Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (Omeprazole - UNII:KG60484QX9)
Safecor Health, LLC
OMEPRAZOLE
OMEPRAZOLE 20 mg
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 [seeClinical Studies (14.1) and Dosage and Administration (2)]. Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared w
Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows: Packaging meets USP specifications for light resistance. For Institutional Use Only The product contained in this package is from NDC# 60505-0065 Apotex Corp. Weston, FL USA 33326 Packaged and Distributed by: Safecor Health, LLC 317 New Boston Street Woburn, MA 01801 Safecor Health, LLC 4060 Business Park Drive Columbus, OH 43204 Questions or comments? Call 1-800-447-1006 Storage Store omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE Safecor Health, LLC ---------- 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: 1. Diarrhea. Omeprazole 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. 1. 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 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 is a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduces the amount of acid in your stomach. Omeprazole delayed- release capsules are used in adults: 1. 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. 2. with certain antibioti Прочитајте комплетан документ
OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE SAFECOR HEALTH, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP. OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP, 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 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) The safety and effectiveness of omeprazole in pediatric patients <1 year of age have not been established. (8.4) DOSAGE AND ADMINISTRATION INDIC ATIO N 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:_ Ome prazole 20 mg Each drug twice daily for 10 days Amoxicillin 1000 mg Clarithromycin 500 mg _Dual Therapy:_ Ome prazole 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 EROSIVE ESOPHAGITIS (2.5) 20 mg Once daily PATHO LO G IC AL HYPE RSE C RE TO RY CONDITIONS (2.6) 60 mg (varies with individual patie nt) Once daily PEDIATRIC PATIENTS (2 TO 16 YEARS OF AGE) (2.7) We ight Dose GERD AND MAINTENANCE OF HEALING OF EROSIVE ESO PHAG ITIS 10 < 20 kg 10 mg Once daily ≥ 20 kg 20 kg DOSAGE FORMS AND STRENGTHS CONTRAINDICATIONS Known hypersensitivity to any component of the formulation or substituted benzimidazoles (angioedema and anaphylaxis have occurred) (4) WARNING Прочитајте комплетан документ