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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.
Gastro-oesophageal reflux disease Clinical criteria: Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor.
“Esomeprazole reversibly reduces gastric acid secretion by specifically inhibiting the gastric enzyme H + , K + -ATPase proton pump in the parietal cell.”
“1–1.5 hours”
Working under the parallel aged-care framework? Aged-care equivalent →
Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion Clinical criteria: Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor. Treatment criteria: Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.
Scleroderma oesophagus Clinical criteria: Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor. Treatment criteria: Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.
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.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.