URESE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for URESE (URESE).
Urease inhibitor; reduces bacterial conversion of urea to ammonia, lowering urine pH and ammonia concentration.
| Metabolism | Hepatic metabolism via glucuronidation and sulfation; active metabolite hydroquinone. |
| Excretion | Renal: 70% unchanged; biliary/fecal: 20% as metabolites; 10% other. |
| Half-life | 4-6 hours; prolonged in renal impairment (up to 12-15 hours in anuria). |
| Protein binding | 85% bound to albumin. |
| Volume of Distribution | 0.3 L/kg; indicates limited extravascular distribution, primarily in extracellular fluid. |
| Bioavailability | Oral: 90-95%. |
| Onset of Action | Oral: 30-60 minutes; IV: 5-10 minutes. |
| Duration of Action | Oral: 6-8 hours; IV: 4-6 hours; dose-dependent with sustained release formulations extending to 12 hours. |
Oral: 20 mg once daily. May increase to 40 mg once daily if needed after 4 weeks. Maximum: 40 mg/day.
| Dosage form | TABLET |
| Renal impairment | GFR 30-89 mL/min: No adjustment. GFR 15-29 mL/min: Use with caution; maximum 20 mg/day. GFR <15 mL/min or dialysis: Contraindicated. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Use with caution; maximum 20 mg/day. Child-Pugh C: Contraindicated. |
| Pediatric use | Not approved for pediatric use. |
| Geriatric use | Start at 10 mg once daily; titrate slowly to maximum 20 mg/day. Monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for URESE (URESE).
| Breastfeeding | Furosemide is excreted in breast milk in trace amounts (M/P ratio approximately 1:1). No adverse effects in nursing infants reported; however, theoretical risk of diuresis and electrolyte imbalance. Use with caution, especially in neonates with jaundice due to binding competition with bilirubin. |
| Teratogenic Risk | Urese (furosemide) is categorized as FDA Pregnancy Category C. First trimester: Limited human data; animal studies show fetal hydronephrosis and delayed ossification at high doses. Second and third trimesters: Potential for maternal hypovolemia and decreased placental perfusion, leading to fetal growth restriction and oligohydramnios; avoid for pregnancy-induced hypertension due to risk of reduced placental blood flow. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to any component; renal insufficiency (e.g., azotemia, oliguria); G6PD deficiency.
| Precautions | May cause hemolytic anemia in patients with G6PD deficiency; contraindicated in renal impairment; avoid concurrent use with sulfonamides. |
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| Fetal Monitoring | Monitor maternal blood pressure, serum electrolytes (especially potassium), renal function (BUN, creatinine), and fluid balance. Fetal monitoring: assess amniotic fluid volume (ultrasound) due to risk of oligohydramnios; fetal growth scans if used long-term in second/third trimester. |
| Fertility Effects | No established direct effect on fertility. However, loop diuretics may exacerbate conditions like PCOS by affecting electrolyte balance and volume status. No significant impact on spermatogenesis in males. |