Chromium / Copper / Iodide / Manganese / Selenium / Zinc (Micro+6)

1. Health Canada Product Monograph — Chromium / Copper / Iodide / Manganese / Selenium / Zinc

• Chromium / Copper / Iodide / Manganese / Selenium / Zinc is indicated as a supplement added to intravenous total parenteral nutrition (TPN) solutions.
• It helps maintain normal plasma levels of these six trace elements and prevents the deficiency symptoms that can develop when a patient depends entirely on intravenous nutrition.

• It is not known whether this trace element combination can harm an unborn baby or affect fertility, so it should be used in pregnancy only if the anticipated nutritional benefit outweighs any theoretical risk.
• Extra attention to the iodide component is warranted in pregnancy, since routine monitoring of thyroid function is recommended.

• It is not known whether the trace elements in this product pass into breast milk in clinically important amounts.
• Because many drugs are excreted in breast milk, caution should be exercised when this product is given to a nursing mother.
• Breastfeeding women may need a higher iodide intake than non-lactating adults to support normal thyroid function in both mother and infant.

• No dosage adjustment is required for geriatric patients receiving this trace element combination.

• This trace element combination is approved for use in pediatric patients, including premature infants, full-term infants, and children, with doses calculated by body weight.
• Premature infants require closer monitoring, since their trace element requirements per kilogram differ substantially from those of older children and adults.

• For metabolically stable adults on TPN, typical additive doses are zinc 2.5 to 5 mg/day, copper 0.3 to 0.5 mg/day, manganese 55 mcg/day, chromium 10 to 15 mcg/day, selenium 60 to 100 mcg/day, and iodide 1 to 2 mcg/kg/day (about 75 to 150 mcg/day).
• Patients in an acute catabolic state may need an additional 2 mg of zinc per day, and those with significant fluid loss from the small bowel or an ileostomy may require substantially higher zinc replacement.
• Pediatric dosing is weight-based and differs by age group; for example, full-term infants typically receive 50 to 250 mcg zinc/kg/day, while premature infants weighing up to 3 kg may need up to 400 mcg zinc/kg/day.
• This product must always be diluted into the amino acid or dextrose component of a TPN admixture using aseptic technique; it must never be given by direct injection into a peripheral vein because it is hypotonic and can cause infusion phlebitis.
• It can be diluted in sodium chloride injection, dextrose injection, amino acid injection, or lipid injection admixtures, as directed for the specific TPN order.
• After dilution, the admixture must be used within 24 hours, or within 48 hours if refrigerated.
• This is a single-use vial; any unused portion must be discarded and not saved for a later dose.
• Routine monitoring of plasma zinc, copper, manganese, chromium, and selenium, along with thyroid function, is recommended as a guide to ongoing dose adjustment.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Excess zinc can cause nausea, vomiting, fever, tachycardia, hypothermia, profuse sweating, blurred vision, and in severe cases edema, jaundice, diarrhea, and reduced urine output.
• Excess copper can cause a metallic taste, burning in the throat and stomach, colic, bloody diarrhea, hemolytic anemia, liver injury, and kidney damage; D-penicillamine has been used as an antidote in reported cases.
• Excess manganese can deposit in the brain's basal ganglia and produce Parkinson-like movement symptoms along with neuropsychiatric changes.
• Excess chromium exposure has been associated with nausea, vomiting, anemia, and kidney or liver damage, though toxicity from the small amounts in this product is rare.
• Excess selenium can cause hair loss, white streaking on the fingernails, a garlic odour on the breath, metallic taste, muscle tenderness, tremor, and in severe acute poisoning, dangerously low blood pressure, an abnormal heart rhythm, and respiratory failure.
• Excess iodide can cause a metallic taste, vomiting, abdominal pain, diarrhea, throat swelling, and in severe cases circulatory collapse.
• Management of overdose is mainly supportive, with discontinuation of the product, cardiopulmonary monitoring, and fluid and electrolyte support; there is no specific antidote for selenium or iodide toxicity.

• Metallic taste may occur.
• Increased salivation may occur.
• Mild burning or pain in the mouth may occur.
• Nasal irritation and a runny nose (coryza) may occur.
• Mild skin eruptions resembling acne may occur with prolonged use.
• Gastrointestinal upset, including diarrhea, may occur.
• Mild eye irritation may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Severe allergic reactions to iodide, including anaphylactic shock, can occur.
• Angioedema (swelling of the face, lips, tongue, or throat) can occur as an allergic reaction.
• Hives (urticaria) and cutaneous hemorrhage or purpura have been reported as allergic reactions to iodide.
• Fever, joint pain, and swollen lymph nodes can occur as part of an allergic reaction to iodide.
• Goitre and hypothyroidism can develop with prolonged iodide exposure, including in infants of mothers who received iodides during pregnancy.
• Hyperthyroidism can also occur with iodide exposure.
• Severe throat swelling and pulmonary edema have been reported with prolonged iodide exposure (iodism).
• Manganese accumulation can cause irreversible Parkinson-like neurological symptoms, particularly with prolonged high-dose use.
• Copper and manganese can accumulate to toxic levels in patients with biliary obstruction, since both are cleared through bile.
• Seek urgent medical attention for facial or throat swelling, difficulty breathing, a rapidly enlarging thyroid, or new tremor or muscle stiffness.

• Use with caution in patients with impaired kidney function, since zinc and selenium are eliminated by the kidneys and can accumulate to toxic levels.
• Use with caution in patients with biliary obstruction or liver disease, since copper and manganese are eliminated in bile and can build up if excretion is impaired.
• Use with caution in patients with known or suspected iodine sensitivity; evaluate for sensitivity before starting therapy.
• Use with caution in patients receiving prolonged therapy (more than four weeks), since manganese levels should be checked periodically to detect early accumulation.
• Use with caution in diabetic patients, since chromium supplementation can affect glucose control and blood sugar should be monitored closely.
• Use with caution in patients also exposed to other sources of iodine, such as topical antiseptics or a high-iodine diet, because total iodide exposure can add up.
• Monitor liver function and manganese and copper blood levels monthly in patients at risk of accumulation.

• Contraindicated in patients with known hypersensitivity to this product or to any ingredient in the formulation, including the container components.

• No specific drug-drug interactions have been established for this trace element combination.
• Because chromium can affect insulin sensitivity, patients on insulin or oral diabetes medications should have their blood glucose monitored more closely when this product is started or stopped.
• High cumulative iodide exposure from other iodine-containing products, such as topical antiseptics or contrast dye, can increase the risk of thyroid dysfunction.

• Not applicable; this product is given only by intravenous infusion as an additive to parenteral nutrition, so oral food-timing considerations do not apply.

• This product is administered continuously as part of a TPN infusion under medical supervision; it is not a self-administered oral medication with a specific time of day.

• Store between 15°C and 30°C.
• Protect from light and from freezing.

• This trace element combination replaces essential minerals for patients who cannot get enough nutrition by mouth and are receiving intravenous feeding.
• It is given only in hospital or supervised infusion settings, mixed into the nutrition bag by trained staff.
• Regular blood tests are needed to check trace element levels and thyroid function during treatment.
• Tell your healthcare team about any other iodine-containing products you use, including antiseptics or contrast dye.