Drug Catalog - Product Detail
OMEPRAZOLE/SODIUM BICARBONATE POWDER FOR ORAL SUSPENSION PCKT 20/1680MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0268-11 | PAR PHARMACEUTICAL | 30 | 20-1680MG | PACKAGE |
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Description
11 DESCRIPTION Omeprazole and sodium bicarbonate for oral suspension is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -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 is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble 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 unit dose packets for oral suspension. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole and 1680 mg of sodium bicarbonate with the following excipients: xylitol, xanthan gum, sucralose powder, peach powder, sucrose and peppermint flavor. Omeprazole and sodium bicarbonate for oral suspension is immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation. This is the structured formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Omeprazole and sodium bicarbonate is supplied as: Omeprazole and Sodium Bicarbonate for Oral Suspension is a white to off white, granular powder packaged in individual dose packets. Each packet contains either 20 mg or 40 mg omeprazole and 1680 mg sodium bicarbonate. NDC 49884-268-11 Cartons of 30: 20 mg/1680 mg unit dose packets NDC 49884-269-11 Cartons of 30: 40 mg/1680 mg unit dose packets Storage Store at 25°C (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.
Indications & Usage
1 INDICATIONS AND USAGE 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. o 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. maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months. Omeprazole and sodium bicarbonate for oral suspension is indicated in adults for the : reduction of risk of upper GI bleeding in critically ill adult patients. 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
2 DOSAGE AND ADMINISTRATION Indication Recommended Adult Dosage 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 * 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. 2.1 Important Administration Instructions Omeprazole and sodium bicarbonate is available as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole. The sodium content of omeprazole and sodium bicarbonate for oral suspension should be taken into consideration when prescribing this product [see WARNINGS AND PRECAUTIONS ( 5.3 ) ]. Omeprazole and sodium bicarbonate for oral suspension: each 20 mg and 40 mg packet contains 1,680 mg (20 mEq) of sodium bicarbonate. The total content of sodium in each packet is 460 mg. Due to the sodium bicarbonate content of omeprazole and sodium bicarbonate for oral suspension: Two packets of 20 mg omeprazole and sodium bicarbonate for oral suspension are not interchangeable with one packet of 40 mg omeprazole and sodium bicarbonate for oral suspension. 2.2 Dosage Regimen The recommended dosage regimen by indication in adults of omeprazole and sodium bicarbonate for oral suspension is summarized in Table 1 . Only 40 mg Omeprazole and sodium bicarbonate for oral suspension is indicated for the reduction of risk of upper GI bleeding in critically ill adult patients and the dosage regimen is summarized in Table 2 . All recommended dosages are based upon omeprazole content. Table 1: Recommended Dosage Regimen of Omeprazole and Sodium Bicarbonate for Oral Suspension in Adults by Indication Indication Dosage of omeprazole and sodium bicarbonate for oral suspension Treatment Duration Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks 1,2 Treatment of Active Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily Up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily 4 to 8 weeks 2 Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily Controlled studies do not extend beyond 12 months. 1 Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. [see CLINICAL STUDIES ( 14.1 ) ] 2 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 . Table 2: Recommended Dosage Regimen of 40 mg Omeprazole and Sodium Bicarbonate for Oral Suspension in Adults by Indication Indication Dosage of 40 mg Omeprazole and Sodium Bicarbonate for oral suspension Treatment Duration 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 14 days 2.3 Preparation and Administration Omeprazole and Sodium Bicarbonate for Oral Suspension Omeprazole and Sodium Bicarbonate for oral suspension is intended to be mixed with water and administered orally or via a nasogastric (NG) or orogastric (OG) tube. If administered orally, take on an empty stomach at least one hour before a meal. If administered via NG or OG tube, suspend enteral feeding approximately 3 hours before and 1 hour after administration of Omeprazole and Sodium Bicarbonate or oral suspension. Oral Administration Empty the contents of a packet into a small cup containing 5 to 10 mL of water. Do not mix with liquids or foods other than water. Stir well and drink immediately. Refill cup with water and drink immediately. Nasogastric (NG) or Orogastric (OG) Tube Administration Add 20 mL of water to a catheter tipped syringe and then add the contents of a packet. Use an appropriately-sized catheter tipped syringe. Do not mix with liquids or foods other than water. Shake the syringe to dissolve the powder. Administer through the NG or orogastric tube into the stomach right away. Refill the syringe with an equal amount of water. Shake and flush any remaining contents from the NG tube or orogastric tube into the stomach.