MANGANESE CHLORIDE IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MANGANESE CHLORIDE IN PLASTIC CONTAINER (MANGANESE CHLORIDE IN PLASTIC CONTAINER).
Manganese chloride dissociates to provide manganese (Mn²⁺), a cofactor for enzymatic reactions including superoxide dismutase (mitochondrial), pyruvate carboxylase, and arginase. It participates in carbohydrate and lipid metabolism, bone development, and antioxidant defense.
| Metabolism | Manganese is eliminated primarily in bile via enterohepatic circulation and excreted in feces. A minor amount is reabsorbed. Renal excretion is negligible. |
| Excretion | Renal (biliary/fecal minimal): ~90% of absorbed manganese excreted in bile into feces, with <5% renal excretion; in parenteral administration, renal elimination is negligible as manganese is predominantly cleared via hepatobiliary system. |
| Half-life | Terminal elimination half-life: 12-40 days (varies with body stores and nutritional status; prolonged in hepatic impairment due to reduced biliary clearance). |
| Protein binding | ~80-90% bound to alpha-2-macroglobulin, albumin, and transferrin; also binds to manganese-specific transport proteins. |
| Volume of Distribution | 0.5-1.2 L/kg (wide distribution into tissues, with highest concentrations in liver, pancreas, and bone). |
| Bioavailability | Intravenous: 100%; oral: <5% (due to extensive first-pass hepatic clearance and biliary excretion). |
| Onset of Action | Intravenous: Immediate, as manganese is a trace element for enzyme function; clinical effects (e.g., correction of deficiency) may take days to weeks. |
| Duration of Action | Parenteral: Effects persist as long as supplementation continues; excess accumulation can occur with prolonged use, especially in cholestatic liver disease. |
Intravenous, 0.1 to 0.4 mg/mL as additive to parenteral nutrition, typically 1 to 5 mg per day depending on clinical status and serum levels. Frequent monitoring of manganese levels recommended.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated or reduce dose with severe renal impairment (GFR < 30 mL/min). For GFR 30-50 mL/min, reduce dose by 50%; monitor levels. No specific adjustments for mild impairment. |
| Liver impairment | Child-Pugh Class C: avoid use due to risk of accumulation. Child-Pugh B: reduce dose by 50% with monitoring. Child-Pugh A: no adjustment but monitor manganese levels. |
| Pediatric use | IV, 0.5 to 1.5 mcg/kg per day (0.5-1.5 µg/kg/day) as part of parenteral nutrition. Adjust based on serum manganese levels, not exceeding 5 mcg/kg/day in term infants. |
| Geriatric use | No specific dose adjustment; use with caution due to potential age-related renal and hepatic function decline. Monitor serum manganese levels regularly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MANGANESE CHLORIDE IN PLASTIC CONTAINER (MANGANESE CHLORIDE IN PLASTIC CONTAINER).
| Breastfeeding | Manganese is endogenously present in breast milk. Exogenous manganese chloride administration is expected to increase milk levels. M/P ratio not established. Parenteral manganese is considered compatible with breastfeeding at standard replacement doses; monitor infant for neurological symptoms with prolonged high-dose exposure. |
| Teratogenic Risk | Manganese chloride is an essential trace element; at recommended parenteral doses, teratogenic risk is low. Inadequate data exist for first trimester: no known structural anomalies reported. Second and third trimesters: no increased risk of fetal harm when used at physiological replacement doses. High doses may be associated with fetal manganese accumulation and potential neurotoxicity, but clinical significance is unclear. Avoid excessive supplementation. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to manganese chloride or any component","Patients with severe liver disease or cholestasis (risk of accumulating toxic levels)"]
| Precautions | ["Accumulation in patients with cholestasis or hepatic dysfunction may lead to neurotoxicity (extrapyramidal symptoms, parkinsonian features)","Monitor blood manganese levels, especially with long-term use or in patients with liver disease","Avoid excessive dosing to prevent toxicity"] |
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| Fetal Monitoring | Monitor serum manganese levels to avoid toxicity (target 4-14 mcg/L). Assess maternal neurological status for signs of manganism (e.g., tremor, gait disturbance). Fetal monitoring: consider ultrasound for growth and amniotic fluid volume if prolonged high-dose therapy. Newborn: evaluate for hypotonia and neurological development if maternal levels elevated. |
| Fertility Effects | No known adverse effects on fertility at physiological doses. High-dose manganese has been associated with reduced sperm quality in animal studies; human data limited. Female fertility not significantly affected at standard doses. |