V-Plex

Approved Indications:

• Prevention and treatment of vitamin deficiencies in infants and children due to:
• Inadequate dietary intake
• Rapid growth phases
• Poor appetite or picky eating
• Chronic illness or malabsorption disorders
• Supplementation during illness, recovery, or hospitalization
• Support for optimal growth and neurodevelopment in:
• Premature or low-birth-weight infants
• Breastfed infants with low maternal micronutrient intake
• Parenteral or enteral nutrition support, especially in:
• Pediatric patients on total parenteral nutrition (TPN)
• Tube-fed children or those with gastrointestinal surgery

Clinically Accepted Off-label Uses:

• Management of failure to thrive
• Adjunctive therapy in children with developmental delays
• Repletion of vitamin levels in patients on long-term medication, such as anticonvulsants (which deplete folate or vitamin D)

Infants (0–12 months):

• Oral Drops:
  0.5 mL to 1 mL daily (depending on brand formulation), typically containing:
• Vitamin A: 1500 IU
• Vitamin D: 400 IU
• Vitamin C: 35 mg
• Vitamin B1, B2, B6, B12: as per age-appropriate RDA

Children 1–8 years:

• Chewable Tablet / Syrup:
  1 tablet or 5 mL syrup daily with food.
• Contains age-appropriate doses of A, B-complex, C, D, and E.

Children 9–13 years:

• 1 chewable or swallowable tablet daily, depending on formulation.

Parenteral Use (TPN):

• Pediatric IV multivitamin (e.g., PediaVite) dosing:
• <11 years: 1 mL/kg/day up to 5 mL/day
• ≥11 years: Adult IV multivitamin may be used (typically 10 mL/day diluted in 100 mL saline/dextrose)

Route & Frequency:

• Oral (drops, syrup, tablets): once daily
• Parenteral (IV): once daily in TPN protocols

Dose Adjustments:

• Tailor doses for renal/hepatic impairment.
• Monitor in premature infants or those with cholestasis.

Pediatric multivitamin formulations supply essential water- and fat-soluble vitamins that support cellular functions vital for child growth and development. B-complex vitamins act as coenzymes in energy metabolism and neural development. Vitamin A supports visual and immune function, while vitamin D regulates calcium-phosphate metabolism for bone health. Vitamin C acts as an antioxidant and supports collagen synthesis. Multivitamin supplementation ensures adequate supply of these cofactors, especially during phases of rapid growth, illness, or in children with limited dietary intake.

Absorption:

• Oral: Primarily in the small intestine; fat-soluble vitamins require bile and dietary fat.
• IV: 100% systemic bioavailability

Distribution:

• Varies by vitamin: Water-soluble circulate freely; fat-soluble stored in liver and fat tissues.

Metabolism:

• Converted to biologically active forms in the liver or tissues (e.g., folic acid → tetrahydrofolate)

Excretion:

• Water-soluble: Renally excreted
• Fat-soluble: Biliary/fecal excretion

Onset of Action:

• Clinical improvement in deficiency symptoms generally seen within 1–2 weeks

Half-life:

• Water-soluble: Short (hours to days)
• Fat-soluble: Longer (days to weeks)

(Not directly applicable to pediatric use, but relevant for maternal supplementation)

• Pregnancy: Pediatric multivitamin is not for use in pregnant women. Maternal prenatal vitamins should be used instead.
• Lactation: Safe for infants receiving breast milk; multivitamin supplementation may be required if maternal diet is deficient or in exclusive breastfeeding without vitamin D supplementation.
• Caution: Avoid vitamin overdose from combined maternal and infant supplementation.

• Primary Class: Nutritional Supplement
• Subclass: Pediatric Multivitamin Formulation (Oral or Parenteral)

• Hypersensitivity to any vitamin or excipient in the preparation
• Hypervitaminosis A or D
• Severe renal impairment (for preparations containing potassium, magnesium, or vitamin D)
• Use of vitamin K-containing products in patients with bleeding disorders on warfarin (without supervision)

• Overdose Risk: Excess intake of fat-soluble vitamins can lead to toxicity, especially vitamins A and D.
• Iron-Free Formulations: Most pediatric multivitamins do not contain iron due to overdose risk; if iron is needed, use separately.
• Allergic Reactions: Rare, but may occur (rash, itching).
• Infant Safety: Use dropper/syringe for accurate dosing in infants. Avoid direct administration into the throat to prevent choking.

Common:

• Mild gastrointestinal upset (nausea, abdominal pain)
• Yellow discoloration of urine (from riboflavin)

Less Common:

• Metallic taste
• Mild rash or skin irritation

Rare but Serious:

• Hypersensitivity (angioedema, urticaria)
• Hypervitaminosis A/D with chronic overuse
• Constipation or diarrhea (if combined with minerals like calcium/iron)

Onset:
Typically occurs within a few hours to days; usually mild and self-limiting.

• Anticonvulsants: May lower levels of folate or vitamin D
• Antibiotics (e.g., tetracyclines): Reduced absorption if taken with mineral-containing formulations
• Warfarin: Vitamin K may reduce anticoagulant effects—monitor INR
• Iron supplements: If taken with multivitamins, may cause GI intolerance

CYP450 Involvement:
No significant CYP-mediated interactions reported with standard pediatric doses.

• WHO/UNICEF (2023): Recommended routine vitamin A supplementation in children under 5 in low-resource countries to prevent blindness and infection-related mortality.
• AAP Guidelines (2022): Support routine vitamin D supplementation (400 IU/day) in all breastfed infants.
• ESPEN/ASPEN Updates: Emphasized tailored pediatric multivitamin needs in children on long-term enteral or parenteral nutrition.

• Oral Drops/Syrup:
• Store at 15°C to 25°C (59°F to 77°F)
• Protect from light and moisture
• Keep bottle tightly closed and out of children's reach
• Shake well before use
• Discard if color or odor changes
• IV Formulations:
• Store between 2°C and 8°C (refrigerated)
• Protect from light
• Use aseptically; discard unused portion
• Do not freeze