Omeprazole
Dosing in kidney impairment
Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).
Dosing in liver impairment
Hepatic Impairment In patients with hepatic impairment (Child-Pugh Class A, B, or C) exposure to omeprazole substantially increased compared to healthy subjects. Dosage reduction of Omeprazole Delayed-Release Capsules to 10 mg once daily is recommended for patients with hepatic impairment for maintenance of healing of EE [see Dosage and Administration, Clinical Pharmacology] .
| Indication | Recommended Adult ( 2.1) and Pediatric Dosage ( 2.2) | |
|---|---|---|
| Treatment of Active Duodenal Ulcer | 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks ( 2.1) | |
| H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence | ||
| Triple Therapy: | ||
| Omeprazole Delayed-Release Capsules | 20 mg | Each drug twice daily for 10 days ( 2.1)* |
| Amoxicillin | 1000 mg | |
| Clarithromycin | 500 mg | |
| Dual Therapy: | ||
| Omeprazole Delayed-Release Capsules | 40 mg once daily for 14 days** | |
| Clarithromycin | 500 mg three times daily for 14 days ( 2.1) | |
| Active Benign Gastric Ulcer | 40 mg once daily for 4 to 8 weeks ( 2.1) | |
| Symptomatic GERD | 20 mg once daily for up to 4 weeks ( 2.1) See full prescribing information for weight based dosing in pediatric patients 1 year of age and older ( 2.2) | |
| EE due to Acid-Mediated GERD | 20 mg once daily for 4 to 8 weeks ( 2.1)*** See full prescribing information for weight based dosing in pediatric patients 1 year of age and older ( 2.2) | |
| Maintenance of Healing of EE due to Acid-Mediated GERD | 20 mg once daily ( 2.1)**** See full prescribing information for weight based dosing in pediatric patients 1 year of age and older ( 2.2) | |
| Pathological Hypersecretory Conditions | Starting dose is 60 mg once daily (varies with individual patient, see full prescribing information) as long as clinically indicated ( 2.1) | |
| * if ulcer present, continue Omeprazole Delayed-Release Capsules 20 mg once daily for an additional 18 days. | ||
| ** if ulcer present, continue Omeprazole Delayed-Release Capsules 20 mg once daily for an additional 14 days. | ||
| *** an additional 4 weeks of treatment may be given if no response; if recurrence additional 4 to 8 week courses may be considered. | ||
| **** studied for 12 months. Reduce the dosage to 10 mg once daily for patients with hepatic impairment (Child Pugh Class A, B, or C) and Asian patients ( 8.6, 8.7) | ||
| Indication | Dosage of Omeprazole Delayed-Release Capsules | Treatment Duration |
| Treatment of Active Duodenal Ulcer | 20 mg once daily | 4 weeks 1 |
| Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence | Triple TherapyOmeprazole 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 TherapyOmeprazole 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 weeks 2 |
| Maintenance of Healing of EE due to Acid-Mediated GERD | 20 mg once daily 3 | 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. |
| 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)]. | ||
Preparation and administration
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: 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. Open the capsule. Carefully empty all of the microtablets inside the capsule on the applesauce. Mix the microtablets with the applesauce. Swallow applesauce and microtablets immediately with a glass of cool water to ensure complete swallowing of the microtablets.
Do not chew or crush the microtablets. Do not save the applesauce and microtablets for future use.