Esomeprazole Magnesium (Page 2 of 12)

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.
Open the esomeprazole magnesium delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce.
Mix the granules with the applesauce.
Administer the mixture immediately. Do not chew or crush the granules
Discard any remaining mixture. Do not store the mixture for future use.

Administration via Nasogastric Tube

Open the esomeprazole magnesium delayed-release capsule and empty the granules into a 60 mL catheter-tipped syringe.
Mix the granules with 50 mL of water.
Replace the plunger and shake the catheter-tipped syringe vigorously for 15 seconds.
Hold the catheter-tipped syringe with the tip up and check for any granules remaining in the tip.
Attach the catheter-tipped syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach.
After administering the granules, flush the nasogastric tube with additional water.
Use the mixture immediately after preparation. Do not administer the granules if they have dissolved or disintegrated.


Esomeprazole Magnesium Delayed-Release Capsules

Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg – Size 4 capsule with pink opaque cap imprinted with ‘RB66′ and pink opaque body imprinted with ’20 mg’ in black ink containing off-white to brownish colored beads.
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40 mg — Size 3 capsule with pink opaque cap imprinted with ‘RB67′ and pink opaque body imprinted with ’40 mg’ in black ink containing off-white to brownish colored beads.


Esomeprazole magnesium 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 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)].


5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with esomeprazole magnesium 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.

5.2 Acute Tubulointerstitial Nephritis

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue esomeprazole magnesium and evaluate patients with suspected acute TIN [see Contraindications (4)].

5.3 Clostridium difficile -Associated Diarrhea

Published observational studies suggest that PPI therapy like esomeprazole magnesium may be associated with an increased risk of Clostridium difficile -associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)].

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with esomeprazole magnesium, refer to Warnings and Precautions section of the corresponding prescribing information.

5.4 Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2) and Adverse Reactions (6.2)].

5.5 Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including esomeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving esomeprazole magnesium, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

5.6 Interaction with Clopidogrel

Avoid concomitant use of esomeprazole magnesium with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as esomeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 40 mg esomeprazole reduces the pharmacological activity of clopidogrel. When using esomeprazole magnesium consider alternative anti-platelet therapy [see Drug Interactions (7)].

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