LOZOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LOZOL (LOZOL).
Thiazide-like diuretic that inhibits sodium and chloride reabsorption in the distal convoluted tubule of the nephron, reducing plasma volume and extracellular fluid volume; also causes direct vasodilation through modulation of calcium channels.
| Metabolism | Primarily hepatic metabolism via cytochrome P450 enzymes (CYP3A4); minor metabolism by CYP2D6 and CYP2C19. |
| Excretion | Renal: 70% unchanged, Biliary/Fecal: 30% as metabolites |
| Half-life | Terminal half-life: 14-18 hours (mean 16 hours); clinically significant for once-daily dosing |
| Protein binding | ~79% bound, primarily to albumin and to a lesser extent to alpha-1-acid glycoprotein |
| Volume of Distribution | 0.8-1.5 L/kg (mean 1.0 L/kg); indicates extensive extravascular distribution |
| Bioavailability | Oral: 93% (absolute); food does not significantly affect absorption |
| Onset of Action | Oral: 1-2 hours; diuretic effect begins within 1 hour, antihypertensive effect over weeks |
| Duration of Action | Diuretic: ~24 hours; antihypertensive: up to 24 hours; once-daily dosing maintains effect |
Indapamide: Oral, 1.25 mg once daily. May increase to 2.5 mg once daily if no response after 4 weeks.
| Dosage form | TABLET |
| Renal impairment | GFR ≥30 mL/min: No adjustment. GFR 15-29 mL/min: Use with caution, typical dose 1.25 mg daily. GFR <15 mL/min: Contraindicated. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Consider reduced dose (1.25 mg daily) due to risk of electrolyte imbalance. Child-Pugh C: Contraindicated. |
| Pediatric use | Not approved; safety and efficacy not established. No standard weight-based dosing available. |
| Geriatric use | Start at 1.25 mg daily. Monitor electrolytes and renal function closely due to increased risk of hyponatremia and hypokalemia. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LOZOL (LOZOL).
| Breastfeeding | Indapamide is excreted in human milk. The M/P ratio is not established. Because of the potential for serious adverse reactions in nursing infants (e.g., electrolyte disturbances, jaundice, thrombocytopenia), breastfeeding is generally not recommended during therapy. If essential, monitor infant for signs of diuresis, electrolyte imbalance, and weight loss. |
| Teratogenic Risk | LOZOL (indapamide) is a thiazide-like diuretic. There are no adequate and well-controlled studies in pregnant women. Thiazide diuretics have been associated with fetal or neonatal jaundice, thrombocytopenia, and possible other adverse effects. Use during pregnancy should be avoided unless the potential benefit justifies the risk. First trimester: Limited data, but theoretical risk of teratogenicity from diuretic-induced hypovolemia and electrolyte disturbances. Second and third trimesters: Diuretics can decrease placental perfusion, possibly causing fetal growth restriction; cases of neonatal jaundice and thrombocytopenia reported. |
■ FDA Black Box Warning
Not applicable; LOZOL (indapamide) has no FDA boxed warning.
| Serious Effects |
["Anuria","Known hypersensitivity to indapamide or sulfonamide-derived drugs","Severe renal failure (CrCl <30 mL/min)"]
| Precautions | ["May cause hypokalemia, hyponatremia, and hypomagnesemia; monitor electrolytes periodically","Can precipitate gout in patients with hyperuricemia","May increase serum calcium","Use caution in severe renal impairment (CrCl <30 mL/min) as thiazides are ineffective","May exacerbate systemic lupus erythematosus"] |
Loading safety data…
| Fetal Monitoring | Monitor maternal blood pressure, serum electrolytes (especially potassium, sodium, chloride), renal function (BUN, creatinine), and blood glucose. Assess fetal growth and amniotic fluid volume via serial ultrasound. Monitor for signs of maternal hypovolemia or electrolyte disturbances. In neonate, observe for jaundice, thrombocytopenia, and electrolyte imbalance. |
| Fertility Effects | Indapamide may cause reversible gynecomastia in males. No specific studies on fertility in humans; animal studies showed no significant impairment. However, thiazide diuretics can affect spermatogenesis and menstrual cycle irregularity due to electrolyte disturbances. Consider these potential effects when counseling patients. |