Omeprazole

Description

Omeprazole Delayed-release Capsules USP are available in three strengths: 10 mg, 20 mg, and 40 mg. Each strength is formulated as a delayed-release capsule, designed to provide effective delivery of the active ingredient. The capsules are packaged in bottles containing 100 units. The National Drug Codes (NDC) for these formulations are as follows: 65841-759-01 for the 10 mg strength, 65841-760-01 for the 20 mg strength, and 65841-761-01 for the 40 mg strength.

Uses and Indications

Omeprazole is indicated for the treatment of gastroesophageal reflux disease (GERD). It is utilized for the healing of erosive esophagitis and for the maintenance of healing of erosive esophagitis. Additionally, omeprazole is indicated for the treatment of Zollinger-Ellison syndrome.

There are no specific teratogenic or nonteratogenic effects associated with omeprazole as per the available data.

Dosage and Administration

Omeprazole Delayed-release Capsules, USP, are available in three strengths: 10 mg, 20 mg, and 40 mg, all of which are administered orally.

For optimal therapeutic effect, healthcare professionals should ensure that the capsules are swallowed whole and not crushed or chewed. The dosing regimen may vary based on the specific condition being treated, and it is essential to adhere to the prescribed dosage and frequency as determined by the healthcare provider.

Patients should be advised to take the medication at least one hour before meals to enhance absorption and efficacy. Regular monitoring and follow-up are recommended to assess the patient's response to therapy and to make any necessary adjustments to the dosage.

Contraindications

Omeprazole is contraindicated in patients with known hypersensitivity to omeprazole or any component of the formulation. Use is not recommended in individuals with a history of allergic reactions to this medication or its ingredients.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients as necessary, although no particular laboratory tests or emergency instructions have been outlined in the provided information.

It is essential for healthcare providers to maintain open communication with patients regarding any potential side effects or changes in their condition, and to encourage them to report any unusual symptoms promptly. Regular follow-up and assessment may be beneficial to ensure the safe and effective use of the medication.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Common adverse reactions reported include headache, nausea, vomiting, diarrhea, constipation, flatulence, abdominal pain, dry mouth, and dizziness.

Serious adverse reactions, although less frequent, can occur and include Clostridium difficile-associated diarrhea, acute interstitial nephritis, hypomagnesemia, bone fractures, cutaneous and systemic lupus erythematosus, acute liver injury, and severe allergic reactions such as anaphylaxis. Allergic reactions may manifest as angioedema, urticaria, or anaphylaxis.

Cardiovascular effects may include palpitations and tachycardia. Neurological adverse reactions reported are dizziness, somnolence, and confusion. Gastrointestinal concerns include gastric cancer with long-term use and esophageal candidiasis. Hepatic adverse reactions may present as elevated liver enzymes and hepatitis, while renal issues can lead to acute kidney injury.

Postmarketing experience has revealed additional adverse reactions, including skin reactions such as Stevens-Johnson syndrome, thrombocytopenia, and agranulocytosis. Long-term use of the medication may also result in vitamin B12 deficiency and an increased risk of developing gastric tumors.

Healthcare professionals should monitor patients for these adverse reactions and manage them appropriately.

Drug Interactions

Omeprazole has several notable drug interactions that may impact its clinical use. These interactions can be categorized into pharmacodynamic and pharmacokinetic effects.

Pharmacodynamic Interactions:

• Clopidogrel: Omeprazole may reduce the effectiveness of clopidogrel, an antiplatelet medication. Clinicians should consider alternative therapies or monitor the patient closely for signs of reduced antiplatelet effect.

• Warfarin: The use of omeprazole may increase the anticoagulant effect of warfarin, which raises the risk of bleeding. Regular monitoring of INR levels is recommended to ensure safe anticoagulation.

Pharmacokinetic Interactions:

• Diazepam: Omeprazole may increase the plasma concentration of diazepam, potentially enhancing its sedative effects. Dose adjustments of diazepam may be necessary, and patients should be monitored for increased sedation.

• Phenytoin: The plasma concentration of phenytoin may be increased by omeprazole, which could lead to toxicity. Monitoring of phenytoin levels is advised, and dose adjustments may be required.

• Methotrexate: High doses of methotrexate may exhibit increased toxicity when administered with omeprazole. Caution is advised, and monitoring for signs of toxicity should be implemented.

• Digoxin: Omeprazole may enhance the absorption of digoxin, leading to potential toxicity. Clinicians should monitor digoxin levels and adjust the dosage as necessary.

• Antifungal Medications (e.g., Ketoconazole, Itraconazole): Omeprazole may reduce the absorption of certain antifungal agents due to increased gastric pH. Alternative antifungal therapies should be considered, or the patient should be monitored for therapeutic efficacy.

Laboratory Test Interactions:

Omeprazole may influence the results of specific laboratory tests, particularly those measuring serum gastrin levels, which may be elevated in patients receiving omeprazole. Clinicians should interpret gastrin levels with caution in the context of omeprazole therapy.

Packaging & NDC

The table below lists all NDC Code configurations of Omeprazole, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric use of omeprazole is not established for children under 1 year of age. For children aged 1 to 16 years, the recommended dosage is weight-based: 10 mg once daily for those weighing less than 10 kg, 20 mg once daily for those weighing between 10 kg and 20 kg, and 40 mg once daily for those weighing more than 20 kg.

Safety and effectiveness in pediatric patients for the treatment of gastroesophageal reflux disease (GERD) have not been established in children under 1 year of age. Therefore, the use of omeprazole in pediatric patients should be based on a careful consideration of the potential benefits and risks.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the effects of omeprazole. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to ensure safety and efficacy. It is important to note that the safety and efficacy of omeprazole in geriatric patients have not been established in clinical studies specifically targeting this demographic. Therefore, healthcare providers should exercise caution when prescribing omeprazole to elderly patients and consider close monitoring for any adverse effects or the need for dosage modifications.

Pregnancy

Omeprazole is contraindicated in pregnancy due to potential risks to the fetus associated with its use. There is a recognized risk to fetal outcomes when omeprazole is administered during pregnancy. Therefore, dosage modifications may be necessary for pregnant patients, and the benefits of treatment must be carefully weighed against the potential risks involved.

It is essential for pregnant women to consult their healthcare provider prior to using omeprazole to ensure that appropriate precautions are taken and to discuss alternative treatment options if necessary.

Lactation

There are no specific warnings or precautions regarding nursing mothers or lactation mentioned in the provided drug insert for Omeprazole. Therefore, healthcare professionals may consider the use of Omeprazole in lactating mothers without specific concerns related to breastfeeding. However, it is always advisable to monitor breastfed infants for any potential adverse effects when the mother is taking this medication.

Renal Impairment

Patients with renal impairment do not require specific dosage adjustments based on the information provided. Additionally, there are no special monitoring or safety considerations indicated for patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment do not require specific dosage adjustments when receiving this medication. Additionally, there are no special monitoring requirements or precautions indicated for patients with compromised liver function. Therefore, standard dosing and monitoring practices may be applied to this patient population without modification.

Overdosage

In cases of omeprazole overdosage, clinical experience in humans is limited. However, potential symptoms that may arise include nausea, vomiting, dizziness, and abdominal pain.

Supportive care is the primary management strategy in the event of an overdose. Healthcare professionals should monitor the patient closely and provide symptomatic treatment as necessary. It is important to note that there is no specific antidote available for omeprazole overdose, emphasizing the need for careful management of symptoms and supportive measures.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, adverse developmental outcomes were not noted, and there was no increase in fetal malformations in the evaluated animal studies. These findings suggest a favorable profile regarding developmental toxicity in the context of nonclinical assessments.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include headache, diarrhea, nausea, vomiting, abdominal pain, constipation, flatulence, dizziness, and somnolence.

Additionally, there have been reports of acute interstitial nephritis, liver enzyme elevations, and hypersensitivity reactions, including anaphylaxis. Rare cases of Clostridium difficile-associated diarrhea have been documented in patients receiving proton pump inhibitors, including omeprazole.

Reports of bone fractures have also been noted in patients taking proton pump inhibitors, particularly among those with risk factors for osteoporosis. Furthermore, the occurrence of cutaneous and systemic lupus erythematosus has been observed in patients using omeprazole.

Patient Counseling

Patients should be advised to take omeprazole at least 1 hour before a meal to ensure optimal absorption and effectiveness. It is important for patients to swallow the capsule whole and to avoid crushing, chewing, or splitting it, as this may affect the medication's action.

In the event that a dose is missed, patients should take it as soon as they remember. However, if it is close to the time of the next scheduled dose, they should skip the missed dose and resume their regular dosing schedule. Patients must be cautioned against taking two doses at the same time.

Patients should be encouraged to inform their healthcare provider if they experience any unusual symptoms or side effects while taking omeprazole. They should also be made aware that long-term use of this medication may increase the risk of bone fractures, and it is advisable to discuss this risk with their healthcare provider.

Additionally, patients should be informed that omeprazole may lead to low magnesium levels, which can manifest as muscle spasms, irregular heartbeat, or seizures. Any occurrence of these symptoms should be reported to their healthcare provider promptly.

It is crucial for patients to avoid using omeprazole if they have a known allergy to any of its ingredients. Furthermore, patients should be instructed to inform their healthcare provider about all medications they are currently taking, including over-the-counter drugs and supplements, to prevent potential drug interactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

To ensure the integrity of the product, it must be protected from light and kept in a tightly closed container. Any unused capsules should be discarded after the expiration date to maintain safety and efficacy. It is important to note that freezing the product is not permitted.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Omeprazole as submitted by Zydus Lifesciences Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)