Included as part of the PRECAUTIONS section.
INFUVITE PEDIATRIC contains
aluminum that may be toxic. Aluminum may reach toxic levels with prolonged
parenteral administration in pediatric patients with renal impairment. Premature
neonates are particularly at risk because their kidneys are immature, and they
require large amounts of calcium and phosphate solution, which contain
Patients with renal impairment,
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. Consider periodic monitoring of aluminum levels
with prolonged parenteral administration of INFUVITE PEDIATRIC.
Allergic Reactions To Thiamine
Allergic reactions such as
urticaria, shortness of breath, wheezing and angioedema have been reported
following intravenous administration of thiamine, which is found in INFUVITE
PEDIATRIC. There have been rare reports of anaphylaxis following intravenous
doses of thiamine. No fatal anaphylaxis associated with INFUVITE PEDIATRIC has
Hypervitaminosis A, manifested
by nausea, vomiting, headache, dizziness, blurred vision has been reported in
patients with renal failure receiving 1.5 mg/day retinol and in patients with
liver disease. Therefore, supplementation of renal failure patients and
patients with liver disease with vitamin A, an ingredient found in INFUVITE
PEDIATRIC, should be undertaken with caution [See Use in Specific
Populations]. Blood levels of Vitamin A should be monitored periodically.
Vitamin K Antagonizes The Anticoagulant
Action Of Warfarin
Vitamin K, which is found in
INFUVITE PEDIATRIC, antagonizes the anticoagulant action of warfarin. In
patients who are on warfarin anticoagulant therapy receiving parenteral
multivitamins such as with INFUVITE PEDIATRIC blood levels of prothrombin/INR
should be periodically monitored to determine if dose of warfarin needs to be
Interferes With Diagnosis Of Megaloblastic
Avoid the use of INFUVITE
PEDIATRIC in patients with suspected or diagnosed megaloblastic anemia prior to
blood sampling for the detection of the folic acid and cyanocobalamin
deficiencies. The folic acid and the cyanocobalamin in INFUVITE PEDIATRIC can
mask serum deficits of folic acid and cyanocobalamin in these patients.
Potential To Develop Vitamin
Deficiencies Or Excesses
In patients receiving
parenteral multivitamins such as with INFUVITE PEDIATRIC, blood concentration
should be periodically monitored to determine if vitamin deficiencies or
excesses are developing. INFUVITE PEDIATRIC may not correct long-standing
specific vitamin deficiencies. The administration of additional doses of
specific vitamins may be required [see DOSAGE AND ADMINISTRATION].
Interference With Urine Glucose Testing
INFUVITE PEDIATRIC contains vitamin C which is also known
as ascorbic acid. Ascorbic acid in the urine may cause false negative urine
Vitamin E Overdose In Infants Receiving Additional
Avoid additional oral or parental doses of vitamin E in
infants. Daily dose of INFUVITE PEDIATRIC contains adequate concentrations of
vitamin E required to achieve normal blood levels of vitamin E. Therefore,
additional vitamin E supplementations of patients receiving INFUVITE PEDIATRIC
may result in elevated blood concentrations of vitamin E and potential vitamin
E toxicity in infants.
Risk Of Low Vitamin A Levels
Vitamin A may adhere to plastic, resulting in lower
vitamin A concentrations after administration of INFUVITE PEDIATRIC. Therefore,
blood vitamin concentrations should be periodically monitored and the
administration of additional therapeutic doses of vitamin A may be required, especially
in low-birth weight infants.
Risk Of E-Ferol Syndrome In Low-Birth Weight Infants
E-Ferol syndrome manifested by thrombocytopenia, renal
dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic
acidosis has been reported in low-birth weight infants following administration
of polysorbates which are found in INFUVITE PEDIATRIC. No E-Ferol syndrome
associated with INFUVITE PEDIATRIC has been reported.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenicity, mutagenicity, and fertility studies have
not been performed with INFUVITE PEDIATRIC.
Use In Specific Populations
Pregnancy Category C.
INFUVITE PEDIATRIC has not been studied in pregnant
women. Pregnant women should follow the U.S. recommended daily allowances for
pregnancy because their vitamin requirements may exceed those of non-pregnant
women. Animal reproduction studies have not been conducted with INFUVITE
PEDIATRIC (multiple vitamins injection).
INFUVITE PEDIATRIC has not been studied in nursing
mothers. Lactating women may have vitamin requirements that exceed those of
non-lactating women. Caution should be exercised when INFUVITE PEDIATRIC is
administered to nursing mothers.
INFUVITE PEDIATRIC is approved for the prevention of
vitamin deficiency in pediatric patients up to 11 years old receiving
parenteral nutrition. INFUVITE PEDIATRIC has not been studied in pediatric
patients older than 11 years.
INFUVITE PEDIATRIC contains aluminum that may be toxic
for premature neonates. Aluminum levels should be monitored periodically during
administration of INFUVITE PEDIATRIC to premature neonates [see WARNINGS AND
Additional vitamin E supplementations of infants
receiving INFUVITE PEDIATRIC may result in elevated blood concentrations of
vitamin E and potential vitamin E toxicity [see WARNINGS AND PRECAUTIONS].
E-Ferol syndrome has been reported in low-birth weight
infants following administration of polysorbates which are found in INFUVITE
PEDIATRIC. No E-Ferol syndrome associated with INFUVITE PEDIATRIC has been
reported [see WARNINGS AND PRECAUTIONS].
INFUVITE PEDIATRIC has not been studied in patients with
renal impairment. Monitor renal function, calcium, phosphorus and vitamin A
levels in patients with renal impairment [see WARNINGS AND PRECAUTIONS].
INFUVITE PEDIATRIC has not been studied in patients with
liver impairments. Monitor vitamin A levels in patients with liver disease [see
WARNINGS AND PRECAUTIONS].