RiteMED Amoxicillin Special Precautions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens. Careful inquiry should be made concerning previous hypersensitivity to penicillins, cephalosporins or other drugs before initiating therapy with amoxicillin. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.
Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with the use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
During administration of high doses of amoxicillin, it is recommended to maintain adequate fluid intake and urinary output in order to reduce the possibility of crystalluria associated with amoxicillin therapy.
In patients with renal impairment, the dose of amoxicillin should be adjusted based on the degree of impairment.
As with any potent drug, periodic assessment of organ system functions, including renal, hepatic, hematopoietic, is recommended during prolonged therapy.
Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Renal Impairment: The doses and/or frequency of amoxicillin administration should be modified in response to the degree of renal impairment, severity of infection, and susceptibility of the causative organisms [see Dosage & Administration].
Use in Children: Neonates and young infants have incompletely developed renal function which may result in delayed elimination of amoxicillin. Dosing of amoxicillin should be modified in pediatric patients 12 weeks old or younger (≤3 months old) [see Dosage & Administration].
Use in the Elderly: Since elderly patients are more likely to have decreased renal function, care should be taken in dose selection.