Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)
Ranbaxy Pharmaceuticals Inc.
PANTOPRAZOLE SODIUM
PANTOPRAZOLE 20 mg
ORAL
PRESCRIPTION DRUG
Pantoprazole sodium delayed-release tablets, USP are indicated for: Pantoprazole sodium delayed-release tablets, USP 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, USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pantoprazole sodium delayed-release tablets, USP 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, USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole sodium is contra
How Supplied Pantoprazole sodium delayed-release tablets, USP 20 mg are supplied as yellow to light yellow colored, oval-shaped, biconvex, enteric-coated tablets, imprinted with ‘RA33 ’ on one side and plain on the other side and are available as follows: NDC 63304-967-90 Bottles of 90 NDC 63304-967-10 Bottles of 1000 NDC 63304-967-77 Blister pack of 100 Pantoprazole sodium delayed-release tablets, USP 40 mg are supplied as yellow to light yellow colored, oval-shaped, biconvex, enteric-coated tablets, imprinted with ‘RA34 ’ on one side and plain on the other side and are available as follows: NDC 63304-968-90 Bottles of 90 NDC 63304-968-10 Bottles of 1000 NDC 63304-968-77 Blister pack of 100 Storage Store pantoprazole sodium delayed-release tablets, USP at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE Ranbaxy Pharmaceuticals Inc. ---------- SPL MEDGUIDE SECTION MEDICATION GUIDE PANTOPRAZOLE SODIUM (pan toe' pra zole soe' dee um) DELAYED-RELEASE TABLETS, USP Rx only Read this Medication Guide before you start taking pantoprazole sodium delayed-release tablets, USP 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, USP? Pantoprazole sodium delayed-release tablets, USP may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Pantoprazole sodium delayed-release tablets, USP can cause serious side effects, including: • Diarrhea. Pantoprazole sodium delayed-release tablets, USP 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 pantoprazole sodium delayed-release tablets, USP 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, USP. Pantoprazole sodium delayed-release tablets, USP can have other serious side effects. See “What are the possible side effects of pantoprazole sodium delayed-release tablets, USP?” What are pantoprazole sodium delayed-release tablets, USP? Pantoprazole sodium delayed-release tablets, USP are a prescription medicine called a proton pump inhibitor (PPI). Pantoprazole sodium delaye Прочетете целия документ
PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE RANBAXY PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PANTOPRAZOLE SODIUM DELAYED- RELEASE TABLETS, USP. PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP, FOR ORAL ADMINISTRATION 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 Pantoprazole sodium delayed-release tablets, USP are a proton pump inhibitor indicated for the following: (1) • • • 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) ≥ 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 (2) 40 mg (2) Once Daily*** (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 • CONTRAINDICATIONS Known hypersensitivity to any component of the formulation or to substituted benzimidazoles (4) (4) WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS The most frequently occurring adverse reactions are as follows: (6) • 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) Delayed-Release Tablets, 20 mg and 40 mg (3) Symptomatic re Прочетете целия документ