warnings and cautions
5 WARNINGS AND PRECAUTIONS Risk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), periodically monitor aluminum levels with prolonged administration ( 5.1 ) Low Vitamin A Levels: Monitor vitamin A levels ( 5.2 ) Allergic Reactions: to thiamine may occur ( 5.3 ) Hypervitaminosis A: Patients with renal failure or liver disease may be at higher risk ( 5.4 ) Interferes with Megaloblastic Anemia Diagnosis: Avoid use during testing for this disorder ( 5.5 ) Risk of Vitamin Deficiencies or Excess: Monitor blood vitamin concentrations ( 5.6 ) False Negative Urine Glucose Tests: May occur due to vitamin C ( 5.7 ) 5.1 Aluminum Toxicity M.V.I.-12 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.-12. 5.2 Risk of Low Vitamin A Levels Vitamin A may adhere to plastic, resulting in lower vitamin A concentrations after administration of M.V.I.-12. Therefore, blood vitamin concentrations should be periodically monitored and the administration of additional therapeutic doses of Vitamin A may be required. 5.3 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.-12. There have been rare reports of anaphylactoid reactions following intravenous doses of thiamine. No fatal anaphylactoid reactions associated with M.V.I.-12 have been reported. 5.4 Hypervitaminosis A 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.-12, should be undertaken with caution [ see Use in Specific Populations (8.6 and 8.7) ]. Blood levels of Vitamin A should be monitored periodically. 5.5 Interference with Diagnosis of Megaloblastic Anemia Patients Avoid the use of M.V.I.-12 in patients with suspected or diagnosed megaloblastic anemia prior to blood sampling for the detection of the folic acid and cyanocobalamin deficiencies. M.V.I.-12 contains folic acid and cyanocobalamin which can mask serum deficits of folic acid and cyanocobalamin in patients with megaloblastic anemia. 5.6 Potential to Develop Vitamin Deficiencies or Excesses In patients receiving parenteral multivitamins, such as with M.V.I.-12, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing. M.V.I.-12 may not correct long-standing specific vitamin deficiencies. The administration of additional doses of specific vitamins may be required [ see Dosage and Administration (2.2) ]. 5.7 Interference with Urine Glucose Testing M.V.I.-12 contains Vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose determinations.