Vitamin B Complex & C + 20% Fat Emulsion

Approved Indications:

• Total Parenteral Nutrition (TPN): As a component of complete intravenous nutrition in patients unable to eat or absorb nutrients via the gastrointestinal tract.
• Prevention and treatment of vitamin deficiencies: In hospitalized, post-operative, or critically ill patients with increased metabolic demand.
• Nutritional support in metabolic stress: Including patients with sepsis, major surgery, trauma, or extensive burns.
• Malnutrition or cachexia: Especially in cancer, gastrointestinal disorders, or anorexia-related weight loss.
• Support during refeeding syndrome prevention: To provide essential vitamins and calories in severely malnourished patients.

Clinically Accepted Off-label Uses:

• Parenteral nutritional support in hepatic/renal impairment: When enteral feeding is not feasible or adequate.
• Adjunct in chemotherapy/radiotherapy: As nutritional support to improve recovery and immune function.
• Post-bariatric surgery recovery: Where vitamin absorption is compromised.

Route of Administration: Intravenous infusion only; must be administered under medical supervision as part of a parenteral nutrition regimen.

Adults:

• Vitamin B Complex (daily average):
• Thiamine (B1): 3 mg
• Riboflavin (B2): 3.6 mg
• Niacinamide (B3): 40 mg
• Pyridoxine (B6): 4 mg
• Folic acid (B9): 400 mcg
• Dexpanthenol (B5): 10 mg
• Biotin (B7): 60 mcg
• Cyanocobalamin (B12): 5 mcg
• Vitamin C: 100–500 mg IV daily, depending on metabolic demand.
• 20% Fat Emulsion:
  Each 100 mL contains 20 g of fat (soybean oil base).
  Dosage: 1–2 g/kg/day (i.e., 70–140 g fat for a 70 kg adult).
  Infusion rate: Max 0.11 g fat/kg/hour.

Pediatric Dose (under specialist guidance):

• Vitamin and fat doses adjusted based on age and weight.
• Fat emulsion: 1–4 g/kg/day depending on caloric need and lipid tolerance.

Elderly:
Same as adult dose, with careful monitoring for hepatic function, lipid clearance, and renal function.

Renal Impairment:

• Vitamins: No routine dose adjustment required.
• Fat emulsion: Reduce dose to 0.5–1 g/kg/day in severe cases; monitor fluid and electrolyte status.

Hepatic Impairment:

• Use with caution.
• Fat emulsions may accumulate; consider reduced dose and frequent liver function monitoring.

Administration Instructions:

• Administer via central or large peripheral vein with sterile technique.
• Combine vitamins and fat emulsion in TPN bag immediately before use.
• Infusion duration: 8–24 hours depending on clinical need.
• Discard unused portion after 24 hours.

Vitamin B Complex acts as essential coenzymes in various metabolic pathways, including energy production, amino acid metabolism, red blood cell formation, and nervous system maintenance. Vitamin C plays a key role as an antioxidant, supports collagen synthesis, immune function, and enhances iron absorption. The 20% fat emulsion provides long-chain triglycerides (LCTs) as a dense caloric source and essential fatty acids (linoleic and α-linolenic acid) for membrane integrity and prostaglandin synthesis. The combined formulation supports cellular energy, prevents deficiency syndromes, and delivers parenteral calories in patients unable to maintain oral nutrition.

• Absorption: 100% bioavailability via IV route; bypasses gastrointestinal tract.
• Distribution:
• Water-soluble vitamins (B, C): Rapid distribution in extracellular fluids.
• Lipid emulsions: Distributed via lipoproteins to adipose and muscle tissue.
• Metabolism:
• Vitamins: Metabolized in the liver to active coenzymes.
• Lipids: Hydrolyzed by lipoprotein lipase into free fatty acids and glycerol.
• Excretion:
• Excess vitamins excreted renally.
• Lipids undergo mitochondrial β-oxidation; minor excretion in bile.
• Half-life:
• Vitamin B/C: Short half-lives (hours).
• Lipid emulsion: ~30–60 minutes plasma half-life; longer in hepatic dysfunction.

• Pregnancy:
  Not assigned formal FDA pregnancy category. However, individual vitamins (B-complex and C) are generally considered safe and essential during pregnancy. Fat emulsions are safe if medically necessary.
  Use under clinical supervision.
• Lactation:
  Safe when used as part of TPN.
  Water-soluble vitamins are excreted in breast milk in small quantities and are not harmful.
  Fat emulsions have not shown adverse effects on nursing infants.

• Class: Intravenous Multivitamin and Lipid Emulsion.
• Subclass: Water-soluble vitamin preparation + parenteral lipid emulsion.
• Formulation Type: Nutritional supplement for intravenous administration.

• Known hypersensitivity to soybean oil, egg phospholipids, or any component of the formulation.
• Severe hyperlipidemia or disorders of fat metabolism.
• Acute pancreatitis (especially with hyperlipidemia).
• Severe liver dysfunction or cholestasis.
• Bleeding disorders (related to lipid component in some cases).

• Lipid Overload Syndrome: Monitor serum triglycerides, liver enzymes.
• Aseptic Technique: Strict asepsis required during mixing and administration.
• Anaphylaxis Risk: Especially in patients allergic to soy or egg proteins.
• Monitoring Parameters: Electrolytes, triglycerides, liver function tests, blood glucose, and coagulation profile.
• Avoid bolus administration. Infuse slowly over 8–24 hours.
• Use caution in diabetics, renal, hepatic, or critically ill patients.

Common:

• Nausea, vomiting
• Mild fever
• Headache
• Transient rise in liver enzymes
• Infusion site irritation

Less Common/Rare:

• Allergic reactions: rash, bronchospasm, hypotension
• Lipid overload: hepatomegaly, thrombocytopenia, jaundice
• Hypertriglyceridemia
• Fat embolism (extremely rare)

Severity: Mostly mild and reversible; serious events are rare with proper monitoring.

• Warfarin: Vitamin K (in some formulations) may reduce anticoagulant effect.
• Propofol: Contains lipid; cumulative fat load may increase with concurrent fat emulsion.
• Heparin: May affect lipid clearance.
• Corticosteroids/Estrogens: May alter lipid metabolism.
• Avoid mixing with incompatible IV solutions: Risk of precipitation or emulsion destabilization.

• ASPEN & ESPEN Guidelines: Recommend daily multivitamin (including B & C) and lipid emulsion inclusion in all long-term TPN regimens.
• Fat emulsions: Preference for omega-3 enriched emulsions in critical care per recent ESPEN consensus.
• WHO/UNICEF Nutritional Guidelines: Reinforce vitamin and essential fatty acid supplementation in malnourished individuals.
• No recent FDA or EMA label changes noted for this fixed combination.

• Temperature: Store between 2°C to 25°C.
• Do not freeze. If frozen, discard.
• Light protection: Protect from direct light; use opaque bags if available.
• Shake well before use.
• Shelf life (unopened): 18–24 months.
• Once mixed or opened: Use within 24 hours.
• Follow manufacturer’s instructions for storage of compounded TPN bags.