Use of Azithromycin in Pregnancy: More Doubts than Certainties

When pregnant, it is crucial to take the right steps in order to ensure that both mother and baby are healthy. Medication can be a tricky subject, which is why it is essential to research and understand the safety of the drugs being taken. One medication that is commonly used, especially during early pregnancy, is Azithromycin. While this medicine is known to help in some cases, it may also have the potential to cause harm. In this blog post, we will cover the potential risks associated with taking Azithromycin during early pregnancy, as well as the potential benefits. We will also discuss the most important factors to consider when deciding whether or not this medication is safe for consumption during early pregnancy.

What is Azithromycin, And What does it Treat?

Azithromycin is an antibiotic that treats specific bacterial infections. The Food and Drug Administration approved this medicine in 1991. Like most antibiotics, Azithromycin cannot treat all types of bacteria. Therefore, it is even more crucial to consult a doctor before starting a course.

Pregnant mothers might contemplate taking Azithromycin in pregnancy. If necessary, then Azithromycin can be taken by expectant mothers under the advice of a doctor. First trial studies on animals did not find an increased risk of miscarriage or congenital disabilities on taking large doses of Azithromycin.

However, there are currently no high-quality studies on a significant number of pregnant women. Because of this, the prescription label on the packaging advises against using azithromycin if necessary during pregnancy. “.

Consequently, if a pregnant woman becomes ill from a bacterial infection, she may take the medication on the doctor’s advice.

In a nutshell, yes, Azithromycin may be safe for pregnancy. However, there haven’t been any thorough studies on pregnant women to confirm this. As a result, the current warning on the drug label reads, “Azithromycin should be used during pregnancy only if clearly needed.” Therefore, it is advised that you speak with your doctor before taking azithromycin while pregnant. Its always better to be safe than sorry!.

Clinical Use of Azithromycin in Pregnancy

Generally speaking, azithromycin may be used instead of other macrolides to treat some STDs, such as chlamydia and gonorrhea.

Antibiotic prophylaxis for P-PROM, adjunctive prophylaxis for cesarean delivery, and treatment of genital Chlamydia trachomatis infection are significant clinical indications for the use of azithromycin in pregnancy (Table).

Clinical indication Monotherapy (M)/ combination therapy (CT) First choice (FC)/ alternative choice (AC) Azithromycin dosage
Antibiotic prophylaxis for P-PROM CT (ampicillin + erythromycin) AC (azithromycin instead of erithromycin) 1 g PO (single dose)
Adjunctive prophylaxis for cesarean delivery M (cephalosporins) AC (cephalosporins + azithromycin) 500 mg IV (single dose)
Treatment of skin infection due to Staphylococcus aureus, Streptococcus pyogenes CT (cephalosporins + clindamycin) AC (azithromycin instead of clindamycin) 500 mg PO (once daily)
Prevention and treatment of Mycobacterium avium complex disease CT (ethambutol + clarithromycin + rifamycin) AC (azithromycin instead of clarithromycin) 1200 mg PO (once weekly)
Prophylactic antibiotic therapy for COPD M FC 250 mg PO (once daily)
Treatment of respiratory infection caused by Chlamydia and Mycoplasma spp. M FC (in pregnancy) 500 mg PO (once daily)
Treatment of respiratory infections caused by Legionella pneumophila M FC 500 mg PO (once daily)
Treatment of respiratory infections caused by Bordetella pertussis (whooping cough) M FC 500 mg PO on day 1 then 250 mg (once daily)
Treatment of respiratory infections caused by Moraxella catarrhalis M (amoxicillin-clavulanate) AC (azithromycin instead of amoxicillin) 500 mg PO (once daily)
Treatment of cervicitis and urethritis caused by Chlamydia trachomatis and Mycoplasma hominis M FC 1 g PO (single dose)
Treatment of gonococcal urethritis and cervicitis CT (cephalosporins + azithromycin) FC 1 g PO (single dose)
Treatment of pelvic inflammatory disease CT (cephalosporins + doxycycline) AC (azithromycin + metronidazole) 500 mg IV once daily for 1–2 days, then 250 mg PO once daily
Treatment of chancroid M FC 1 g PO (single dose)
Treatment of granuloma inguinale/Donovanosis M FC 1 g PO (once weekly)
Treatment of severe travelers diarrhea M FC 500 mg – 1 g PO (single dose)
Treatment of bacterial enteritis due to Campylobacter jejuni M FC 500 mg PO (once daily)
Treatment of enteric fever (caused by Salmonella typhi and S. Paratyphi). M FC 500 mg PO (once daily)
Treatment of cholera M FC (in pregnancy) 1 g PO (single dose)
Treatment of early Lyme disease M (amoxicillin-clavulanate) AC (azithromycin instead of amoxicillin) 500 mg PO (once daily)
Treatment of AIDS with toxoplasmosis encephalitis CT (pyrimethamine + sulfadiazine + leucovorin) AC (azithromycin instead of sulfadiazine) 900–1200 mg PO (once daily)
Treatment of lymphadenopathy due to Bartonella henselae (cat-scratch disease) M FC 500 mg PO on day 1 then 250 mg (once daily)
Prevention of streptococcal/staphylococcal endocarditis (Penicillin allergy) M (ampicillin) AC (azithromycin instead of ampicillin) 500 mg PO (single dose before the procedure)
Treatment of uncomplicated malaria CT (azithromycin + chloroquine) AC (sulphadoxine‐pyrimethamin + chloroquine) 1 g PO (once daily)

P-PROM stands for pre-labor amniotic membrane rupture occurring before 37 weeks of pregnancy. It is the most frequent factor linked to preterm delivery and accounts for about one-third of preterm births [56]. Antibiotics used as preventative measures, or “latency antibiotics,” lengthen the interval between the rupture of the membranes and delivery while lowering maternal and neonatal morbidity. The most frequently prescribed medications are beta-lactams and macrolides, both separately and in combination. The current recommended regimen includes 48 hours of intravenous (IV) ampicillin and erythromycin, followed by 5 days of oral amoxicillin and erythromycin, according to the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. Additionally, a common deviation from this protocol is the use of azithromycin instead of erythromycin. Due to its simplicity of administration, improved adverse effect profile, and lower cost, azithromycin is preferred over erythromycin [56].

Infection is both a cause and a consequence of P-PROM. Antibiotic prophylaxis is therefore advised, though the ideal regimen is still unknown. Mercer et al. A randomized controlled trial was carried out by [56] to see if the use of antibiotics during the expectant management of P-PROM could lower infant morbidity. In this study, 614 pregnant women with P-PROM received the following treatment: oral amoxicillin (250 mg every 8 hours) and erythromycin (333 mg every 8 hours) for five days after receiving IV ampicillin (2 g every 6 hours) and erythromycin (250 mg every 6 hours) for 48 hours.

When compared to erythromycin, azithromycin has a slower elimination rate and a greater pharmacokinetic distribution. Azithromycin also has lower rates of side effects, better compliance, fewer drug interactions, and fewer dosing intervals [57].

Martingano et al.’s multicenter prospective observational cohort study was published recently. [58] investigated whether azithromycin versus erythromycin antibiotic regimens could affect pregnancy latency and the emergence of clinical chorioamnionitis in P-PROM women. All enrolled women received latency antibiotic treatment with either azithromycin or erythromycin in the context of P-PROM. For 48 hours, the azithromycin group received amoxicillin 250 mg every 8 hours orally, followed by 5 days of azithromycin 1 g orally once daily and ampicillin 2 g every 6 h IV. Amoxicillin 250 mg and erythromycin 500 mg were given orally every 8 hours for five days in the erythromycin group after receiving erythromycin 250 mg and ampicillin 2 g every 6 hours intravenously for 48 hours. A total of 310 participants were enrolled in this study, and 142 of them received the azithromycin regimen and 168 the erythromycin regimen. Patients on the azithromycin regimen experienced significantly lower rates of clinical chorioamnionitis overall (13). 4% vs. 25%; p = 0. 010), postpartum endometritis (14. 8% vs. 31%; p = 0. 001), and neonatal sepsis (4. 9% vs. 14. 9%; p = 0. 004). A reduced risk for clinical chorioamnionitis, postpartum endometritis, and neonatal sepsis was observed in the azithromycin group in both crude and adjusted models. Pregnancy latency did not significantly differ between the two groups in either of the models.

Other authors [59] investigated whether there were variations in the latency from P-PROM to delivery in women treated with various azithromycin versus erythromycin dosing regimens. Patients who were contraindicated for expectant management of P-PROM were not included in the multicenter, retrospective cohort of singleton pregnancies with confirmed P-PROM between 230 and 336 gestational weeks. Ampicillin IV was administered to all patients for two days, followed by five days of oral amoxicillin. 453 patients were enrolled. One day of azithromycin treatment was given to 78 patients, five days of azithromycin treatment was given to 191 patients, seven days of azithromycin treatment was given to 52 patients, and erythromycin was given to 132 patients. There were no statistically significant variations in azithromycin’s 1-day median latency time (4 9 days, 95% confidence interval (CI) 3. 3–6. 4), azithromycin 5 days (5. 0, 95% CI 3. 9–6. 1), or azithromycin 7 days (4. 9 days, 95% CI 2. 8–7. 0) in comparison to erythromycin (5. 1 days, 95% CI 3. 9–6. 4), after adjusting for demographic variables (p = 0. 99). In the modified model, clinical chorioamnionitis did not differ between groups. Respiratory distress syndrome was found to be increased in the azithromycin 5-day group versus azithromycin 1 day versus erythromycin (44% vs 29% and 29%; p = 0. 005, respectively). When erythromycin is unavailable or inappropriate, azithromycin might be considered as a substitute in the expectant management of P-PROM. A prolonged course of azithromycin appears to have no additional benefits over a single-day dose, but clinical trials should form the basis of firm recommendations on dosing methods. The outcomes of the ongoing superiority study “Treatment of P-PROM with Erythromycin vs. The Azithromycin Trial (TREAT), a clinical trial that is currently recruiting participants (NCT 03060473), will provide more details on treatment alternatives.

Kole-White et al. [60] compared the pregnancy latency after P-PROM following oral-only antibiotic therapy to IV antibiotic therapy followed by oral antibiotic therapy. There are no discernible differences in the maternal infection relative risk (RR, 0). 43; 95% CI, 0. 05−3. 53) or neonatal infection (RR, 0. 43; 95% CI, 0. 05−3. 52) were found. The adoption of an oral-only antibiotic regimen for pregnancy latency following P-PROM may be an alternative to a conventional combined antibiotic regimen, the authors concluded.

The most common major surgical procedure in the USA is a cesarean section (CS), with over 1 2 million carried out annually [61]. Each year, up to 12% of the cesarean deliveries carried out in the USA are complicated by surgical site infection [62], a significant cause of morbidity and mortality [63] Tita et al. According to [16], patients undergoing unscheduled CS who were given a single dose of perioperative azithromycin (azithromycin-based extended-spectrum antibiotic prophylaxis) had a lower risk of developing postoperative infectious morbidities, such as wound infections and endometritis. 1% vs. 12%). The effectiveness of such prophylaxis was due to the inclusion of ureaplasma species, which were discovered to be more frequently linked to infections after CS than anaerobes. Additionally, secondary neonatal composite outcomes did not significantly differ (14). 3% vs. 13. 6%).

Azithromycin in Lactation & Breastfeeding: Is it Safe?

The duration of Azithromycin’s presence in breast milk after your last dose is approximately 48 hours. While azithromycin during lactation is typically safe, it is best to speak with a medical professional in order to prevent any negative effects.

Although studies have not found any negative effects on infants, and it is generally safe to use while nursing, azithromycin may still cause mild health issues in some infants, such as diarrhea, vomiting, or a rash. Therefore, there is no clear answer to the question of whether azithromycin is completely safe while nursing. However, it typically doesn’t result in any significant harm and is considered safe during lactation and breastfeeding.

Azithromycin can be taken orally, with or without food, during pregnancy. After eating, take the medication if you have an upset stomach. Take the entire dosage as directed by your doctor. To ensure that Azithromycin is effective, it must be taken for the full recommended duration. Typically, medical professionals advise patients to take azithromycin once daily at the same time.

If you feel better, don’t stop taking the medication because doing so could encourage the growth of bacteria and cause the infection to return. Consult your doctor if your symptoms worsen. To ensure that you remember to take Azithromycin every day, set a reminder.

Antacids may reduce the absorption of azithromycin because they frequently contain aluminum or magnesium. Have your antacid at least two hours before or after taking azithromycin if you take one. Book an online consultation with.

We have listed the most crucial azithromycin effects below. However, this might not be a comprehensive list. Consult your doctor to learn more.

  • Nausea
  • Vomiting
  • Diarrhoea
  • Abdominal pain
  • Irregular heartbeat
  • Acid reflux
  • Headache
  • Fatigue
  • Dizziness
  • Rashes
  • Chest pain
  • Dry skin
  • Women with a history of allergy to macrolides or ketolides should not take the medication.
  • Women with a previous condition of myasthenia gravis that causes muscle weakness might face worsening symptoms or breathing problems after taking Azithromycin.
  • One cannot prescribe this medication to treat pneumonia if a woman has bacteremia, cystic fibrosis or an underlying immune system issue.
  • Women should not rely on Azithromycin to treat syphilis.
  • If a woman suffers from an irregular heartbeat or existing kidney and liver disease, they should consult a doctor before taking this medication.
  • Azithromycin can be detected in breast milk and may remain for 48 hours after a womans last dose. Generally, it is safe to use Azithromycin when breastfeeding, but the drug may cause diarrhoea, vomiting or a rash in babies.
  • Some drugs are considered safe to consume during pregnancy. But some medications’ effects on an unborn child have not yet been researched. When taken in the first few months of pregnancy, some medications are harmful to the unborn child.

    Some medications, such as tetracycline, can enter the womb and have negative effects on the unborn child. Because of this, it is crucial to seek medical advice before taking medication while pregnant. Most doctors think that using Azithromycin is safe in pregnancy.

    As previously mentioned, no human studies have connected the use of the medication to miscarriage or birth defects. The data, however, is not entirely conclusive because studies have only been done on small groups. Therefore, only use azithromycin during pregnancy if necessary and as prescribed by your doctor.


    Can azithromycin antibiotics cause miscarriage in early pregnancy?

    An increased risk of miscarriage was found among pregnant women treated with azithromycin [20].

    Which antibiotic is safe in first trimester of pregnancy?

    Here’s a sampling of antibiotics generally considered safe during pregnancy: Penicillins, including amoxicillin (Amoxil, Larotid) and ampicillin. Cephalosporins, including cefaclor and cephalexin (Keflex) Clindamycin (Cleocin, Clinda-Derm, Clindagel)

    Which pregnancy category is azithromycin?

    Azithromycin is categorized as pregnancy class B. The data for risk of congenital malformations associated with use of azithromycin during pregnancy ranges from no risk to a small increased risk.

    Can azithromycin cause birth defects?

    Taking antibiotics like erythromycin, clarithromycin or azithromycin early in the course of pregnancy may increase the risk of birth defects.

    Azithromycin and pregnancy

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