Ceftriaxone

 Risk Factor: BM
 Class: ANTI-INFECTIVES / Cephalosporins

Contents of this page:

Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers

Fetal Risk Summary

Ceftriaxone is a parenteral, semisynthetic cephalosporin antibiotic. Reproduction studies in rats found no evidence of impaired fertility or reproduction performance at a dose approximately 20 times the recommended human dose or, in mice, rats, and nonhuman primates, of embryotoxicity, fetotoxicity, or teratogenicity at doses approximately 20, 20, and 3 times, respectively, the recommended human dose (1).

A 1993 report described the pharmacokinetics of cetriaxone, 2 g IV once daily for about 10 days, in nine women at 28 to 40 weeks' gestation who were being treated for chorioamnionitis or pyelonephritis (2). No accumulation of the antibiotic was noted and the pharmacokinetic profile was similar to healthy, nonpregnant adults. No adverse effects in fetuses or newborns were observed.

Peak levels in cord blood following 1- or 2-g IV doses occurred at 4 hours with concentrations varying between 19.6 and 40.6 g/mL (18 hours) (3,4 and 5). Amniotic fluid levels over 24 hours ranged from 2.2 to 23.4 g/mL with peak levels occurring at 6 hours (3,4 and 5). Ceftriaxone concentrations in the first voided newborn urine were highly variable, ranging from 6 to 92 g/mL. Elimination half-lives from cord blood (7 hours), amniotic fluid (6.8 hours), and placenta (5.4 hours) were nearly identical to maternal serum (3,4,6). No adverse effects in the newborns were mentioned.

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 60 newborns had been exposed to ceftriaxone during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Four (6.7%) major birth defects were observed (three expected), including three cardiovascular defects (one expected). No anomalies were observed in five other categories of defects (oral clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias) for which specific data were available. A possible association between ceftriaxone and cardiovascular defects is suggested, but other factors, such as the mother's disease, concurrent drug use, and chance, may be involved. However, other cephalosporin antibiotics from this study have shown possible associations with congenital malformations (see also Cefaclor, Cephalexin, and Cephradine).

Cephalosporins are usually considered safe to use during pregnancy. Ceftriaxone, 1 g IV daily, has been used in the treatment of pyelonephritis occurring in the second half of pregnancy (7). No adverse fetal outcomes attributable to the drug were observed.

Ceftriaxone 1 g IV has been used for preoperative prophylaxis prior to emergency cesarean section (8). Amniotic fluid and fetal serum levels ranged from 0.016 to 0.25 g/mL (mean 0.085 g/mL) and from 0.66 to 18.4 g/mL (mean 4.6 g/mL), respectively.

Gonorrhea infecting 114 pregnant women in the 2nd trimester was treated with a single 250-mg IM dose of ceftriaxone in a study published in 1993 (9). The treatment was compared with approximately similar numbers of pregnant women treated with spectinomycin or amoxicillin with probenecid. Ceftriaxone and spectinomycin were similar in efficacy and both were superior to the amoxicillin/probenecid regimen. A 20-year-old woman with endocarditis due to Neisseria sicca was treated for 4 weeks with ceftriaxone, 2 g IV every 12 hours, late in the 3rd trimester (10). She eventually delivered a term, small-for-gestational-age female infant, whose low weight was attributed to the mother's chronic disease state.

Breast Feeding Summary

Ceftriaxone is excreted into breast milk in low concentrations. Following either 1- or 2-g IV or IM doses, peak levels of 0.50.7 g/mL occurred at 5 hours, approximately 3%4% of maternal serum (3,4). High protein binding in maternal serum probably limited transfer to the milk (3,4). The antibiotic was still detectable in milk at 24 hours (3). Elimination half-lives after IV and IM doses were 12.8 and 17.3 hours, respectively (3). Chronic dosing would eventually produce calculated steady-state levels in 1.53 days in the 3- to 4-g/mL range (4). Although these levels are low, three potential problems exist for the nursing infant: modification of bowel flora, direct effects on the infant, and interference with the interpretation of culture results if a fever workup is required. The American Academy of Pediatrics considers the drug to be compatible with breast feeding (11).

References

1. Product information. Rocephin. Roche Laboratories, 1997.
2. Bourget P, Fernandez H, Quinquis V, Delouis C. Pharmacokinetics and protein binding of ceftriaxone during pregnancy. Antimicrob Agents Chemother 1993;37:549.
3. Kafetzis DA, Brater DC, Fanourgakis JE, Voyatzis J, Georgakopoulos P. Placental and breast-milk transfer of ceftriaxone (C). In Proceedings of the 22nd Intersci Conf on Antimicrob Ag Chemother, Miami, Florida, October 46, 1982:155. New York:Academic Press, 1983.
4. Kafetzis DA, Brater DC, Fanourgakis JE, Voyatzis J, Georgakopoulos P. Ceftriaxone distribution between maternal blood and fetal blood and tissues at parturition and between blood and milk postpartum. Antimicrob Agents Chemother 1983;23:8703.
5. Cho N, Kunii K, Fukunago K, Komoriyama Y. Antimicrobial activity, pharmacokinetics and clinical studies of ceftriaxone in obstetrics and gynecology. In Proceedings of the 13th Inter Cong Chemother, Vienna, Austria, August 28 to September 2, 1983:100/6466. Princeton:Excerpta Medica, 1984.
6. Graber H, Magyar T. Pharmacokinetics of ceftriaxone in pregnancy. Am J Med 1984;77:1178.
7. Sanchez-Ramos L, McAlpine KJ, Adair CD, Kaunitz AM, Delke I, Briones DK. Pyelonephritis in pregnancy: once-a-day ceftriaxone versus multiple doses of cefazolin. Am J Obstet Gynecol 1995;172:12933.
8. Lang R, Shalit I, Segal J, Arbel Y, Markov S, Hass H, Fejgin M. Maternal and fetal and tissue levels of ceftriaxone following preoperative prophylaxis in emergency cesarean section. Chemotherapy 1993;39:7781.
9. Cavenee MR, Farris JR, Spalding TR, Barnes DL, Castaneda YS, Wendel GD Jr. Treatment of gonorrhea in pregnancy. Obstet Gynecol 1993;81:338.
10. Deger R, Ludmir J. Neisseria sicca endocarditis complicating pregnancy. A case report. J Reprod Med 1992;37:4735.
11. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
    
    

Questions and Answers

how long does it take for ceftriaxone to work?how long does it stay in your system?, Ceftriaxone is used to treat gonorrhea.

Ceftriaxone is administered parenterally. It is not absorbed from the GI tract. Peak serum concentrations occur within 1.5—4 hours following an IM dose and of course, reaches therapeutic levels within a few minutes if it was administered via IV route. So to answer your questions, suppression of bacterial growth (assuming its not resistant) works almost right away WHEN drug level concentrations reaches therapeutic levels. Bacterialcidal effects works shortly after, within the day of treatment. Usually patients signs and symptoms of improvement are seen as early as day 1 to about 3-4 days and as long as 7-10 days. It all depends on the bacterial load in your body and the individual.

Approximately 33—67% of ceftriaxone is excreted into the urine, primarily via glomerular filtration, and into feces via bile. Following biliary excretion, a small amount of the drug is metabolized in the intestines to an inactive metabolite prior to fecal excretion. In patients with normal renal function, the elimination half-life is 6—9 hours. Of course the elimination half-life increases as renal function declines. Since I dont know the dose, strength, and which route you took, ill list them both and you can do the math as to how long it stays in your body.

For the treatment of gonorrhea:
Adults and adolescents: The CDC recommends ceftriaxone 125 mg IM as a single dose in combination with a regimen effective against uncomplicated genital C. trachomatis infection (e.g., azithromycin as a single dose or doxycycline for 7 days), if chlamydial infection is not ruled out

Parenteral dosage:
Adults and adolescents: The CDC recommends 1 g IV or IM every 24 hours. Ceftriaxone should be continued for 24—48 hours after clinical improvement begins at which time therapy may then be switched to an oral regimen (e.g., cefixime or cefpodoxime) to complete 7 days of antibiotic therapy

Hope this answers your question!

im looking for a ceftriaxone sodium standard. do you a place or manufacturer i could buy it from?,

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patient allergic to keflex given ceftriaxone?, someone close to me had a non-severe surgery, and was given ceftriaxone (aka Rocephin) IV by hospital staff even though patient chart said she was allergic to keflex (aka Ceflexin)(rash, nausea). Did the hospital make a mistake by administering ceftriaxone even though they had record of patient that she was allergic to keflex?

She developed severe rash and had an acute renal failure in hospital and had to sit in ICU for 7 days, nearly died . Doctors/nurses won't confirm it caused the kidney failure but nurse says "the pharmacy made a mistake". Seeking legal/medical advice. thank you.

saying that the pharmacy made a mistake is complete bull. the person that ordered the medication and the person that administered the medication is at fault. they should have read her chart very carefully and should have caught that mistake before giving it to her. sounds like a malpractice suit if you ask me.

for hospital inpatient order for ceftriaxone 1 q qd iv piggyback the technician?, pharmacy question

I am uncertain what the question is, but Ceftriaxone is normally dosed as 1 Gram every 24 hours, and usually diluted in 50ml of normal saline for a 15-20 minute infusion.

There are a few conditions where a higher dose (2 grams Q24H) are needed.

It is called a 'Piggyback' infusion because there is typically a main IV fluid infusing, and the Piggyback infuses in a separate infusion port.

Are e.Nafcillin and ceftriaxone are eliminated mainly via biliary secretion?,

Nafcillin is excreted mainly in the bile
Excretion:
Nafcillin is excreted in urine (30% as unchanged), and primarily eliminated in bile. Serum t is 33 to 61 min (IV).

Ceftriaxone - mainly kidneys
Excretion 33-67% renal, 35–45% biliary

Will a shot of rocephin (ceftriaxone) cure gonorrhea and a UTI at the same time?, I went to the clinic and had a shot for gonorrhea and asked them also to do a urine dip... being a county health facility they seem a little like they could care less... so when time came to ask about my urine dip they didnt have it requested on my charts to be done, and i was in pain from my UTI and didn't want to sit 2 more hours in their facility. I know i have a UTI since i have had chronic ones since the age of 4. So i read about the antibiotic they gave me and it states it is also given for UTI's... Will it be able to cure both at once? Or do I need to go back for separate treatment?

Rocephin can be used for UTI but the dosing is different, You had a one time shot (probably 125mg), the treatment for UTI would be different. Rocephin isnt the 1st choice for UTI either. You will probably feel better shortly, but it'll come back. You need a more effective antibiotic over 3-7 days.

You should get further treatment for the UTI. Sorry. Take care.

Does ceftriaxone cause neurotoxicity?,

Possible side effects of ceftriaxone?
• If you experience any of the following rare but serious side effects, seek emergency medical attention or contact your doctor immediately:
· an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, face, or tongue; hives; or a rash);
· rash, redness, or itching;
· severe nausea, vomiting, or diarrhea;
· mucous or blood in the stool; or
· unusual bleeding or bruising.
• Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience
· mild nausea or diarrhea;
· yeast infection of the mouth or vagina; or
· pain or tenderness at the injection site.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.