Lithostat

Lithostat is part of the drug class:

• Other urologicals

You should not use acetohydroxamic acid if you have kidney disease, or if you have bladder symptoms that have not been checked by a doctor.

This medicine can harm an unborn baby or cause birth defects. Do not use acetohydroxamic acid if you are pregnant or if you are not using birth control.

You should not use acetohydroxamic acid if you are allergic to it, or if you have:

• kidney disease;

• bladder symptoms that have not been checked by a doctor with lab tests; or

• if you are pregnant or are not using birth control.

To make sure acetohydroxamic acid is safe for you, tell your doctor if you have:

• liver disease;

• hemolytic anemia (a lack of red blood cells); or

• a weak immune system.

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not use acetohydroxamic acid if you are pregnant. Use effective birth control to prevent pregnancy while taking acetohydroxamic acid. Tell your doctor right away if you become pregnant or if you stop using birth control for any reason during treatment with this medicine.

It is not known whether acetohydroxamic acid passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include general ill feeling, vomiting, and feeling anxious or uneasy.

You may have a skin rash or flushing (warmth, redness, or tingly feeling) if you drink alcohol while taking this medicine.

Ask your doctor before taking any vitamin or mineral supplement that contains iron.

Other drugs may interact with acetohydroxamic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

A Coombs negative hemolytic anemia has occurred in patients receiving AHA. Gastrointestinal upset characterized by nausea, vomiting, anorexia and generalized malaise have accompanied the most severe forms of hemolytic anemia. Approximately 15% of patients receiving AHA have had only laboratory findings of an anemia. However, most patients developed a mild reticulocytosis. The untoward reactions have reverted to normal following cessation of treatment. A complete blood count, including a reticulocyte count, is recommended after two weeks of treatment. If the reticulocyte count exceeds 6%, a reduced dosage should be entertained. A CBC and reticulocyte count are recommended at 3-month intervals for the duration of treatment.

Well controlled, long-term animal studies that identify the carcinogenic potential of AHA treatment have not been conducted. Acetamide, a metabolite of AHA, has been shown to cause hepatocellular carcinoma in rats at oral doses 1,500 times the human dose. AHA is cytotoxic and was positive for mutagenicity in the Ames test.

Pregnancy Category X. (See Contraindications.)

Applies to acetohydroxamic acid: oral tablet