Caffeine / sodium benzoate Pregnancy and Breastfeeding Warnings

Caffeine / sodium benzoate Pregnancy Warnings

This drug should be used by pregnant women only if clearly needed.

US FDA pregnancy category: C

Comments: It is unknown whether this drug can cause fetal harm or can affect reproduction capacity. Animal reproduction studies have not been conducted.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Caffeine / sodium benzoate Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes

Comments:
-The average caffeine levels in the milk of 5 postpartum women given a 150 mg oral dose of this drug were 1.6, 1.5, and 0.9 mg/L at 30, 60, and 120 minutes after the dose, respectively.
-The milk caffeine levels of one woman who also received a 300 mg dose were about double those after her 150 mg dose.

-Fussiness, jitteriness, and poor sleep patterns have been reported in infants of mothers with caffeine intakes equivalent to about 10 or more cups of coffee daily.
-No stimulatory effects were observed in infants 3 weeks of age and older of mothers who drank 5 cups of coffee daily.
-Caffeine clearance is very low in preterm and newborn infants, but reaches adult levels by 3 to 5 months of age.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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