Esomeprazole Magnesium

ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release
Proficient Rx LP

1 INDICATIONS AND USAGE

1.1 Treatment of Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

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 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.

In infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD.

Maintenance of Healing of Erosive Esophagitis

Esomeprazole magnesium delayed-release capsules are 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 are 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.

1.2 Risk Reduction of 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 patients at risk for developing gastric ulcers. Patients are considered to be at risk 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

Triple Therapy (esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin):

Esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and clarithromycin, are 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

Esomeprazole magnesium delayed-release capsule USP is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

2 DOSAGE AND ADMINISTRATION

Esomeprazole magnesium 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

Indication

Dose

Frequency

Gastroesophageal Reflux Disease (GERD)

Healing of Erosive Esophagitis

20 mg or 40 mg

Once Daily for 4 to 8 Weeks1

Maintenance of Healing of Erosive Esophagitis

20 mg

Once Daily2

Symptomatic Gastroesophageal Reflux Disease

20 mg

Once Daily for 4 Weeks3

Pediatric GERD

12 to 17 Year Olds

Healing of Erosive Esophagitis

20 mg or 40 mg

Once Daily for 4 to 8 Weeks

Symptomatic GERD

20 mg

Once Daily for 4 Weeks

1 to 11 Year Olds4

Short-term Treatment of Symptomatic GERD

10 mg

Once Daily for up to 8 Weeks

Healing of Erosive Esophagitis

weight < 20 kg

10 mg

Once Daily for 8 Weeks

weight ≥ 20 kg

10 mg or 20 mg

Once Daily for 8 Weeks

1 month to < 1 year old 5

Erosive esophagitis due to acid- mediated GERD

weight 3 kg to 5 kg

2.5 mg

Once Daily for up to 6 Weeks

weight > 5 kg to 7.5 kg

5 mg

Once Daily for up to 6 Weeks

weight >7.5 kg to 12 kg

10 mg

Once Daily for up to 6 Weeks

Risk Reduction of NSAID- Associated Gastric Ulcer

20 mg or 40 mg

Once Daily for up to 6 months

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

Triple Therapy:

Esomeprazole magnesium

40 mg

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

40 mg6

Twice Daily7

1 [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.

2 Controlled studies did not extend beyond six months.

3 If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

4 Doses over 1 mg/kg/day have not been studied.

5 Doses over 1.33 mg/kg/day have not been studied.

6 The dosage of esomeprazole magnesium delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs.

7 Doses up to 240 mg daily have been administered [see Drug Interactions (7)]

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

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