País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
Mylan Pharmaceuticals Inc.
OMEPRAZOLE
OMEPRAZOLE 10 mg
ORAL
PRESCRIPTION DRUG
Omeprazole delayed-release capsules 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. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. 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. 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 are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If
Omeprazole Delayed-Release Capsules, USP are available containing 10 mg, 20 mg or 40 mg of omeprazole, USP. The 10 mg capsules are hard-shell gelatin capsules with a dark green opaque cap and a dark green opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 5211 in white ink both on the cap and the body. They are available as follows: NDC 0378-5211-93 bottles of 30 capsules The 20 mg capsules are hard-shell gelatin capsules with a dark green opaque cap and a blue-green opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6150 in white ink both on the cap and the body. 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 capsules are hard-shell gelatin capsules with a dark green opaque cap and a light-blue opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 5222 in white ink both on the cap and the body. 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
Mylan Pharmaceuticals Inc. ---------- 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: • 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 in the body). Some people who take PPI Leia o documento completo
OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE MYLAN 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, FOR ORAL USE INITIAL U.S. APPROVAL: 1989 RECENT MAJOR CHANGES Warnings and Precautions, Fundic Gland Polyps (5.12) 5/2018 INDICATIONS AND USAGE Omeprazole is a proton pump inhibitor (PPI) indicated for the: • • • • • • • DOSAGE AND ADMINISTRATION INDIC ATIO N 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 Capsules Amoxicillin Clarithromycin 20 mg 1000 mg 500 mg Each drug twice daily for 10 days (2.1)* _Dual Therapy:_ Omeprazole Delayed-Release Capsules Clarithromycin 40 mg once daily for 14 days** 500 mg three times daily for 14 days (2.1) Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks (2.1) Symptomatic GERD 20 mg once daily for up to 4 weeks (2.1) See full prescribing information for weight based dosing in pediatric patients 1 year of age and older (2.2) EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks (2.1)*** See full prescribing information for weight based dosing in pediatric patients 1 month of age and older (2.2) Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily (2.1)**** See full prescribing information for weight based dosing in pediatric patients 1 year of age and older (2.2) Pathological Hypersecretory Conditions Starting dose is 60 mg once daily (varies with individual patient, see full prescribing information) as long as clinically indicated (2.1) * if ulcer present, continue omeprazole delayed-release capsules 20 mg once daily for an additional 1 Leia o documento completo