Title: Designates the agents or agent groups (categories) involved in the
described interaction. The members of an agent category are listed in the
Interacting Members section of the monograph.
Risk Rating: Rapid indicator regarding how to respond to the interaction data.
Each Interact monograph is assigned a risk rating of A, B, C, D, or X.
The progression from A to X is accompanied by increased urgency for responding
to the data. In general, A and B monographs are of academic, but not clinical
concern. Monographs rated C, D, or X always require the user's attention.
The text of the Patient Management section of the monographs will provide
assistance regarding the types of actions that could be taken. The definition
of each risk rating is as follows:
||Data have not demonstrated either pharmacodynamic or
pharmacokinetic interactions between the specified agents
||No action needed
||Data demonstrate that the specified agents may interact with each other, but there is little to no evidence of clinical concern resulting from their concomitant use.
||Data demonstrate that the specified agents may interact with each other in a clinically significant manner. The benefits of concomitant use of these two medications usually outweigh the risks. An appropriate monitoring plan should be implemented to identify potential negative effects. Dosage adjustments of one or both agents may be needed in a minority of patients.
||Data demonstrate that the two medications may interact with each other in a clinically significant manner. A patient-specific assessment must be conducted to determine whether the benefits of concomitant therapy outweigh the risks. Specific actions must be taken in order to realize the benefits and/or minimize the toxicity resulting from concomitant use of the agents. These actions may include aggressive monitoring, empiric dosage changes, choosing alternative agents.
||Data demonstrate that the specified agents may interact with each other in a clinically significant manner. The risks associated with concomitant use of these agents usually outweigh the benefits. These agents are generally considered contraindicated.
Summary: A statement qualifying the nature of the interaction(s) detailed in
the monograph. This statement may be followed by an indication of outcome
severity and/or onset for an unmanaged interaction. Severity indicators
include: Minor (effects would be considered tolerable in most cases - no
need for medical intervention); Moderate (medical intervention needed to
treat effects; effects do not meet criteria for Major); and Major (effects
may result in death, hospitalization, permanent injury, or therapeutic
failure. Onset indicators describe the anticipated elapsed time from
therapy initiation to adverse event, and include: Immediate (0 - 12 hours);
Rapid (12 - 72 hours); and Delayed (More than 72 hours); A Yes/No indication
regarding whether or not agent administration sequence is important may be
included as well.
Patient Management: Recommended action steps for preventing adverse outcomes
resulting from an anticipated drug interaction. Note: a patient-specific
risk:benefit assessment must always be employed.
Interacting Category Members: A listing of the agents contained within a
specified interacting category. Agents marked with an "*" have been
specifically identified in the published reports described in the Discussion
section. Non-interacting category members are noted as "Exceptions".
Discussion: A brief presentation of published data pertaining to the
Footnotes: Complete medical literature citations for the data contained in
the Discussion section.