First immediate-release PPI capsule approved

March 6, 2006

Specialty pharmaceutical company Santarus has received FDA approval for immediate-release proton pump inhibitor Zegerid. The new product contains omeprazole and sodium bicarbonate in 40 mg/1100 mg and 20 mg/1100 mg combinations.

First immediate-release PPI capsule approved

Specialty pharmaceutical company Santarus has received FDA approval for immediate-release proton pump inhibitor Zegerid. The new product contains omeprazole and sodium bicarbonate in 40 mg/1100 mg and 20 mg/1100 mg combinations. All previously available PPIs are delayed-release formulations that have an enteric coating that protects the drug from degradation by gastric acid, according to the company. The new capsules utilize sodium bicarbonate as a buffer that protects omeprazole from degradation without delaying absorption and initial acid suppression. Zegerid is approved for multiple indications, including the treatment of heartburn and other GERD-related symptoms; the short-term treatment of erosive esophagitis, active benign gastric ulcers, and active duodenal ulcers; and the maintenance of healing of erosive esophagitis. Dosing is once-daily on an empty stomach, at least one hour before a meal. Zegerid should be used with caution in patients on a sodium-restricted diet, as each capsule contains 1100 mg (13 mEq) of sodium. The drug is contraindicated in patients with metabolic alkalosis and hypocalcemia.

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