Country: United States
Language: English
Source: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)
Oceanside Pharmaceuticals
OMEPRAZOLE
OMEPRAZOLE 20 mg
ORAL
PRESCRIPTION DRUG
Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules are 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 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 may be considered. - maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not
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 Authorized Generic
OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE, SODIUM BICARBONATE CAPSULE Oceanside Pharmaceuticals ---------- MEDICATION GUIDE Omeprazole and Sodium Bicarbonate for oral suspension and capsules, for oral use What is the most important information I should know about Omeprazole and Sodium Bicarbonate? Omeprazole and Sodium Bicarbonate may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Omeprazole and Sodium Bicarbonate 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, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Omeprazole and Sodium Bicarbonate. 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 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 yo Read the complete document
OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE, SODIUM BICARBONATE POWDER, FOR SUSPENSION OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE, SODIUM BICARBONATE CAPSULE OCEANSIDE PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEPRAZOLE AND SODIUM BICARBONATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEPRAZOLE AND SODIUM BICARBONATE. OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE Omeprazole and Sodium Bicarbonate is a proton pump inhibitor (PPI). Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules are 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 INDICATION (2) RECOMMENDED ADULT DOSAGE (2) OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION OR OMEPRAZOLE AND SODIUM BICARBONATE 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 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 OMEPRAZOLE AND SODIUM BICARBONATE 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 Read the complete document