Manganese Sulfate Injection

Generic name: manganese sulfate
Dosage form: injection, solution

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx Only

STERILE, NONPYROGENIC, TRACE ELEMENT ADDITIVE
FOR IV USE AFTER DILUTION
(MANGANESE 0.1 mg/mL)
PRESERVATIVE FREE

Manganese Sulfate Injection Description

Manganese Sulfate Injection, USP is a sterile, nonpyrogenic solution intended for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains 0.308 mg of Manganese Sulfate Monohydrate, USP, Water for Injection q.s. pH adjusted with Sulfuric Acid. It delivers elemental manganese 0.1 mg/mL. It is a single dose preservative free vial. Discard any unused portion.

Manganese Sulfate Injection - Clinical Pharmacology

Manganese is an activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase. Providing manganese during TPN prevents development of the following deficiency symptoms: nausea and vomiting, weight loss, dermatitis and changes in growth and color of hair.

Indications and Usage for Manganese Sulfate Injection

Manganese Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for Total Parenteral Nutrition (TPN). Administration helps to maintain plasma levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

Contraindications

Manganese Sulfate Injection, USP should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.

Warnings

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 cen...