Omeprazole (Page 2 of 15)

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:

  1. 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.

  2. Open the capsule.

  3. Carefully empty all of the microtablets inside the capsule on the applesauce.

  4. Mix the microtablets with the applesauce.

  5. 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.


Omeprazole Delayed-Release Capsules, 10 mg, are opaque white cap and opaque white body capsules imprinted with “KU” and “114″ in black ink.

Omeprazole Delayed-Release Capsules, 20 mg, are opaque white cap and opaque gold body capsules imprinted with “KU” and “118″ in black ink.

Omeprazole Delayed-Release Capsules, 40 mg, are opaque gold cap and opaque gold body capsules imprinted with “KU” and “136″ in black ink.


  • Omeprazole Delayed-Release Capsules is 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 [see W arnings and Precautions ( 5.2), A dverse Reactions ( 6)] .

  • Proton pump inhibitors (PPIs), including Omeprazole Delayed-Release Capsules, are contraindicated in patients receiving rilpivirine-containing products [see D rug Interactions ( 7)].

  • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with Omeprazole Delayed-Release Capsules, refer to the CONTRAINDICATIONS section of their package inserts.


5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with Omeprazole Delayed-Release Capsules does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

5.2 Acute Interstitial Nephritis

Acute interstitial nephritis has been observed in patients taking PPIs including Omeprazole Delayed-Release Capsules. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Omeprazole Delayed-Release Capsules if acute interstitial nephritis develops [see C o ntraindications ( 4)] .

5.3 Clostridium difficile -Associated Diarrhea

Published observational studies suggest that PPI therapy like Omeprazole Delayed-Release Capsules may be associated with an increased risk of Clostridium difficile -associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see A d verse Reactions ( 6.2)] .

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with Omeprazole Delayed-Release Capsules, refer to Warnings and Precautions sections of the corresponding prescribing information.

5.4 Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see D o sage and A dministration ( 2.1), A dverse Reactions ( 6.3)] .

5.5 Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving Omeprazole Delayed-Release Capsules, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

5.6 Interaction with Clopidogrel

Avoid concomitant use of Omeprazole Delayed-Release Capsules with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 80 mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using Omeprazole Delayed-Release Capsules, consider alternative anti-platelet therapy [see Drug I nteractions ( 7) and C l i n i cal Pharmacology ( 12.3 )].

5.7 Cyanocobalamin (Vitamin B-12) Deficiency

Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with Omeprazole Delayed-Release Capsules.

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