From the FDA Drug Label
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 to 10 mg once daily is recommended for patients with hepatic impairment for maintenance of healing of EE [see Dosage and Administration (2.1), Clinical Pharmacology (12.3)].
Omeprazole levels may be increased with liver damage.
- The FDA recommends a dosage reduction to 10 mg once daily for patients with hepatic impairment to avoid increased exposure to omeprazole 1.
- This is because liver damage can substantially increase exposure to omeprazole compared to healthy subjects.
- As a result, caution is advised when administering omeprazole to patients with liver damage.
From the Research
Omeprazole levels can be increased in patients with liver damage, and dose reduction is often recommended for patients with severe liver disease. Omeprazole is primarily metabolized by the liver through the cytochrome P450 enzyme system, specifically CYP2C19 and CYP3A4. When liver function is impaired, the metabolism of omeprazole slows down, leading to higher blood levels of the medication and potentially prolonged effects. For patients with severe liver disease, a dose reduction of omeprazole is often recommended, typically reducing the standard dose of 20mg daily or decreasing the frequency in patients with significant hepatic impairment 2. This is particularly important for patients with cirrhosis or severe hepatitis. The increased blood levels of omeprazole in liver disease patients can potentially lead to more side effects such as headaches, diarrhea, or abdominal pain. Healthcare providers should monitor these patients more closely when prescribing omeprazole and consider regular liver function tests to assess any changes in liver status that might require dose adjustments.
Some key points to consider when prescribing omeprazole to patients with liver disease include:
- The liver has a major role in the pharmacokinetics and pharmacodynamics of medicines, and hepatic impairment could lead to increased plasma levels and adverse drug reactions 2
- Important pharmacokinetic alterations that could occur in cirrhosis include a decreased first-pass effect, impaired metabolism by liver enzymes, and in an advanced stage, also impairment of renal elimination 2
- Patients with cirrhosis could be more sensitive to certain adverse drug reactions at normal drug levels, such as renal impairment due to NSAIDs or the sedative effect of morphinomimetics and psychotropic drugs 2
- Prescribing in patients with cirrhosis is complex, and healthcare professionals could use a website with guidance for prescribing almost 300 medicines to help with decision-making 2
In terms of specific guidance, the most recent and highest quality study recommends that healthcare providers use caution when prescribing omeprazole to patients with liver disease and consider dose reduction or alternative treatments as needed 2. Additionally, regular monitoring of liver function and potential side effects is crucial to ensure safe and effective treatment.