Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)
Santarus, Inc..
OMEPRAZOLE
OMEPRAZOLE 20 mg
ORAL
PRESCRIPTION DRUG
ZEGERID for oral suspension and ZEGERID capsules are indicated in adults for the : ZEGERID for oral suspension is indicated in adults for the : ZEGERID is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)] . Proton pump inhibitors (PPIs), including ZEGERID, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions (7)] . Risk Summary There are no adequate and well-controlled studies with ZEGERID in pregnant women. ZEGERID contains omeprazole and sodium bicarbonate. Omeprazole There are no adequate and well-controlled studies with omeprazole in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcom
Storage 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]. Keep container tightly closed. Protect from light and moisture.
New Drug Application
ZEGERID- OMEPRAZOLE AND SODIUM BICARBONATE POWDER, FOR SUSPENSION ZEGERID- OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE Santarus, Inc.. ---------- MEDICATION GUIDE ZEGERID® (ze-ger-id) (omeprazole and sodium bicarbonate) for oral suspension and capsules, for oral use What is the most important information I should know about ZEGERID? ZEGERID may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. ZEGERID can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including ZEGERID, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with ZEGERID. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • ZEGERID contains sodium bicarbonate. Long-term use of bicarbonate with calcium or milk can cause a condition called “milk-alkali syndrome”. Long-term use of sodium bicarbonate can cause a condition called “systemic alkalosis”. Talk to your doctor about any questions you may have. Too much sodium can cause swelling and weight gain. Tell your doctor if you are on a low-sodium diet or if you have Bartter’s Syndrome (a rare kidney disorder). Tell your doctor right away if you have confusion, shaking hands, dizziness, muscle twitching, nausea, vomiting, and numbness or tingling in the face, arms, or legs. • Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have bone fracture, especially in the hip, wrist, or spine. Certain types of lupus erythematosu Citiți documentul complet
ZEGERID- OMEPRAZOLE AND SODIUM BICARBONATE POWDER, FOR SUSPENSION ZEGERID- OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE SANTARUS, INC.. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZEGERID SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZEGERID. ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) FOR ORAL SUSPENSION ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE ZEGERID is a proton pump inhibitor (PPI). ZEGERID for oral suspension and ZEGERID capsules are indicated in adults for: • • • • ZEGERID for oral suspension is indicated in adults for: • DOSAGE AND ADMINISTRATION INDICATION (2) RECOMMENDED ADULT DOSAGE (2) ZEGERID FOR ORAL SUSPENSION OR ZEGERID CAPSULES (2) Active Duodenal Ulcer (2) 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks (2) Active Benign Gastric Ulcer (2) 40 mg once daily for 4 to 8 weeks (2) Treatment of Symptomatic GERD (2) 20 mg once daily for up to 4 weeks (2) Treatment of EE due to Acid-Mediated GERD (2) 20 mg once daily for 4 to 8 weeks* (2) Maintenance of Healing of EE due to Acid- Mediated GERD (2) 20 mg once daily** (2) 40 MG ZEGERID FOR ORAL SUSPENSION (2) Reduction of Risk of Upper GI Bleeding in Critically Ill Patients (2) 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days (2) * an additional 4 weeks of treatment may be given if no response; if recurrence, additional 4 to 8-week courses may be considered. (2) ** studied for 12 months. (2) DOSAGE FORMS AND STRENGTHS For Capsules (3): • • For Oral Suspension (3): • • CONTRAINDICATIONS ® ® Treatment of active duodenal ulcer (1) Treatment of active benign gastric ulcer (1) Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) (1) Maintenance of healing of EE (1) Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients (1) 20 mg omepra Citiți documentul complet