ORETICYL 50
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ORETICYL 50 (ORETICYL 50).
Hydrochlorothiazide inhibits the Na+/Cl- cotransporter in the distal convoluted tubule of the kidney, reducing sodium and chloride reabsorption and increasing diuresis.
| Metabolism | Minimally metabolized; eliminated mainly unchanged by renal tubular secretion. |
| Excretion | Renal: ~95% (50% as unchanged drug, remainder as inactive metabolites); Biliary/fecal: <5%. |
| Half-life | Terminal elimination half-life: 6–15 hours (mean 10 hours), prolonged in renal impairment (up to 24–30 hours) and elderly. |
| Protein binding | Hydrochlorothiazide: ~40–70% bound to albumin. |
| Volume of Distribution | Hydrochlorothiazide: Vd 0.8–1.0 L/kg, indicating distribution into total body water. |
| Bioavailability | Oral: ~65–75% (hydrochlorothiazide); absorption reduced by food. |
| Onset of Action | Oral: diuresis begins within 1–2 hours; peak effect at 4–6 hours. |
| Duration of Action | Oral: diuretic effect lasts 6–12 hours; antihypertensive effect persists for up to 24 hours with continuous dosing. |
Hydrochlorothiazide 50 mg orally once daily in the morning; may increase to 100 mg daily in divided doses.
| Dosage form | TABLET |
| Renal impairment | Contraindicated if GFR <30 mL/min. For GFR 30-50 mL/min: reduce dose to 25 mg daily; monitor electrolytes. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B or C: avoid due to risk of electrolyte disturbances and hepatic encephalopathy; if necessary, use with caution at 25 mg daily. |
| Pediatric use | Not established for ages <2 years. For ages 2-12: 1-2 mg/kg/day in 1-2 divided doses; maximum 50 mg/day. |
| Geriatric use | Start at 12.5-25 mg daily; monitor for hypotension, electrolyte imbalance, and renal function due to age-related decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ORETICYL 50 (ORETICYL 50).
| Breastfeeding | Excreted in breast milk in low amounts; M/P ratio unknown. Considered compatible with breastfeeding by AAP, but observe infant for electrolyte imbalances and jaundice. |
| Teratogenic Risk | First trimester: Possible association with oral clefts and neural tube defects based on limited human data. Second/third trimesters: Risk of fetal renal impairment, oligohydramnios, and neonatal thrombocytopenia. Thiazide diuretics may cause electrolyte disturbances in the neonate. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Anuria","Hypersensitivity to hydrochlorothiazide or sulfonamides"]
| Precautions | ["Hypokalemia","Hyperuricemia","Photosensitivity","Electrolyte disturbances","Sulfonamide allergy cross-reactivity"] |
Loading safety data…
| Monitor maternal blood pressure, serum electrolytes, renal function, and fluid status. Fetal ultrasound for growth and amniotic fluid volume. Neonatal monitoring for hypoglycemia, thrombocytopenia, and electrolyte disturbances. |
| Fertility Effects | No specific adverse effects on fertility reported; thiazide diuretics may cause reversible gynecomastia in males. |