Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)
Medarbor Llc
OMEPRAZOLE
OMEPRAZOLE 40 mg
ORAL
PRESCRIPTION DRUG
Omeprazole and sodium bicarbonate capsules is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1) ] Omeprazole and sodium bicarbonate capsules is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies (14.2) ] Symptomatic GERD Omeprazole and sodium bicarbonate capsules is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. [See Clinical Studies (14.3) ] Erosive Esophagitis Omeprazole and sodium bicarbonate capsules is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy. The efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. I
Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg are hard gelatin capsules with a light blue opaque cap and white opaque body, imprinted in black ink with 'U' on the cap, '88' on the body and filled with white to off-white powder. Bottles of 30 NDC 69665-215-30 Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg are hard gelatin capsules with a dark blue opaque cap and white opaque body, imprinted in black ink with 'U' on the cap, '89' on the body and filled with white to off-white powder. Bottles of 30 NDC 69665-216-30 Storage Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture.
Abbreviated New Drug Application
OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE Medarbor Llc ---------- MEDICATION GUIDE Omeprazole and Sodium Bicarbonate Capsules (oh mep' ra zole and soe' dee um bye kar' bo nate) Read this Medication Guide before you start taking omeprazole and sodium bicarbonate capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. What is the most important information I should know about omeprazole and sodium bicarbonate capsules? Omeprazole and sodium bicarbonate capsules may help with your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Omeprazole and sodium bicarbonate capsules can cause serious side effects, including: • Omeprazole and sodium bicarbonate capsules contains sodium bicarbonate. Tell your doctor if you are on a sodium restricted 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. Omeprazole and sodium bicarbonate 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 and sodium bicarbonate 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 and sodium bicarbonate capsules. Omeprazole and sodium bicarbonate capsules can have other serious side effects. See “Wha Կարդացեք ամբողջական փաստաթուղթը
OMEPRAZOLE AND SODIUM BICARBONATE- OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE MEDARBOR LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES. OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES FOR ORAL USE INITIAL U.S. APPROVAL: 2004 RX ONLY RECENT MAJOR CHANGES 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 and sodium bicarbonate capsules is a proton pump inhibitor indicated for: (1) Short-term treatment of active duodenal ulcer (1.1) Short-term treatment of active benign gastric ulcer (1.2) Treatment of gastroesophageal reflux disease (GERD) (1.3) Maintenance of healing of erosive esophagitis (1.4) The safety and effectiveness of omeprazole and sodium bicarbonate capsules in pediatric patients (<18 years of age) have not been established. (8.4) (1) DOSAGE AND ADMINISTRATION Short-Term Treatment of Active Duodenal Ulcer: 20 mg once daily for 4 weeks (some patients may require an additional 4 weeks of therapy (14.1)) (2) Gastric Ulcer: 40 mg once daily for 4-8 weeks (2) Gastroesophageal Reflux Disease (GERD) (2) - Symptomatic GERD (with no esophageal erosions): 20 mg once daily for up to 4 weeks - Erosive Esophagitis: 20 mg once daily for 4-8 weeks (2) • Maintenance of Healing of Erosive Esophagitis: 20 mg once daily* (2) *studied for 12 months (2) DOSAGE FORMS AND STRENGTHS Omeprazole and sodium bicarbonate is available as a capsule in 20 mg and 40 mg strengths (3) CONTRAINDICATIONS Known hypersensitivity to any components of the formulation (4) WARNINGS AND PRECAUTIONS Concomitant Gastric Malignancy: Symptomatic response to therapy with omeprazole and sodium bicarbonate does not preclude the presence of gastric malignancy (5.1) Atrophic Gastritis: Has been observed in gastric Կարդացեք ամբողջական փաստաթուղթը