NOXICID CAPS

What it is

NOXICID CAPS contains esomeprazole, a proton pump inhibitor. Each enteric-coated tablet of ESOMEPRAZOLE RBX comprises enteric-coated pellets with esomeprazole magnesium equivalent to esomeprazole 20 mg or 40 mg.

Approved indications

— Treatment of erosive reflux oesophagitis. — Long-term management of patients with healed oesophagitis to prevent relapse. — Symptomatic treatment of gastro-oesophageal reflux disease (GORD). — Short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID therapy. — Healing of gastric ulcers associated with NSAID therapy. — Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. — Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion. — Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion. — Healing of duodenal ulcer associated with Helicobacter pylori, in combination with appropriate antibiotics. — Eradication of Helicobacter pylori in patients with active or healed peptic ulcer, in combination with appropriate antibiotics.

Dosing overview

For treatment of erosive reflux oesophagitis in adults, NOXICID CAPS is given at 40 mg once daily for four weeks, with an additional 4 weeks treatment recommended for patients in whom oesophagitis has not healed or who have persistent symptoms. Long-term management of healed oesophagitis requires 20 mg once daily. For symptomatic GORD in patients with normal endoscopy, 20 mg once daily for four weeks is recommended. For short-term treatment of upper gastrointestinal symptoms in patients requiring NSAID therapy, the dose is 20 mg once daily. For healing of gastric ulcers associated with NSAID therapy, the usual dose is 20 mg once daily for 4 to 8 weeks. For prevention of gastric and duodenal ulcers in patients at risk, 20 mg once daily is used. For pathological hypersecretory conditions, the recommended initial dosage is 40 mg twice daily, with dosage then individually adjusted and treatment continued as long as clinically indicated. For Helicobacter pylori eradication, 20 mg esomeprazole twice daily is given for 7 days in combination with appropriate antibiotics.

Key safety warnings

The presence of any alarm symptom such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena requires malignancy exclusion, as treatment with NOXICID CAPS may alleviate symptoms and delay diagnosis. Decreased gastric acidity increases gastric counts of bacteria normally present in the gastrointestinal tract, and treatment may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalised patients, possibly also Clostridium difficile. Acute tubulointerstitial nephritis has been observed in patients taking proton pump inhibitors including NOXICID CAPS, may occur at any point during therapy, and can progress to renal failure. Daily treatment over a long period of time (longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Proton pump inhibitor therapy may be associated with an increased risk for osteoporosis-related fractures, particularly in patients who received high-dose and long-term therapy (a year or longer), and patients should use the lowest dose and shortest duration appropriate to the condition being treated. Hypomagnesaemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors, with serious adverse events including tetany, arrhythmias, and seizures. 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 with NOXICID CAPS, and NOXICID CAPS should be discontinued immediately upon signs and symptoms of severe skin reactions.

Contraindications

NOXICID CAPS is contraindicated in patients with known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation. NOXICID CAPS should not be administered with atazanavir. NOXICID CAPS is contraindicated in patients taking cilostazol.

Regulatory history

NOXICID CAPS esomeprazole 20 mg (as magnesium) enteric capsule was first registered on the ARTG on 16 October 2015, and NOXICID CAPS esomeprazole 40 mg (as magnesium) enteric capsule was first registered on the same date. NOXICID CAPS HEARTBURN RELIEF esomeprazole 20 mg (as magnesium) enteric capsule blister pack was first listed on 8 May 2020.