Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Avera McKennan Hospital
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 40 mg
ORAL
PRESCRIPTION DRUG
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX is 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 PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. PROTONIX is 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. PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reac
How Supplied PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as 40 mg yellow, oval biconvex delayed-release tablets imprinted with PROTONIX (brown ink) on one side and are available as follows: Storage Store PROTONIX For Delayed-Release Oral Suspension and PROTONIX 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
PROTONIX DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE Avera McKennan Hospital ---------- MEDICATION GUIDE PROTONIX (pro-TAH-nix) (pantoprazole sodium) Delayed-Release Tablets and For Delayed-Release Oral Suspension Read this Medication Guide before you start taking PROTONIX 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 PROTONIX? PROTONIX may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. PROTONIX can cause serious side effects, including: • Diarrhea. PROTONIX 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 PROTONIX 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 PROTONIX. PROTONIX can have other serious side effects. See "What are the possible side effects of PROTONIX?" What is PROTONIX? PROTONIX is a prescription medicine called a proton pump inhibitor (PPI). PROTONIX reduces the amount of acid in your stomach. PROTONIX 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 PROTONIX. • to maintain the healing of acid-related damage to the lining of the esophagus and help prevent return of heartburn symptoms cause Lugege kogu dokumenti
PROTONIX DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PROTONIX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROTONIX. PROTONIX (PANTOPRAZOLE SODIUM) DELAYED-RELEASE TABLETS PROTONIX (PANTOPRAZOLE SODIUM) FOR DELAYED- RELEASE ORAL SUSPENSION INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Dosage and Administration, Recommended Dosing Schedule (2.1) 12/2014 Contraindications (4) 12/2014 Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014 INDICATIONS AND USAGE PROTONIX 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) For Delayed-Release Oral Suspension, 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) Acute interstitial nephritis has been observed in patients taking PPIs. (5.3) Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to m Lugege kogu dokumenti