pantoprazole 40 MG as pantoprazole sodium sesquihydrate 45.1 MG Delayed Release Tablet
1 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated for the following: • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) • Maintenance of Healing of Erosive Esophagitis ( 1.2 ) • Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
Mylan Pharmaceuticals Inc.
OVAL YELLOW M P9
M P9 OVAL YELLOW
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pantoprazole 20 MG Delayed Release Oral Tablet
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pantoprazole 40 MG as pantoprazole sodium sesquihydrate 45.1 MG Delayed Release Tablet
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied:
PANTOPRAZOLE SODIUM Delayed-Release Tablets, USP are available containing 22.55 mg or 45.10 mg of
PANTOPRAZOLE SODIUM, USP equivalent to 20 mg or 40 mg of pantoprazole, respectively. The 20 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with M P8 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6688-77 bottles of 90 tablets The 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with M P9 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6689-77 bottles of 90 tablets NDC 0378-6689-10 bottles of 1000 tablets Storage: Store at 20° to 25°C (68 ° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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