Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
Omeprazole Delayed-Release Capsules is indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Omeprazole Delayed-Release Capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults. Dual Therapy Omeprazole Delayed-Release Capsules in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H . pylori in adults. Among patients who fail therapy, Omeprazole Delayed-Release Capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility
Omeprazole Delayed-Release Capsules, 40 mg, are opaque gold cap and opaque gold body capsules imprinted with KU and 136 in black ink. They are supplied as follows: NDC 68071-4146 Bottles of 30 Storage Store Omeprazole Delayed-Release Capsules in a tight container protected from light and moisture. Store at 20° - 25°C (68° - 77°F) (See USP Controlled Room Temperature). Dispense in a tight and light-resistant container, as described in USP.
Abbreviated New Drug Application
NuCare Pharmaceuticals,Inc. ---------- MEDICATION GUIDE MEDICATION GUIDE Omeprazole (oh-MEP-ra-zole) Delayed-Release Capsules, USP CIA77775H Rev. 12/2016 Read this Medication Guide before you start taking Omeprazole Delayed-Release Capsules 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 Omeprazole Delayed-Release Capsules? Omeprazole Delayed-Release Capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Omeprazole Delayed-Release Capsules can cause serious side effects, including: • A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Omeprazole Delayed-Release Capsules, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with Omeprazole Delayed-Release Capsules. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea. Omeprazole Delayed-Release Capsules 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 Omeprazole Delayed-Release Capsules 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 Omeprazole Delayed-Release Capsules. • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs Lugege kogu dokumenti
OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE NUCARE PHARMACEUTICALS,INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEPRAZOLE DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE DELAYED-RELEASE CAPSULES USP INITIAL U.S. APPROVAL: 1989 RECENT MAJOR CHANGES Indications and Usage, Treatment of Erosive Esophagitis (EE) due to Acid-Mediated GERD ( 1.5) 02/2016 Dosage and Administration, Recommended Pediatric Dosage Regimen by Indication ( 2.2) 02/2016 Contraindications ( 4) 02/2016 Warnings and Precautions, Atrophic Gastritis ( 5.2) removed 10/2016 Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus ( 5.5) 10/2016 INDICATIONS AND USAGE Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults (1.1) Eradication _of Helicobacter pylori _to reduce the risk of duodenal ulcer recurrence in adults (1.2) Treatment of active benign gastric ulcer in adults (1.3) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) Pathologic hypersecretory conditions in adults (1.7) The safety and effectiveness of Omeprazole Delayed-Release Capsules in pediatric patients < 1 year of age have not been established ( 8.4). DOSAGE AND ADMINISTRATION INDIC ATIO NS RECOMMENDED ADULT ( 2.1) AND PEDIATRIC DOSAGE ( 2.2) Treatment of Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks ( 2.1) _H. pylori _Eradication to Reduce the Risk of Duodenal Ulcer Recurrence _Triple Therapy:_ Omeprazole Delayed-Release Capsule s 20 mg Each drug twice daily for 10 days ( 2.1)* Amoxicillin 1000 mg Clarithromycin 500 mg _Dual Lugege kogu dokumenti