FLUIDIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLUIDIL (FLUIDIL).
Fluidil is a thiazide-like diuretic that inhibits the sodium-chloride symporter (NCC) in the distal convoluted tubule of the nephron, reducing sodium and chloride reabsorption and promoting diuresis.
| Metabolism | Fluidil is extensively metabolized in the liver, primarily via glucuronidation and sulfation; cytochrome P450 enzymes play a minor role. |
| Excretion | Renal: 60-70% unchanged; biliary/fecal: <5%; hepatic metabolism: 25-35%. |
| Half-life | Terminal elimination half-life: 1.5-2 hours (prolonged in hepatic impairment to 4-6 hours). |
| Protein binding | 85-92% bound to albumin, alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8-1.2 L/kg (extensive tissue distribution). |
| Bioavailability | Oral: 60-80% (first-pass metabolism). |
| Onset of Action | Oral: 30-60 minutes; IV: 5-10 minutes. |
| Duration of Action | Oral: 4-6 hours; IV: 2-4 hours (varies with dose and hepatic function). |
5 mg orally once daily.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min. Not recommended for GFR <30 mL/min. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: 2.5 mg once daily. Child-Pugh Class C: not recommended. |
| Pediatric use | Not established for pediatric patients <18 years. |
| Geriatric use | No specific adjustment; use caution due to increased sensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FLUIDIL (FLUIDIL).
| Breastfeeding | Excreted in human milk; M/P ratio not established. Use is not recommended during breastfeeding due to potential for serious adverse reactions in nursing infants. |
| Teratogenic Risk | FLUIDIL is contraindicated in pregnancy. First trimester: Associated with increased risk of major malformations, including neural tube defects and cardiac anomalies. Second and third trimesters: May cause oligohydramnios due to diminished fetal renal function; use may lead to fetal renal impairment, persistent ductus arteriosus, and craniofacial abnormalities. |
■ FDA Black Box Warning
No FDA black box warning has been issued for Fluidil.
| Serious Effects |
["Anuria","Hypersensitivity to Fluidil or other sulfonamide-derived drugs","Hepatic coma or pre-coma","Severe electrolyte depletion"]
| Precautions | ["Electrolyte imbalance (hypokalemia, hyponatremia, hypomagnesemia)","Hypovolemia and hypotension","Hyperuricemia and gout","Azotemia and renal impairment","Sulfonamide allergy cross-reactivity"] |
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| Fetal Monitoring |
| Maternal: Renal function, blood pressure, electrolyte levels, and fluid status. Fetal: Serial ultrasound for amniotic fluid volume and fetal growth; fetal echocardiography if exposure occurred during first trimester. |
| Fertility Effects | May impair fertility in both males and females. In males, can cause reversible azoospermia or oligospermia. In females, may disrupt ovulatory cycles and reduce implantation rates. |