Monograph: |
Manganese
Same as manganese sulphate.
Manganese Sulphate
Indications: Nutritional support
DESCRIPTION:
Manganese sulfate injection 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. 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.
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:
Manganese sulfate injection 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 should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
PRECAUTIONS:
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.
Pregnancy: 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:
Adverse reactions to manganese at the dosage levels recommended have not been reported.
OVERDOSAGE:
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.
DOSAGE AND ADMINISTRATION:
Manganese sulfate injection 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 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.
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