Acetohydroxamic acid

Preview FDA label, Mission Pharmacal Company, oral, effective 2026-01-08. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Urease Inhibitor

Dosing in kidney impairment

The dosage should be reduced in patients with reduced renal function. Patients whose serum creatinine is greater than 1.8 mg/dl should take no more than 1.0 gm/day; such patients should be dosed at q-12-h intervals. Further reductions in dosage to prevent the accumulation of toxic concentrations in the blood may also be desirable.

Drug interactions

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Label text (1 paragraph)

DRUG INTERACTIONS AHA has been used concomitantly with insulin, oral and parenteral antibiotics, and progestational agents. No clinically significant interactions have been noted, but until wider clinical experience is obtained, AHA should be used with caution in patients receiving other therapeutic agents. AHA taken in association with alcoholic beverages has resulted in a rash. (See Adverse Reactions.) AHA chelates heavy metals-notably iron. The absorption of iron and AHA from the intestinal lumen may be reduced when both drugs are taken concomitantly. When iron administration is indicated, intramuscular iron is probably the product of choice.

Contraindications

Acetohydroxamic acid should not be used in: a. patients whose physical state and disease are amenable to definitive surgery and appropriate antimicrobial agents b. patients whose urine is infected by non-urease producing organisms c. patients whose urinary infections can be controlled by culture-specific oral antimicrobial agents d. patients whose renal function is poor (i.e., serum creatinine more than 2.5 mg/dl and/or creatinine clearance less than 20 ml/min) e. female patients who do not evidence a satisfactory method of contraception f. patients who are pregnant Acetohydroxamic acid may cause fetal harm when administered to a pregnant woman.

AHA was teratogenic (retarded and/or clubbed rear leg at 750 mg/kg and above and exencephaly and encephalocele at 1,500 mg/kg) when given intraperitoneally to rats. AHA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to the fetus.

Pregnancy and lactation

Pregnancy

(See Contraindications.)

Lactation

It is not known whether AHA is secreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from AHA, a decision should be made to discontinue nursing or the drug, taking into account the significance of the drug to the mother’s well being.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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