Esomeprazole Strontium: Package Insert and Label Information

ESOMEPRAZOLE STRONTIUM- esomeprazole strontium capsule, delayed release
Amneal Pharmaceuticals of New York LLC

1 INDICATIONS AND USAGE

1.1 Treatment of Gastroesophageal Reflux Disease (GERD) in Adults

Healing of Erosive Esophagitis

Esomeprazole strontium 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 strontium may be considered.

Maintenance of Healing of Erosive Esophagitis

Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.

Symptomatic Gastroesophageal Reflux Disease

Esomeprazole strontium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.

1.2 Risk Reduction of NSAID-Associated Gastric Ulcer in Adults

Esomeprazole strontium is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk either due to their age (≥60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults

Triple Therapy (esomeprazole strontium plus amoxicillin and clarithromycin): esomeprazole strontium, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Dosage and Administration (2) and Clinical Studies (14)].

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 ].

1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome in Adults

Esomeprazole strontium is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

2 DOSAGE AND ADMINISTRATION

Esomeprazole strontium is supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in Table 1. Esomeprazole strontium 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 of Esomeprazole Strontium Delayed-Release Capsules

Indication

Dose

Frequency

Gastroesophageal Reflux Disease (GERD) in Adults

Healing of Erosive Esophagitis

24.65 mga or 49.3 mgb

Once Daily for 4 to 8 Weeks*

Maintenance of Healing of Erosive Esophagitis

24.65 mga

Once Daily**

Symptomatic Gastroesophageal Reflux Disease

24.65 mga

Once Daily for 4 Weeks***

Risk Reduction of NSAID-Associated Gastric Ulcer in Adults

24.65 mga or 49.3 mgb

Once Daily for up to 6 months**

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults

Triple Therapy:

esomeprazole strontium

49.3 mgb

Once Daily for 10 Days

Amoxicillin

1000 mg

Twice Daily for 10 Days

Clarithromycin

500 mg

Twice Daily for 10 Days

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome in Adults

49.3 mg†b

Twice Daily

* [See Clinical Studies (14.1). ] The majority of 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 considered.

** Controlled studies did not extend beyond six months.

*** If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
The dosage of esomeprazole strontium in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs.
Doses up to 240 mg daily have been administered [see Drug Interactions (7) ].
a 24.65 mg of esomeprazole strontium is equivalent to 20 mg of esomeprazole
b 49.3 mg of esomeprazole strontium is equivalent to 40 mg of esomeprazole

Refer to amoxicillin and clarithromycin full prescribing information for Contraindications, Warnings, and dosing in elderly and in renally-impaired patients.

Special 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 24.65 mg of esomeprazole strontium (equivalent to 20 mg of esomeprazole) should not be exceeded [see Clinical Pharmacology (12.3) ].

Administrative Options

Directions for use specific to the route and available methods of administration are presented in Table 2.

Table 2: Administration Options

Administration Options (See text following table for additional instructions.)

Dosage Form

Route

Options

Delayed-Release Capsules

Oral

Capsule can be swallowed whole. Do not chew or crush; or

Capsule can be opened and granules mixed with applesauce. Do not chew or crush granules.

Delayed-Release Capsules

Nasogastric Tube

Capsule can be opened and the intact granules emptied into a catheter tipped syringe and delivered through the nasogastric tube.

Esomeprazole strontium delayed-release capsules should be swallowed whole. Do not chew or crush capsule.

Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the esomeprazole strontium delayed-release capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce. The granules 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 granules should not be chewed or crushed. If the granules/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 strontium delayed-release capsules can be opened and the intact granules 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 strontium 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 granules 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 granules, the nasogastric tube should be flushed with additional water. Do not administer the granules if they have dissolved or disintegrated.

The mixture must be used immediately after preparation.

3 DOSAGE FORMS AND STRENGTHS

Delayed-release capsules: 24.65 mg of esomeprazole strontium (equivalent to 20 mg of esomeprazole) — hard capsules with light pink cap and body containing off white to pale brown granules with HMP 20 printed in black ink.

Delayed-release capsules: 49.3 mg of esomeprazole strontium (equivalent to 40 mg of esomeprazole) — hard capsules with dark pink cap and body containing off white to pale brown granules with HMP 40 printed in black ink.

4 CONTRAINDICATIONS

Esomeprazole strontium is contraindicated in patients with known hypersensitivity to proton pump inhibitors. Hypersensitivity reactions, e.g., angioedema and anaphylactic shock, have been reported with esomeprazole use.

For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole strontium, refer to the CONTRAINDICATIONS section of their package inserts.

5 WARNINGS AND PRECAUTIONS

5.1 Concurrent Gastric Malignancy

Symptomatic response to therapy with esomeprazole strontium does not preclude the presence of gastric malignancy.

5.2 Atrophic Gastritis

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which esomeprazole is an enantiomer.

5.3 Clostridium difficile Associated Diarrhea

Published observational studies suggest that PPI therapy like esomeprazole strontium 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 strontium, refer to WARNINGS and PRECAUTIONS sections of those package inserts.

5.4 Interaction with Clopidogrel

Avoid concomitant use of esomeprazole strontium 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 strontium, consider alternative anti-platelet therapy [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)].

5.5 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)].

5.6 Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2) ].

5.7 Concomitant Use of esomeprazole strontium with St. John’s Wort or Rifampin

Drugs which induce CYP2C19 or CYP3A4 (such as St. John’s Wort or rifampin) can substantially decrease esomeprazole concentrations [see Drug Interactions (7.3) ]. Avoid concomitant use of esomeprazole strontium with St. John’s Wort or rifampin.

5.8 Interactions with Diagnostic Investigations for Neuroendocrine Tumors

Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop esomeprazole treatment before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.

5.9 Concomitant Use of esomeprazole strontium with Methotrexate

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7.7)].

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