Included as part of the "PRECAUTIONS" Section
INFUVITE ADULT contains 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. To prevent aluminum toxicity
periodically monitor aluminum levels with prolonged parenteral administration of INFUVITE ADULT in patients with renal impairment.
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 ADULT. There have been rare reports of anaphylactoid reactions following intravenous doses of thiamine. No fatal anaphylactoid reactions associated with INFUVITE 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 disease with vitamin A, an ingredient found in INFUVITE ADULT, should be undertaken with caution [see Use In Specific Populations].
Decreased Anticoagulant Effect Of Warfarin
INFUVITE ADULT contains Vitamin K, which may decrease the anticoagulant action of warfarin. In patients who are on warfarin anticoagulant therapy receiving INFUVITE ADULT monitor blood levels of prothrombin/INR to determine if dose of warfarin needs to be adjusted.
Interference With Diagnosis Of Megaloblastic Anemia
INFUVITE ADULT contains folic acid and cyanocobalamin which can mask serum deficiencies of folic acid and cyanocobalamin in patients with megaloblastic anemia. Avoid the use of INFUVITE 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 INFUVITE ADULT, blood concentration should be periodically monitored to determine if deficiencies or excesses are developing. INFUVITE ADULT may not correct long-standing specific vitamin deficiencies. The administration of additional therapeutic doses of specific vitamins may be required [see DOSAGE AND ADMINISTRATION].
Interference With Urine Glucose Testing
INFUVITE ADULT contains vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose results.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE ADULT.
Use In Specific Population
Pregnancy Category C
INFUVITE ADULT has not been studied in pregnant women. Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. Animal reproduction studies have not been conducted with INFUVITE ADULT.
INFUVITE ADULT has not been studied in lactating women.Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women. Caution should be exercised when INFUVITE ADULT is administered to a nursing mother.
Safety and effectiveness in children below the age of 11 years have not been established.
Safety and effectiveness for geriatric use have not been established.
INFUVITE 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].
INFUVITE ADULT has not been studied in patients with liver impairments. Monitor vitamin A level in patients with liver disease, high alcohol consumption [see WARNINGS AND PRECAUTIONS].