Omeprazole

OMEPRAZOLE — omeprazole capsule, delayed release
NorthStar Rx LLC

1 INDICATIONS AND USAGE

1.1 Treatment of Active Duodenal Ulcer

Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

1.2 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

Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.

Dual Therapy
Omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. 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 clarithromycin prescribing information, Microbiology section].

1.3 Treatment of Active Benign Gastric Ulcer

Omeprazole delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.

1.4 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)

Omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 2 years of age and older.

1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD

Pediatric Patients 2 Years of Age to Adults

Omeprazole delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 2 years of age and older.

The efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered.

1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD

Omeprazole delayed-release capsules are indicated for the maintenance healing of EE due to acid-mediated GERD in patients 2 years of age and older.

Controlled studies do not extend beyond 12 months.

1.7 Pathological Hypersecretory Conditions

Omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Adult Dosage Regimen by Indication

Table 1 shows the recommended dosage of omeprazole delayed-release capsules in adult patients by indication.

Table 1: Recommended Dosage Regimen of Omeprazole Delayed-Release Capsules in Adults by Indication
1. Most patients heal within 4 weeks; some patients may require an additional 4 weeks of therapy to achieve healing2. The efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered.3. Dosage reduction to 10 mg once daily is recommended for patients with hepatic impairment (Child-Pugh Class A, B or C) and Asian patients when used for the maintenance of healing of EE [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3, 12.5)].
Indication Dosage of Omeprazole Delayed-Release Capsules Treatment Duration
Treatment of Active DuodenalUlcer 20 mg once daily 4 weeks1
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Omeprazole delayed-release capsules 20 mgAmoxicillin 1000 mgClarithromycin 500 mgTake all three drugs twice daily 10 daysIn patients with an ulcer present at the time of initiation of therapy, continue omeprazole delayed-release capsules 20 mg once daily for an additional 18 days for ulcer healing and symptom relief.
Dual Therapy Omeprazole delayed-release capsules 40 mg once daily Clarithromycin 500 mg three times daily 14 daysIn patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
Active Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks
Treatment of Symptomatic GERD 20 mg once daily Up to 4 weeks
Treatment of EE due to Acid-Mediated GERD 20 mg once daily 4 to 8 weeks2
Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily3 Controlled studies do not extend beyond 12 months.
Pathological Hypersecretory Conditions Starting dose is 60 mg once daily;adjust to patient needsDaily dosages of greater than 80 mg should be administered in divided doses.Dosages up to 120 mg three timesdaily have been administered. As long as clinically indicated.Some patients with Zollinger- Ellison syndrome have been treated continuously for more than 5 years.

2.2 Recommended Pediatric Dosage Regimen by Indication

Table 2 shows the recommended dosage of omeprazole delayed-release capsules in pediatric patients by indication.

Table 2: Recommended Dosage Regimen of Omeprazole Delayed-Release Capsules in Pediatric Patients by Indication
1. The efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered.
Indication Omeprazole Delayed-Release Capsules Dosage Regimen and Duration
Patient Age Weight-Based Dose (mg) Regimen and Duration
Treatment of Symptomatic GERD 2 to 16 years 10 to less than 20 kg: 10 mg Once daily for up to 4 weeks
20 kg and greater: 20 mg
Treatment of EE due to Acid- Mediated GERD 2 to 16 years 10 to less than 20 kg: 10 mg Once daily for 4 to 8 weeks1
20 kg and greater: 20 mg
Maintenance of Healing of EE due to Acid-Mediated GERD 2 to 16 years 10 to less than 20 kg: 10 mg Once daily. Controlled studies do not extend beyond 12 months
20 kg and greater: 20 mg

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