indicated by the clinical status. Blood vitamin concentrations should be periodically monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as their sole source of vitamins for long periods of time.
CONTRAINDICATIONS
INFUVITE Pediatric is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product.
Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits.
WARNINGS
INFUVITE Pediatric is administered in intravenous solutions, which may contain aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
PRECAUTIONS
Caution should be exercised when administering INFUVITE Pediatric to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs. In such patients, periodic monitoring of prothrombin time/INR response is essential in determining the appropriate dosage of anticoagulant therapy.
Adequate blood levels of vitamin E are achieved when INFUVITE Pediatric is given to infants at the recommended dosage. Larger doses or supplementation with oral or parenteral vitamin E are not recommended because elevated blood levels of vitamin E may result.
Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with INFUVITE Pediatric. Additional vitamin A supplementation may be required, especially in low-birth-weight infants. Long-standing specific vitamin deficiencies may require additional therapeutic amounts of specific vitamins to supplement the maintenance vitamins provided by INFUVITE Pediatric.
In patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing.
Polysorbates have been associated with the E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomagaly, cholestasis, ascites, hypotension and metabolic acidosis) in low-birth-weight infants. However, no such adverse reports have been associated with the use of pediatric multiple vitamins for infusion such as INFUVITE Pediatric.
INFUVITE Pediatric should be aseptically transferred to the infusion fluid.
Drug-Drug InteractionsPhysical incompatibilities
INFUVITE Pediatric (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, and chlorothiazide sodium, aminopylline or sodium bicarbonate. INFUVITE Pediatric is not physically com |
