Manganese Chloride
FDA Drug Information • Also known as: Manganese
- Brand Names
- Manganese
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is a sterile, nonpyrogenic solution intended for use as an additive to intravenous solutions for total parenteral nutrition (TPN). Each mL of solution contains 0.36 mg manganese chloride, tetrahydrate and 9 mg sodium chloride. The solution contains no bacteriostat, antimicrobial agent or added buffer. The pH is 2.0 (1.5 to 2.5); product may contain hydrochloric acid and sodium hydroxide for pH adjustment. The osmolarity is 0.313 mOsmol/mL (calc.). Manganese Chloride, USP is chemically designated manganese chloride, tetrahydrate (MnCl 2
What Is Manganese Chloride Used For?
INDICATIONS AND USAGE Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is indicated for use in adult patients as a supplement to intravenous solutions given for TPN. Administration helps to maintain manganese serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Dosage and Administration
DOSAGE AND ADMINISTRATION Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) contains 0.1 mg manganese/mL and is administered intravenously only after dilution. The additive should be administered in a volume of fluid at least 100 mL. For the adult receiving TPN, the suggested additive dosage for manganese is 55 mcg/day (0.55 mL/day). Periodic monitoring of manganese plasma levels is suggested as a guideline for subsequent administration. (See WARNINGS .) Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)
Side Effects (Adverse Reactions)
ADVERSE REACTIONS None known.
Warnings and Precautions
WARNINGS Direct intramuscular or intravenous injection of Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is contraindicated as the acidic pH of the solution (pH 2.0) may cause considerable tissue irritation. Neurologic Toxicity with Manganese Manganese accumulation in the basal ganglia has been reported in adult and pediatric patients on long‑term parenteral nutrition receiving manganese at higher than recommended dosages and in association with cholestatic liver disease. Brain MRI findings and clinical symptoms have also been observed in patients who received manganese at or below the recommended dosage and with normal blood manganese concentrations. Some adult patients with brain MRI findings reportedly experienced neuropsychiatric symptoms, including changes in mood or memory, seizures and/or parkinsonian‑like tremors, dysarthria, mask-face, and halting gait. Some pediatric patients experienced dystonic movements or seizures. Regression of symptoms and MRI findings have occurred over weeks to months following discontinuation of manganese in most patients but have not always completely resolved. Monitor patients receiving parenteral nutrition solutions containing manganese for neurologic signs and symptoms and routinely measure whole blood manganese concentrations and liver tests. In case of suspected manganese toxicity or new neuropsychiatric manifestations, temporarily discontinue manganese, check manganese whole blood concentrations, and consider brain MRI evaluation. Hepatic Accumulation of Manganese Manganese is primarily eliminated in the bile and excretion is decreased in patients with cholestasis and/or cirrhosis. Hepatic accumulation of manganese has been reported in autopsies of patients receiving long-term parenteral nutrition containing manganese at dosages higher than recommended. Patients with cholestasis and/or cirrhosis receiving parenteral nutrition are at increased risk of manganese brain deposition and neurotoxicity. If a patient develops signs or symptoms of hepatobiliary disease during the use of this drug product, obtain manganese whole blood concentrations; consider discontinuing manganese supplementation in these patients until a full clinical evaluation is completed. Aluminum Toxicity This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contraindications
CONTRAINDICATIONS None known.
Pregnancy and Breastfeeding
Pregnancy Animal reproduction studies have not been conducted with manganese chloride. It is also not known whether manganese chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Manganese chloride should be given to a pregnant woman only if clearly indicated.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) additive is administered to a nursing woman.
Overdosage
OVERDOSAGE Acute manganese toxicity was reported in adult patients following infusion of manganese more than 10,000-fold the recommended dosage and after use of dialysis fluid contaminated with manganese. Signs and symptoms included skin flushing, acute pancreatitis, elevated whole blood manganese concentrations, and MRI evidence of brain accumulation of manganese. Chronic infusion and oral intake of manganese above recommended dosage have resulted in neuropsychiatric symptoms and MRI evidence of brain accumulation of manganese (see WARNINGS ).
How Supplied
HOW SUPPLIED Manganese 0.1 mg/mL (Manganese Chloride Injection, USP) is supplied in 10 mL Single-dose Plastic Vials. Unit of Sale Concentration NDC 0409-4091-01 Tray of 25 Single-dose plastic vials 1 mg/10 mL (0.1 mg/mL) Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1068-4.0 Revised: 12/2023 Logo
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.