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Drug overview for LITHOSTAT (acetohydroxamic acid):
Generic name: ACETOHYDROXAMIC ACID (a-SEET-oh-HYE-drox-AM-ik AS-id)
Drug class: Urinary Stone Agents
Therapeutic class: Genitourinary Therapy
Acetohydroxamic acid, a urease inhibitor, is an ammonia detoxicant.
No enhanced Uses information available for this drug.
Generic name: ACETOHYDROXAMIC ACID (a-SEET-oh-HYE-drox-AM-ik AS-id)
Drug class: Urinary Stone Agents
Therapeutic class: Genitourinary Therapy
Acetohydroxamic acid, a urease inhibitor, is an ammonia detoxicant.
No enhanced Uses information available for this drug.
DRUG IMAGES
LITHOSTAT 250 MG TABLET
The following indications for LITHOSTAT (acetohydroxamic acid) have been approved by the FDA:
Indications:
Bacterial urinary tract infection
Struvite renal calculi
Professional Synonyms:
Magnesium ammonium phosphate nephrolithiasis
Struvite nephrolithiasis
Indications:
Bacterial urinary tract infection
Struvite renal calculi
Professional Synonyms:
Magnesium ammonium phosphate nephrolithiasis
Struvite nephrolithiasis
The following dosing information is available for LITHOSTAT (acetohydroxamic acid):
To obtain optimum results, patients should be given a copy of the patient information provided by the manufacturer. Patients should be advised of the importance of complying with the prescribed dosage regimen for acetohydroxamic acid, since failure to comply may result in decreased efficacy of the drug and recurrence of stone formation.
The usual initial adult dosage of acetohydroxamic acid is 250 mg 3 or 4 times daily (about 12 mg/kg daily), given at 6- to 8-hour intervals. A total daily dose of 10-15 mg/kg (not to exceed 1.5 g), given in divided doses, is recommended for adults.
The usual dose and frequency of administration of acetohydroxamic acid in children have not been established; however, the manufacturer states that an initial dosage of 10 mg/kg daily administered in 2 or 3 divided doses has been tolerated satisfactorily for periods up to 1 year in children 8-10 years of age. Close monitoring of the child's clinical condition and hematologic status is recommended. Dosage should be adjusted according to individual tolerance and response, using the lowest possible effective dosage.
The optimum dose and frequency of administration of acetohydroxamic acid in patients with moderate degrees of renal impairment have not been determined. In patients with serum creatinine concentrations of 1.8-2.5
mg/dL, the manufacturer currently recommends that the total daily dose of acetohydroxamic acid not exceed 1 g, given in 2 divided doses at 12-hour intervals; however, pending further accumulation of data, some clinicians recommend that the drug be used with extreme caution in patients with a serum creatinine concentration of 1.3-2.5 mg/dL and that total daily dose also not exceed 1 g in patients with a serum creatinine concentration of 1.3-1.8
mg/dL. These clinicians also recommend that serum creatinine concentration be determined periodically and monitored closely during therapy with the drug in patients with renal impairment or changing renal function. Additional dosage reduction may be necessary to prevent the accumulation of toxic concentrations of the drug.
The drug should not be administered to patients with serum creatinine concentration greater than 2.5 mg/dL or creatinine clearance less than 20 mL/minute. (See Cautions: Precautions and Contraindications.)
The usual initial adult dosage of acetohydroxamic acid is 250 mg 3 or 4 times daily (about 12 mg/kg daily), given at 6- to 8-hour intervals. A total daily dose of 10-15 mg/kg (not to exceed 1.5 g), given in divided doses, is recommended for adults.
The usual dose and frequency of administration of acetohydroxamic acid in children have not been established; however, the manufacturer states that an initial dosage of 10 mg/kg daily administered in 2 or 3 divided doses has been tolerated satisfactorily for periods up to 1 year in children 8-10 years of age. Close monitoring of the child's clinical condition and hematologic status is recommended. Dosage should be adjusted according to individual tolerance and response, using the lowest possible effective dosage.
The optimum dose and frequency of administration of acetohydroxamic acid in patients with moderate degrees of renal impairment have not been determined. In patients with serum creatinine concentrations of 1.8-2.5
mg/dL, the manufacturer currently recommends that the total daily dose of acetohydroxamic acid not exceed 1 g, given in 2 divided doses at 12-hour intervals; however, pending further accumulation of data, some clinicians recommend that the drug be used with extreme caution in patients with a serum creatinine concentration of 1.3-2.5 mg/dL and that total daily dose also not exceed 1 g in patients with a serum creatinine concentration of 1.3-1.8
mg/dL. These clinicians also recommend that serum creatinine concentration be determined periodically and monitored closely during therapy with the drug in patients with renal impairment or changing renal function. Additional dosage reduction may be necessary to prevent the accumulation of toxic concentrations of the drug.
The drug should not be administered to patients with serum creatinine concentration greater than 2.5 mg/dL or creatinine clearance less than 20 mL/minute. (See Cautions: Precautions and Contraindications.)
Acetohydroxamic acid is administered orally. Although the manufacturer states that acetohydroxamic acid should always be administered at a time when the stomach is empty, the effect of food on GI absorption of the drug has not been determined. Absorption of the drug may potentially be reduced by dietary metals (e.g., iron). (See Drug Interactions: Iron.)
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LITHOSTAT 250 MG TABLET | Maintenance | Adults take 1 tablet (250 mg) by oral route 3 times per day on an empty stomach |
No generic dosing information available.
The following drug interaction information is available for LITHOSTAT (acetohydroxamic acid):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for LITHOSTAT (acetohydroxamic acid):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Alcohol use disorder |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Pregnancy |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Phlebitis |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Anemia |
| Hemolytic anemia |
| Leukopenia |
| Thrombocytopenic disorder |
The following adverse reaction information is available for LITHOSTAT (acetohydroxamic acid):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 7 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute cognitive impairment Depression Hemolytic anemia Nervousness Phlebitis Thrombotic disorder Tremor |
None. |
| Rare/Very Rare |
|---|
| None. |
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anorexia Headache disorder Malaise Nausea Symptoms of anxiety Vomiting |
None. |
| Rare/Very Rare |
|---|
|
Alopecia Skin rash |
The following precautions are available for LITHOSTAT (acetohydroxamic acid):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Acetohydroxamic acid may cause fetal harm when administered to pregnant women. The drug has been shown to be teratogenic in rats, causing retarded and/or clubbed rear leg, exencephaly, encephalocele, cleft palate, and ectrodactyly and polydactyly when given intraperitoneally at doses of 750-1500 mg/kg. The teratogenic effects and dose relationships in these rats were similar for acetohydroxamic acid and hydroxyurea; the fetuses were more sensitive to the lethal effects of the drugs than were the mothers.
Since the risks clearly outweigh any possible benefits in women who are or may become pregnant, acetohydroxamic acid is contraindicated in such women. Women of childbearing age should be instructed to use an effective form of contraception during acetohydroxamic acid therapy and informed of the potential hazard to the fetus should they become pregnant during therapy with the drug. If the drug is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, the potential hazard to the fetus should be considered.
Since the risks clearly outweigh any possible benefits in women who are or may become pregnant, acetohydroxamic acid is contraindicated in such women. Women of childbearing age should be instructed to use an effective form of contraception during acetohydroxamic acid therapy and informed of the potential hazard to the fetus should they become pregnant during therapy with the drug. If the drug is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, the potential hazard to the fetus should be considered.
It is not known if acetohydroxamic acid is distributed into milk. Because of the potential for serious adverse reactions to acetohydroxamic acid in nursing infants, a decision should be made whether to discontinue nursing or to not use the drug, taking into account the importance of the drug to the woman.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for LITHOSTAT (acetohydroxamic acid):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for LITHOSTAT (acetohydroxamic acid)'s list of indications:
| Bacterial urinary tract infection | |
| N30.0 | Acute cystitis |
| N30.00 | Acute cystitis without hematuria |
| N30.01 | Acute cystitis with hematuria |
| N30.9 | Cystitis, unspecified |
| N30.90 | Cystitis, unspecified without hematuria |
| N30.91 | Cystitis, unspecified with hematuria |
| N39.0 | Urinary tract infection, site not specified |
| O23.0 | Infections of kidney in pregnancy |
| O23.00 | Infections of kidney in pregnancy, unspecified trimester |
| O23.01 | Infections of kidney in pregnancy, first trimester |
| O23.02 | Infections of kidney in pregnancy, second trimester |
| O23.03 | Infections of kidney in pregnancy, third trimester |
| O23.1 | Infections of bladder in pregnancy |
| O23.10 | Infections of bladder in pregnancy, unspecified trimester |
| O23.11 | Infections of bladder in pregnancy, first trimester |
| O23.12 | Infections of bladder in pregnancy, second trimester |
| O23.13 | Infections of bladder in pregnancy, third trimester |
| O23.2 | Infections of urethra in pregnancy |
| O23.20 | Infections of urethra in pregnancy, unspecified trimester |
| O23.21 | Infections of urethra in pregnancy, first trimester |
| O23.22 | Infections of urethra in pregnancy, second trimester |
| O23.23 | Infections of urethra in pregnancy, third trimester |
| O23.3 | Infections of other parts of urinary tract in pregnancy |
| O23.30 | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
| O23.31 | Infections of other parts of urinary tract in pregnancy, first trimester |
| O23.32 | Infections of other parts of urinary tract in pregnancy, second trimester |
| O23.33 | Infections of other parts of urinary tract in pregnancy, third trimester |
| O23.4 | Unspecified infection of urinary tract in pregnancy |
| O23.40 | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
| O23.41 | Unspecified infection of urinary tract in pregnancy, first trimester |
| O23.42 | Unspecified infection of urinary tract in pregnancy, second trimester |
| O23.43 | Unspecified infection of urinary tract in pregnancy, third trimester |
| O23.90 | Unspecified genitourinary tract infection in pregnancy, unspecified trimester |
| O23.91 | Unspecified genitourinary tract infection in pregnancy, first trimester |
| O23.92 | Unspecified genitourinary tract infection in pregnancy, second trimester |
| O23.93 | Unspecified genitourinary tract infection in pregnancy, third trimester |
| P39.3 | Neonatal urinary tract infection |
| T83 | Complications of genitourinary prosthetic devices, implants and grafts |
| T83.5 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.51 | Infection and inflammatory reaction due to urinary catheter |
| T83.59 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.6 | Infection and inflammatory reaction due to prosthetic device, implant and graft in genital tract |
| Struvite renal calculi | |
| N20 | Calculus of kidney and ureter |
| N20.0 | Calculus of kidney |
| N20.1 | Calculus of ureter |
| N20.2 | Calculus of kidney with calculus of ureter |
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