Included as part of the PRECAUTIONS section.
Decreased Anticoagulant Effect Of Warfarin
M.V.I. Adult contains Vitamin K which may decrease the
anticoagulant effect of warfarin. In patients who are on warfarin anticoagulant
therapy receiving M.V.I. Adult, prothrombin time/INR should be periodically
monitored to determine if the dose of warfarin needs to be adjusted.
M.V.I. Adult contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration in
patients with renal impairment. Premature neonates are particularly at risk
because their kidneys are immature, and they require large amounts of calcium
and phosphate solutions, which contain aluminum.
Patients with impaired kidney function, including
premature neonates, who receive parenteral levels of aluminum at greater than 4
to 5 micrograms per kg per day, accumulate aluminum at levels associated with
central nervous system and bone toxicity. Tissue loading may occur at even
lower rates of administration. To prevent aluminum toxicity monitor
periodically aluminum levels with prolonged parenteral administration of M.V.I.
Risk Of Low Vitamin A Levels
Vitamin A may adhere to plastic, resulting in lower
vitamin A concentrations after administration of M.V.I. Adult. Therefore, blood
vitamin concentrations should be periodically monitored and the administration
of additional therapeutic doses of Vitamin A may be required.
Allergic Reactions To Thiamine
Allergic reactions such as urticaria, periorbital and
digital edema, have been reported following intravenous administration of
thiamine, which is found in M.V.I. Adult. There have been rare reports of
anaphylaxis following intravenous doses of thiamine. No fatal anaphylaxis
reactions associated with M.V.I. Adult have been reported.
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
diseases with vitamin A, an ingredient found in M.V.I. Adult, should be
undertaken with caution [see Use In Specific Populations]. Blood levels
of Vitamin A should be monitored periodically.
Interference With Diagnosis Of Megaloblastic Anemia
M.V.I. Adult contains folic acid and cyanocobalamin which
can mask serum deficits of folic acid and cyanocobalamin in patients with
megaloblastic anemia. Avoid the use of M.V.I. Adult in patients with suspected
or diagnosed megaloblastic anemia prior to blood sampling for the detection of
the folic acid and cyanocobalamin deficiencies.
Potential To Develop Vitamin Deficiencies Or Excesses
In patients receiving parenteral multivitamins, such as
with M.V.I. Adult, blood vitamin concentrations should be periodically monitored
to determine if vitamin deficiencies or excesses are developing. M.V.I. Adult
may not correct long-standing specific vitamin deficiencies. The administration
of additional doses of specific vitamins may be required [see DOSAGE AND
Interference With Urine Glucose Testing
M.V.I. Adult contains Vitamin C which is also known as
ascorbic acid. Ascorbic acid in the urine may cause false negative urine
Impairment Of Fertility
and fertility studies were not performed.
Use In Specific Populations
Pregnancy Category C
M.V.I. Adult 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 nonpregnant women.
Animal reproduction studies have not been conducted with M.V.I. Adult (multiple
vitamins injection) administered by intravenous infusion.
M.V.I. Adult has not been studied in lactating women.
Lactating women should follow the U.S. Recommended Daily Allowances for their
condition, because their vitamin requirements may exceed those of nonlactating
women. Caution should be exercised when M.V.I. Adult is administered to a
M.V.I. Adult is indicated for the prevention of vitamin
deficiency in pediatric patients aged 11 years and older receiving parenteral
nutrition. M.V.I. Adult is not indicated for use in pediatric patients below
the age of 11 years.
Reported clinical experience has not identified
differences in responses between the elderly and younger patients.
M.V.I. Adult 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].
M.V.I. Adult has not been studied in patients with
hepatic impairment. Monitor vitamin A level in patients with liver disease or
high alcohol consumption [see WARNINGS AND PRECAUTIONS].