Co-Avox Special Precautions

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporin, or other allergens. If an allergic reaction occurs, should be discontinued and appropriate therapy instituted.
Patients with Renal impairment: Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with glomerular filtration rate of <30 mL/min should not receive the 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive additional dose both during and at the end of dialysis.
Hepatic Dysfunction: Hepatic dysfunction, including hepatitis, and cholestatic jaundice has been associated with hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment.
Clostridium difficile Associated Diarrhea (CDAD): Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxin A and B which contribute to the development of CDAD.
Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use.
Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Skin Rash in Patients with Mononucleosis: A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, should not be administered to patients with mononucleosis.
Potential for Microbial Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfection occurs, amoxicillin/clavulanate potassium should be discontinued and appropriate therapy instituted.
Development of Drug-Resistant Bacteria: Prescribing in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient, and increases the risk of the development of drug-resistant bacteria.
Dosing in Renal Impairment: Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See Dosage & Administration.
Use in Children: Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of should be modified in pediatric patients aged <12 week (<3 months).
Use in Elderly: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.