Drug Catalog - Product Detail
ESOMEPRAZOLE MAGNESIUM DR CP 40MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 43598-0510-90 | DR.REDDY'S LABORATORIES, INC. | 90 | 40MG | CAPSULE |
PACKAGE FILES
Generic Name
ESOMEPRAZOLE MAGNESIUM
Substance Name
ESOMEPRAZOLE MAGNESIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA078279
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 trihydrate. 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 x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. 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 is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac. Figure1
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to brown colored pellets filled in Size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's. Bottles of 30 NDC 43598-509-30 Bottles of 90 NDC 43598-509-90 Bottles of 1000 NDC 43598-509-10 Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to brown colored pellets filled in Size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s, 90's and 1000's. Bottles of 30 NDC 43598-510-30 Bottles of 90 NDC 43598-510-90 Bottles of 1000 NDC 43598-510-10 Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules product package is subdivided.
Indications & Usage
1 INDICATIONS AND USAGE Esomeprazole magnesium is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) Maintenance of healing of EE in adults. ( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4 ) Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5 ) Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6 ) 1.1 Healing of Erosive Esophagitis (EE) Adults 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 EE in adults. 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. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. 1.2 Maintenance of Healing of EE Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. 1.3 Treatment of Symptomatic GERD Adults 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. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age. 1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (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 adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months. 1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H.pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and clarithromycin, are indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori . 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 clarithromyci n]. 1.6 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, in adults.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Population Recommended Adult ( 2.1 ) and Pediatric Dosage ( 2.2 ) Healing of EE (1 year and older) Adults 20 mg or 40 mg 1 once daily for 4 to 8 weeks; some patients may require an additional 4 to 8 weeks 12 years to 17 years 20 mg or 40 mg1 once daily for 4 to 8 weeks Maintenance of Healing of EE Adults 20 mg once daily. Controlled studies do not extend beyond 6 months Treatment of Symptomatic GERD Adults 20 mg once daily once daily for 4 weeks some patients may require an additional 4 weeks 12 years to 17 years 20 mg once daily for 4 weeks Risk Reduction of NSAID-Associated Gastric Ulcer Adults 20 mg or 40 mg 1 once daily for up to 6 months2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Adults Esomeprazole magnesium delayed-release capsules 40 mg 1 once daily for 10 days Amoxicillin 1000 mg twice daily for 10 days 3 Clarithromycin 500 mg twice daily for 10 days 3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults Starting dosage is 40 mg twice daily 4 (varies with the individual patient) as long as clinically indicated. 1 A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). 2 Controlled studies do not extend beyond 6 months. 3 Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients. 4 A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C). Preparation and Administration Information Swallow capsules whole; do not crush or chew. For patients who cannot swallow intact capsule, the capsule can be opened, and the contents mixed with applesauce. ( 2.3 ) Opened capsules can be administered through a nasogastric tube. ( 2.3 ) 2.1 Recommended Dosage in Adults by Indication Table 1 shows the recommended adult dosage of esomeprazole magnesium delayed-release capsules by indication. The duration of esomeprazole magnesium delayed-release capsules treatment should be based on available safety and efficacy data specific to the defined indication and dosing frequency and individual patient medical needs. Esomeprazole magnesium delayed-release capsules should only be initiated and continued if the benefits outweigh the risks of treatment. Table 1: Recommended Dosage of Esomeprazole Magnesium Delayed-Release Capsules in Adults by Indication Adult Indication Recommended Dosage of Esomeprazole magnesium delayed-release capsules Treatment Duration Healing of EE 20 mg or 40 mg 1 once daily 4 to 8 weeks 2 Maintenance of Healing of EE 20 mg once daily Controlled studies do not extend beyond 6 months Treatment of Symptomatic GERD 20 mg once daily 4 weeks; if symptoms do not resolve completely, consider an additional 4 weeks Risk Reduction of NSAID-Associated Gastric Ulcer 20 mg or 40 mg 1 once daily Controlled studies do not extend beyond 6 months H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (Triple Therapy) Esomeprazole 40 mg once daily 1 10 days Amoxicillin 1000 mg twice daily 3 10 days Clarithromycin 500 mg twice daily 3 10 days Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Starting dosage is 40 mg twice daily 4 ; individualize the regimen to patient needs. Dosages of up to 240 mg/day have been administered [see Clinical Studies (14.7)] As long as clinically indicated 1. A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations ( 8.6 )]. 2. Most 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 required to achieve healing [see Clinical Studies ( 14.1 )]. 3. Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients. 4. A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations ( 8.6 )]. 2.2 Recommended Dosage in Pediatric Patients by Indication Table 2 shows the recommended dosage of esomeprazole magnesium delayed-release capsules in pediatric patients by indication. Table 2: Recommended Dosage of Esomeprazole Magnesium Delayed-Release Capsules in Pediatric Patients by Indication Indication Patient Age Recommended Dosage Duration Healing of EE 12 years to 17 years Esomeprazole magnesium delayed-release capsules 20 mg or 40 mg once daily 4 to 8 Weeks Treatment of Symptomatic GERD 12 years to 17 years Esomeprazole magnesium delayed-release capsules 20 mg once daily 4 weeks 1 Dosages over 1 mg/kg/day have not been studied 2 Dosages over 1.33 mg/kg/day have not been studied 2.3 Preparation and Administration Instructions Take esomeprazole magnesium delayed-release capsules at least one hour before meals [see Clinical Pharmacology ( 12.3 )]. Antacids may be used concomitantly with esomeprazole magnesium delayed-release capsules. Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time. Esomeprazole Magnesium Delayed-Release Capsules Administer esomeprazole magnesium delayed-release capsules orally or via a nasogastric tube, as described below. Oral Administration Swallow esomeprazole magnesium delayed-release capsules whole; do not chew or crush the capsules. For patients who have difficulty swallowing capsules, esomeprazole magnesium delayed-release capsules can be opened, and the contents sprinkled on applesauce. Use with other foods has not been evaluated and is not recommended. 1. Add one tablespoon of applesauce to an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. 2. Open the esomeprazole magnesium delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce. 3. Mix the granules with the applesauce. 4. Administer the mixture immediately. Do not chew or crush the granules 5. Discard any remaining mixture. Do not store the mixture for future use. Administration via Nasogastric Tube 1. Open the esomeprazole magnesium delayed-release capsule and empty the granules into a 60 mL catheter-tipped syringe. 2. Mix the granules with 50 mL of water. 3. Replace the plunger and shake the catheter-tipped syringe vigorously for 15 seconds. 4. Hold the catheter-tipped syringe with the tip up and check for any granules remaining in the tip. 5. Attach the catheter-tipped syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach. 6. After administering the granules, flush the nasogastric tube with additional water. Use the mixture immediately after preparation. 7. Do not administer the granules if they have dissolved or disintegrated.