Esomeprazole Magnesium: Package Insert and Label Information

ESOMEPRAZOLE MAGNESIUM — esomeprazole magnesium capsule, delayed release
Graviti Pharmaceuticals Private Limited

1 INDICATIONS AND USAGE

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 is 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 clarithromycin].

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.

2 DOSAGE AND ADMINISTRATION

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 buy Indication

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)].

Adult Indication Recommended Dosage of Esomeprazole magnesium delayed-release capsules Treatment Duration
Healing of EE 20 mg or 40 mg1 once daily 4 to 8 Weeks2 Controlled studies do not extend beyond 6 months 4 weeks; if symptoms do not resolve completely, consider an additional 4 weeks
Maintenance of Healing of EE 20 mg once daily
Treatment of Symptomatic GERD 20 mg once daily
Risk Reduction of NSAID-Associated Gastric Ulcer 20 mg or 40 mg1 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 daily1 Amoxicillin 1000 mg twice daily3 Clarithromycin 500 mg twice daily3 Starting dosage is 40 mg twice daily4 ; individualize the regimen to patient needs. 10 days 10 days 10 days
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Dosages of up to 240 mg/day have been administered [see Clinical Studies (14.7)] As long as clinically indicated

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

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.
  • 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.
  7. Use the mixture immediately after preparation. Do not administer the granules if they have dissolved or disintegrated.

3 DOSAGE FORMS AND STRENGTHS

Esomeprazole magnesium delayed-release capsules, USP 20 mg are size ‘4’ hard gelatin white opaque colored capsule, imprinted with ‘186’ on cap and ’20 mg’ on body and filled with white to slightly yellow colored pellets.

Esomeprazole magnesium delayed-release capsules, USP 40 mg are size ‘3’ hard gelatin white opaque colored capsule, imprinted with ‘187’ on cap and ’40 mg’ on body and filled with white to slightly yellow colored pellets.

4 CONTRAINDICATIONS

  • Esomeprazole magnesium delayed-release capsules are 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 delayed-release capsules 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 delayed-release capsules, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)].

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

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.

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 delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules, 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 Severe Cutaneous Adverse Reactions

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs [see Adverse Reactions (6.2)]. Discontinue esomeprazole magnesium delayed-release capsules at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

5.6 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 delayed-release capsules, 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.

5.7 Interaction with Clopidogrel

Avoid concomitant use of esomeprazole magnesium delayed-release capsules 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 delayed-release capsules consider alternative anti-platelet therapy [see Drug Interactions (7)].

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