Omeprazole DR

OMEPRAZOLE DR- omeprazole capsule, delayed release
Advanced Rx Pharmacy of Tennessee, LLC

1. Indications and Usage Section

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, 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 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 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 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 Section

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Adult Dosage Regimen by Indication

Table 1 shows the recommended dosage of omeprazole in adult patients by indication.

Table 1: Recommended Dosage Regimen of Omeprazole in Adults by Indication

Indication

Dosage of Omeprazole

Treatment Duration

Treatment of Active Duodenal
Ulcer

20 mg once daily

4 weeks1

Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy
Omeprazole 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
Take all three drugs twice daily

10 days
In patients with an ulcer present at the time of initiation of therapy, continue omeprazole 20 mg once daily for an additional 18 days for ulcer healing and symptom relief.

Dual Therapy
Omeprazole 40 mg once daily Clarithromycin 500 mg three times daily

14 days
In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 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 needs
Daily dosages of greater than 80 mg should be administered in divided doses.
Dosages up to 120 mg three times
daily have been administered.

As long as clinically indicated.
Some patients with Zollinger-Ellison syndrome have been treated continuously for more than 5 years.

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 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 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 in pediatric patients by indication.

Table 2: Recommended Dosage Regimen of Omeprazole in Pediatric Patients by Indication

Indication

Omeprazole 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

1 The efficacy of omeprazole 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 may be considered.

2.3 Administration Instructions

•
Take omeprazole delayed-release capsules before meals.
•
Antacids may be used concomitantly with omeprazole delayed-release capsules.
•
Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.

Omeprazole Delayed-Release Capsules

•
Swallow omeprazole delayed-release capsules whole; do not chew.
•
For patients unable to swallow an intact capsule, omeprazole delayed-release capsules can be opened and administered as follows:

1.
Place one tablespoon of applesauce into a clean container (e.g., empty bowl). The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
2.
Open the capsule.
3.
Carefully empty all of the pellets inside the capsule on the applesauce.
4.
Mix the pellets with the applesauce.
5.
Swallow applesauce and pellets immediately with a glass of cool water to ensure complete swallowing of the pellets. Do not chew or crush the pellets. Do not save the applesauce and pellets for future use.

3. Dosage Forms and Strengths

Omeprazole Delayed-Release Capsules, USP 10 mg are size ‘3’ two piece hard gelatin capsules with a light blue to blue body with “G” imprinting in black ink and an orange cap with “G230” imprinting in black ink. The capsules are filled with white to off-white pellets.

Omeprazole Delayed-Release Capsules, USP 20 mg are size ‘2’ two piece hard gelatin capsules with a light blue to blue body with “G” imprinting in black ink and a light blue to blue cap with “G231” imprinting in black ink. The capsules are filled with white to off-white pellets.

Omeprazole Delayed-Release Capsules, USP 40 mg are size ‘1’ two piece hard gelatin capsules with an orange body with ‘G’ imprinting in black ink and a light blue to blue cap with ‘G232’ imprinting in black ink. The capsules are filled with white to off-white pellets.