Drug Catalog - Product Detail
OMEPRAZOLE-SODIUM BICARBONATE CAPS 40MG-1100MG 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69336-0112-30 | STERLING KNIGHT PHARMACEUTICAL | 30 | 40-1100MG | CAPSULE |
PACKAGE FILES
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Description
11 DESCRIPTION Omeprazole and sodium bicarbonate is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17 H 19 N 3 O 3 S, with a molecular weight of 345.42. The structural formula is: Omeprazole, USP is a white or almost white powder which melts with decomposition at about 155°C. Soluble in dichloromethane, practically insoluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole and sodium bicarbonate is supplied as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate. The capsules consist of gelatin and titanium dioxide. In addition the 20 mg/1100 mg capsule shell contains sodium lauryl sulfate and the 40 mg/1100 mg capsule shell contains FD&C Blue 1. The capsules are printed with edible ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac and strong ammonia solution. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: White to off white powder filled in size “00” hard gelatin capsules with opaque white colored cap and opaque white colored body imprinted “SG” on cap and “363” on body with black ink. They are supplied as: NDC: 69336-110-30 Bottles of 30s NDC: 69336-110-05 Bottles of 500s Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: White to off white powder filled in size “00” hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted “SG” on cap and “364” on body with black ink. They are supplied as: NDC: 69336-112-30 Bottles of 30s NDC: 69336-112-05 Bottles of 500s Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture.
Indications & Usage
1 INDICATIONS AND USAGE Omeprazole and sodium bicarbonate is a proton pump inhibitor indicated for: 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 ) 1.1 Duodenal Ulcer Omeprazole and sodium bicarbonate 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)] Gastric Ulcer Omeprazole and sodium bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies ( 14.2 )] 1.2 Treatment of Gastroesophageal Reflux Disease (GERD) Symptomatic GERD Omeprazole and sodium bicarbonate 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 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 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. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8 week courses of omeprazole and sodium bicarbonate may be considered. [See Clinical Studies (14.3)] 1.3 Maintenance of Healing of Erosive Esophagitis Omeprazole and sodium bicarbonate is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. [See Clinical Studies ( 14.4 )]
Dosage and Administration
2 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 Maintenance of Healing of Erosive Esophagitis: 20 mg once daily* ( 2 ) *Studied for 12 months Omeprazole and sodium bicarbonate is available as a capsule in 20 mg and 40 mg strengths of omeprazole for adult use. Directions for use for each indication are summarized in Table 1. All recommended doses throughout the labeling are based upon omeprazole. Since both the 20 mg and 40 mg capsules contain the same amount of sodium bicarbonate (1100 mg), two capsules of 20 mg are not equivalent to one capsule of omeprazole and sodium bicarbonate 40 mg; therefore, two 20 mg capsules of omeprazole and sodium bicarbonate should not be substituted for one capsule of omeprazole and sodium bicarbonate 40 mg. Omeprazole and sodium bicarbonate capsules should be taken on an empty stomach at least one hour before a meal. Special Populations Hepatic Insufficiency Consider dose reduction, particularly for maintenance of healing of erosive esophagitis. [ See Clinical Pharmacology (12.3)] Administration of Capsules Omeprazole and sodium bicarbonate capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD. Table1