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Esomeprazole Magnesium
Overview
What is Esomeprazole Magnesium?
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-benzimidazole-1-yl) magnesium dihydrate. 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 (CHNOS)Mg x 2 HO with molecular weight of 749.2 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:
Figure 1
The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water. 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 is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.7 mg, or 43.4 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: diglycerin, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, monoglycerides, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, sodium lauryl sulfate, and titanium dioxide. In addition, the 20 mg capsule shell contains FD & C Red #40 and the 40 mg capsule shell contains FD&C Red #3. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. The 20 mg ink also contains titanium dioxide. The 40 mg ink may also contain n-butyl alcohol.
USP dissolution test is pending
What does Esomeprazole Magnesium look like?
What are the available doses of Esomeprazole Magnesium?
Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg - opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets.
Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, - opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets.
What should I talk to my health care provider before I take Esomeprazole Magnesium?
How should I use Esomeprazole Magnesium?
Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-release Capsules is 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 is 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 is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
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Esomeprazole Magnesium Delayed-release Capsules, USP is supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in 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
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 [].
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
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 pellets inside the capsule carefully emptied onto the applesauce. The pellets 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 pellets should not be chewed or crushed. If the pellets/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 pellets 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 pellets 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 pellets, the nasogastric tube should be flushed with additional water. Do not administer the pellets if they have dissolved or disintegrated.
The mixture must be used immediately after preparation.
What interacts with Esomeprazole Magnesium?
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What are the warnings of Esomeprazole Magnesium?
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What are the precautions of Esomeprazole Magnesium?
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What are the side effects of Esomeprazole Magnesium?
Sorry No records found
What should I look out for while using Esomeprazole Magnesium?
Esomeprazole Magnesium Delayed-release Capsules 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 interstitial nephritis, and urticaria [ ()].
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with Esomeprazole Magnesium Delayed-release Capsules, refer to the CONTRAINDICATIONS section of their package inserts.
What might happen if I take too much Esomeprazole Magnesium?
A single oral dose of esomeprazole at 510 mg/kg (about 124 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions.
The symptoms described in connection with deliberate Esomeprazole Magnesium Delayed-release Capsules overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of esomeprazole were uneventful. Reports of overdosage with omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert - ). No specific antidote for esomeprazole is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive.
As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose contact a Poison Control Center at 1–800–222–1222.
How should I store and handle Esomeprazole Magnesium?
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows:NDC 62175-820-32 unit of use bottles of 30NDC 62175-820-46 unit of use bottles of 90NDC 62175-820-43 bottles of 1000Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows:NDC 62175-840-32 unit of use bottles of 30NDC 62175-840-46 unit of use bottles of 90NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°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.Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows:NDC 62175-820-32 unit of use bottles of 30NDC 62175-820-46 unit of use bottles of 90NDC 62175-820-43 bottles of 1000Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows:NDC 62175-840-32 unit of use bottles of 30NDC 62175-840-46 unit of use bottles of 90NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°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.Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows:NDC 62175-820-32 unit of use bottles of 30NDC 62175-820-46 unit of use bottles of 90NDC 62175-820-43 bottles of 1000Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows:NDC 62175-840-32 unit of use bottles of 30NDC 62175-840-46 unit of use bottles of 90NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°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.Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows:NDC 62175-820-32 unit of use bottles of 30NDC 62175-820-46 unit of use bottles of 90NDC 62175-820-43 bottles of 1000Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows:NDC 62175-840-32 unit of use bottles of 30NDC 62175-840-46 unit of use bottles of 90NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°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.Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows:NDC 62175-820-32 unit of use bottles of 30NDC 62175-820-46 unit of use bottles of 90NDC 62175-820-43 bottles of 1000Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows:NDC 62175-840-32 unit of use bottles of 30NDC 62175-840-46 unit of use bottles of 90NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°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.Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows:NDC 62175-820-32 unit of use bottles of 30NDC 62175-820-46 unit of use bottles of 90NDC 62175-820-43 bottles of 1000Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows:NDC 62175-840-32 unit of use bottles of 30NDC 62175-840-46 unit of use bottles of 90NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°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.Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows:NDC 62175-820-32 unit of use bottles of 30NDC 62175-820-46 unit of use bottles of 90NDC 62175-820-43 bottles of 1000Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows:NDC 62175-840-32 unit of use bottles of 30NDC 62175-840-46 unit of use bottles of 90NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°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.Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows:NDC 62175-820-32 unit of use bottles of 30NDC 62175-820-46 unit of use bottles of 90NDC 62175-820-43 bottles of 1000Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows:NDC 62175-840-32 unit of use bottles of 30NDC 62175-840-46 unit of use bottles of 90NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°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.Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows:NDC 62175-820-32 unit of use bottles of 30NDC 62175-820-46 unit of use bottles of 90NDC 62175-820-43 bottles of 1000Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows:NDC 62175-840-32 unit of use bottles of 30NDC 62175-840-46 unit of use bottles of 90NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H/K-ATPase in the gastric parietal cell. The S- and R-isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion.
Non-Clinical Toxicology
Esomeprazole Magnesium Delayed-release Capsules 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 interstitial nephritis, and urticaria [ ()].For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with Esomeprazole Magnesium Delayed-release Capsules, refer to the CONTRAINDICATIONS section of their package inserts.
Cyclobenzaprine HCl may have life-threatening interactions with MAO inhibitors. (See .) Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).
Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.
Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.
† ULTRAM (tramadol hydrochloride tablets, Ortho-McNeil Pharmaceutical)
† ULTRACET (tramadol hydrochloride and acetaminophen tablets, Ortho-McNeil Pharmaceutical)
In adults, symptomatic response to therapy with Esomeprazole Magnesium Delayed-release Capsules does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
The following serious adverse reactions are described below and elsewhere in labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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