Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)
Ajanta Pharma USA Inc.
OMEPRAZOLE
OMEPRAZOLE 20 mg
ORAL
PRESCRIPTION DRUG
Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for the: - short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. - short-term treatment (4 to 8 weeks) of active benign gastric ulcer. - treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. - short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. The efficacy of Omeprazole and Sodium Bicarbonate for oral suspension used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate for oral suspension may be considered. - The efficacy of Omeprazole and Sodium Bicarbonate for oral suspension used for longer than 8
Omeprazole and Sodium Bicarbonate for Oral Suspension is supplied as: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.
Abbreviated New Drug Application
OMEPRAZOLE AND SODIUM BICARBONATE - OMEPRAZOLE AND SODIUM BICARBONATE FOR SUSPENSION Ajanta Pharma USA Inc. ---------- MEDICATION GUIDE Omeprazole and Sodium Bicarbonate (oh mep’ ra zole and soe’ dee um bye kar’ bo nate) for Oral Suspension, for oral use What is the most important information I should know about Omeprazole and Sodium Bicarbonate for oral suspension? Omeprazole and Sodium Bicarbonate for oral suspension may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Omeprazole and Sodium Bicarbonate for oral suspension can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Omeprazole and Sodium Bicarbonate for oral suspension, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Omeprazole and Sodium Bicarbonate for oral suspension. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Omeprazole and Sodium Bicarbonate for oral suspension 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 fra Aqra d-dokument sħiħ
OMEPRAZOLE AND SODIUM BICARBONATE - OMEPRAZOLE AND SODIUM BICARBONATE FOR SUSPENSION AJANTA PHARMA USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION. OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE Omeprazole and Sodium Bicarbonate for oral suspension is a proton pump inhibitor (PPI). Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for: 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) Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for: Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients (1) DOSAGE AND ADMINISTRATION * an additional 4 weeks of treatment may be given if no response; if recurrence, additional 4 to 8-week courses may be considered. ** studied for 12 months. INDICATION (2) RECOMMENDED ADULT DOSAGE (2) OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily for up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks* Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily** 40 MG OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days DOSAGE FORMS AND STRENGTHS For Oral Suspension (3): 20 mg omeprazole and 1,680 mg sodium bicarbonate in unit- Aqra d-dokument sħiħ