Summary of Use during Lactation

Apazone (azapropazone) is not approved for marketing in the United States by the U.S. Food and Drug Administration. Relatively small amounts of the drug are excreted into breastmilk; however, the toxicity of the drug limits its usefulness in nursing mothers.[1] An alternate drug is preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Four women received apazone 600 mg intravenously within 2 hours postpartum, then twice daily for 5 to 10 days. Apazone was measured in the blood and breastmilk twice between days 4 and 6 postpartum at 4, 8 and 12 hours after the morning dose. The authors calculated that and average of 0.8 mg (range 0.2 to 1.3 mg) of apazone was excreted in milk over a 12-hour dosage interval.[2] Using reported infant and maternal body weights, a fully breastfed infant would receive an average of 2.13% (range 1.04 to 3.03%) of the mother's weight-adjusted dosage.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Analgesia) Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Naproxen, Piroxicam; (Hyperuricemia) Probenecid

References

1.

Spigset O, Hägg S. Analgesics and breast-feeding: Safety considerations. Paediatr Drugs 2000;2:223-38. [PubMed: 10937472]

2.

Bald R, Bernbeck-Betthauser EM, Spahn H, et al. Excretion of azapropazone in human breast milk. Eur J Clin Pharmacol 1990;39:271-3. [PubMed: 2257865]

Substance Name

Apazone

CAS Registry Number

13539-59-8

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Inflammatory Agents, Nonsteroidal

Uricosuric Agents