البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
Blenheim Pharmacal, Inc.
ORAL
PRESCRIPTION DRUG
Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. Omeprazole delayed-release capsules, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to one year history) to eradicate H. pylori in adults. Omeprazole delayed-release capsules, 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 with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In pati
Omeprazole Delayed-Release Capsules, USP are available in the following strengths: 10 mg, 20 mg or 40 mg. The 10 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a dark green opaque body axially printed with MYLAN over 5211 in white ink both on the cap and the body. The capsule is filled with white to off-white beads. They are available as follows: NDC 0378-5211-93 bottles of 30 capsules The 20 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a blue-green opaque body axially printed with MYLAN over 6150 in white ink both on the cap and the body. The capsule is filled with white to off-white beads. They are available as follows: NDC 0378-6150-93 bottles of 30 capsules NDC 0378-6150-01 bottles of 100 capsules NDC 0378-6150-10 bottles of 1000 capsules The 40 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light-blue opaque body axially printed with MYLAN over 5222 in white ink both on the cap and the body. The capsule is filled with white to off-white beads. They are available as follows: NDC 0378-5222-93 bottles of 30 capsules NDC 0378-5222-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE Blenheim Pharmacal, Inc. ---------- MEDICATION GUIDE OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP (oh mep′ ra zole) 10 mg, 20 mg and 40 mg 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 اقرأ الوثيقة كاملة
OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE BLENHEIM PHARMACAL, 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 FOR ORAL USE INITIAL U.S. APPROVAL: 1989 RECENT MAJOR CHANGES Warnings and Precautions: Interactions with Diagnostic Investigations for Neuroendocrine Tumors ( 5.10) 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 * † 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 Amoxicillin 1000 mg daily for 10 days 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 PATHOLOGICAL HYPERSECRETORY CONDITIONS ( 2.6 اقرأ الوثيقة كاملة