Rocephin Special Precautions

General: Hypersensitivity: As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported (see Post Marketing Experience under Adverse Reactions). In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of hypersensitivity reactions to ceftriaxone, to other cephalosporins, or to any other type of beta-lactam agent. Caution should be used if ceftriaxone is given to patients with a history of hypersensitivity to other beta-lactam agents.
Hemolytic Anemia: An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterial including Rocephin. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children. If a patient develops anemia while on ceftriaxone, the diagnosis of a cephalosporin associated anemia should be considered and ceftriaxone discontinued until the etiology is determined.
Clostridium difficile associated diarrhea (CDAD): Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Rocephin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Toxin hyperproducing 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 antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Superinfections: Superinfections with non-susceptible micro-organisms may occur as with other antibacterial agents.
Calcium-ceftriaxone precipitates: Calcium-ceftriaxone precipitates in the gallbladder have been observed on ultrasound scan in patients receiving ceftriaxone, particularly at doses of 1 g per day and above. The probability of such precipitates appears to be greatest in pediatric patients. Precipitates disappear after discontinuation of ceftriaxone therapy and are rarely symptomatic. In symptomatic cases, conservative nonsurgical management is recommended, and discontinuation of ceftriaxone treatment should be considered by the physician based on an individual benefit-risk assessment.
In the available scientific data, there are no reports of intravascular precipitations in patients, other than newborns, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products. However, ceftriaxone should not be mixed or administered to any patient simultaneously with calcium-containing solutions, even via different infusion lines (see Contraindications for information regarding newborns, Interactions and Post Marketing Experience under Adverse Reactions).
Pancreatitis: Cases of pancreatitis, possibly of biliary obstruction aetiology, have been rarely reported in patients treated with Rocephin. Most patients presented with risk factors for biliary stasis and biliary sludge, e.g. preceding major therapy, severe illness and total parenteral nutrition. A trigger or cofactor role of Rocephin-related biliary precipitation can not be ruled out.
Blood Monitoring: During prolonged treatment the complete blood count should be done at regular intervals.
Influence on diagnostic tests: In patients treated with Rocephin the Coombs' test may rarely become falsely positive. Rocephin, like other antibiotics, may result in false-positive test results for galactosemia.
Likewise, nonenzymatic methods for the glucose determination in urine may give false-positive results. For this reason, urine-glucose determination during therapy with Rocephin should be done enzymatically.
The presence of ceftriaxone may falsely lower estimated blood glucose values obtained with some blood glucose monitoring systems. Please refer to instructions for use for each system. Alternative testing methods should be used if necessary.
Drug Abuse and Dependence: Not applicable.
Renal Impairment: See Special Dosage Instructions under Dosage & Administration.
Hepatic Impairment: See Special Dosage Instructions under Dosage & Administration.
Ability to Drive and Use Machines: During treatment with Rocephin, undesirable effects may occur (e.g. dizziness), which may influence, the ability to drive and use machines (see Adverse Reactions). Patients should be cautious when driving or operating machinery.
Use in Children: Safety and effectiveness of Rocephin in neonates, infants and children have been established for the dosages described under Dosage & Administration. Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.
Rocephin should not be used in neonates (especially prematures) at risk of developing bilirubin encephalopathy (see Contraindications).
See Special Dosage Instructions under Dosage & Administration.
Use in the Elderly: See Special Dosage Instructions under Dosage & Administration.