Category C—No published reports in human pregnancy however human data from the Teratology Information Service in France suggests high risk, but the very limited human pregnancy experience prevents an assessment of the embryo-fetal risk. However, the use of alcohol in pregnancy is well known to cause dose-related developmental toxicity. In pregnant women with alcohol dependency, the risk:benefit ratio may favor its use.
No reports describing the use of acamprosate during human lactation have been located. The molecular weight, lack of metabolism and protein binding, and long t½ suggest that the drug will be excreted in breast milk. The effect on a nursing infant from exposure in milk is unknown. However, alcohol is excreted into milk and is known to be a neurotoxin ∴ if a lactating woman requires acamprosate to refrain from drinking, the benefit to the nursing infant appears to outweigh the unknown risk from the drug.
There were too few patients in the ≥65 age group to evaluate any differences in safety or effectiveness for geriatric patients compared to younger patients.
Disposition is significantly impacted by renal impairment w/ t½'s of 33.4±6.6° & 46.6±12.9°, respectively. The mean renal CLs for the moderate and severe impairment groups were 3.29±0.85 L/h and 1.10±0.21 L/h, respectively ∴ ecommended acamprosate be very carefully dosed or avoided in patients with moderate or severe renal impairment.
No dose adjustment necessary