Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Quality Care Products, LLC
ORAL
PRESCRIPTION DRUG
Pantoprazole Sodium Delayed-Release Tablets are indicated for: Pantoprazole Sodium Delayed-Release Tablet 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 (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 (ZE) syndrome. • Pantoprazole Sodium Delayed-Release Tablets are contraindica
How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted “H125” on one side with black ink and plain on the other side. They are supplied as follows: Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted “H126” on one side with black ink and plain on the other side. They are supplied as follows: 55700-850-30 55700-850-60 55700-850-90 Storage Store pantoprazole sodium delayed-release tablets, USP at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
Quality Care Products, LLC ---------- MEDICATION GUIDE MEDICATION GUIDE Pantoprazole Sodium Delayed-Release Tablets USP (pan toe’ pra zole soe’dee um) What is the most important information I should know about pantoprazole sodium delayed-release tablets? You should take pantoprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. 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 right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. • 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 sodium delayed-release tablet, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms tha Lire le document complet
PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE QUALITY CARE PRODUCTS, 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, Fundic Gland Polyps (5.9) 06/2018 Warnings and Precautions, Interference with Investigations for Neuroendocrine Tumors (5.10) 12/2017 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablet is 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 (ZE) Syndrome (1.3) DOSAGE AND ADMINISTRATION 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 *Controlled studies did not extend beyond 12 months See full prescribing information for administration instructions (2) 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, 7) WARNINGS AND PRECAUTIONS • Gastric Malignancy: In adults, Symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagonostic testing. (5.1) •Acute interstitia Lire le document complet