APO-OMEPRAZOLE

What it is

APO-OMEPRAZOLE is omeprazole 20 mg, supplied as enteric-coated capsules. The capsules are enteric-coated, off-white to cream-white spherical pellets contained in opaque yellow hard gelatin capsules.

Approved indications

— Relief of heartburn and other symptoms associated with gastro-oesophageal reflux disease (GORD). — Treatment and prevention of relapse in erosive oesophagitis. — Treatment of duodenal and gastric ulcer. — Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. — Treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs (NSAIDs). — Prevention of gastric and duodenal ulcers and erosions associated with NSAIDs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. — Long-term prevention of relapse in gastric and duodenal ulceration in patients proven to be H. pylori negative or in whom eradication is inappropriate or ineffective. — Treatment of Zollinger-Ellison syndrome.

Dosing overview

Dosing varies by indication. For symptomatic GORD, omeprazole 10 mg to 20 mg is given once daily for a maximum of four weeks. For erosive oesophagitis, the recommended healing dosage is omeprazole 20 mg once daily for four to eight weeks. After healing, maintenance therapy is commenced with omeprazole 10 mg once daily, with increase to omeprazole 20 mg once daily if needed. For H. pylori-associated peptic ulcer disease, omeprazole is administered at a dose of 40 mg once daily or 20 mg twice daily in association with antimicrobial combinations. For duodenal ulcer, the recommended healing dosage is omeprazole 20 mg once daily for four to eight weeks. For gastric ulcer, omeprazole 20 mg once daily for four to eight weeks is recommended. For NSAID-associated gastric or duodenal ulcers or erosions, the recommended dose is omeprazole 20 to 40 mg daily. For Zollinger-Ellison syndrome, the recommended initial dose is omeprazole 60 mg once daily, with dosage adjusted to the individual patient's response.

Key safety warnings

As with all antisecretory agents, the presence of alarm symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with omeprazole may alleviate symptoms and delay diagnosis. A pharmacokinetic/pharmacodynamic interaction between clopidogrel and omeprazole results in decreased exposure to the active metabolite of clopidogrel and decreased maximum inhibition of platelet aggregation. Concomitant use of omeprazole and clopidogrel should be avoided. Subacute cutaneous lupus erythematosus (SCLE) has been reported with the use of proton pump inhibitors. If lesions occur, especially in sun-exposed areas of the skin and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping omeprazole. Decreased gastric acidity increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with acid-reducing drugs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalised patients, possibly also Clostridium difficile. Daily treatment with acid-suppressing medicines over a long period of time (longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors. Serious adverse events include tetany, delirium, arrhythmias, and seizures. In most patients, treatment required magnesium replacement and discontinuation of the proton pump inhibitor. Proton pump inhibitors, especially if used in high doses and over long durations, may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture. Acute interstitial nephritis has been observed in patients taking proton pump inhibitors including omeprazole. Acute interstitial nephritis may occur at any point during proton pump inhibitor therapy and is generally attributed to idiopathic hypersensitivity reaction. Discontinue omeprazole if acute interstitial nephritis develops. Severe cutaneous adverse reactions such as erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms, which can be life-threatening or fatal, have been reported very rarely in association with omeprazole treatment.

Contraindications

APO-OMEPRAZOLE is contraindicated in patients with hypersensitivity to omeprazole, substituted benzimidazoles or any other ingredient. Omeprazole is contraindicated in patients taking cilostazol. Omeprazole must not be used concomitantly with nelfinavir.

Regulatory history

APO-OMEPRAZOLE omeprazole 20 mg capsules in blister pack (ARTG 149518) was first listed on 7 July 2009. APO-OMEPRAZOLE omeprazole 20 mg capsules in bottle (ARTG 167316) was first listed on 9 April 2010.