INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
Clinical safety rating: caution
Comprehensive clinical and safety monograph for INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) (INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)).
INFUVITE PEDIATRIC is a multivitamin formulation providing essential vitamins for metabolic processes, serving as cofactors in enzymatic reactions (e.g., B vitamins in energy metabolism, vitamin A in vision, vitamin D in calcium homeostasis).
| Metabolism | Vitamins are metabolized via various pathways: B vitamins undergo hepatic metabolism; vitamin A is metabolized in the liver; vitamin D undergoes hepatic 25-hydroxylation and renal 1α-hydroxylation; vitamin E is metabolized in the liver; vitamin K is metabolized in the liver. |
| Excretion | Renal excretion of water-soluble vitamins; fat-soluble vitamins (A, D, E, K) are excreted in bile/feces; minimal unchanged renal elimination. |
| Half-life | Variable; thiamine ~18 min, riboflavin ~1.1 h, pyridoxine ~2.5 h, ascorbic acid ~16 d, vitamin A ~18 d (fat-soluble storage). |
| Protein binding | Vitamin A ~90% bound to retinol-binding protein; vitamin E ~90% bound to lipoproteins; vitamin K ~99% bound to lipoproteins; water-soluble vitamins minimally protein-bound (<10% each). |
| Volume of Distribution | Not applicable as a fixed value; highly variable due to multiple components; e.g., thiamine ~0.35 L/kg, pyridoxine ~2 L/kg; total body water distribution for water-soluble vitamins. |
| Bioavailability | Intravenous: 100% (sole route for this product); not administered orally. |
| Onset of Action | Intravenous: immediate (minutes) for replenishment of depleted water-soluble vitamins; clinical effect within 24 hours. |
| Duration of Action | Water-soluble vitamins: hours to days (dependent on tissue saturation); fat-soluble vitamins: weeks to months (due to hepatic storage). |
Not applicable; INFUVITE PEDIATRIC is indicated for pediatric patients (≤11 years old). For adult use, consider adult multivitamin products.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment provided for renal impairment; use with caution in severe renal dysfunction due to potential accumulation of vitamins (e.g., vitamin A). |
| Liver impairment | No specific dose adjustment provided; use with caution in significant hepatic impairment due to potential vitamin A and D toxicity. |
| Pediatric use | For infants and children ≤11 years: 5 mL (one vial) added to appropriate intravenous solution, administered as a single daily dose. Do not exceed 5 mL per day. |
| Geriatric use | Not indicated for geriatric use; consider adult multivitamin products. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) (INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)).
| Breastfeeding | Components are excreted into breast milk at low levels. No specific M/P ratio available. At recommended doses, no adverse effects in breastfed infants are anticipated. Caution with high doses of fat-soluble vitamins (A, D, E, K). |
| Teratogenic Risk | Infuvite Pediatric (multivitamin infusion) contains vitamins A, D, E, K, C, B complex, and biotin. At recommended doses, no teratogenic effects are expected. Excessive vitamin A (retinol) >10,000 IU/day is associated with congenital malformations (first trimester). Vitamin D excess may cause fetal hypercalcemia. Vitamin K at high doses may increase neonatal jaundice risk. Routine prophylactic use in pregnancy is not indicated. |
■ FDA Black Box Warning
None known.
| Serious Effects |
["Hypersensitivity to any component of the formulation","Patients with hypervitaminosis A or D","Patients with severe renal impairment (due to aluminum content)"]
| Precautions | ["Hypersensitivity reactions (anaphylaxis) have occurred, especially with vitamin B1 (thiamine) and B12 (cyanocobalamin).","Aluminum toxicity risk in patients with renal impairment (product may contain aluminum).","Monitor for vitamin toxicity (especially vitamins A, D, E, K) in prolonged use.","Contains sulfites may cause allergic reactions in susceptible individuals."] |
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| Fetal Monitoring | Monitor serum vitamin levels (especially A and D) if prolonged use or high doses. Assess liver function tests. Fetal ultrasound if vitamin A >10,000 IU/day in first trimester. Neonatal monitoring for jaundice if high-dose vitamin K. |
| Fertility Effects | No known adverse effects on fertility at recommended doses. Excessive vitamin A (hypervitaminosis A) may impair spermatogenesis and ovarian function. |