AZITHROMYCIN
Drugs in Pregnancy and Lactation.
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Name: AZITHROMYCIN
Class: Antibiotic
Risk Factor: BM
Fetal Risk Summary
Azithromycin, an azalide antibiotic that is categorized as a member of the macrolides, is derived from erythromycin. Animal studies using mice and rats treated with doses up to maternal toxic levels (i.e., 200 mg/kg/day) revealed no impairment of fertility or harm to the fetus (1).
Azithromycin crosses the human placenta at term (2,3). In 20 women scheduled for elective cesarean section, a single 1-g oral dose of azithromycin was given 6 (N=2), 12 (N=7), 24 (N=5), 72 (N=5), or 168 (N=1) hours before delivery. The mean maternal concentrations at delivery for the five groups were 311, 144, 63, 60, and <10 ng/mL, respectively, where as the corresponding mean cord serum levels were 19, 26, 27, 19, and <10 ng/mL, respectively. Cerebrospinal fluid levels in the mothers (all had spinal anesthesia) were undetectable (<16 ng/mL) in each group.
In an ex vivo experiment with term human placentas utilizing a single placental cotyledon model, the mean transplacental transfer of three macrolide antibiotics (azithromycin, erythromycin, and roxithromycin) were 2.6%, 3.0%, and 4.3%, respectively (3). The percentages were calculated as the ratio between the steady state level in fetal venous and maternal arterial sides (3).
A number of reports have described the use of azithromycin in human pregnancy, but in only one of the studies (10) was the drug used early in gestation (4,5,6,7,8,9 and 10). A 1994 abstract reported that 16 pregnant patients with cervicitis caused by chlamydia had been treated with a single 1-g oral dose of the antibiotic in a comparison trial with erythromycin (4). Fifteen of the women had negative tests for chlamydia after treatment. No data were given on gestational age at the time of treatment or on the pregnancy outcomes. In a second, similar report, also comparing efficacy with erythromycin, 15 pregnant women with chlamydial cervicitis were treated with a single 1-g oral dose (5). All of the women had negative cervical swabs for chlamydia as analyzed by direct DNA assay 14 days after the dose. Three more recent reports have also documented the efficacy of azithromycin in the treatment of pregnant women with chlamydia (6,7 and 8). Of the five reports, only the last study (8) indicated the gestational age at treatment (about 24 weeks'), but none provided information on fetal outcome. In contrast to the effectiveness of azithromycin for chlamydia infections, a single 1-g oral dose of the antibiotic was ineffective in reducing lower genital colonization with ureaplasma in pregnant women between 22 and 34 weeks' gestation with ruptured membranes or preterm labor (9).
A 1998 noninterventional observational cohort study described the outcomes of pregnancies in women who had been prescribed one or more of 34 newly marketed drugs by general practitioners in England (10). Data were obtained by questionnaires sent to the prescribing physicians one month after the expected or possible date of delivery. In 831 (78%) of the pregnancies, a newly marketed drug was thought to have been taken during the 1st trimester with birth defects noted in 14 (2.5%) singleton births of the 557 newborns (10 sets of twins). In addition, two birth defects were observed in aborted fetuses. However, few of the aborted fetuses were examined. Azithromycin was taken during the 1st trimester in 11 pregnancies. The outcomes of these pregnancies were 1 elective abortion and 10 normal, term babies (10).
Although no congenital malformations were observed in the above study, the data are too limited to assess the safety of azithromycin. Moreover, the study lacked sensitivity to identify minor anomalies because of the absence of standardized examinations. Late appearing major defects may also have been missed due to the timing of the questionnaires. However, macrolide antibiotics are not considered to be major human teratogens.
Breast Feeding Summary
Azithromycin accumulates in breast milk (11). A woman, in the 1st week after a term vaginal delivery, was treated with a single 1-g oral dose of azithromycin for a wound infection following a bilateral tubal ligation and then, because of worsening symptoms, given 48 hours of IV gentamicin and clindamycin. She was discharged from the hospital on a 5-day course of azithromycin, 500 mg daily, but only took three doses because she wanted to resume breast feeding that had been stopped during azithromycin therapy. The patient continued pumping her breasts during this time to maintain milk flow and resumed breast feeding 24 hours after the third dose of the antibiotic. Drug doses and approximate time from the first dose were 1 g (0 hours), 500 mg (59 hours), 500 mg (83 hours), and 500 mg (107 hours). Milk concentrations of azithromycin and times from the first dose were 0.64 µg/mL (48 hours), 1.3 µg/mL (60 hours), and 2.8 µg/mL (137 hours) (maternal serum concentrations were not determined). The authors attributed the antibioticís milk accumulation to its lipid solubility and ion trapping of a weak base.
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References
- Product information. Zithromax. Pfizer Labs, 1994.
- Ramsey PS, Vaules MB, Vasdev G, Andrews WW, Ramin KD. Maternal and transplacental pharmacokinetics of azithromycin (abstract). Am J Obstet Gynecol 2000;182:S98.
- Heikkinen T, Laine K, Neuvonen PJ, Ekblad U. The transplacental transfer of the macrolide antibiotics erythromycin, roxithromycin and azithromycin. Br J Obstet Gynaecol 2000;107:770–5.
- Edwards M, Rainwater K, Carter S, Williamson F, Newman R. Comparison of azithromycin and erythromycin for Chlamydia cervicitis in pregnancy (abstract). Am J Obstet Gynecol 1994;170:419.
- Bush MR, Rosa C. Azithromycin and erythromycin in the treatment of cervical chlamydial infection during pregnancy. Obstet Gynecol 1994;84:61–3.
- Rosenn M, Macones GA, Silverman N. A randomized trial of erythromycin and azithromycin for the treatment of chlamydia infection in pregnancy (abstract). Am J Obstet Gynecol 1996;174:410.
- Wehbeh H, Ruggiero R, Ali Y, Lopez G, Shahem S, Zarou D. A randomized clinical trial of a single dose of zithromycin in the treatment of chlamydia among pregnant women (abstract). Am J Obstet Gynecol 1996;174:361.
- Wehbeh HA, Ruggeirio RM, Shahem S, Lopez G, Ali Y. Single-dose azithromycin for chlamydia in pregnant women. J Reprod Med 1998;43:509–14.
- Ogasawara KK, Goodwin TM. Efficacy of azithromycin in reducing lower genital ureaplasma colonization in women at risk for preterm delivery (abstract). Am J Obstet Gynecol 1997;176:S57.
- Wilton LV, Pearce GL, Martin RM, Mackay FJ, Mann RD. The outcomes of pregnancy in women exposed to newly marketed drugs in general practice in England. Br J Obstet Gynaecol 1998;105: 882–9.
- Kelsey JJ, Moser LR, Jennings JC, Munger MA. Presence of azithromycin breast milk concentrations: a case report. Am J Obstet Gynecol 1994;170:1375–6.
Q&A about Azithromycin
hi i was diagnosed with chylmedia> my doctor prescribed 4 250mg azithromycin tablets. he told me to take them all at once so i did i just dont think that is enough to get rid of the std
I was prescribed azithromycin for cold infections related 3 months by my doctor, but now it's back again. I just don't wanna to go to doc because I don't a Health care insurance and I pay cash. Is there a fast online pharmacy that deliver the next day? I Live in the Bronx New York btw,
I caught strep throat about 2 weeks ago, and I was prescribed amoxicillin. I went back for a checkup on Wednesday because even though I was done with my medication, I still felt sick. I had some blood drawn and the clinic called and said I had gotten strep again. The new prescription I got is azithromycin. What is the difference between these two medications?
I'm taking the generic brand of Zithromax: azithromycin 250 mg. I'm currently taking the 5-day pack and will take 1 tablet 3 times a week for 6 more weeks.
How effective is it for acne? What are my chances of developing an allergic reaction? What is the worse that can happen? And is there anything else I should know about it? (I researched it but I can't find too much info.)
Thanks =)
I think i have a uti and i have some azithromycin will this help? all antbiotics kill bacteria right? I have no medical insurance right now so i cant go to a doctor.
Just wondering because I have tonsilitis and there aren't many antibiotics I can take because of allergies, but the z-pack is a very safe one for me - however, I am in australia and they've never heard of azithromycin!!!! Help please.
Arithromycin doesnt exist - i assume you mean erythromycin!
Well,
erythromycin and azithromycin are two antibiotics.
they are in a class of antibiotic called macrolides.
they have similar properties but are different.
Erythromycin is more likely to cause some unwanted side effects than azithromycin, but it is still unlikely.
zithromax is simply a proprietary name, i.e. a drug company's marketing name for a specific drug. in this case - azithromycin, most commonly used for chlamydial infections.
hope this helps
I have a wisdom tooth that is slowly coming through. I 1/3 of it has broken the skin and when I was prescribed the azithromycin it was b/c when my dentist took a look at it and touched it with the explorer it had puss(gross) come from the gums. Just a note!
I just gave both of my kids azithromycin (generic?, liquid, cherry-flavored) for ear infections. My 4-year-old son has had it a few times before and I don't remember him ever complaining about the taste. However, this time he said his tongue felt funny and wanted a drink. My 2-year old daughter just kept crying and pointing to her tongue (she was already crabby and stopped after about ten minutes). So, I tasted it and it tastes horrible. Is it supposed to be this way?
I am 6 months pregnant and at a recent visit to my doctor they diagnosed me with ureaplasma. My husband and I have both been treated now, but we are not sure when we can go back to having sex? Even with a condom? Wondering if anyone had any info. Also does anyone know if this can be spread through oral sex?
