Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Aphena Pharma Solutions - Tennessee, LLC
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 40 mg
ORAL
PRESCRIPTION DRUG
Pantoprazole Sodium Delayed-Release Tablets are indicated for: 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. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pantoprazole Sodium Delayed-Release Tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. Pantoprazole Sodium Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole Sodium Delayed-Release Tablets are contraindicated in patients wi
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. How Supplied Pantoprazole Sodium Delayed-Release Tablets are supplied as 40 mg yellow, oval biconvex delayed-release tablets imprinted with P40 (brown ink) on one side and are available as follows: Pantoprazole Sodium Delayed-Release Tablets are supplied as 20 mg yellow oval biconvex delayed-release tablets imprinted with P20 (brown ink) on one side and are available as follows: Storage Store Pantoprazole Sodium Delayed-Release Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ see USP Controlled Room Temperature] .
New Drug Application
PANTOPRAZOLE SODIUM DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE Pantoprazole sodium Delayed-Release Tablets Read this Medication Guide before you start taking pantoprazole sodium and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about pantoprazole sodium? Pantoprazole sodium may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Pantoprazole sodium can cause serious side effects, including: • Diarrhea. Pantoprazole sodium may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. • Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take pantoprazole sodium exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take pantoprazole sodium. Pantoprazole sodium can have other serious side effects. See "What are the possible side effects of pantoprazole sodium?" What is pantoprazole sodium? Pantoprazole sodium is a prescription medicine called a proton pump inhibitor (PPI). Pantoprazole sodium reduces the amount of acid in your stomach. Pantoprazole sodium is used in adults: • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (erosive esophagitis or EE) and to relieve symptoms caused by gastroesophageal reflux disease (GERD). If needed, your doctor may decide to prescribe another 8 weeks of pantoprazole sodium. • to maintain Lees het volledige document
PANTOPRAZOLE SODIUM DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PANTOPRAZOLE SODIUM DELAYED-RELEASE T ABLE TS. PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS INITIAL U.S. APPROVAL: 2000 INDICATIONS AND USAGE Pantoprazole sodium is a proton pump inhibitor 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 Syndrome (1.3) DOSAGE AND ADMINISTRATION INDIC ATIO N DO SE FREQUENCY SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (2.1) Adults 40 mg Once Daily for up to 8 wks Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once Daily for up to 8 wks ≥ 40 kg 40 mg MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (2.1) Adults 40 mg Once Daily PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME (2.1) Adults 40 mg Twice Daily See full prescribing information for administration instructions DOSAGE FORMS AND STRENGTHS Delayed-Release Tablets, 20 mg and 40 mg (3) CONTRAINDICATIONS Known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4) WARNINGS AND PRECAUTIONS Symptomatic response does not preclude presence of gastric malignancy (5.1) Atrophic gastritis has been noted with long-term therapy (5.2) PPI therapy may be associated with increased risk of_ Clostridium difficile _associated diarrhea. (5.4) Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.5) Hypomagnesemia has been reported rarely with prolonged treatment with PPIs (5.6) ADVERSE REACTIONS The most freq Lees het volledige document