Rocephin IM (250 mg) Injection
sterile crystalline powder for injection
Antibiotic, Cephalosporin (Third Generation).
have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery.
When administered prior to surgical procedures for which it is indicated, a single 1 gm dose of Rocephin (ceftriaxone) provides protection from most infections due to susceptible organisms throughout the course of the procedure.
Medicines are sometimes prescribed for purposes other than those listed above. Use only for the condition for which it was prescribed. Do not give this medicine to other people even if they have the same symptoms you have, as it may not be right for them.
The suitable dosage for each patient should be prescribed by a doctor.
Method of Administration:
IM route: Reconstitute ceftriaxone powder with the appropriate diluent. As with all IM preparations, Ceftriaxone should be injected well within the body of a relatively large muscle; aspiration helps to avoid unintentional injection into a blood vessel
Rocephin (ceftriaxone) contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.
Patients with impaired vitamin K synthesis or low vitamin K stores (eg, chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during ceftriaxone treatment. Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy.
Usual dosage range: Adults: I.M., I.V.: 1-2 g every 12-24 hours
Indication-specific dosing: Children >15 years and Adults:
Arthritis, septic (unlabeled use): I.V.: 1-2 g once daily
Brain abscess (unlabeled use): I.V.: 2 g every 12 hours with metronidazole
Cavernous sinus thrombosis (unlabeled use): I.V.: 2 g once daily with vancomycin or linezolid
Chancroid (unlabeled use): I.M.: 250 mg as single dose
Chemoprophylaxis for high-risk contacts and persons with invasive meningococcal disease (unlabeled use): I.M.: 250 mg in a single dose
Conjunctivitis, complicated (unlabeled use): I.M.: 1 g in a single dose
Disseminated (unlabeled use): I.M., I.V.: 1 g once daily for 7 days
Endocarditis (unlabeled use): I.M., I.V.: 1-2 g every 12 hours for at least 28 days
Epididymitis, acute (unlabeled use): I.M.: 250 mg in a single dose with doxycycline
Prostatitis (unlabeled use): I.M.: 125-250 mg in a single dose with doxycycline
Uncomplicated: I.M.: 125-250 mg in a single dose
Infective endocarditis: I.M., I.V.:
Native valve: 2 g once daily for 2-4 weeks; Note: If using 2-week regimen, concurrent gentamicin is recommended
Prosthetic valve: I.M., I.V.: 2 g once daily for 6 weeks (with or without 2 weeks of gentamicin [dependent on penicillin MIC]); Note: For HACEK organisms, duration of therapy is 4 weeks
Enterococcus faecalis (resistant to penicillin, aminoglycoside, and vancomycin), native or prosthetic valve: 2 g twice daily for ?8 weeks administered concurrently with ampicillin
Prophylaxis: I.M., I.V.: 1 g 30-60 minutes before procedure. Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Lyme disease (unlabeled use): I.V.: 2 g once daily for 14-28 days
Mastoiditis (hospitalized; unlabeled use): I.V.: 2 g once daily; >60 years old: 1 g once daily
Meningitis: I.V.: 2 g every 12 hours for 7-14 days (longer courses may be necessary for selected organisms)
Orbital cellulitis (unlabeled use) and endophthalmitis: I.V.: 2 g once daily
Pelvic inflammatory disease: I.M.: 250 mg in a single dose
Pneumonia, community-acquired: I.V.: 1 g once daily, usually in combination with a macrolide; consider 2 g/day for patients at risk for more severe infection and/or resistant organisms (ICU status, age >65 years, disseminated infection)
Pyelonephritis (acute, uncomplicated): Females: I.V.: 1-2 g once daily (Stamm, 1993). Many physicians administer a single parenteral dose before initiating oral therapy (Warren, 1999).
Septic/toxic shock/necrotizing fasciitis (unlabeled use): I.V.: 2 g once daily; with clindamycin for toxic shock
STD prophylaxis in sexual assault victims: I.M.: 125 mg as a single dose
Surgical prophylaxis: I.V.: 1 g 30 minutes to 2 hours before surgery
Syphilis (unlabeled use): I.M., I.V.: 1 g once daily for 8-10 days
Typhoid fever (unlabeled use): I.V.: 2 g once daily for 14 days
Whipple's disease (unlabeled use): Initial: 2 g once daily for 10-14 days, then oral therapy for ~1 year.
Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin
Rocephin (ceftriaxone) is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium
Ceftriaxone is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
Neonates (28 days)
Hyperbilirubinemic neonates, especially prematures, should not be treated with Rocephin. In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a possible risk of bilirubin encephalopathy in these patients.
Rocephin is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of ceftriaxone-calcium.
A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Rocephin and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Rocephin and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom Rocephin and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.
BEFORE THERAPY WITH ROCEPHIN IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS OR OTHER DRUGS.
As with other cephalosporins, anaphylactic reactions with fatal outcome have been reported, even if a patient is not known to be allergic or previously exposed.
Interaction with Calcium-Containing Products
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.
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.
An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials 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 stopped until the etiology is determined.
Although transient elevations of BUN and serum creatinine have been observed, at the recommended dosages, the nephrotoxic potential of Rocephin is similar to that of other cephalosporins.
Ceftriaxone is excreted via both biliary and renal excretion Therefore, patients with renal failure normally require no adjustment in dosage when usual doses of Rocephin are administered.
Dosage adjustments should not be necessary in patients with hepatic dysfunction; however, in patients with both hepatic dysfunction and significant renal disease, caution should be exercised and the Rocephin dosage should not exceed 2 gm daily.
Alterations in prothrombin times have occurred rarely in patients treated with Rocephin. Patients with impaired vitamin K synthesis or low vitamin K stores (eg, chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during Rocephin treatment. Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy.
Prolonged use of Rocephin may result in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Rocephin should be prescribed with caution in individuals with a history of gastrointestinal disease, especially colitis.
There have been reports of sonographic abnormalities in the gallbladder of patients treated with Rocephin; some of these patients also had symptoms of gallbladder disease. These abnormalities appear on sonography as an echo without acoustical shadowing suggesting sludge or as an echo with acoustical shadowing which may be misinterpreted as gallstones. The chemical nature of the sonographically detected material has been determined to be predominantly a ceftriaxone-calcium salt. The condition appears to be transient and reversible upon discontinuation of Rocephin and institution of conservative management. Therefore, Rocephin should be discontinued in patients who develop signs and symptoms suggestive of gallbladder disease and/or the sonographic findings described above.
Cases of pancreatitis, possibly secondary to biliary obstruction, have been reported rarely in patients treated with Rocephin. Most patients presented with risk factors for biliary stasis and biliary sludge (preceding major therapy, severe illness, total parenteral nutrition). A cofactor role of Rocephin-related biliary precipitation cannot be ruled out.
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Pregnancy Category B. Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have no evidence of embryotoxicity, fetotoxicity or teratogenicity. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Dermatologic: Rash (2%)
Gastrointestinal: Diarrhea (3%)
Hematologic: Eosinophilia (6%), thrombocytosis (5%), leukopenia (2%)
Hepatic: Transaminases increased (3%)
Local: Tenderness at injection site (I.V. 1%), pain
Renal: BUN increased (1%)
Serious ADR (<1%)
Abdominal pain, agranulocytosis, alkaline phosphatase increased, allergic pneumonitis, anaphylaxis, anemia, basophilia, biliary lithiasis, bilirubin increased, bronchospasm, chills, colitis, creatinine increased, diaphoresis, dizziness, dysgeusia, dyspepsia, epistaxis, fever, flatulence, flushing, gallbladder sludge, gallstones, glycosuria, headache, hematuria, hemolytic anemia, jaundice, leukocytosis, lymphocytosis, lymphopenia, monocytosis, moniliasis, nausea, nephrolithiasis, neutropenia, palpitation, pancreatitis, phlebitis, prolonged or decreased PT, pruritus, pseudomembranous colitis, seizure, serum sickness, thrombocytopenia, urinary casts, vaginitis, vomiting