Zegerid with Magnesium Hydroxide Chewable Tablets Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Zegerid with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) Chewable Tablets 40 mg/600 mg/700 mg and 20 mg/600 mg/700 mg, an immediate-release proton pump inhibitor (PPI).

Zegerid Chewable Tablets are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), the short-term treatment (four to eight weeks) of erosive esophagitis diagnosed by endoscopy and active benign gastric ulcers, the short-term treatment of active duodenal ulcers and for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months).

About Zegerid

The Zegerid family of products, including capsule, powder for oral suspension and chewable tablet dosage forms, offer a distinct pharmacological profile -- rapidly reaching maximal plasma levels (in approximately 30 minutes) and providing acid control, with a median 24-hour gastric pH of greater than 4 ranging from 12.2 hours to 18.6 hours, depending on the strength and dosage form, after repeated once-daily dosing. Zegerid can be conveniently taken once-a-day anytime during the day on an empty stomach, at least one hour before a meal.

PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. All currently marketed oral PPIs, other than Zegerid, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, which delays absorption and initial acid suppression. Unlike delayed-release PPIs, Zegerid utilizes one or more antacids in lieu of an enteric coating to protect the omeprazole from gastric acid degradation. The antacids neutralize stomach acid and protect the PPI, omeprazole, from gastric acid degradation and allow for its rapid absorption and suppression of gastric acid.