País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Clinical Solutions Wholesale, 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 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 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 is contraindicated in patients w
How Supplied Pantoprazole sodium delayed-release tablets, USP are supplied as 20 mg white to pale yellow colored, oval shape, biconvex, enteric-coated tablets, plain on one side and "96" printed with brown ink on the other side. They are available as follows: Bottles of 30 NDC 13668-096-30 Bottles of 90 NDC 13668-096-90 Bottles of 500 NDC 13668-096-05 100 Unit Dose Tablets NDC 13668-096-74 Pantoprazole sodium delayed-release tablets, USP are supplied as 40 mg white to pale yellow colored, oval shape, biconvex, enteric-coated tablets, plain on one side and "97" printed with brown ink on the other side. They are available as follows: Bottles of 30 NDC 13668-429-30 Bottles of 90 NDC 13668-429-90 Bottles of 500 NDC 13668-429-05 80 Unit Dose Tablets NDC 13668-429-77 Storage Store 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].
Abbreviated New Drug Application
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE Clinical Solutions Wholesale, LLC ---------- MEDICATION GUIDE MEDICATION GUIDE Pantoprazole sodium (pan TOE pra zole SO-dee-um) delayed-release tablets, USP 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. • Leer el documento completo
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE CLINICAL SOLUTIONS WHOLESALE, 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 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 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 INDICATION (2) DOSE (2) FREQUENCY (2) SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (2.1) (2) Adults (2) 40 mg (2) Once Daily for up to 8 wks (2) Children (5 years and older) (2) ≥ 15 kg to < 40 kg (2) 20 mg (2) Once Daily for up to 8 wks (2) ≥ 40 kg (2) 40 mg (2) MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (2.1) (2) Adults 40 mg Once Daily* (2) (2) (2) PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME (2.1) (2) Adults (2) 40 mg (2) Twice Daily (2) Controlled studies did not extend beyond 12 months (2) See full prescribing information for administration instructions (2) 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 In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1) Acute interstitial nephritis has been observed in patients taking PPIs. (5.2) PPI the Leer el documento completo