KLOROMIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for KLOROMIN (KLOROMIN).
KLOROMIN is a potassium-sparing diuretic that acts by antagonizing aldosterone in the distal renal tubules, inhibiting sodium reabsorption and potassium excretion.
| Metabolism | Hepatic (primarily via CYP3A4) to inactive metabolites. |
| Excretion | Primarily renal (60-70% as unchanged drug, 10-20% as glucuronide conjugate), biliary/fecal (10-15% as metabolites). |
| Half-life | Terminal elimination half-life is 8-12 hours in adults with normal renal function; extends to 20-30 hours in moderate renal impairment (CrCl 30-50 mL/min) and up to 50 hours in severe impairment (CrCl <30 mL/min). |
| Protein binding | 70-80% bound primarily to albumin and to a lesser extent alpha-1-acid glycoprotein. |
| Volume of Distribution | 2.1-2.8 L/kg, indicating extensive extravascular distribution and tissue binding. |
| Bioavailability | Oral: 75-90% (first-pass metabolism 10-25%). |
| Onset of Action | Intravenous: 2-5 minutes; Oral: 30-60 minutes. |
| Duration of Action | Intravenous: 4-6 hours; Oral: 6-8 hours. Extended with hepatic impairment or drug interactions. |
1 g IV every 6 hours; infuse over 30 minutes.
| Dosage form | TABLET |
| Renal impairment | CrCl >50 mL/min: no adjustment; CrCl 10-50 mL/min: 1 g every 8-12 hours; CrCl <10 mL/min: 1 g every 24 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 25%; Child-Pugh C: reduce dose by 50%. |
| Pediatric use | 15-25 mg/kg IV every 6 hours; maximum 1 g per dose. |
| Geriatric use | Start at lower end of dosing range; monitor renal function; adjust per renal adjustment guidelines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for KLOROMIN (KLOROMIN).
| Breastfeeding | KLOROMIN is excreted into human breast milk in small amounts. M/P ratio is approximately 0.5-0.7. The drug is considered compatible with breastfeeding, but may cause irritability or drowsiness in the infant. The American Academy of Pediatrics considers it compatible with breastfeeding. |
| Teratogenic Risk | KLOROMIN (chlorpheniramine maleate) is an antihistamine. It is FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, but no adequate human studies in pregnant women. First trimester: Generally considered safe, but use only if clearly needed. Second and third trimesters: No known specific risks, but use with caution. There is a potential for neonatal respiratory depression if used near term. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hyperkalemia","Addison's disease","Severe renal impairment (CrCl <30 mL/min)","Concurrent use of eplerenone or other potassium-sparing diuretics"]
| Precautions | ["Hyperkalemia: risk increased with renal impairment, concomitant ACE inhibitors, or potassium supplements.","Electrolyte imbalance: hyponatremia, hypomagnesemia.","Endocrine effects: gynecomastia, menstrual irregularities."] |
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| Fetal Monitoring | Monitor maternal heart rate, blood pressure, and central nervous system effects (sedation, dizziness). Monitor fetal heart rate if used near term due to potential for anticholinergic effects. No specific fetal monitoring is routinely required. |
| Fertility Effects | No known adverse effects on fertility in humans. Animal studies have not shown impaired fertility at clinically relevant doses. |