Drug Notebook

FDA Alerts

Special Alerts:

[UPDATED 09/11/2007] Roche informed healthcare professionals about revisions made to the prescribing information for ceftriaxone (Rocephin) to clarify the potential risk associated with concomitant use of ceftriaxone with calcium or calcium-containing solutions or products.

Healthcare professionals are advised that ceftriaxone and calcium-containing solutions including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. Ceftriaxone and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient. No data are available on the potential interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral). For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rocephin, http://www.fda.gov/medwatch/safety/2007/Rocephin_HCP_august2007.pdf, http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?id=5057&type=display and http://www.fda.gov/cder/drug/InfoSheets/HCP/ceftriaxone.htm.

[Posted 07/05/2007] Roche and FDA informed healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections of the prescribing information for ceftriaxone sodium (Rocephin for Injection). The revisions are based on new information that describes the potential risk associated with concomitant use of ceftriaxone with calcium or calcium containing solutions or products. Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates were reported. Hyperbilirubinemic neonates, especially prematures, should not be treated with ceftriaxone. The drug must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines. Additionally, calcium-containing solutions or products must not be administered within 48-hours of the last administration of ceftriaxone. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rocephin, http://www.fda.gov/medwatch/safety/2007/rocephin_PI_may2007.pdf and http://www.fda.gov/medwatch/safety/2007/rocephin_DHCP_june2007.pdf.

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What is the most important information I should know about ceftriaxone injection?

Do not use this medication if you are allergic to ceftriaxone, or to similar antibiotics, such as Ceclor, Ceftin, Cefzil, Duricef, Keflex, Omnicef, Spectracef, Suprax, and others.

Before using this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have liver or kidney disease, liver disease, a stomach or intestinal disorder, or if you are malnourished.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ceftriaxone is usually given for at least 2 days after symptoms disappear.

Ceftriaxone will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What is ceftriaxone injection?

Ceftriaxone is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Ceftriaxone injection is used to treat many kinds of bacterial infections, including severe or life-threatening forms such as meningitis.

Ceftriaxone may also be used for purposes other than those listed in this medication guide.

What should I discuss with my health care provider before using ceftriaxone injection?

Do not use this medication if you are allergic to ceftriaxone, or to other cephalosporin antibiotics, such as:

Before using ceftriaxone, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have:

  • kidney disease;

  • liver disease;

  • a stomach or intestinal disorder such as colitis; or

  • if you are malnourished.

If you have any of these conditions, you may not be able to use ceftriaxone, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ceftriaxone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use ceftriaxone in a child without a doctor's advice, and never give more than the child's prescribed dose.
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