NALIDIXIC ACID
Drugs in Pregnancy and Lactation.
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Name: NALIDIXIC ACID
Class: Urinary Germicide
Risk Factor: CM
Fetal Risk Summary
No reports linking the use of nalidixic acid, a quinolone antibacterial agent, with congenital defects have been located. At oral doses 6 times the human dose, nalidixic acid was embryocidal and teratogenic in rats (1). Prolongation of pregnancy was also noted, especially at 4 times the human dose. Similar to other agents in this class, nalidixic acid causes arthropathy in immature animals (1).
Chromosomal damage was not observed in human leukocytes cultured with varying concentrations of the drug (2). One author cautioned that the drug should be avoided in late pregnancy because it may produce hydrocephalus (3). However, a subsequent report examined the newborns of 63 patients treated with nalidixic acid at various stages of gestation (4). No defects attributable to the drug or intracranial hypertension were observed.
Breast Feeding Summary
Nalidixic acid is excreted into breast milk in low concentrations (5,6 and 7). Hemolytic anemia was reported in one infant with glucose-6-phosphate dehydrogenase deficiency whose mother was taking 1 g 4 times a day (5). Milk levels were not measured in this case, but the author noted data from the manufacturer in which milk levels from four women taking a similar dose were found to be 4 µg/mL. The milk:plasma ratio has been reported as 0.08–0.13 (6).
A 1980 report described the excretion of unmetabolized nalidixic acid into the breast milk of 13 women, 3–8 days postpartum, following a 2-g oral dose (7). Nursing was suspended on the day of the test. Milk was collected from each woman for a 24-hour period and serum samples were taken 7 hours after the dose. The highest milk concentration of the drug occurred in the sample collected from 0 to 4 hours, 0.64 µg/mL, but the total unchanged drug excreted over 24 hours was only 0.003% of the mother's dose. The milk:serum ratio at 7 hours was 0.061, and the minimal inhibitory concentration of about 3 µg/mL was never reached (7).
The quantities measured above are normally considered insignificant (8). Although noting the single case of hemolytic anemia described above, the American Academy of Pediatrics considers nalidixic acid to be compatible with breast feeding (9).
References
- Product information. NegGram. Sanofi Winthrop Pharmaceuticals, 1997.
- Stenchever MA, Powell W, Jarvis JA. Effect of nalidixic acid on human chromosome integrity. Am J Obstet Gynecol 1970;107:329–30.
- Asscher AW. Diseases of the urinary system. Urinary tract infections. Br Med J 1977;1:1332.
- Murray EDS. Nalidixic acid in pregnancy. Br Med J 1981;282:224.
- Belton EM, Jones RV. Hemolytic anemia due to nalidixic acid. Lancet 1965;2:691.
- Wilson JT. Milk/plasma ratios and contraindicated drugs. In Wilson JT, ed. Drugs in Breast Milk. Balgowlah, Australia: ADIS Press, 1981:78–9.
- Traeger A, Peiker G. Excretion of nalidixic acid via mother's milk. Arch Toxicol 1980;Suppl 4:388–90.
- Takyi BE. Excretion of drugs in human milk. J Hosp Pharm 1970;28:317–25.
- Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:137–50.
Q&A about Nalidixic Acid
Naladixic Acid is a gram negative antibacterial medication that can sometimes work for treating Neon Tetra Disease in tropical aquariums. Aquarium Pharmaceuticals used to sell Nala Gram which used Naladixic Acid as it's active ingredient, but it appears that they've discontinued it.
I'd prefer a product that just had Naladixic Acid as it's active ingredient over a pure concentrate of it.
Thank you!

