Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
Omeprazole delayed-release capsules, USP are 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. Omeprazole delayed-release capsules, USP in combination with clarithromycin and amoxicillin, are 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. Omeprazole delayed-release capsules, USP in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2)] . Among patients who fail therapy, omeprazole delayed-release capsules, USP with clarithromycin are more likely to be associated with the development of clarithromycin resistance a
Product: 50090-3060 NDC: 50090-3060-0 30 CAPSULE, DELAYED RELEASE in a BOTTLE
Abbreviated New Drug Application
A-S Medication Solutions ---------- MEDICATION GUIDE Omeprazole Delayed-Release Capsules, USP (oh mep' ra zole) 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: • 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 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 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. Omeprazole delayed-release capsules can have other serious side effects. See “What are the possible side effects of omeprazole delayed-release capsules?” What are omeprazole delayed-release capsules? Omeprazole delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduce the amount of acid in your stomach. Omeprazole delayed-release capsules are used in adults: • for up to 8 weeks for the healing of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach. • with certain an Lesen Sie das vollständige Dokument
OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEPRAZOLE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEPRAZOLE. OMEPRAZOLE DELAYED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1989 RECENT MAJOR CHANGES Warnings and Precautions, Interactions with Diagnostic Investigations for Neuroendocrine Tumors (5.8) 03/2014 Indications and Usage, Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients) (1.3) 12/2014 Dosage and Administration, Maintenance of Healing of Erosive Esophagitis (2.5) 12/2014 Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014 Warnings and Precautions, Cyanocobalamin (vitamin B-12) Deficiency (5.4) 12/2014 INDICATIONS AND USAGE Omeprazole is a proton pump inhibitor indicated for: Treatment in adults of duodenal ulcer (1.1) and gastric ulcer. (1.2) Treatment in adults and children of gastroesophageal reflux disease (GERD) (1.3) and maintenance of healing of erosive esophagitis. (1.4) Pathologic Hypersecretory Conditions (1.5) The safety and effectiveness of omeprazole in pediatric patients <1 year of age have not been established. (8.4) DOSAGE AND ADMINISTRATION INDICATION OMEPRAZOLE DOSE FREQUENCY TREATMENT OF ACTIVE DUODENAL ULCER (2.1) 20 mg Once daily for 4 weeks. Some patients may require an additional 4 weeks _H. PYLORI_ ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE (2.2) _Triple Therapy:_ Omeprazole 20 mg Each drug twice daily for 10 days Amoxicillin 1000 mg Clarithromycin 500 mg _Dual Therapy:_ Omeprazole 40 mg Once daily for 14 days Clarithromycin 500 mg Three times daily for 14 days GASTRIC ULCER (2.3) 40 mg Once daily for 4 to 8 weeks GERD (2.4) 20 mg Once daily for 4 to 8 weeks MAINTENANCE OF HEALING OF ERO SIVE ESOPHAGITIS (2.5) 20 mg Once daily* PATHOLOGICAL HYPERSECRETORY CO NDITIO NS (2.6) 60 mg (varies with individual patie nt) Once daily PEDIATRIC PATIENTS (2 T Lesen Sie das vollständige Dokument