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Omeprazole Delayed-release Capsules, USP Strength: 10/20/40 mg per Capsule Pack Size: 30/90/100/500/1000 capsules per bottle Revision No.: 02
EMERGENCY OVERVIEW Omeprazole Delayed-release capsule for oral administration that contains omeprazole and excipients generally considered to be non- toxic and non-hazardous in small quantities and under conditions of normal occupational exposure. Section 1. Identification Identification of the product Product name: Omeprazole Delayed-release Capsules, USP Formula: C 17 H 19 N 3 O 3 S Chemical Name: substituted benzimidazole, 5-methoxy- 2 - [[(4-methoxy-3, 5- dimethyl- 2 - pyridinyl) methyl] sulfinyl]1H-benzimidazole
Omeprazole
Manufacturer / supplier identification Company: Cadila Healthcare Ltd. Ahmedabad, India Address: Sarkhej – Bavla. N.H. 8A, Moraiya. Tal. Sanand. Dist. Ahmedabad – 382210. State: Gujarat. India Contact for information: Tel.: +91 79 6868100 Fax: +91 79 3750319 Emergency Telephone No. Tel.: +91 79 6868100 Recommended use / Therapeutic Category Omeprazole delayed-release capsules are proton pump inhibitor indicated for: Treatment in adults of duodenal ulcer and gastric ulcer. Treatment in adults and children of gastroesophageal reflux disease (GERD) and maintenance of healing of erosive esophagitis.
Omeprazole Delayed-release Capsules, USP Strength: 10/20/40 mg per Capsule Pack Size: 30/90/100/500/1000 capsules per bottle Revision No.: 02
Restriction on Use / Contraindications: Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis and urticarial. Section 2. Hazard(s) Information Dose and Administration Omeprazole delayed-release capsules should be taken before eating. Patients should be informed that the omeprazole delayed-release capsules should be swallowed whole.
- Short-Term Treatment of Active Duodenal Ulcer- The recommended adult oral dose of omeprazole is 20 mg once daily. - H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence Triple Therapy (omeprazole/clarithromycin/amoxicillin) The recommended adult oral regimen is omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief. Dual Therapy (omeprazole/clarithromycin) The recommended adult oral regimen is omeprazole 40 mg once daily plus clarithromycin 500 mg three times daily for 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. - Gastric Ulcer The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks. - Gastroesophageal Reflux Disease (GERD) The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks. - Maintenance of Healing of Erosive Esophagitis The recommended adult oral dose is 20 mg daily. - Pathological Hypersecretory Conditions The dosage of omeprazole in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients
Omeprazole Delayed-release Capsules, USP Strength: 10/20/40 mg per Capsule Pack Size: 30/90/100/500/1000 capsules per bottle Revision No.: 02
drug you may be taking may need to be temporarily withdrawn. Especially tell your doctor if you take: atazanavir (Reyataz ®* ),nelfinavir (Viracept ®* ) ,saquinavir (Fortovase®) ,cilostazol (Pletal®) ,ketoconazole (Nizoral®) ,voriconazole (Vfend®) ,ampicillin (Unasyn®) ,products that contain iron,warfarin (Coumadin ® ),digoxin (Lanoxin ®* ,Lanoxincaps ®* ) ,tacrolimus (Prograf ®* ) ,diazepam (Valium ®* ) ,phenytoin (Dilantin ®* ) ,disulfiram (Antabuse ®* ) ,clopidogrel (Plavix ®* ) ,St. John’s Wort (Hypericum perforatum) ,Rifampin, erlotinib ,methotrexate Contraindications Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria Pregnancy Comments There are no adequate and well-controlled studies on the use of omeprazole in pregnant women. This drug should be used during pregnancy only if clearly needed. Pregnancy Category C Section 3. Composition / information on ingredients Component Exposure Limit CAS No. Principle Component: Omeprazole Not Found 73590 - 58 - 6 Inactive Ingredients : Acetone Not Found 67 - 64 - 1 di-sodium hydrogen phosphate dihydrate Not Found 10028 - 24 - 7 FD&C blue 1 Not Found NA Gelatin Not Found 9000 - 70 - 8 Hydroxypropyl cellulose Not Found 9004 - 64 - 2 Hypromellose Not Found 9004 - 65 - 3 Hypromellose phthalate Not Found 9050 - 31 - 1 Polyethylene glycol Not Found 25322 - 68 - 3 Sodium lauryl sulphate Not Found 151 - 21 - 3 Sugar spheres Not Found NA Talc Not Found 14807 - 96 - 6 Titanium dioxide Not Found 13463 - 67 - 7 Triethyl citrate Not Found 77 - 93 - 0
Omeprazole Delayed-release Capsules, USP Strength: 10/20/40 mg per Capsule Pack Size: 30/90/100/500/1000 capsules per bottle Revision No.: 02
Section 4. First - aid measures General Inhalation: Remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. Seek medical attention. Contact with skin: Immediately wash skin with soap and copious amounts of water for at least 15 minutes. If irritation persists, seek medical attention. Contact with eyes: Immediately flush eyes with copious amounts of water for at least 15 minutes. Seek medical advice Ingestion: If swallowed, wash out mouth with water, provided person is conscious. Seek medical advice. Remove and wash/dispose of contaminated clothing promptly. Overdose Treatment 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. As with the management of any overdose, the possibility of multiple drug ingestion should be considered. Section 5. Fire - fighting measures Flash point Not Found Upper Flammable limit: Not Found Auto-Ignition Temperature: Not Found Lower Flammable limit: Not Found Extinguishing Media Water Spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and material. Fire and Explosion Hazard This material is assumed to be combustible. Fire Fighting Procedure As with all fires, evacuate personnel to a safe area. Fire fighter should use self- contained breathing equipment and protective clothing. Section 6. Accidental Release Measures Spill Response Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up spillage or collect spillage using high efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labelled container for disposal. Wash spill site. Section 7. Handling and Storage Storage Incompatibility Store at 20° to 25°C (68° to 77°F) .Protect from light and moisture. Keep in a tightly closed container. Dispense in a tight, light-resistant container. Reactive with oxidizing substance.
Omeprazole Delayed-release Capsules, USP Strength: 10/20/40 mg per Capsule Pack Size: 30/90/100/500/1000 capsules per bottle Revision No.: 02
Section 10. Stability and Reactivity Condition to avoid Avoid exposure to extreme heat, light and moisture. Stable Stable under temperature if Store at 20° to 25°C Decomposition Products No Data Available Hazardous Reaction No data available. Incompatibilities Reactive with oxidizing substance. Section 11. Toxicological information General Handling of formulated product is not expected to cause any toxicological affects. The data pertains to the ingredient in formulations, rather than this specie formulation. Target organ Eye contact, Skin contact and inhalation is not great risk. Other Not Applicable Section 12. Ecological information Do not allow product to enter drinking water supplies, waste water or soil Section 13. Disposal Consideration Dispose the waste in accordance with all applicable Federal, State and local laws. Section 14. Transport Information The product is not hazardous when shipping via air (IATA), ground(DOT), or sea(IMDG). Section 15. Regulatory Information Generic Medicine. Approved by USFDA & the ANDA Number is 91352 Section 16. Other information None Date of issue: 28 /0 5 /201 5 Supersedes edition of: 01 The information contained herein is based on the state of our knowledge. It Characterises the product with regard to the appropriate safety precautions. It does not represent a guarantee of the properties of the product.
