Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Sandoz SA (Pty) Ltd, 72 Steel Road, Spartan, Kempton Park, 1619
TOPRAFLUX 40 mg is indicated for the short-term treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis. If the duodenal ulcer has been demonstrated to be associated with Helicobacter pylori infection, TOPRAFLUX 40 mg used in combination with appropriate antibiotics may be useful.
TOPRAFLUX 40 mg is indicated for the treatment of Zollinger-Ellison Syndrome. TOPRAFLUX 20 mg is indicated for the symptomatic improvement (e.g. heartburn, acid regurgitation, pain on swallowing) and healing of mild gastro-oesophageal reflux disease (GORD).
TOPRAFLUX 20 mg is indicated for long-term management and prevention of relapse in gastro-oesophageal reflux disease (GORD).
No dosage adjustment is required in the elderly or in the presence of impaired renal and liver function.
The recommended oral dose is 40 mg of TOPRAFLUX once daily. The total treatment with pantoprazole should be 2 to 4 weeks. If the duodenal ulcer has been demonstrated to be associated with Helicobacter pylori infection, 40 mg of TOPRAFLUX used in combination with appropriate antibiotics may be useful.
The recommended oral dose is 40 mg of TOPRAFLUX once daily for 4 to 8 weeks. In the case of a suspected gastric ulcer, malignancy of the gastric ulcer should be excluded, as treatment could conceal the symptoms and may delay diagnosis.
The recommended oral dose is 40 mg of TOPRAFLUX once daily in the morning for 4 to 8 weeks.
For the management of Zollinger-Ellison Syndrome patients should start their treatment with a daily dose of 80 mg of TOPRAFLUX (two TOPRAFLUX 40 mg tablets). Thereafter, the dosage can be titrated up or down as needed using measurements of gastric acid secretion as a guide. With doses above 80 mg daily, the dose should be divided and given twice daily.
The recommended oral dose is 20 mg of TOPRAFLUX per day. A 4-week period is usually required. If this is not sufficient, further 4 weeks of treatment may be used.
For long-term management a maintenance dose of one 20 mg TOPRAFLUX tablet per day is recommended, increasing to 40 mg TOPRAFLUX per day if a relapse occurs. After healing of the relapse, the dose can be reduced to 20 mg of TOPRAFLUX. Experience with long- term administration is limited.
For prevention of gastro-duodenal lesions and dyspeptic symptoms induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk and with a need for continuous NSAID treatment, the recommended oral dose is one 20 mg TOPRAFLUX tablet per day.
If symptom control has not been achieved after four weeks of treatment with the prescribed daily dose, further investigation is recommended.
No dosage adjustment is necessary in the elderly.
No dosage adjustment is required in the presence of impaired renal function. A daily dose of 20 mg of TOPRAFLUX should not be exceeded in patients with mild to moderately severe liver impairment (see “Pharmacokinetics” and “WARNINGS AND SPECIAL PRECAUTIONS”).
The recommended once daily dose of TOPRAFLUX should be taken in the morning. TOPRAFLUX should be swallowed whole with a little water either before or during breakfast.
There are no known symptoms of overdose in man.
Systemic exposure with up to 240 mg administered intravenously over 2 minutes was well tolerated.
As pantoprazole is extensively protein bound, it is not readily dialysable.
In the case of overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
48 months.
Store tightly closed at or below 25°C.
KEEP OUT OF THE REACH OF CHILDREN.
White polyethylene containers with white polypropylene screw cap (tamper evident) with a desiccant insert, containing 14, 28, 30, 56, 100, 250, 300 or 500 tablets.
Aluminium foil and OPA/Al/PVC foil blisters strips packed in cardboard cartons, containing 14, 28, 30 or 56 tablets.
No special requirements.
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