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Drug Catalog - Product Detail

ESOMEPRAZOLE MAGNESIUM DR CP 40MG 30

NDC Mfr Size Str Form
13668-0155-30 TORRENT PHARMACEUTICALS 30 40MG CAPSULE
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Description
11 DESCRIPTION The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole Magnesium Delayed-Release Capsules are supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 20.7 mg, or 41.4 mg esomeprazole magnesium) in the form of enteric-coated granules with the following inactive ingredients: 20mg: D&C Red 28, ethyl cellulose, FD & C Red 40, gelatin, iron oxide yellow, magnesium oxide (light), magnesium stearate, methacrylic acid co-polymer, mono and diglycerides, polysorbate 80, povidone (K90D), sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate. 40mg: D&C Red 28, ethyl cellulose, FD & C Red 40, gelatin, magnesium oxide (light), magnesium stearate, methacrylic acid co-polymer, mono and diglycerides, polysorbate 80, povidone (K90D), sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate. Capsules have pharmaceutical grade printing ink that contains black iron oxide, potassium hydroxide, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, are size '4' hard gelatin capsule having yellow cap and pink body imprinted as '20 mg' on the body with white ink and '1154' on the cap with black ink, containing off white to cream colored granules. They are supplied as follows: Bottles of 30 NDC 13668-154-30 Bottles of 90 NDC 13668-154-90 Bottles of 500 NDC 13668-154-05 Bottles of 1000 NDC 13668-154-10 100 Unit dose capsules NDC 13668-154-74 Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, are size '2' hard gelatin capsule having pink cap and body, imprinted as '40 mg' on the body and '1155' on the cap with white ink, containing off white to cream colored granules. They are supplied as follows: Bottles of 30 NDC 13668-155-30 Bottles of 90 NDC 13668-155-90 Bottles of 500 NDC 13668-155-05 Bottles of 1000 NDC 13668-155-10 100 Unit dose capsules NDC 13668-155-74 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 Esomeprazole Magnesium Delayed-Release Capsules, USP container tightly closed. Dispense in a tight container with a child-resistant closure.
Indications & Usage
1 INDICATIONS AND USAGE Esomeprazole Magnesium Delayed-Release Capsules is a proton pump inhibitor indicated for the following: Treatment of gastroesophageal reflux disease (GERD). ( 1.1 ) Risk reduction of NSAID-associated gastric ulcer. ( 1.2 ) H. pylori eradication to reduce the risk of duodenal ulcer recurrence. ( 1.3 ) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. ( 1.4 ) 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole Magnesium Delayed-Release Capsules may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole Magnesium Delayed-Release Capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. 1.2 Risk Reduction of NSAID-Associated Gastric Ulcer Esomeprazole Magnesium Delayed-Release Capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months. 1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy (Esomeprazole Magnesium Delayed-Release Capsules plus amoxicillin and clarithromycin): Esomeprazole Magnesium Delayed-Release Capsules in combination with amoxicillin and clarithromycin, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Dosage and Administration (2) and Clinical Studies (14) ] . In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the prescribing information for clarithromycin ] . 1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Esomeprazole Magnesium Delayed-Release Capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Indication Dose Frequency Gastroesophageal Reflux Disease (GERD) Adults 20 mg or 40 mg Once daily for 4 to 8 weeks 12 to 17 years 20 mg or 40 mg Once daily for up to 8 weeks 1 to 11 years 10 mg or 20 mg Once daily for up to 8 weeks Risk Reduction of NSAID-Associated Gastric Ulcer 20 mg or 40 mg Once daily for up to 6 months H. pylori Eradication (Triple Therapy): Esomeprazole Magnesium Delayed-Release Capsules 40 mg Once daily for 10 days Amoxicillin 1000 mg Twice daily for 10 days Clarithromycin 500 mg Twice daily for 10 Days Pathological Hypersecretory Conditions 40 mg Twice daily See full prescribing information for administration options. ( 2 ) Patients with severe liver impairment-do not exceed dose of 20 mg. ( 2 ) Esomeprazole Magnesium Delayed-Release Capsules are supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in the Table 1. Esomeprazole Magnesium Delayed-Release Capsules should be taken at least one hour before meals. The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the prescribing information, and individual patient medical needs. Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment. Table 1:Recommended Dosage Schedule for Esomeprazole Magnesium Delayed-Release Capsules 1. [See Clinical Studies (14.1) ] The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be considered. 2. Controlled studies did not extend beyond six months. 3. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered. 4. Doses over 1 mg/kg/day have not been studied. 6. The dosage of Esomeprazole Magnesium Delayed-Release Capsules in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs. 7. Doses up to 240 mg daily have been administered [see Drug Interactions (7)] . Indication Dose Frequency Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis 20 mg or 40 mg Once Daily for 4 to 8 Weeks 1 Maintenance of Healing of Erosive Esophagitis 20 mg Once Daily 2 Symptomatic Gastroesophageal Reflux Disease 20 mg Once Daily for 4 Weeks 3 Pediatric GERD 12 to 17 Year Olds Healing of Erosive Esophagitis Symptomatic GERD 20 mg or 40 mg 20 mg Once Daily for 4 to 8 Weeks Once Daily for 4 Weeks 1 to 11 Year Olds 4 Short-term Treatment of Symptomatic GERD 10 mg Once Daily for up to 8 Weeks Healing of Erosive Esophagitis weight < 20 kg 10 mg Once Daily for 8 Weeks weight ≥ 20 kg 10 mg or 20 mg Once Daily for 8 Weeks Risk Reduction of NSAID-Associated Gastric Ulcer 20 mg or 40 mg Once Daily for up to 6 months 2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Esomeprazole Magnesium Delayed-Release Capsules 40 mg Once Daily for 10 Days Amoxicillin 1000 mg Twice Daily for 10 Days Clarithromycin 500 mg Twice Daily for 10 Days Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 40 mg 6 Twice Daily 7 Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients. Specific Populations Hepatic Insufficiency In patients with mild to moderate liver impairment (Child-Pugh Classes A and B), no dosage adjustment is necessary. For patients with severe liver impairment (Child-Pugh Class C), a dose of 20 mg of Esomeprazole Magnesium Delayed-Release Capsules should not be exceeded [see Clinical Pharmacology (12.3) ] . Directions for use specific to the route and available methods of administration for each of these dosage forms are presented in Table 2. Table 2: Administration Options Administration Options ( See text following table for additional instructions .) Dosage Form Route Options Delayed-Release Capsules Oral Capsule can be swallowed whole. -or- Capsule can be opened and mixed with applesauce. Delayed-Release Capsules Nasogastric Tube Capsule can be opened and the intact granules emptied into a syringe and delivered through the nasogastric tube. Esomeprazole Magnesium Delayed-Release Capsules Esomeprazole Magnesium Delayed-Release Capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the Esomeprazole Magnesium Delayed-Release Capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce. The granules should be mixed with the applesauce and then swallowed immediately: do not store for future use. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The granules should not be chewed or crushed. If the granules/applesauce mixture is not used in its entirety, the remaining mixture should be discarded immediately. For patients who have a nasogastric tube in place, Esomeprazole Magnesium Delayed-Release Capsules can be opened and the intact granules emptied into a 60 mL catheter tipped syringe and mixed with 50 mL of water. It is important to only use a catheter tipped syringe when administering Esomeprazole Magnesium Delayed-Release Capsules through a nasogastric tube. Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the syringe with the tip up and check for granules remaining in the tip. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach. After administering the granules, the nasogastric tube should be flushed with additional water. Do not administer the granules if they have dissolved or disintegrated. The mixture must be used immediately after preparation.