Drug Catalog - Product Detail
OMEPRAZOLE DR 10MG CP 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-2785-31 | SANDOZ | 30 | 10MG | CAPSULE |
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Description
11 DESCRIPTION The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1 H -benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 17 H 19 N 3 O 3 S, with a molecular weight of 345.42. The structural formula is: Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. The Dissolution test to be performed according to USP Test 2. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules. The 10 mg and 20 mg capsule contains the following inactive ingredients: anhydrous lactose, low-substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, microcrystalline cellulose, methacrylic acid copolymer dispersion type C, polysorbate 80, povidone and talc, triethyl citrate. The capsule shells for the 10 mg have the following inactive ingredients: black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. The capsule shells for the 20 mg have the following inactive ingredients: gelatin and titanium dioxide. The ink used for printing contains: black iron oxide, propylene glycol and shellac. The 40 mg capsule contains the following inactive ingredients: acetone, anhydrous lactose, croscarmellose sodium, dehydrated alcohol, dibutyl sebacate, hypromellose phthalate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 80, povidone and talc. The capsule shells for the 40 mg have the following inactive ingredients: hypromellose, red iron oxide, titanium dioxide, and yellow iron oxide. In addition, the capsule shells may also contain black iron oxide, carrageenan, and potassium chloride. The ink used for printing contains black iron oxide. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Omeprazole delayed-release capsules, USP, 10 mg, are light brown cap and light brown body, each imprinted with "OME 10". They are supplied as follows: NDC 0781-2785-31, bottle of 30 capsules (with desiccant) NDC 0781-2785-01, bottle of 100 capsules (with desiccant) NDC 0781-2785-10, bottle of 1000 capsules (with desiccant) Omeprazole delayed-release capsules, USP, 20 mg, are white cap and white body, each imprinted with "OME 20".They are supplied as follows: NDC 0781-2790-31, bottle of 30 capsules (with desiccant) NDC 0781-2790-92, bottle of 90 capsules (with desiccant) NDC 0781-2790-01, bottle of 100 capsules (with desiccant) NDC 0781-2790-10, bottle of 1000 capsules (with desiccant) Omeprazole delayed-release capsules, USP, 40 mg, are white opaque colored cap, light brown colored body, hypromellose capsules, coded “OME 40” on cap and body. They are supplied as follows: NDC 0781-2234-31, bottle of 30 capsules (with desiccant) NDC 0781-2234-01, bottle of 100 capsules (with desiccant) NDC 0781-2234-10, bottle of 1000 capsules (with desiccant) Storage Store omeprazole delayed-release capsules, USP in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Treatment of active benign gastric ulcer in adults ( 1.3 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4 ) Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older ( 1.5 ) Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6 ) Pathologic hypersecretory conditions in adults ( 1.7 ) 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, are 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 are 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 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 are 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.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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 20 mg Each drug twice daily for 10 days ( 2.1 )* Amoxicillin 1000 mg Clarithromycin 500 mg Dual Therapy: Omeprazole 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 2 years 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 2 years 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 2 years 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 ) 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* 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 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. *Most patients heal within 4 weeks; some patients may require an additional 4 weeks of therapy to achieve healing. †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. ‡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 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 weeks* 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 *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. 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: 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 pellets inside the capsule on the applesauce. Mix the pellets with the applesauce. 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.