Microsoft word - pregnancy breastfeeding - safe use of anti-infective agents oct 14 post-mr.doc

Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIBACTERIAL AGENTS
Name of Agent / Class
Pregnancy
Breastfeeding
Aminoglycosides
Amikacin
• Not expected to increase risk of major congenital • Considered safe during breastfeeding • Monitor nursing infant for GI symptoms. • Monitor drug concentrations for efficacy as higher • Theoretical risk of ototoxicity and nephrotoxicity. Penicillins
Ampicillin
• Not expected to increase risk of major congenital • Considered safe during breastfeeding • Monitor nursing infant for GI symptoms. • Amoxicillin/clavulinic acid should be avoided in women at risk of preterm delivery due to increased risk of neonatal necrotising enterocolitis. 1. Human data on cloxacillin, piperacillin/tazobactam, and ticarcillin are limited; however, penicillins as a class are considered safe during pregnancy. Cephalosporins
Cefazolin
• Not expected to increase risk of major congenital • Considered safe during breastfeeding • Monitor nursing infant for GI symptoms.
The information in this table was prepared by Motherisk and is to be used for guidance purposes only.

For more information, please contact the Motherisk hotline Monday to Friday 9 AM to 5 PM.
Phone 416-813-6780. Fax 416-813-7562.
Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIBACTERIAL AGENTS
Name of Agent / Class
Pregnancy
Breastfeeding
Carbapenems
Ertapenem
• No human data; however, there is no evidence of increased risk of major congenital malformations cause adverse effects in breastfed infants • Use when benefit outweighs unknown risk to the • Monitor nursing infant for GI symptoms. Macrolides
Azithromycin
• Not expected to increase risk of major congenital • Not expected to cause adverse effects in • Monitor nursing infant for GI symptoms. • Not expected to cause adverse effects in • Not expected to increase risk of major congenital • Monitor nursing infant for GI symptoms. • Not expected to increase risk of major congenital • Not expected to cause adverse effects in • Monitor nursing infant for GI symptoms. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIBACTERIAL AGENTS
Name of Agent / Class
Pregnancy
Breastfeeding
Quinolones
Ciprofloxacin
• Not expected to increase risk of major congenital • Monitor nursing infant for GI symptoms. • Limited human data; however, short-term • Not expected to increase risk of major congenital • Monitor nursing infant for GI symptoms. * It would be preferable to use of a drug other than moxifloxacin for which safety information is available. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIBACTERIAL AGENTS
Name of Agent / Class
Pregnancy
Breastfeeding
Sulfonamides
Co-trimoxazole
• Case control studies suggest an association with • Trimethoprim is present at low levels in neural tube defects (NTDs), cardiovascular breast milk and is not expected to cause malformations and facial clefting as a result of • During 1st trimester, use of an alternate agent • If use during the 1st trimester cannot be avoided, high dose folic acid (4-5mg/day) should be given to • Sulfamethoxazole should be used with • Sulfamethoxazole should be avoided near term due to potential toxicity to the newborn (hemolytic while breastfeeding an infant with G6PD deficiency. • Monitor nursing infant for GI symptoms. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIBACTERIAL AGENTS
Name of Agent / Class
Pregnancy
Breastfeeding
Tetracyclines
Doxycycline
• Should be avoided after 15 weeks of gestation due • Low levels in breast milk and reduced oral to reports of possible discoloration of the deciduous • Short-term use is not expected to cause • Prolonged or repeated treatment courses during nursing should be avoided (theoretical precaution). • Monitor nursing infant for GI symptoms. • Black discoloration of breast milk has Miscellaneous Antibacterial Agents
Clindamycin
• Not expected to increase risk of major congenital diarrhea, oral thrush, and for blood in the stool suggestive of antibiotic-associated colitis (rare). • No human data on exposure during 1st trimester. • Animal studies show no evidence of fetal risk. • Should be used only when benefit outweighs • Not expected to cause adverse effects in • Monitor nursing infant for GI symptoms. • An alternate agent with a known safety profile • An alternate agent with a known safety • Should be used only when benefit outweighs • Monitor nursing infant for GI symptoms. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIBACTERIAL AGENTS
Name of Agent / Class
Pregnancy
Breastfeeding
• Not expected to increase risk of major congenital • Not expected to cause adverse effects in • The theoretical risk suggested by in vitro and • Infant dose via breast milk is lower than animal studies has not been observed in clinical 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. • Not expected to increase risk of major congenital • There is a theoretical risk of hemolytic anemia in newborns, particularly in those with G6PD • Not expected to cause adverse effects in deficiency, who are exposed in utero to nitrofurantoin close to delivery. If there is a • Monitor nursing infant for GI symptoms. concern, an alternate agent should be used after 37 weeks of gestation. • Not expected to increase risk of major congenital • Limited information; however, amounts in • Prenatal exposure to rifampin has been linked to • Breastfeeding should not be discouraged hemorrhagic disease of the newborn. Prophylactic administration of vitamin K is recommended to • Monitor nursing infant for GI symptoms. • No reports on use during human pregnancy. • Tigecycline is structurally related to tetracycline and thus should be avoided after 15 weeks of • Use of an alternate agent with a known • Use of an alternate agent with a known safety • Monitor nursing infant for GI symptoms. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIBACTERIAL AGENTS
Name of Agent / Class
Pregnancy
Breastfeeding
• Limited information; however, amounts in • Should be used only when benefit outweighs breast milk and oral bioavailability are low.
• Monitor nursing infant for GI symptoms. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIFUNGAL AGENTS
Name of Agent / Class

Pregnancy
Breastfeeding
• Not expected to increase risk of major congenital • Should be used only when benefit outweighs • Not expected to cause adverse effects in • Should be avoided in 1st trimester, whenever • Not expected to cause adverse effects in • Monitor breastfed infant for symptoms of • Monitor breastfed infant for GI symptoms. • Not expected to increase risk of major congenital • Amounts found in breast milk are lower malformations when used in low-doses (150 mg) • Considered safe during breastfeeding • There are case reports of congenital anomalies with prolonged use in doses > 400 mg/day during the 1st trimester. (Causation has not been proven). • Not expected to increase risk of major congenital • Use of an alternate agent with a known • Can be considered when other agents have failed and the benefit outweighs the unknown risk to the fetus. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIFUNGAL AGENTS
Name of Agent / Class

Pregnancy
Breastfeeding
• Should be used only when benefit outweighs • Animal studies have suggested voriconazole is • Should be avoided during pregnancy at least for the 1st trimester unless other treatments have failed and the benefit outweighs the unknown risk to the fetus. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIVIRAL AGENTS
Name of Agent / Class
Pregnancy
Breastfeeding
• Not expected to increase risk of major congenital • Considered safe during breastfeeding. • Amounts found in breast milk are lower • Case reports of congenital malformation with • Use of an alternate antiviral agent with a • Use of an alternate antiviral agent with a known safety profile would be preferred when possible. • Not expected to increase risk of major congenital malformations, based on a small number of • Use of an alternate antiviral agent with a known safety profile would be preferred when possible. • Case reports describe treatment in 2nd and 3rd • Should be avoided during breastfeeding. trimester with no adverse effects in the neonates. • Should be used only when the benefit outweighs • Due to potential for renal toxicity, close follow up of the fetus and monitoring of amniotic fluid volume are recommended. • Should be used only when the benefit outweighs • Not expected to increase risk of major congenital • Not expected to cause adverse effects in Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIMALARIAL AGENTS
Name of Agent / Class

Pregnancy
Breastfeeding
• Limited human data, mostly on use in 2nd and 3rd • Should be used only when the benefit outweighs transferred in breast milk is insufficient to provide adequate protection against malaria for the infant. • Limited human data, mostly on use in 2nd and 3rd • Not expected to cause adverse effects in • May be used to treat uncomplicated chloroquine- resistant P. falciparum infection if: o Other options are not available or not suitable transferred in breast milk is insufficient to o The benefit of its use outweighs the unknown • Plasma concentrations of atovaquone and proguanil were found in one study to be lower in pregnant women due to an increase in clearance and volume of distribution. It should be noted that all women in this study were cured of their initial infection in 1-3 days. Thus, the clinical significance of those pharmacokinetic changes is unclear. • Not expected to increase risk of major congenital • Not expected to cause adverse effects in transferred in breast milk is insufficient to provide adequate protection against malaria for the infant. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIMALARIAL AGENTS
Name of Agent / Class

Pregnancy
Breastfeeding
• Not expected to increase risk of major congenital malformations above the baseline risk in general diarrhea, oral thrush, and for blood in the stool suggestive of antibiotic-associated • Recommended for treatment of uncomplicated chloroquine-resistant P. falciparum infection. transferred in breast milk is insufficient to provide adequate protection against malaria for the infant. • Should be avoided after 4-5 months of gestation, • Low levels in breast milk and low oral due to reports of possible discoloration of the • Short-term use is not expected to cause • Prolonged or repeated treatment courses during nursing should be avoided (theoretical precaution). • Monitor nursing infant for GI symptoms. • The quantity of antimalarial drugs transferred in breast milk is insufficient to provide adequate protection against malaria for the infant. • Should be used only when the benefit of its use • Not expected to cause adverse effects outweighs the unknown risk to the fetus. • Prophylactic administration of this drug should be • There is a theoretical risk of hemolytic anemia in a transferred in breast milk is insufficient to provide adequate protection against malaria for the infant. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
ANTIMALARIAL AGENTS
Name of Agent / Class

Pregnancy
Breastfeeding
• Not expected to increase risk of major congenital • Not expected to cause adverse effects malformations when used in therapeutic doses. • Recommended for treatment of uncomplicated chloroquine-resistant infection caused by P. falciparum and P. vivax. transferred in breast milk is insufficient to provide adequate protection against malaria for the infant. Pregnancy & Breastfeeding – Safe Use of Anti‐infective Agents  
Appendix A

Dosage Adjustment in Pregnancy – General Considerations

Some of the physiological changes occurring in pregnancy may affect the pharmacokinetics of drugs taken during the gestational period and postpartum. Depending on the clinical significance of these changes, adjustment of the dose and/or dosing interval may warrant consideration. Below are some examples of altered drug distribution and elimination in pregnancy. • Increased maternal plasma volume may increase the volume of distribution of some drugs, which may require a dose increase. • Decreased plasma protein concentration, specifically albumin, may increase the free fraction of highly protein bound drugs, which • Increased renal blood flow and glomerular filtration rate may increase the elimination of drugs that are excreted primarily in the urine. This may require use of an increased dose and/or a shorter dosing interval. • Alterations in the activity of hepatic drug metabolizing enzymes may require dosage adjustment as follows. o Decreased activity (e.g., CYP1A2 and CYP2C19). For drugs that are dependent on these enzymes for elimination, a dose reduction may be required. For drugs that require these enzymes for conversion to their active form, a dose increase may be appropriate. o Increased activity (e.g., CYP3A, CYP2D6 and CYP2C9). For drugs that are dependent on these enzymes for elimination, a dose increase may be required. For drugs that require these enzymes for conversion to their active form, a dose reduction may be required.
Note: there is a lack of pharmacokinetic data on which to base dosage adjustment of anti-infective agents in pregnancy, and there is
a lack of evidence demonstrating benefit. Accordingly, routine dosage adjustment is not practiced at SHSC.

Source: http://www.obstetricmed.utoronto.ca/Assets/obsmed+Digital+Assets/Obstetric+Medicine/obsmed+Digital+Assets/Pregnancy__Breastfeeding_Anti-infective_Agents.pdf

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