Mix of 9 Trace Elements

Approved Indications:

• Nutritional supplementation in patients on long-term parenteral nutrition (TPN) to prevent trace element deficiencies
• Support for metabolic demands in critically ill patients (e.g., sepsis, trauma, burns)
• Replacement therapy in patients with diagnosed or suspected multiple trace element deficiencies
• Chronic gastrointestinal disorders that impair nutrient absorption (e.g., Crohn’s disease, short bowel syndrome, chronic diarrhea)
• Severe malnutrition or prolonged starvation, including cancer cachexia and advanced chronic illness

Clinically Accepted Off-label Uses:

• Adjunctive supplementation in dialysis patients with documented low trace element levels
• Supportive therapy in patients with high-output fistulas or stomas
• Perioperative supplementation in gastrointestinal or bariatric surgery patients

Note: The exact dose may vary by country, brand formulation, and patient condition.

Adults (on Parenteral Nutrition):

Typical daily dose (may vary per product):

• Zinc: 2.5–5 mg
• Copper: 0.3–0.5 mg
• Chromium: 10–15 mcg
• Manganese: 55–100 mcg
• Selenium: 20–60 mcg
• Iron (if included): 1–2 mg
• Iodine: 75–150 mcg
• Molybdenum: 20–45 mcg
• Fluoride: 0.95–1.5 mg (included in some formulations)

Route: IV infusion, typically added to TPN admixture
Frequency: Once daily
Duration: As long as parenteral nutrition continues or deficiency persists

Pediatrics (Including Neonates):

Dosing is weight-based:

• Zinc: 50–250 mcg/kg/day
• Copper: 20–50 mcg/kg/day
• Chromium: 0.14–0.2 mcg/kg/day
• Manganese: 1–2 mcg/kg/day
• Selenium: 1–2 mcg/kg/day
• Iodine: 1–10 mcg/kg/day
• Molybdenum: 0.25–1 mcg/kg/day
• Iron & Fluoride: Usually not included in neonatal PN unless specifically indicated

Neonatal considerations: Use lower doses, and avoid/minimize manganese and copper in cholestasis or liver dysfunction.

Elderly:

• Same as adult dose; monitor renal and hepatic function more closely.

Renal/Hepatic Impairment:

• Renal impairment: Reduce manganese, selenium, and fluoride to prevent accumulation.
• Hepatic impairment: Reduce manganese and copper due to hepatobiliary elimination.
• Monitoring required to avoid toxicity.

The Mix of 9 Trace Elements acts by replenishing essential micronutrients that serve as cofactors for numerous enzymatic reactions in the body. Zinc, copper, selenium, manganese, and molybdenum are essential for antioxidant defense systems, immune function, wound healing, and DNA/protein synthesis. Iodine is critical for thyroid hormone synthesis, while chromium enhances insulin sensitivity. Iron supports oxygen transport and mitochondrial function, and fluoride contributes to dental and bone health. By ensuring optimal levels of these elements, the formulation supports metabolic homeostasis, tissue repair, and immune competence in patients unable to maintain adequate trace element intake via oral or enteral routes.

Absorption:

• Not applicable for IV administration; 100% bioavailable.

Distribution:

• Most trace elements bind to plasma proteins or are stored in the liver, muscle, bone, or erythrocytes depending on the element.

Metabolism:

• Trace elements are not metabolized but incorporated into functional enzymes or proteins.

Half-life:

• Varies widely by element:
• Zinc: 12–30 hours
• Copper: 13–33 hours
• Selenium: Days to weeks (long half-life in tissues)

Excretion:

• Renal: Selenium, chromium, fluoride, molybdenum
• Biliary: Copper, manganese
• Fecal: Zinc, iron (if excess)
• Accumulation possible in renal or hepatic dysfunction

• Pregnancy: Trace elements are essential and considered safe during pregnancy when administered at physiological doses. Requirements may increase during pregnancy.
• Lactation: Excreted into breast milk in small amounts; safe at recommended doses.
• Caution: Avoid excessive accumulation. Monitor levels in parenteral-fed pregnant or breastfeeding women.

• Primary Class: Parenteral Nutritional Supplement
• Subclass: Multi-Trace Element Combination

• Hypersensitivity to any trace element or formulation excipient
• Wilson’s disease (contraindicated for copper-containing formulations)
• Hemochromatosis or iron overload conditions
• Severe hepatic cholestasis (avoid manganese and copper due to hepatobiliary retention)
• Manganese or selenium toxicity (from prior accumulation)

• Trace element toxicity: Risk increases with prolonged use or organ dysfunction
• Hepatic retention: Copper and manganese may accumulate in liver failure
• Neurotoxicity: Manganese accumulation may lead to Parkinsonian symptoms
• Fluoride overdose: Can cause skeletal fluorosis if not carefully dosed
• Zinc-copper imbalance: Excessive zinc can suppress copper absorption
• Iodine-induced thyroid dysfunction in neonates and sensitive individuals

Monitoring:

• Serum levels of zinc, selenium, copper
• Liver function tests (for manganese/copper clearance)
• Thyroid function (if iodine is included)
• Neurologic symptoms in long-term use

Common (dose-related or prolonged use):

• Nausea, vomiting (rare with proper IV dilution)
• Local irritation at injection site

Serious/Rare:

• Manganese toxicity: Neurotoxicity, Parkinsonian features
• Copper overload: Hepatic injury, hemolysis
• Zinc overdose: GI distress, immunosuppression
• Selenium excess: Hair loss, garlic breath, nail changes
• Chromium toxicity: Renal impairment (rare)
• Fluoride overdose: Skeletal or dental fluorosis (only with long-term high doses)

Timing: Chronic toxicity typically occurs after prolonged administration without monitoring.

• Chelating agents (e.g., penicillamine, EDTA): Can reduce absorption of zinc, copper, or chromium if given orally
• Excessive zinc: Can reduce copper and iron absorption or activity
• Antacids or PPIs (oral only): May impair enteral absorption of zinc, iron
• No CYP450 interactions, as trace elements are not enzyme substrates or inhibitors

• ASPEN 2022–2024 guidelines: Recommends individualized trace element dosing and regular monitoring in long-term TPN
• ESPEN and WHO guidelines: Emphasize the need for reduced manganese and copper in cholestatic patients
• Neonatal updates: New formulations include lower copper and manganese content for neonates with impaired excretion
• Iodine inclusion: Supported in long-term PN formulations based on recent deficiency cases in preterm infants

• Temperature: Store at 20°C to 25°C (68°F to 77°F); brief excursions between 15°C and 30°C allowed
• Humidity: Store in a dry place; protect from excessive moisture
• Light protection: Store in original packaging away from light
• Handling precautions: Use single-dose vials immediately once opened; avoid contamination
• Reconstitution: Not required; supplied in ready-to-use liquid ampoules or vials
• Refrigeration: Not required unless specified by the manufacturer