Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Preferred Pharmaceuticals, Inc.
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 20 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 (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. 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. Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Teratogenic Effects Pregnancy Category C Repr
How Supplied Pantoprazole Sodium Delayed-Release Tablets USP, 20 mg are yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with ‘I’ and ‘51’ with brown ink on one side and plain on other side. Bottle of 30 - 68788-9510-3 Bottle of 60 - 68788-9510-6 Bottle of 90 - 68788-9510-9 Bottle of 100 - 68788-9510-1 Bottle of 120 - 68788-9510-8 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE Preferred Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Pantoprazole Sodium Delayed-Release Tablets, USP (pan toe' pra zole soe' dee um) Read this Medication Guide before you start taking pantoprazole sodium delayed-release tablets 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 delayed-release tablets? Pantoprazole sodium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Pantoprazole sodium delayed-release tablets can cause serious side effects, including: • A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including pantoprazole sodium delayed-release tablets, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with pantoprazole sodium delayed-release tablets. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea. Pantoprazole sodium delayed-release tablets 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 PPI 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 delayed-release tablets 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 delayed-release tablets. • Certain types o Lesen Sie das vollständige Dokument
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE PREFERRED PHARMACEUTICALS, INC. ---------- 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 TABLETS. PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Warnings and Precautions, Atrophic Gastritis removed (5.2) 10/2016 Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (5.5) 10/2016 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated for the following: • • • DOSAGE AND ADMINISTRATION * Controlled studies did not extend beyond 12 months See full prescribing information for administration instructions. INDICATION DOSE 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 DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • 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) Delayed-Release Tablets, 20 mg and 40 mg (3) Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4) Patients receiving rilpivirine-containing products (4) Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1) Lesen Sie das vollständige Dokument