Source: FDA, National Drug Code (US) Revision Year: 2020
PRILOSEC 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.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
PRILOSEC 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.
PRILOSEC 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, PRILOSEC 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].
PRILOSEC is indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
PRILOSEC 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.
PRILOSEC 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 PRILOSEC 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 PRILOSEC may be considered.
PRILOSEC is indicated for the short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.
PRILOSEC 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.
PRILOSEC is indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
Table 1 shows the recommended dosage of PRILOSEC in adult patients by indication.
Table 1. Recommended Dosage Regimen of PRILOSEC in Adults by Indication:
| Indication | Dosage of PRILOSEC | Treatment Duration |
|---|---|---|
| Treatment of Active Duodenal Ulcer | 20 mg once daily | 4 weeks* |
| Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence | Triple Therapy PRILOSEC 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 PRILOSEC 20 mg once daily for an additional 18 days for ulcer healing and symptom relief. |
| Dual Therapy PRILOSEC 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 PRILOSEC 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 weeks† |
| Maintenance of Healing of EE due to Acid-Mediated GERD | 20 mg once daily‡ | 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 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. |
* Most patients heal within 4 weeks; some patients may require an additional 4 weeks of therapy to achieve healing
† The efficacy of PRILOSEC 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 PRILOSEC may be considered.
‡ 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)].
Table 2 shows the recommended dosage of PRILOSEC in pediatric patients by indication.
Table 2. Recommended Dosage Regimen of PRILOSEC in Pediatric Patients by Indication:
| Indication | PRILOSEC Dosage Regimen and Duration | ||
|---|---|---|---|
| Patient Age | Weight-Based Dose (mg) | Regimen and Duration | |
| Treatment of Symptomatic GERD | 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* |
| 10 to less than 20 kg: 10 mg | |||
| 20 kg and greater: 20 mg | |||
| 1 month to less than 1 year | 3 to less than 5 kg: 2.5 mg | Once daily up to 6 weeks | |
| 5 to less than 10 kg: 5 mg | |||
| 10 kg and greater: 10 mg | |||
| Maintenance of Healing of EE due to Acid-Mediated GERD | 1 to 16 years | 5 to less than 10 kg: 5 mg | Once daily. Controlled studies do not extend beyond 12 months |
| 10 to less than 20 kg: 10 mg | |||
| 20 kg and greater: 20 mg | |||
* The efficacy of PRILOSEC 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 PRILOSEC may be considered.
Oral Administration in Water:
Administration with Water via a NG or Gastric Tube (Size 6 or Larger):
Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience [see Adverse Reactions (6)]. Symptoms were transient, and no serious clinical outcome has been reported when PRILOSEC was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
Store PRILOSEC for delayed-release oral suspension at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.]
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