Can I give amoxicillin to a patient with a family history of adverse reaction to Augmentin (amoxicillin-clavulanic acid), if the reaction is attributed to the clavulanic acid component?

From the FDA Drug Label

6 ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling: • Anaphylactic reactions [see Warnings and Precautions (5.1)] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] • Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5. 3)] • Clostridioides difficile-Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4)] ... • Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5. 1)].

The patient's family history of adverse reaction to Augmentin (amoxicillin-clavulanic acid) attributed to the clavulanic acid component does not directly imply a risk for amoxicillin. Hypersensitivity reactions to amoxicillin can occur, but the label does not specify cross-reactivity with clavulanic acid.

• Key consideration: The label warns about anaphylactic reactions and hypersensitivity reactions to amoxicillin, which could be a concern if the patient has a history of severe allergic reactions.
• Clinical decision: Given the uncertainty and potential for hypersensitivity reactions, it is recommended to exercise caution and consider alternative treatments or closely monitor the patient for signs of an allergic reaction if amoxicillin is prescribed 1.

From the Research

Yes, you can generally give amoxicillin to a patient with a family history of adverse reaction to Augmentin (amoxicillin-clavulanic acid) if the reaction was specifically attributed to the clavulanic acid component. However, before proceeding, it's essential to verify that the reaction was indeed to clavulanic acid and not to the amoxicillin component, as documented in studies such as 2, which highlights the differential effect of impaired renal function on the kinetics of clavulanic acid and amoxicillin. This distinction should ideally be documented in the patient's medical record or confirmed through allergy testing. When administering amoxicillin, start with standard dosing appropriate for the patient's condition, age, weight, and renal function, taking into consideration the findings from studies like 3, which discusses the complexities of dosing in critically ill patients. Monitor the patient closely after the first dose for any signs of allergic reaction such as rash, itching, swelling, dizziness, or difficulty breathing. If the patient has never personally taken amoxicillin before, consider administering the first dose in a monitored setting. The rationale is that while family history of drug allergies slightly increases risk, allergic reactions to antibiotics are not strictly hereditary, and the specific component causing the reaction in Augmentin (clavulanic acid) is absent in amoxicillin alone, as supported by the pharmacokinetic studies such as 4. Document this clinical decision-making in the patient's chart, including the basis for believing the reaction was to clavulanic acid rather than amoxicillin, ensuring that the approach is tailored to the individual patient's needs and medical history.

Some key points to consider include:

• The importance of verifying the specific component of Augmentin that caused the adverse reaction, as this directly influences the decision to administer amoxicillin.
• The need for careful monitoring of the patient after the first dose of amoxicillin, especially if they have never taken it before.
• The consideration of the patient's renal function, as it affects the clearance of both amoxicillin and clavulanic acid, as discussed in 2.
• The documentation of the clinical decision-making process in the patient's chart, which is crucial for continuity of care and legal purposes.

Given the most recent and highest quality evidence, the administration of amoxicillin in this context is supported, with the understanding that each patient's situation must be evaluated individually, considering their unique medical history, current condition, and potential risks associated with antibiotic use, as highlighted by studies such as 5 and 3.