Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Contract Pharmacy Services-PA
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 (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. - Pantoprazole sodium delayed-release tablets are contraindicated
How Supplied 40 mg: Yellow, oval shaped, unscored tablets imprinted with black ink on one side of the tablet “93/12” and plain on the other side. They are available in the following: NDC 67046-534-07 blisterpacks of 7 NDC 67046-534-14 blisterpacks of 14 NDC 67046-534-15 blisterpacks of 15 NDC 67046-534-20 blisterpacks of 20 NDC 67046-534-21 blisterpacks of 21 NDC 67046-534-28 blisterpacks of 28 NDC 67046-534-30 blisterpacks of 30 NDC 67046-534-60 blisterpacks of 60 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
Contract Pharmacy Services-PA ---------- MEDICATION GUIDE Pantoprazole Sodium (pan-TOE-pra-zole SOE-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: 1. 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 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. 2. 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. 3. 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. 4. Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack ot Perskaitykite visą dokumentą
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE CONTRACT PHARMACY SERVICES-PA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 534 PANTOPRAZOLE 40 MG 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: 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 Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles ( 4) Patients receiving rilpivirine-containing products ( 4) WARNINGS AND PRECAUTIONS Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1) Acute Interstitial Nephritis: Observed in patients taking PPIs. ( 5.2) Perskaitykite visą dokumentą