PROTONIX 40 mg Delayed-Release Tablets
Indications
- PROTONIX Delayed-Release Tablets are indicated for the treatment and maintenance of healing of erosive esophagitis with associated GERD symptoms. Controlled studies did not extend beyond 12 months.
- PROTONIX Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Important Safety Information
- In clinical trials, the most frequently reported adverse events with PROTONIX Delayed-Release Tablets were headache, diarrhea, and flatulence. Symptomatic response to therapy does not preclude the presence of gastric malignancy. PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation. Patients treated with PPIs and warfarin concomitantly should be monitored for increases in INR and prothrombin time.
Please see Prescribing Information
PROTONIX I.V.
Indications
- PROTONIX I.V. for Injection is indicated for short-term treatment (7 to 10 days) of patients with GERD and a history of erosive esophagitis.
- PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison syndrome (ZES) or other neoplastic conditions.
Important Safety Information
- In clinical trials, the most frequently reported adverse events with PROTONIX I.V. were injection site reactions (including thrombophlebitis and abscess), headache, diarrhea, nausea, and dyspepsia. PROTONIX I.V. is contraindicated in patients with known hypersensitivity to any component of the formulation. Anaphylaxis has been reported. As with any other intravenous product containing EDTA, zinc supplementation should be considered in patients treated with PROTONIX I.V. who are prone to zinc deficiency.
Please see Prescribing Information
120805-01
