SALURON
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SALURON (SALURON).
Saluron (hydroflumethiazide) is a thiazide diuretic that inhibits the sodium-chloride symporter (NCC) in the distal convoluted tubule of the nephron, increasing excretion of sodium, chloride, and water. It also reduces peripheral vascular resistance through direct vasodilatory effects.
| Metabolism | Hydroflumethiazide is not extensively metabolized; it is primarily excreted unchanged in the urine. Small amounts may be metabolized via hepatic pathways, but specific enzymes have not been well characterized. |
| Excretion | Primarily renal (≥95%) via glomerular filtration and tubular secretion; approximately 70% as unchanged drug, 25% as metabolites. Biliary/fecal excretion accounts for <5%. |
| Half-life | Terminal elimination half-life is 8-12 hours in adults with normal renal function; prolonged in renal impairment (up to 24-36 hours with creatinine clearance <30 mL/min). |
| Protein binding | Approximately 90-95%, primarily to albumin. |
| Volume of Distribution | 0.2-0.4 L/kg; indicates distribution largely confined to extracellular fluid and plasma. |
| Bioavailability | Oral: 60-70% due to first-pass metabolism; bioavailability reduced with food. Intravenous: 100%. |
| Onset of Action | Oral: diuresis begins within 1-2 hours; peak effect at 3-6 hours. Intravenous: onset within 15-30 minutes. |
| Duration of Action | Oral: diuretic effect lasts 6-12 hours; antihypertensive effect persists 12-24 hours. Intravenous: diuresis lasts 2-4 hours. Note: Duration may be extended in renal impairment. |
Initial: 50-100 mg orally once daily; maintenance: 50-200 mg orally once daily or in divided doses.
| Dosage form | TABLET |
| Renal impairment | GFR 10-50 mL/min: 50% of normal dose; GFR <10 mL/min: avoid use. |
| Liver impairment | Child-Pugh Class A: no adjustment; Class B: reduce dose by 50%; Class C: avoid use. |
| Pediatric use | 2-12 years: 1-2 mg/kg orally once daily; maximum 50 mg/day. |
| Geriatric use | Initiate at 25 mg orally once daily; titrate cautiously due to risk of electrolyte imbalance and hypotension. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SALURON (SALURON).
| Breastfeeding | Chlorothiazide is excreted into breast milk in low concentrations; milk/plasma ratio is approximately 0.05. It may suppress lactation with high doses. Use with caution, monitor infant for electrolyte imbalances, jaundice, and dehydration. |
| Teratogenic Risk | SALURON (chlorothiazide) is a thiazide diuretic. First trimester: limited human data, but thiazides have been associated with increased risk of neural tube defects and other malformations in some studies; avoid if possible. Second and third trimesters: crosses placenta, may cause fetal electrolyte disturbances, jaundice, thrombocytopenia, and maternal electrolyte imbalance. Use only if clearly needed. |
■ FDA Black Box Warning
None
| Serious Effects |
["Anuria","Hypersensitivity to hydroflumethiazide or other sulfonamide-derived drugs (cross-sensitivity possible)","Pre-existing severe electrolyte abnormalities (e.g., hyponatremia, hypokalemia)"]
| Precautions | ["May cause hypokalemia, hyponatremia, hypomagnesemia, and hypochloremic alkalosis","May precipitate new-onset or exacerbate existing hyperuricemia and gout","Can cause hyperglycemia and worsen glycemic control in diabetic patients","May increase serum calcium levels","Can cause hyperlipidemia","Use with caution in patients with severe renal impairment (CrCl <30 mL/min) as effectiveness diminishes","Can cause acute angle-closure glaucoma","May cause systemic lupus erythematosus exacerbation","Can cause photosensitivity reactions"] |
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| Fetal Monitoring | Maternal: electrolytes, renal function, blood pressure, blood glucose. Fetal/neonatal: weight, bilirubin, platelets, electrolytes if exposed near term. |
| Fertility Effects | Thiazide diuretics have not been associated with adverse effects on fertility in humans; no significant impact on spermatogenesis or ovulation in animal studies. |