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Infuvite Pediatric Pharmacy Bulk Package

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Infuvite Pediatric Pharmacy Bulk Package

WARNINGS

INFUVITE (multiple vitamins for infusion pharmacy bulk package) PEDIATRIC (PHARMACY BULK PACKAGE) 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 (multiple vitamins for infusion pharmacy bulk package) PEDIATRIC (PHARMACY BULK PACKAGE) 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 (multiple vitamins for infusion pharmacy bulk package) PEDIATRIC (PHARMACY BULK PACKAGE) 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 (multiple vitamins for infusion pharmacy bulk package) PEDIATRIC (PHARMACY BULK PACKAGE). 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 (multiple vitamins for infusion pharmacy bulk package) PEDIATRIC (PHARMACY BULK PACKAGE).

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, hepatomegaly, 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 (multiple vitamins for infusion pharmacy bulk package) PEDIATRIC (PHARMACY BULK PACKAGE).

INFUVITE (multiple vitamins for infusion pharmacy bulk package) PEDIATRIC (PHARMACY BULK PACKAGE) should be aseptically transferred to the infusion fluid.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenicity, mutagenicity and fertility studies have not been performed.

Last reviewed on RxList: 2/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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