INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo AMPHOJEL® (suspension)

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

AMPHOJEL® (suspension)

COMPOSITION:
Each 5 mL contains
aluminium hydroxide 300 mg
Preservatives:
Sodium benzoate         0,45% m/v
Benzoic acid         0,05% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.1. (Antacids - Acid Neutralizers)

PHARMACOLOGICAL ACTION:
AMPHOJEL Suspension reacts chemically to neutralize or buffer existing quantities of stomach acids but have no direct effects on its production. The action increases gastric pH, providing symptomatic relief of hyperacidity.
A small amount of aluminium from aluminium hydroxide is absorbed from the intestine.

INDICATIONS:
For the relief of acid indigestion, heartburn, hyperacidity, dyspepsia, gastritis, oesophageal reflux with heartburn, reflux oesophagitis, peptic ulceration.

CONTRA-INDICATIONS:
In patients with symptoms of appendicitis since these medicines may increase the danger of perforation or rupture due to their constipating effects. In patients with hypophosphataemia due to the phosphate binding properties of aluminium salts.
Do not use this product if you are presently taking a prescription antibiotic drug containing any form of tetracycline.
Do not use this product if there is a known history of sensitivity to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
Shake well before use.
For the symptomatic relief of hyperacidity states:
Two 5 mL measures, 5 or 6 times a day, between meals and at bedtime, followed by a sip of water if desired, or as directed by a physician.
Do not take more than the recommended dosage in a 24 hour period.
Do not use the maximum dosage of this product for more than two weeks, except under the advice and supervision of a physician.
Paediatric use - Not recommended in infancy. Otherwise in childhood proportional to the adult dosage for a 70 kg adult.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Nausea, vomiting, constipation.
Large doses can cause obstruction.
Excessive doses, or normal doses in patients with low phosphate diets may lead to phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia.
Osteomalacia, encephalopathy and dementia have occurred in patients with chronic renal failure on high aluminium-dose as a phosphate-binding agent.
May alter the absorption of other medicines from the gastro-intestinal tract if administered concomitantly. Decreased bowel motility, dehydration or fluid restriction may predispose patients who take antacids containing only aluminium salts to intestinal obstruction.
Special Precautions:
In patients with chronic renal failure, hyperaluminaemia may occur.
Hypophosphataemia may occur with prolonged administration of large doses of aluminium-containing antacids (except aluminium-phosphate) especially in patients with an inadequate dietary uptake of phosphorus.
Laboratory Tests - Serum phosphate levels should be monitored at monthly or bi-monthly intervals in patients on maintenance haemodialysis who are receiving chronic AMPHOJEL therapy.
Interactions - The rate and/or the extent of absorption of many medicines may be altered when they are used concurrently with aluminium hydroxide. Therefore, as a general rule, medication should not be taken within one or two hours of AMPHOJEL, if possible.
Medicines for which the above statement has been shown to apply include: iron, tetracyclines, isoniazid, ethambutol, some anti-muscarinic agents, benzodiazepines, phenothiazines, ranitidine, indomethacin, phenytoin, nitrofurantoin, vitamin A, fluoride and phosphate.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear, white suspension, free from any foreign odour or taste.

PRESENTATION:
200 mL and 500 mL glass amber bottles.

STORAGE INSTRUCTIONS:
Keep bottle tightly closed in a cool (below 25°C) place, but keep from freezing.
Protect from direct sunlight.
Keep out of reach of children.

REGISTRATION NUMBER:
E/11.4.1/1229

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
AKROMED PRODUCTS (PTY) LTD.
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
5 July 1993

PRODUCT AND TRADEMARK UNDER LICENSE FROM WYETH-AYERST LABORATORIES, U.S.A.

Updated on this site: January 2005
Source: Pharmaceutical Industry

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