Pregnancy

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Background Information

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Requestor details

• Pregnancy

• community pharmacist from rural MB
• call him back asap
• resources he has were not helpful

• ASAP
• pregnant women with infection (risk to mom & fetus)
• patient is waiting in pharmacy for prescription
• no time for written answer, verbal most appropriate

• Rx for azithromycin 1 g PO stat and cefixime 400 mg PO stat
• Treating chlamydia
• Otherwise healthy
• No other medications
• No allergies
• Trimester unknown by pharmacist

In a pregnant woman with a chlamydia can azithromycin 1 g PO stat (in combination with cefixime 400 mg PO stat) be used safely?

If no, what are safe alternatives?

Is azithromycin safe in pregnancy?

Manitoba Health Chlamydia Protocol Feb 2008

Micromedex

Drugs During Pregnancy and Lactation (Schaefer)

Canadian Guidelines on Sexually Transmitted Infections 2008

Erythromycin is still the drug of choice among the macrolides during pregnancy. Erythromycin estolate and troleandomycin should not be given in the second and third trimesters. Newer macrolides, such as azithromycin, clarithromycin, etc are second choice macrolides.

Although there are limited data on the safety of azithromycin during pregnancy, significant adverse effects have not been observed. The theoretical risk of adverse effects during pregnancy (particularly during the first trimester) should therefore be weighed against the risk of non-compliance with the recommended alternative, a 7-day course of erythromycin.

Clinical Management

a) There are no well-controlled studies of azithromycin in pregnant women. Animal studies have shown no teratogenic effect when pregnant rats and mice were treated with moderately maternally toxic doses of azithromycin. . Because reproduction studies in animals do not always predict human response, azithromycin should be used during pregnancy only if clearly needed (Prod Info ZITHROMAX(R) oral tablets, suspension, 2007).

Chlamydia chapter

Table 5. Pregnant women and nursing mothers: urethral, endocervical, rectal infection

Amoxicillin 500 mg PO tid for 7 days* [A-I]

OR

Erythromycin 2 g/day PO in divided doses for 7 days*† [B-I]

OR

Erythromycin 1g/day PO in divided doses for 14 days*† [B-I]

OR

Azithromycin 1 g PO in a single dose, if poor compliance is expected‡ [B-I]

Drug Information Handbook:

Lexi-Comp

AHFS Drug Information

Briggs: Drugs in Pregnancy and Lactation

CPS

Risk Factor: BM

FETAL RISK SUMMARY

RECOMMENDATION: Limited Human Data – Animal Data Suggest Low Risk

There are no adequate and well-controlled studies in pregnant women. In animal studies at doses up to moderately maternally toxic dose concentrations (i.e., 200 mg/kg/day), no evidence of harm to the fetus due to azithromycin was found. ZITHROMAX should not be used during pregnancy unless the expected benefit to the mother outweighs any potential risk to the fetus.

Pregnancy Risk FactorB

Pregnancy ConsiderationsAdverse events were not observed in animal studies; therefore, azithromycin is classified as pregnancy category B. Low levels of azithromycin have been shown to cross the placenta. Azithromycin may be used for the treatment of some infections during pregnancy. The CDC and IDSA provide recommendations for the treatment of chlamydial infections and MAC in pregnant patients. Since serum concentrations determine fetal exposure and azithromycin has much higher concentrations in tissue than serum, treatment results in the mother may be obtained with lower exposure to the fetus. Although no adverse reports in human or animal fetuses have been documented, information in pregnant women is limited.

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.

Found under Pregnancy:

There are no adequate and controlled studies to date using azithromycin in pregnant women, and the drug should be used during pregnancy only when clearly needed.Ref

Preliminary data indicate that azithromycin may be safe and effective in the treatment of chlamydial infections in pregnant women; however, there are insufficient data to recommend routine use of the drug during pregnancy.Ref(See Chlamydial Infections: Urogenital Chlamydial Infections, in Uses.)

Found under Uses: Chlamydia

The CDC, AAP, and others recommend that urogenital chlamydial infections in pregnant women be treated with a single-dose regimen of a conventional formulation of azithromycin or a 7-day regimen of oral amoxicillin. Alternative regimens recommended for these infections in pregnant women are a 7- or 14-day regimen of oral erythromycin base or ethylsuccinate. The CDC states that clinical experience and studies suggest that the single-dose azithromycin regimen is safe and effective, and some clinicians suggest that this is the regimen of choice for treatment of urogenital chlamydial infections in pregnant women.