Is Ceftazidime (Ceftazidime) safe during pregnancy?

From the Guidelines

Ceftazidime is considered safe for use during pregnancy when clinically indicated, as most studies have found that cephalosporin antibiotics are safe to use in pregnancy, with no fetal damage in animals and no increase in risk in humans, particularly in the second and third trimesters 1.

Key Points to Consider

• Ceftazidime is classified as a category B antibiotic, indicating that animal studies have not demonstrated fetal risk, and there are no adequate well-controlled studies in pregnant women showing adverse effects.
• The standard adult dosing of ceftazidime, typically 1-2 grams administered intravenously or intramuscularly every 8-12 hours, remains appropriate during pregnancy, depending on the severity of infection and renal function.
• Ceftazidime is particularly useful for treating serious gram-negative infections, including those caused by Pseudomonas aeruginosa, and its benefits in controlling maternal infection typically outweigh the theoretical risks to the fetus 1.
• As with any medication during pregnancy, ceftazidime should be used at the lowest effective dose for the shortest duration necessary to treat the infection, and renal function should be monitored during treatment, as pregnancy can alter drug clearance.
• If a patient has a history of penicillin allergy, cross-reactivity with cephalosporins like ceftazidime should be considered, though this risk is generally lower than previously thought.

Important Considerations for Use

• Low presence in breast milk has been noted, but there is limited human data available on its use during breastfeeding 1.
• Monitoring for potential side effects and adjusting the dose as necessary is crucial to ensure the safety and efficacy of ceftazidime treatment during pregnancy.
• The decision to use ceftazidime during pregnancy should be made on a case-by-case basis, considering the specific clinical circumstances and the potential benefits and risks to both the mother and the fetus 1.

From the FDA Drug Label

Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to FORTAZ. There are, however, no adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Ceftazidime is classified as a Pregnancy Category B drug, meaning that reproduction studies in animals have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Therefore, ceftazidime should be used during pregnancy only if clearly needed 2.

• Key points:
  • No evidence of impaired fertility or harm to the fetus in animal studies
  • No adequate and well-controlled studies in pregnant women
  • Use during pregnancy only if clearly needed

From the Research

Ceftazidime Use in Pregnancy

• Ceftazidime is a parenteral cephalosporin frequently used in pregnant women for treatment of urinary tract or intrauterine infections 3.
• A study found that ceftazidime readily crosses the placenta and indicates that perinatal pharmacokinetic behavior of ceftazidime in preterm neonates can be expected to be similar to those observed in their mothers 3.
• Clinical effect and safety of ceftazidime in obstetrics and gynaecology were studied in 20 cases, showing an overall efficacy rate of 65% and no adverse reactions or abnormal laboratory findings attributable to ceftazidime 4.

Pharmacokinetics of Ceftazidime During Pregnancy

• A study found that renal elimination of ceftazidime during pregnancy is increased, with clearance values raised by 50% to 100% compared with the values found in the postpartum period 5.
• The results strongly indicate that ceftazidime is excreted exclusively by glomerular filtration with no tubular reabsorption, and the excretion pattern is unaltered during pregnancy 5.

Ceftazidime-Avibactam for Complicated Infections

• Ceftazidime-avibactam is a combination of ceftazidime with avibactam, a novel non-β-lactam β-lactamase inhibitor, which restores the activity of ceftazidime against many β-lactamase-producing Gram-negative bacteria 6.
• Clinical and nonclinical studies support the safety and efficacy of ceftazidime-avibactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections 6.

General Properties and Uses of Ceftazidime

• Ceftazidime is a 'third generation' cephalosporin with a broad spectrum of in vitro activity against Gram-positive and Gram-negative aerobic bacteria, and is particularly active against Enterobacteriaceae and Pseudomonas aeruginosa 7.
• Ceftazidime appears to be similar in efficacy to 'standard' comparative drugs in lower respiratory tract infections and complicated and/or chronic urinary tract infections, and may be a valuable alternative in patients having Gram-negative infections 7.