Omeprazole

OMEPRAZOLE- omeprazole capsule, delayed release
Denton Pharma, Inc. DBA Northwind Pharmaceuticals

1 INDICATIONS AND USAGE

1.1 Treatment of Active Duodenal Ulcer

Omeprazole Delayed-Release Capsules is 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, is 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 is 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 is 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 is 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 is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 1 year of age and older.

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

Pediatric Patients 1 Year of Age to Adults

Omeprazole Delayed-Release Capsules is 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 1 year 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 is indicated for the maintenance healing of EE due to acid-mediated GERD in patients 1 year of age and older.

Controlled studies do not extend beyond 12 months.

1.7 Pathological Hypersecretory Conditions

Omeprazole Delayed-Release Capsules is 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

Indication Dosage of Omeprazole Delayed-Release Capsules Treatment Duration
Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks 1

H elicobacter pylori Eradication to

T riple Therapy

Omeprazole Delayed-Release Capsules 20 mg

Amoxicillin 1000 mg

Clarithromycin 500 mg

10 days

D ual Therapy

14 days

Active Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks
Treatment of Symptomatic GERD 20 mg once daily Up to 4 weeks
Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily 4 to 8 weeks 2

Pathological Hypersecretory

20 mg once daily 3 Controlled studies do not extend beyond 12 months.

1. Most patients heal within 4 weeks; some patients may require an additional 4 weeks of therapy to achieve healing.

2. 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)].


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

Indication Omeprazole Delayed-Release Capsules Dosage Regimen and Duration
Patient Age Weight-Based Dose (mg) Regimen and Duration

Treatment of Symptomatic

1 to 16 years 5 to less than 10 kg: 5 mg Once daily for up to 4 weeks
10 to less than 20 kg: 10 mg
20 kg and greater: 20 mg
Treatment of EE due to Acid-Mediated GERD 1 to 16 years 5 to less than 10 kg: 5 mg Once daily for 4 to 8 weeks 1
10 to less than 20 kg: 10 mg
20 kg and greater: 20 mg

Maintenance of Healing of

1 to 16 years 5 to less than 10 kg: 5 mg

Once daily. Controlled

10 to less than 20 kg: 10 mg
20 kg and greater: 20 mg
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.

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