Prescription Drug Information: Prilosec
PRILOSEC- omeprazole magnesium granule, delayed release
Covis Pharma US, Inc
1 INDICATIONS AND USAGE
1.1 Treatment of Active Duodenal Ulcer
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.
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
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.
Dual Therapy
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].
1.3 Treatment of Active Benign Gastric Ulcer
PRILOSEC 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)
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.
1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD
Pediatric Patients 1 Year of Age to Adults
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.
Pediatric Patients 1 Month to Less than 1 Year of Age
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.
1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD
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.
1.7 Pathological Hypersecretory Conditions
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.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Adult Dosage Regimen by Indication
Table 1 shows the recommended dosage of PRILOSEC in adult patients 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 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. |
2.2 Recommended Pediatric Dosage Regimen by Indication
Table 2 shows the recommended dosage 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 |
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