Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191
TRUSTAN tablets are indicated for:
Gastro-oesophageal Reflux Disease (GORD):
Patients requiring continued NSAID therapy:
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and:
20 mg TRUSTAN with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.
Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion:
The recommended initial dosage is TRUSTAN 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Doses up to 120 mg twice daily have been administered.
Dose adjustment is not required in the elderly.
Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution.
Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg TRUSTAN should be used.
Gastro-oesophageal Reflux Disease (GORD):
40 mg once daily for 4 weeks.
An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed, or who have persistent symptoms.
20 mg once daily.
Symptomatic treatment of gastro-oesophageal reflux disease (GORD) 20 mg once daily in patients without oesophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily under medical supervision.
The safety and efficacy of TRUSTAN in children younger than 12 years of age has not been established.
No data is available.
For oral administration.
The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed.
The tablets can also be dispersed in half a glass of non-carbonated water. No other liquids should be used. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.
For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a gastric tube.
There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280 mg were gastrointestinal symptoms and weakness. In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8).
No specific antidote is known. TRUSTAN is extensively plasma protein bound and is therefore not readily dialysable. Treatment should be symptomatic and general supportive measures should be utilised.
36 months.
Store at or below 30°C.
Store in a dry place.
Keep the container tightly closed (bottle).
The blisters are to be kept in the carton until required for use.
White HDPE bottles (with desiccated, white, screw type caps, with or without child resistance and a tamper proof ring) of 2, 5, 7, 14, 15, 28, 30, 56, 60, 100 tablets. The bottles are packed in a cardboard carton.
PVC/aluminium blister packages of 3, 7, 14, 15, 28, 30, 50, 56, 60, 98, 100 tablets.
The blisters are packed in a cardboard carton.
Not all packs or pack sizes may be marketed.
No special requirements.
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