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Infuvite Adult Pharmacy Bulk Package

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Infuvite Adult Pharmacy Bulk Package

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Aluminum Toxicity

INFUVITE ADULT (Pharmacy Bulk Package) 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.

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 (Pharmacy Bulk Package). There have been rare reports of anaphylactoid reactions following intravenous doses of thiamine. No fatal anaphylactoid reactions associated with INFUVITE ADULT (Pharmacy Bulk Package) have been reported

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 disease with vitamin A, an ingredient found in INFUVITE ADULT, should be undertaken with caution [See Use In Specific Populations].

Vitamin K Antagonizes the Anticoagulant Action of Warfarin

Vitamin K, which is found in INFUVITE ADULTS (Pharmacy Bulk Package) antagonizes the anticoagulant action of warfarin. In patients who are on warfarin anticoagulant therapy receiving parenteral multivitamins such as with INFUVITE ADULT (Pharmacy Bulk Package) blood levels of prothrombin/INR should be periodically monitored to determine if dose of warfarin needs to be adjusted.

Interferes with Diagnosis of Megaloblastic Anemia

Do not administer INFUVITE ADULTS (Pharmacy Bulk Package) to 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 the INFUVITE ADULTS (Pharmacy Bulk Package) solution can mask serum deficits of folic acid and cyanocobalamin in these patients

Monitor Blood Vitamin Concentrations to Determine if Deficiencies or Excesses are Developing

In patients receiving parenteral multivitamins such as with INFUVITE ADULTS (Pharmacy Bulk Package) , blood concentration should be periodically monitored to determine if deficiencies or excesses are developing. INFUVITE ADULTS (Pharmacy Bulk Package) 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 (Pharmacy Bulk Package) contains vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose determinations

Incompatibility with Intravenous Fat Emulsions

Do not add INFUVITE ADULT (Pharmacy Bulk Package) directly to intravenous fat emulsions.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE ADULT (Pharmacy Bulk Package).

Use In Specific Populations

Pregnancy

INFUVITE ADULT (Pharmacy Bulk Package) 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.

Nursing Mothers

INFUVITE ADULT (Pharmacy Bulk Package) 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 (Pharmacy Bulk Package) is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in children below the age of 11 years have not been established.

Geriatric Use

Safety and effectiveness for geriatric use have not been established.

Renal Impairment

INFUVITE ADULT (Pharmacy Bulk Package) has not been studied in patients with renal impairment. Monitor renal function, calcium, phosphorus and vitamin A levels in patients with renal impairment [see WARNING AND PRECAUTIONS].

Hepatic Impairment

INFUVITE ADULT (Pharmacy Bulk Package) has not been studied in patients with liver impairments. Monitor vitamin A level in patients with liver disease, high alcohol consumption [see WARNING AND PRECAUTIONS].

Last reviewed on RxList: 12/17/2012
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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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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