LITHOSTAT Tablet (2022)

Βιβλιογραφική αναφορά

Συγγραφείς

Mission Pharmacal Company

Λέξεις κλειδιά

0178-0500

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1. Description

Acetohydroxamic acid (AHA) is a stable, synthetic compound derived from hydroxylamine and ethyl acetate. Its molecular structure is similar to urea: AHA is weakly acidic, highly soluble in water, and ...

2. Clinical Pharmacology

AHA reversibly inhibits the bacterial enzyme urease, thereby inhibiting the hydrolysis of urea and production of ammonia in urine infected with urea-splitting organisms. The reduced ammonia levels and ...

3. Indications and Usage

Acetohydroxamic acid is indicated as adjunctive therapy in patients with chronic urea-splitting urinary infection. AHA is intended to decrease urinary ammonia and alkalinity, but it should not be used ...

4. Contraindications

<u>Acetohydroxamic acid should not be used in:</u> a. patients whose physical state and disease are amenable to definitive surgery and appropriate antimicrobial agents b. patients whose urine is infected ...

5. Warnings

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 ...

6.1. General

Hematologic Effects Bone marrow depression (leukopenia, anemia, and thrombocytopenia) has occurred in experimental animals receiving large doses of AHA, but has not been seen in man to date. AHA is a known ...

6.4. 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 ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

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 ...

6.7. Pregnancy

(See Contraindications.)

6.9. Nursing Mothers

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 ...

6.10. Pediatric Use

Children with chronic, recalcitrant, urea-splitting urinary infection may benefit from treatment with AHA. However, detailed studies involving dosage and dose intervals in children have not been established. ...

7. Adverse Reactions

Experience with AHA is limited. About 150 patients have been treated, most for periods of more than a year. Adverse reactions have occurred in up to thirty percent (30%) of the patients receiving AHA. ...

9. Overdosage

Acute deliberate overdosage in man has not occurred, but would be expected to induce the following symptoms: anorexia, malaise, lethargy, diminished sense of well being, tremulousness, anxiety, nausea ...

10. Dosage and Administration

AHA should be administered orally, one tablet 3-4 times a day in a total daily dose of 10-15 mg/kg/day. The recommended starting dose is 12 mg/kg/day, administered at 6-8 hour intervals at a time when ...

11. How Supplied

LITHOSTAT, NDC 0178-0500-01, is available for oral administration as 250 mg white, round tablets, in unit of use packages of 100 tablets. Each LITHOSTAT tablet is debossed MPC 500 on one side and blank ...

12. Storage and Handling

LITHOSTAT should be stored in a dry place at room temperature, 15°-30°C (59°-86°F). Container should be closed tightly.