MANGANESE SULFATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MANGANESE SULFATE (MANGANESE SULFATE).
Manganese sulfate is a source of manganese, a trace element that acts as a cofactor for various enzymes including arginase, pyruvate carboxylase, and superoxide dismutase. It is essential for normal bone formation, blood clotting, and nervous system function.
| Metabolism | Manganese is primarily excreted via bile into feces; small amounts are reabsorbed. Some metabolism may occur via hepatic conjugation. |
| Excretion | Primarily fecal (biliary) elimination of unabsorbed manganese; absorbed manganese is excreted mainly in bile (99%) with minimal renal excretion (<1%). Small amounts secreted in pancreatic juice and reabsorbed enterally. |
| Half-life | Terminal elimination half-life approximately 37 days (range 30–45 days) in whole body; reflects slow turnover in tissues, especially bone and liver. Clinical context: Accumulation occurs with chronic high exposure or impaired biliary excretion (e.g., hepatic disease). |
| Protein binding | Approximately 80–90% bound in serum; primarily to transferrin and albumin, with minor binding to alpha-2-macroglobulin. In the brain, transported via transferrin receptor-mediated uptake. |
| Volume of Distribution | Apparent Vd ~2–4 L/kg based on total body manganese; concentrates in mitochondria-rich tissues (liver, pancreas, kidney, brain). High Vd indicates extensive tissue distribution, especially bone (skeleton contains ~40% of total body manganese). |
| Bioavailability | Oral bioavailability is low, estimated at 3–5% due to limited gastrointestinal absorption and extensive hepatic first-pass extraction. Variable based on dietary factors, chelators, and iron status (competing transporters). |
| Onset of Action | Intravenous: Rapid (within minutes) as a cofactor for enzymatic systems; clinical effects (e.g., antioxidative function) not immediately observable. Oral: Absorption occurs over 4–6 hours; systemic effects delayed. |
| Duration of Action | Duration depends on tissue storage and turnover; single dose effects persist for days to weeks due to slow elimination. Clinical note: Manganese is an essential trace element and is tightly regulated; prolonged supplementation can lead to accumulation. |
Intravenous: 0.1-0.2 mg manganese/kg/day (as manganese sulfate) added to TPN. Maximum 0.15-0.8 mg/day. Injection IV: 0.1-0.2 mg manganese/kg/day.
| Dosage form | INJECTABLE |
| Renal impairment | GFR >50 mL/min: No adjustment. GFR 10-50: Reduce dose by 50% or monitor manganese levels. GFR <10: Avoid use or monitor levels closely; consider discontinuation. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: Reduce dose by 50% and monitor levels. Child-Pugh C: Avoid use due to risk of manganese accumulation. |
| Pediatric use | Neonates and infants: 1-2 mcg/kg/day (0.001-0.002 mg/kg/day) IV. Children: 2-5 mcg/kg/day (0.002-0.005 mg/kg/day) IV. Maximum 0.05 mg/day. Use weight-based dosing via TPN or direct supplementation. |
| Geriatric use | Start at lower end of dosing range (0.1 mg/kg/day IV) due to potential reduced renal function. Monitor serum manganese levels and neurological status regularly. Adjust dose based on renal clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MANGANESE SULFATE (MANGANESE SULFATE).
| Breastfeeding | Manganese is present in breast milk; M/P ratio approximately 0.3-0.7. Concentrations are regulated homeostatically. Use with caution; avoid excessive supplementation. |
| Teratogenic Risk | Manganese is an essential trace element; however, excessive exposure during pregnancy may be associated with neurodevelopmental toxicity. No adequate human studies exist. Animal studies show fetal toxicity at high doses. Risk cannot be excluded. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to manganese sulfate; severe hepatic insufficiency; known manganese toxicity.
| Precautions | Use with caution in patients with hepatic impairment due to reduced biliary excretion; risk of manganese accumulation and neurotoxicity (manganism). Monitor manganese levels in long-term parenteral nutrition; avoid excessive intake. |
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| Monitor serum manganese levels to avoid toxicity (target <1.2 mcg/L). Assess liver function and neurological symptoms in mother. |
| Fertility Effects | High levels of manganese may impair spermatogenesis in males and cause hormonal disturbances. Effects on female fertility are unclear. |