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Omeprazole is marketed in Australia as Acimax, Losec and Maxor Heartburn Relief, among others.
Gastro-oesophageal reflux disease Clinical criteria: The treatment must be for long-term maintenance of gastro-oesophageal reflux disease in a patient with symptoms inadequately controlled using a low dose proton pump inhibitor.
Complex gastro-oesophageal reflux disease (GORD) Clinical criteria: Treatment Phase: One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control Treatment criteria: Must be treated by a gastroenterologist; OR Must be treated by a surgeon with expertise in the upper gastrointestinal tract; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist's name documented in the patient's medical records for auditing purposes; OR Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist's name documented in the patient's medical records for auditing purposes. The treatment must be: (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI, AND Patient must must have symptoms inadequately controlled with each of: (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control; OR Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for: (2) maintenance treatment; OR Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for: (3) re-establishment of symptom control; OR Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for: (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing. Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.
“Esomeprazole reversibly reduces gastric acid secretion by specifically inhibiting the gastric enzyme H+, K+-ATPase proton pump in the parietal cell.”
“The plasma elimination half-life is about 1.3 hours after repeated once-daily dosing.”
Esomeprazole is completely metabolised by the cytochrome P450 system (CYP450). The major part of the metabolism of esomeprazole is dependent on the polymorphic CYP2C19, responsible for the formation of the hydroxy- and desmethyl metabolites of esomeprazole.
Omeprazole is marketed in Australia as Acimax, Losec and Maxor Heartburn Relief, among others.
16 brand names are recorded against this substance from the TGA eBS Product Information repository. The full list is in the Also known as card.
Peptic ulcer Clinical criteria: Treatment Phase: Initial treatment Patient must have tested negative for helicobacter pylori infection; OR Patient must have failed treatment with helicobacter pylori eradication therapy.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.