RENESE-R
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENESE-R (RENESE-R).
Thiazide diuretic; inhibits sodium-chloride symporter in distal convoluted tubule, reducing sodium and water reabsorption.
| Metabolism | Metabolized by liver (CYP450) to active metabolite; excreted in feces (65%) and urine (35%). |
| Excretion | Renal: 50% unchanged; fecal: 0%; biliary: 0% |
| Half-life | Terminal elimination half-life: 13-16 hours; clinical context: supports once-daily dosing |
| Protein binding | 80-90% bound to plasma proteins, primarily albumin |
| Volume of Distribution | 0.2-0.3 L/kg; indicates distribution mainly in extracellular fluid |
| Bioavailability | Oral: 70-80% |
| Onset of Action | Oral: 1-2 hours; IV: not applicable |
| Duration of Action | Oral: 22-24 hours; note: diuretic effect may last up to 24 hours |
Initial: 5 mg orally once daily, increased as needed to 10 mg once daily; maximum 10 mg/day.
| Dosage form | TABLET |
| Renal impairment | GFR 30-50 mL/min: reduce dose by 50%; GFR <30 mL/min: not recommended. |
| Liver impairment | Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce dose by 50%; Child-Pugh Class C: avoid use. |
| Pediatric use | Not approved for use in pediatric patients; safety and efficacy not established. |
| Geriatric use | Initiate at 2.5 mg orally once daily; use caution due to increased sensitivity to electrolyte disturbances and hypotension. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENESE-R (RENESE-R).
| Breastfeeding | Thiazides are excreted in human milk in small amounts. There is no published M/P ratio for polythiazide specifically; however, based on thiazide class, the M/P ratio is approximately 0.1-0.5. Breastfeeding is generally discouraged due to potential for adverse effects in the infant, including electrolyte imbalance and thrombocytopenia. Alternative agents are preferred, especially in high-dose therapy or when monitoring is not feasible. |
| Teratogenic Risk | Renese-R (polythiazide) is a thiazide diuretic. Use in pregnancy, especially during the first and second trimesters, is associated with an increased risk of fetal or neonatal jaundice, thrombocytopenia, and possible other adverse reactions that have occurred in adults. Because thiazides cross the placental barrier and appear in cord blood, use during the third trimester may cause electrolyte disturbances, hypoglycemia, and other effects. The drug should be used only if clearly needed and if the potential benefit justifies the potential risk to the fetus. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
["Anuria","Hypersensitivity to sulfonamides or thiazides","Severe renal impairment (creatinine clearance <30 mL/min)","Hepatic coma or pre-coma"]
| Precautions | ["May cause hypokalemia and hypomagnesemia","Can precipitate hyperuricemia and gout","May increase serum calcium","Use with caution in diabetes (may increase blood glucose)","Photosensitivity reactions reported","Sulfonamide allergy: possible cross-reactivity"] |
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| Fetal Monitoring | Maternal monitoring: Blood pressure, serum electrolytes (especially potassium, sodium), blood glucose, and renal function. Fetal monitoring: Ultrasound to assess growth and amniotic fluid volume due to potential for oligohydramnios. Fetal heart rate monitoring should be considered in third trimester if signs of fetal distress are present. |
| Fertility Effects | No specific studies have been conducted on polythiazide's effects on fertility. Thiazide diuretics have been associated with reversible oligospermia and erectile dysfunction in males. In females, thiazides have not been directly linked to impaired fertility, but electrolyte disturbances may theoretically affect ovulatory function. |