabs in a 24-hr period or use the maximum dosage for >2 weeks or use if the patient has kidney disease except under strict medical supervision.
Administration: Maalox/Maalox Plus may be taken 20 min to 1 hr after meals and at bedtime or as required.
Maalox: Knead the sachet carefully before opening. Drink the suspension as is, do not dilute.
Overdosage
Not applicable.
Contraindications
Maalox: Hypersensitivity to any of the ingredients of the Maalox oral suspension. Severe renal insufficiency, as it contains magnesium. Patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency, as it contains sorbitol.
Maalox Plus: Should not be used in patients who are debilitated or suffering from kidney failure.
Warnings
Maalox Plus: Do not take >16 teaspoon or 16 tablets in a 24-hour period or use the maximum dosage for >2 weeks or use if the patient have kidney disease except under the advice and supervision of a physician.
Maalox Plus suspension contains approximately sodium 0.06mEq/teaspoon. To be taken into consideration by patients on a controlled sodium diet.
Special Precautions
Maalox: Seek medical advice if the following occur eg, weight loss; difficulty swallowing or persistent abdominal discomfort; digestive disorders occurring for the 1st time or recent changes in existing disorders; renal insufficiency.
In patients with renal insufficiency or undergoing chronic dialysis, the aluminum content must be taken into account (risk of encephalopathy). If disorders persist after 10 days of treatment or worsen, the cause should be investigated and the treatment reassessed. Maalox oral suspension contains sucrose 3.15 g/sachet; this should be taken into consideration as part of the daily allowance.
Effects on the Ability to Drive or Operate Machinery: Not applicable.
Use in pregnancy & lactation: There are no reliable data on teratogenic effects in animals. To date, no particular teratogenic or fetotoxic effects have been observed in humans. However, the follow-up of pregnancies exposed to Maalox oral suspension is insufficient to rule out any risk. Consequently, Maalox oral suspension should only be used during pregnancy if necessary. It contains aluminum or magnesium ions which may affect gastrointestinal transit, and must therefore be taken into account.
Magnesium hydroxide salts may cause diarrhea, aluminum salts cause constipation which may exacerbate the constipation commonly associated with pregnancy. Use of Maalox oral suspension for prolonged periods and at high doses should be avoided.
Breastfeeding may be continued during treatment.
Use In Pregnancy & Lactation
There are no reliable data on teratogenic effects in animals. To date, no particular teratogenic or fetotoxic effects have been observed in humans. However, the follow-up of pregnancies exposed to Maalox oral suspension is insufficient to rule out any risk. Consequently, Maalox oral suspension should only be used during pregnancy if necessary. It contains aluminum or magnesium ions which may affect gastrointestinal transit, and must therefore be taken into account.
Magnesium hydroxide salts may cause diarrhea, aluminum salts cause constipation which may exacerbate the constipation commonly associated with pregnancy. Use of Maalox oral suspension for prolonged periods and at high doses should be avoided.
Breastfeeding may be continued during treatment.
Adverse Reactions
Maalox: Gastrointestinal transit disorders (diarrhea or constipation), phosphorus depletion at prolonged or high doses, as Maalox oral suspension contains aluminum.
Maalox Plus: The adverse events encountered were rare and essentially consisted of diarrhoea; the accelerating effect of magnesium hydroxide on intestinal transit is generally moderated by the constipating action of aluminum hydroxide.
Drug Interactions
Antacids interact with certain other medicinal products taken orally.
Combinations Requiring Precautions for Use: A reduction in the gastrointestinal absorption of concomitantly administered medicinal products is observed. As a precautionary measure, an interval should be allowed between taking antacids and other medications. If possible, allow an interval of >2 hrs between taking Maalox/Maalox Plus and the following drugs: H2-antagonists, atenolol, chloroquine, tetracyclines, diflunisal, digoxin, biphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids (described for prednisolone and dexamethasone), indomethacin, isoniazid, kayexalate, ketoconazole, lincosamides, metoprolol, phenothiazinic neuroleptics, penicillamines, propranolol, iron salts; fexofenadine, lansoprazole, phosphorus supplements, thyroxine (for Maalox).
Do not use with patients taking a prescription antibiotic containing any form of tetracycline.
As with all aluminum-containing antacids, Maalox/Maalox Plus may prevent the proper absorption of the tetracycline.
Maalox: Combination to be Taken Into Consideration: Salicylates: Increased renal excretion of salicylates through urine alkalinization.
Maalox Plus: Concomitant use w/ quinidine may increase serum quinidine levels and lead to a quinidine overdose. Simultaneous use of aluminum hydroxide and citrates may lead to an increased aluminum levels, particularly in patients with kidney failure.
Storage
Maalox: Do not store above 30°C.
Maalox Plus: Store below 25°C.
ATC Classification
A02AF02 - ordinary salt combinations and antiflatulents ; Belongs to the class of antacids with antiflatulents.
Presentation/Packing
Maalox oral susp 6 g (white to faintly yellow, homogenous susp in sachet) x 4.3 mL x 20's. Maalox Plus tab (lemon swiss creme-flavored) 40's. Maalox Plus oral susp (lemon swiss creme-flavored) 250 mL.
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