País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
NuCare Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole 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 Pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pantoprazole 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. Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole Sodium Delayed‑Release Tablets is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hyp
How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg white, oval biconvex delayed-release tablets imprinted in black ink with "KU" on one side and "180" on the other side and are available as follows: NDC 68071-3140-3 bottles of 30 NDC 68071-3140-6 bottles of 60 Storage Store Pantoprazole Sodium Delayed-Release Tablets, USP 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 NuCare Pharmaceuticals, Inc. ---------- MEDICATION GUIDE MEDICATION GUIDE Pantoprazole (pan-TOE-pruh-zole) Sodium Delayed-Release Tablets, USP CIA77568H Rev. 12/2016 Read this Medication Guide before you start taking Pantoprazole 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? Pantoprazole may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Pantoprazole 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, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with Pantoprazole. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea. Pantoprazole 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 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. • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Pantoprazole, may develop certain types of lupus erythematosus or hav Leer el documento completo
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE NUCARE 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 Gastric 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 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 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 therapy may be associated with increased risk of _Clostridium difficile_-associated diarrhea. ( 5.3) Bone Fracture: Long-term and multiple daily Leer el documento completo