Esomeprazole Magnesium for delayed-release oral suspension 20 mg/1
Esomeprazole Magnesium · GRANULE, DELAYED RELEASE · Torrent Pharmaceuticals Limited
Esomeprazole magnesium is a proton pump inhibitor used to reduce stomach acid and treat conditions like acid reflux, heartburn, and ulcers. This delayed-release oral suspension comes as granules that dissolve in your mouth or can be mixed with liquid before swallowing.
Key Facts
- Brand Name
- Esomeprazole Magnesium for delayed-release oral suspension
- Generic Name
- Esomeprazole Magnesium
- NDC Code (Product)
13668-549- Manufacturer
- Torrent Pharmaceuticals Limited
- Strength
- 20 mg/1
- Dosage Form
- GRANULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA212651
- Drug Class
- Cytochrome P450 2C19 Inhibitors [MoA]; Proton Pump Inhibitor [EPC]
- Marketing Start
- 03/05/2025
Recall History
CIPLA
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
CIPLA
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Zydus Pharmaceuticals (USA) Inc
Labeling: Not Elsewhere Classified - Wrong NDC number
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
CIPLA
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Esomeprazole magnesium for delayed-release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed-release oral suspension is 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 ) Esomeprazole magnesium for delayed-release oral suspension is indicated for the: Short-term treatment in the healing of EE in pediatric patients 1 year to 11 years of age and of EE du…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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). Population Recommended Adult ( 2.1 ) and Pediatric Dosage ( 2.2 ) Healing of EE (1 year and older) EE due to Acid-Mediated GERD (1 month to less than 1 year) 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 mg 1 once daily for 4 to 8 weeks 1 month to 11 years see full prescribing information for weight-based dosing and duration of treatment ( 2.2 ) 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 1 year to 11 years 10 mg onc…
Contraindications
4 CONTRAINDICATIONS Esomeprazole magnesium for delayed-release oral suspension is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2) , Adverse Reactions (6.2) ] . For information about contraindications of amoxicillin and clarithromycin, indicated in combination with esomeprazole magnesium for delayed-release oral suspension for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information. Proton pump inhibitors (PPIs), including esomeprazole magnesium, are contraindicated in patients receiving rilpivirine-containing products [ see Drug Interactions (7) ]. Known hypersensitivity to substituted benzimidazoles or any component of the formulation. ( 4 ) Patients receiving rilpivirine-containing products. ( 4 , 7 ) Refer to the Contraindications section of the prescribing information for amoxicillin and clarithromycin, when administered in co…
Drug Interactions
7 DRUG INTERACTIONS Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with esomeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Esomeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with esomeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology (12.3) ] . Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with esomeprazole may increase toxicity [see Clinical Pharmacology (12.3) ]. There are other antiretroviral drugs which do not result in clinically relevant interactions with esomeprazole. Intervention: Rilpivirine-con…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] Bone Fracture [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6) ] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.8) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.9) ] Fundic Gland Polyps [see Warnings and Precautions (5.13) ] Most common adverse reactions ( 6.1 ): Adults (≥ 18 years) (≥1%) are: headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. Pediatrics (1 to 17 years) (≥2%) are: headache, diarrhea, abdominal pain, nausea, and somnolence. Pediatrics (1 month to less than 1 year) (>1%) are: abdominal pain, regurgitation, tachypnea, and increased ALT. To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial…
Frequently Asked Questions
What is Esomeprazole Magnesium for delayed-release oral suspension used for?
Esomeprazole magnesium is a proton pump inhibitor used to reduce stomach acid and treat conditions like acid reflux, heartburn, and ulcers. This delayed-release oral suspension comes as granules that dissolve in your mouth or can be mixed with liquid before swallowing.
Is Esomeprazole Magnesium for delayed-release oral suspension a controlled substance?
Esomeprazole Magnesium for delayed-release oral suspension is not classified as a controlled substance by the DEA.
What is the generic name for Esomeprazole Magnesium for delayed-release oral suspension?
The generic name for Esomeprazole Magnesium for delayed-release oral suspension is Esomeprazole Magnesium. There are 12 other brand versions of Esomeprazole Magnesium.
What is the NDC code for Esomeprazole Magnesium for delayed-release oral suspension 20 mg/1?
The NDC (National Drug Code) for Esomeprazole Magnesium for delayed-release oral suspension 20 mg/1 is 13668-549, listed by Torrent Pharmaceuticals Limited.
Other Esomeprazole Brands
See all →- Esomeprazole Magnesium20 mg/172559-011
- Esomeprazole Magnesium20 mg/173581-014
- Esomeprazole magnesium40 mg/176420-227
- Esomeprazole Magnesium40 mg/10615-8396
- Esomeprazole Magnesium20 mg/121130-257
- Esomeprazole Magnesium Delayed-Release 20 mg mini20 mg/125000-112
- Esomeprazole Magnesium20 mg/137808-364
- Esomeprazole Magnesium20 mg/143598-407
- NEXIUM20 mg/10186-4020
- NEXIUM40 mg/10186-5040
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)