DARANIDE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DARANIDE (DARANIDE).
Carbonic anhydrase inhibitor. Inhibits carbonic anhydrase in the proximal renal tubule, reducing bicarbonate reabsorption and causing alkaline diuresis.
| Metabolism | Not extensively metabolized; excreted unchanged in urine. |
| Excretion | Renal: unchanged drug (approximately 50% of absorbed dose) and metabolites. Biliary/fecal: minimal. |
| Half-life | Terminal elimination half-life: 2.5-3.5 hours (prolonged in renal impairment). Clinical context: Short half-life necessitates multiple daily dosing for sustained diuretic effect. |
| Protein binding | ~90% bound, primarily to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg. Clinical meaning: Confined primarily to extracellular fluid; low Vd indicates minimal tissue distribution. |
| Bioavailability | Oral: 75-85% (tablet). |
| Onset of Action | Oral: 30-60 minutes. Intravenous: 5-15 minutes. |
| Duration of Action | Oral: 6-12 hours (dose-dependent). Intravenous: 2-4 hours. Note: Longer duration may occur in renal impairment. |
50 mg orally once or twice daily; maximum 100 mg/day.
| Dosage form | TABLET |
| Renal impairment | GFR 10-50 mL/min: 50 mg every 12-24 hours; GFR <10 mL/min: 50 mg every 24-48 hours; not effective if GFR <10 mL/min. |
| Liver impairment | Child-Pugh Class A: no adjustment; Class B: reduce dose by 50%; Class C: use not recommended. |
| Pediatric use | Not established; use not recommended in children. |
| Geriatric use | Start at 25 mg once daily; monitor renal function and electrolyte balance due to increased risk of adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DARANIDE (DARANIDE).
| Breastfeeding | Contraindicated in breastfeeding. Excreted in breast milk; M/P ratio not established. Potential for serious adverse effects in infant (metabolic acidosis, electrolyte imbalance). |
| Teratogenic Risk | Pregnancy Category C. First trimester: Possible association with congenital malformations (limited human data; animal studies show fetal toxicity). Second/third trimester: Risk of electrolyte disturbances and acidosis in neonate; avoid use unless benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to dichlorphenamide or other sulfonamides","Severe renal or hepatic dysfunction","Hypokalemia","Hyponatremia","Metabolic acidosis","Adrenal insufficiency"]
| Precautions | ["May cause drowsiness, confusion, or paresthesias","Monitor electrolytes and renal function","Can cause metabolic acidosis","Use caution in patients with hepatic impairment or cirrhosis"] |
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| Monitor maternal electrolytes (Na, K, Cl, HCO3), blood pH (metabolic acidosis), renal function, and hepatic function. Fetal monitoring: ultrasound for growth and amniotic fluid volume (risk of oligohydramnios). |
| Fertility Effects | No adequate studies; potential for reversible effects on reproductive function (inhibition of carbonic anhydrase may affect sperm motility and oocyte maturation). |