Manganese Sulfate

American Regent, Inc.

FULL PRESCRIBING INFORMATION

Rx Only

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

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 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.

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.

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

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.

Manganese is eliminated via the bile. The possibility of manganese retention should be considered in patients with biliary tract obstruction. Decreasing or omitting manganese supplements entirely may be necessary for such patients. However, ancillary routes of manganese excretion include pancreatic juice, or reabsorption into the lumen of the duodenum, jejunum or ileum.

Safety for use in pregnancy has not been established. Use of manganese in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

Adverse reactions to manganese at the dosage levels recommended have not been reported.

Manganese Sulfate Injection, USP provides 0.1 mg manganese/mL. For the metabolically stable adult receiving TPN, the suggested additive dosage level for manganese is 0.15 to 0.8 mg/day. For pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended.

Aseptic addition of Manganese Sulfate Injection, USP to the TPN solution under a laminar flow hood is recommended. Manganese is physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN. Periodic monitoring of manganese plasma levels is suggested as a guideline for subsequent administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

Manganese toxicity has not been reported in patients receiving TPN. Neither have reports of manganese toxicity from excessive intake in foods and/or beverages been published.

Manganese Sulfate Injection, USP 0.1 mg/mL

NDC 0517-6410-25                                 10 mL SDV                        packed in a box of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

IN6410

Rev. 1/09

MG #14479

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL – 10 mL Container

NDC 0517-6410-25

MANGANESE SULFATE INJECTION, USP

Manganese 1 mg/10 mL

(0.1 mg/mL)

10 mL SINGLE DOSE VIAL

Trace Element Additive

FOR IV USE AFTER DILUTION

PRESERVATIVE FREE

Rx Only

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05