Mix of 5 Trace Elements

Approved Indications:

• Parenteral or enteral supplementation of trace elements in patients with:
• Prolonged parenteral nutrition (TPN)
• Chronic malabsorption syndromes
• Severe malnutrition
• Gastrointestinal fistulas or short bowel syndrome
• Severe burns
• Critical illness requiring ICU nutrition
• Prolonged NPO (nothing by mouth) status
• Correction of individual trace element deficiencies when specific diagnosis is unavailable or multiple deficiencies are suspected.

Clinically Accepted Off-label Uses:

• Prevention of micronutrient deficiencies in long-term enteral tube feeding
• Adjunct to dialysis nutrition management (in trace element-depleted ESRD patients)
• Trace mineral repletion in oncology or transplant patients with high catabolic states
• Neonatal or pediatric supplementation in preterm or low birth weight infants receiving PN

Note: Dosing may vary slightly depending on national guidelines, age, clinical condition, and product formulation.

Adults (on parenteral nutrition):

Typical daily parenteral dose:

• Iron: 1–2 mg (if included; often provided separately)
• Zinc: 2.5–5 mg
• Copper: 0.3–0.5 mg
• Manganese: 55–100 mcg
• Selenium: 20–60 mcg

Administer as a slow IV infusion, usually added to a total parenteral nutrition (TPN) admixture.

Pediatrics (based on weight and age):

• Zinc: 50–250 mcg/kg/day
• Copper: 20–50 mcg/kg/day
• Manganese: 1–2 mcg/kg/day
• Selenium: 1–2 mcg/kg/day
• Iron: Typically avoided in neonates unless specifically indicated

Neonates/Preterm Infants:

• Formulations with reduced manganese and copper are preferred due to immature excretion mechanisms (esp. in cholestasis)

Geriatrics:

• Same as adult dose; monitor for age-related renal/hepatic impairment

Renal/Hepatic Impairment:

• Renal failure: Reduce or avoid manganese, selenium, and copper due to accumulation risk
• Hepatic failure: Use copper and manganese with caution; risk of cholestatic retention and toxicity

Route: Intravenous (IV) infusion, usually mixed in PN

Frequency: Once daily

Duration: As long as parenteral nutrition or supplementation is required

Each trace element in the mix serves as a cofactor for numerous enzymatic and metabolic processes essential to cellular and systemic function:

• Iron supports hemoglobin synthesis and oxygen transport.
• Zinc is critical for DNA synthesis, immune function, wound healing, and enzymatic reactions.
• Copper plays a role in iron metabolism, mitochondrial respiration, and antioxidant defense.
• Manganese is involved in bone formation, amino acid metabolism, and as a cofactor in antioxidant enzymes.
• Selenium is a component of glutathione peroxidase, protecting cells from oxidative damage and regulating thyroid hormone metabolism.

Combined, these trace elements support metabolic homeostasis, immune function, antioxidant defense, tissue repair, and cellular signaling.

Absorption:

• IV administration bypasses absorption pathways
• In enteral use, absorption varies: zinc and copper are absorbed in the small intestine; manganese and selenium depend on specific transporters

Distribution:

• Bind to plasma proteins or cellular carriers
• Stored in liver, bone, muscle, or red blood cells depending on the element

Metabolism:

• Not metabolized in the conventional sense but incorporated into enzymes or coenzyme systems

Half-life:

• Varies per element (e.g., zinc: ~12–30 hours; selenium: ~65–115 days)

Excretion:

• Primarily through feces (zinc, copper, iron) and urine (selenium, manganese)
• Copper and manganese may accumulate in hepatic impairment
• Selenium and manganese clearance is impaired in renal dysfunction

• Pregnancy: Use is generally considered safe when indicated, especially in patients with nutritional deficiencies or on TPN. Requirements may be increased during pregnancy.
• Lactation: Trace elements are excreted into breast milk in small, physiologic amounts. Supplementation is safe at therapeutic doses.
• Caution: Avoid excessive dosing due to risk of toxicity (especially manganese or copper in preterm neonates or patients with hepatic dysfunction)

• Primary Class: Nutritional supplement
• Subclass: Parenteral trace element combination / Micronutrient formulation

• Known hypersensitivity to any component in the formulation
• Wilson’s disease (contraindicated for copper-containing solutions)
• Hemochromatosis or iron overload (if formulation contains iron)
• Severe hepatic cholestasis (relative contraindication due to risk of trace element retention, especially manganese and copper)
• Acute toxicity from individual trace elements (e.g., selenium or manganese)

• Trace element toxicity: Accumulation can occur, especially in hepatic or renal dysfunction
• Copper/manganese retention: Monitor liver enzymes and trace element levels in cholestasis
• Iron overload risk in patients receiving long-term iron supplementation or transfusions
• Zinc-copper imbalance: High-dose zinc can induce copper deficiency
• Selenium excess: Can cause hair loss, nail changes, and neurological symptoms

Monitoring Required:

• Periodic serum levels (zinc, copper, selenium)
• Liver function tests
• Renal function (creatinine, eGFR)
• Signs of toxicity (neurologic, hematologic, hepatic)

Common:

• Nausea (if infused rapidly)
• Injection site irritation (rare with diluted solutions)

Serious/Rare (often related to overdose or accumulation):

• Manganese toxicity: Neurological symptoms, parkinsonism-like tremors
• Copper overload: Hepatic toxicity, hemolysis
• Zinc excess: Gastrointestinal upset, immunosuppression
• Selenium toxicity: Hair loss, nail brittleness, garlic odor breath
• Iron toxicity: Hypotension, organ damage (when infused rapidly or in overdose)

Timing: Toxicity usually arises with prolonged or high-dose exposure, not acute therapeutic use.

• Chelating agents (e.g., penicillamine): May reduce zinc and copper absorption
• High-dose zinc: Can impair copper and iron metabolism
• Iron + vitamin C: Enhances absorption (in enteral regimens)
• Antacids or PPIs: May affect enteral absorption of certain minerals
• No significant CYP450 interactions, as elements are not metabolized via hepatic enzymes

• ASPEN (American Society for Parenteral and Enteral Nutrition) 2022–2024 Guidelines:
• Recommend individualized trace element dosing based on clinical condition and laboratory monitoring
• Suggest dose reductions in hepatic and renal failure
• Caution against over-supplementation in TPN formulations
• ESPEN (Europe): Supports separate dosing for critically ill patients (e.g., burns, sepsis, ICU)
• Updated neonatal guidance recommends reduced manganese and copper in cholestatic infants due to retention risk.

• Temperature: Store between 20°C to 25°C (68°F to 77°F); allow excursions between 15°C and 30°C
• Humidity & Light: Store in original container, protected from excessive light and moisture
• Handling Precautions:
• Single-dose vials should be used immediately after opening
• Avoid contamination when mixing into TPN
• Reconstitution: Not required for pre-mixed solutions
• Refrigeration: Not necessary unless specified by manufacturer