Drugs in Pregnancy and Lactation: Tenth Edition

DEFINITIONS OF BREASTFEEDING RECOMMENDATIONS

COMPATIBLE

Either the drug is not excreted in clinically significant amounts into human breast milk or its use during lactation does not, or is not expected to, cause toxicity in a nursing infant.

HOLD BREASTFEEDING

The drug may or may not be excreted into human breast milk, but the maternal benefit of therapy far outweighs the benefits of breast milk to an infant. Breastfeeding should be held until maternal therapy is completed and the drug has been eliminated (or reaches a low concentration) from her system.

NO (LIMITED) HUMAN DATA—PROBABLY COMPATIBLE

Either there is no human data or the human data are limited. The available data suggest that the drug does not represent a significant risk to a nursing infant.

NO (LIMITED) HUMAN DATA—POTENTIAL TOXICITY

Either there is no human data or the human data are limited. The characteristics of the drug suggest that it could represent a clinically significant risk to a nursing infant. Breastfeeding is not recommended.

HUMAN DATA SUGGEST POTENTIAL TOXICITY

Human data suggest a risk to a nursing infant. The drug is best avoided during breastfeeding. Depending on the drug, short-term use by the mother may be possible, but the infant should be closely monitored for potential adverse effects.

NO (LIMITED) HUMAN DATA—POTENTIAL TOXICITY (MOTHER)

Either there is no human data or the human data are limited. The characteristics of the drug suggest that breastfeeding could represent a clinically significant risk to the mother such as further loss of essential vitamins or nutrients. Breastfeeding is not recommended.

CONTRAINDICATED

There may or may not be human experience, but the combined data suggest that the drug may cause severe toxicity in a nursing infant, or breastfeeding is contraindicated because of the maternal condition for which the drug is indicated. Women should not breastfeed if they are taking the drug or have the condition.

COMPARISON OF AGENTS WITHIN THE SAME PHARMACOLOGIC CLASS

The Appendix arranges the drugs by their pharmacologic category. This allows the reader to identify all of the drugs that have been reviewed within a specific category, thus allowing, if desired, a comparison of the drugs. For example, the subsection Antihypertensives lists together those agents used for this purpose under the general heading Cardiovascular Drugs. To assist the reader in locating an agent in the Appendix, page numbers (in parentheses) referring to the location in the Appendix have been added to the generic names (shown in bold) in the Index.

FDA RISK CATEGORIES DEFINITIONS

Although the FDA risk categories have been excluded from this edition, readers wanting this information can obtain it from the manufacturer’s product information.

*AUC = area under the plasma concentration vs. time curve; a measure of the systemic exposure of a drug



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