Safe use of antibacterial agents: pregnancy & breastfeeding

Amikacin

Pregnancy

Not expected to increase risk of major congenital malformations.

Monitor drug concentrations for efficacy as higher doses may be needed during pregnancy.

Theoretical risk of ototoxicity and nephrotoxicity.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Amoxicillin/clavulinic acid

Pregnancy

Not expected to increase risk of major congenital malformations.

Amoxicillin/clavulinic acid should be avoided in women at risk of preterm delivery due to increased risk of neonatal necrotising enterocolitis.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Ampicillin

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Azithromycin

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Not expected to cause adverse effects in breastfed infants.

Monitor nursing infant for GI symptoms.

Cefazolin

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Cefepime

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Ceftazidime

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Ceftriaxone

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Cefuroxime

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Cephalexin

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Ciprofloxacin

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Limited human data; however, not expected to cause adverse effects in breastfed infants.

Monitor nursing infant for GI symptoms.

Clarithromycin

Pregnancy

Limited human data.

Not expected to increase risk of major congenital malformations.

Breastfeeding

Not expected to cause adverse effects in breastfed infants.

Monitor nursing infant for GI symptoms.

Clindamycin

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Monitor nursing infant for possible diarrhea, oral thrush, and for blood in the stool suggestive of antibiotic-associated colitis (rare).

Cloxacillin

Pregnancy

Not expected to increase risk of major congenital malformations.

Human data on cloxacillin, piperacillin/tazobactam, and ticarcillin are limited; however, penicillins as a class are considered safe during pregnancy.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Co-trimoxazole (TMP + SMX) (trimethoprim + sulfamethoxazole)

Pregnancy

Case control studies suggest an association with neural tube defects (NTDs), cardiovascular malformations and facial clefting as a result of antifolate effect.

During 1st trimester, use of an alternate agent would be preferable where feasible.

If use during the 1st trimester cannot be avoided, high dose folic acid (4-5mg/day) should be given to minimize the risk of NTDs.

Sulfamethoxazole should be avoided near term due to potential toxicity to the newborn (hemolytic anemia and kernicterus).

Breastfeeding

Trimethoprim is present at low levels in breast milk and is not expected to cause adverse effects in breastfed infants.

Sulfamethoxazole use during breastfeeding is not expected to cause adverse effects in healthy, full term infants.

Sulfamethoxazole should be used with caution while breastfeeding premature infants or neonates with hyperbilirubinemia.

Sulfamethoxazole should be avoided while breastfeeding an infant with G6PD deficiency.

Monitor nursing infant for GI symptoms.

Daptomycin

Pregnancy

No human data on exposure during 1st trimester.

Animal studies show no evidence of fetal risk.

Should be used only when benefit outweighs unknown risk to the fetus.

Breastfeeding

Limited human data.

Low oral bioavailability.

Not expected to cause adverse effects in breastfed infants.

Monitor nursing infant for GI symptoms.

Doxycycline

Pregnancy

Should be avoided after 15 weeks of gestation due to reports of possible discoloration of the deciduous teeth.

Breastfeeding

Low levels in breast milk and reduced oral bioavailability in the infant.

Short-term use is not expected to cause adverse effects in breastfed infants.

Prolonged or repeated treatment courses during nursing should be avoided (theoretical precaution).

Monitor nursing infant for GI symptoms.

Ertapenem

Pregnancy

No human data; however, there is no evidence of increased risk of major congenital malformations with other beta-lactam antibiotics.

Use when benefit outweighs unknown risk to the fetus.

Breastfeeding

No human data; however, other beta-lactam antibiotics are not expected to cause adverse effects in breastfed infants.

Monitor nursing infant for GI symptoms.

Erythromycin

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Not expected to cause adverse effects in breastfed infants.

Monitor nursing infant for GI symptoms.

Fidaxomicin

Pregnancy

No human data.

Animal studies show no evidence of fetal risk.

Should be used only when benefit outweighs unknown risk to the fetus.

Should be used with caution when treating patients with inflammatory bowel disease.

Breastfeeding

No human data.

Theoretically, due to the low oral bioavailability, it is not expected to cause adverse effects.

Due to the lack of data, it should be sued with caution in breastfeeding women.

Fosfomycin

Pregnancy

Limited human data.

Based on the limited data available, it is not expected to increase risk of major congenital malformations.

Breastfeeding

Limited human data.

Not expected to cause adverse effects in breastfed infants.

Monitor nursing infant for GI symptoms.

Gentamicin

Pregnancy

Not expected to increase risk of major congenital malformations.

Monitor drug concentrations for efficacy as higher doses may be needed during pregnancy.

Theoretical risk of ototoxicity and nephrotoxicity.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Levofloxacin

Pregnancy

Limited human data.

Not expected to increase risk of major congenital malformations.

Breastfeeding

Limited human data; however, short-term use is acceptable during breastfeeding.

Monitor nursing infant for GI symptoms.

Linezolid

Pregnancy

No human data.

An alternate agent with a known safety profile would be preferred.

Should be used only when benefit outweighs unknown risk to the fetus.

Breastfeeding

No human data.

An alternate agent with a known safety profile would be preferred.

Monitor nursing infant for GI symptoms.

Meropenem

Pregnancy

No human data; however, there is no evidence of increased risk of major congenital malformations with other beta-lactam antibiotics.

Use when benefit outweighs unknown risk to the fetus.

Breastfeeding

No human data; however, other beta-lactam antibiotics are not expected to cause adverse effects in breastfed infants.

Monitor nursing infant for GI symptoms.

Metronidazole

Pregnancy

Not expected to increase risk of major congenital malformations.

The theoretical risk suggested by in vitro and animal studies has not been observed in clinical experience.

Breastfeeding

Not expected to cause adverse effects in breastfed infants.

Infant dose via breast milk is lower than therapeutic dose used in infants.

Some recommend discontinuing breastfeeding (pump and discard milk) for 12 to 24 hours after single-dose (e.g., 2 g) maternal treatment of Trichomonas infection.

Monitor nursing infant for GI symptoms.

Minocycline

Pregnancy

Should be avoided after 15 weeks of gestation due to reports of possible discoloration of the deciduous teeth.

Breastfeeding

Low levels in breast milk and reduced oral bioavailability in the infant.

Short-term use is not expected to cause adverse effects in breastfed infants.

Prolonged or repeated treatment courses during nursing should be avoided (theoretical precaution).

Monitor nursing infant for GI symptoms.

Black discoloration of breast milk has been reported with minocycline.

Moxifloxacin

Pregnancy

Limited human data.

Not expected to increase risk of major congenital malformations.

Breastfeeding

Limited human data; however, short-term use is acceptable during breastfeeding.

Monitor nursing infant for GI symptoms.

* It would be preferable to use a drug other than moxifloxacin for which safety information is available.

Nitrofurantoin

Pregnancy

Not expected to increase risk of major congenital malformations.

There is a theoretical risk of hemolytic anemia in newborns, particularly in those with G6PD deficiency, who are exposed in utero to nitrofurantoin close to delivery. If there is a concern, an alternate agent should be used after 37 weeks of gestation.

Breastfeeding

Use with caution when breastfeeding infants under 1 month of age and those with G-6-PD deficiency.

Not expected to cause adverse effects in breastfed infants > 1 month old.

Monitor nursing infant for GI symptoms.

Penicillin G

Pregnancy

Not expected to increase risk of major congenital malformations.

Breastfeeding

Considered safe during breastfeeding

Monitor nursing infant for GI symptoms.

Piperacillin/tazobactam

Pregnancy

Not expected to increase risk of major congenital malformations.

Human data on cloxacillin, piperacillin/tazobactam, and ticarcillin are limited; however, penicillins as a class are considered safe during pregnancy.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Human data on ticarcillin and piperacillin/tazobactam are limited; however, penicillins as a class are considered safe during breastfeeding.

Rifampin

Pregnancy

Not expected to increase risk of major congenital malformations.

Prenatal exposure to rifampin has been linked to hemorrhagic disease of the newborn. Prophylactic administration of vitamin K is recommended to prevent this complication.

Breastfeeding

Limited information; however, amounts in breast milk are low.

Breastfeeding should not be discouraged in women taking rifampin.

Monitor nursing infant for GI symptoms.

Tetracycline

Pregnancy

Should be avoided after 15 weeks of gestation due to reports of possible discoloration of the deciduous teeth.

Breastfeeding

Low levels in breast milk and reduced oral bioavailability in the infant.

Short-term use is not expected to cause adverse effects in breastfed infants.

Prolonged or repeated treatment courses during nursing should be avoided (theoretical precaution).

Monitor nursing infant for GI symptoms.

Ticarcillin/clavulanic acid

Pregnancy

Not expected to increase risk of major congenital malformations.

Human data on cloxacillin, piperacillin/tazobactam, and ticarcillin are limited; however, penicillins as a class are considered safe during pregnancy.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Human data on ticarcillin and piperacillin/tazobactam are limited; however, penicillins as a class are considered safe during breastfeeding.

Tigecycline

Pregnancy

No reports on use during human pregnancy.

Tigecycline is structurally related to tetracycline and thus should be avoided after 15 weeks of gestation.

Use of an alternate agent with a known safety profile would be preferred.

Breastfeeding

No human data.

Low oral bioavailability.

Use of an alternate agent with a known safety profile would be preferred.

Monitor nursing infant for GI symptoms.

Tobramycin

Pregnancy

Not expected to increase risk of major congenital malformations.

Monitor drug concentrations for efficacy as higher doses may be needed during pregnancy.

Theoretical risk of ototoxicity and nephrotoxicity.

Breastfeeding

Considered safe during breastfeeding.

Monitor nursing infant for GI symptoms.

Vancomycin

Pregnancy

Limited human data.

Should be used only when benefit outweighs unknown risk to the fetus.

Breastfeeding

Limited information; however, amounts in breast milk and oral bioavailability are low.

Monitor nursing infant for GI symptoms.

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