Infuvite— Multivitamins for Infusion

Indication(s) and Important Risk Information

Infuvite Pediatric Multiple Vitamins for Infusion

Indications

INFUVITE Pediatric is indicated as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition. INFUVITE Pediatric is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients.

Important Risk Information

INFUVITE Pediatric is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits.

• INFUVITE Pediatric 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.
• Caution should be exercised when administering INFUVITE Pediatric 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.
• If this formulation is the only source of vitamins for a long period of time, blood concentrations of each of the vitamins should be monitored to determine if deficiencies or excesses are occurring.
• Caution should be exercised when administering INFUVITE Pediatric due to possible physical incompatibilities and clinical interactions. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion and specific vitamin-drug interactions.
• Ascorbic acid in the urine may cause false negative urine glucose determinations.
• There have been rare reports of anaphylactic reactions following parenteral multivitamin administration.

Infuvite Pediatric (Pharmacy Bulk Package)

Indications

INFUVITE Pediatric (Pharmacy Bulk Package) is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition

Important Risk Information

INFUVITE Pediatric (Pharmacy Bulk Package) is contraindicated in patients who have:

• Hypersensitivity to any of the vitamins
• Existing hypervitaminosis
• Risk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels
• Allergic reactions: to thiamine may occur
• Hypervitaminosis A: Patients with renal failure or liver disease may be at higher risk
• Vitamin K Antagonizes Warfarin’s Anticoagulant Action: Monitor INR
• Interferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder
• Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations
• False Negative Urine Glucose Tests: due to Vitamin C
• Risk of Vitamin E Toxicity: Additional oral and parenteral Vitamin E may result in elevated Vitamin E blood concentrations in infants
• Low Vitamin A Levels: Monitor Vitamin A levels
• Risk of E-Ferol Syndrome: due to polysorbates
• Adverse reactions have included anaphylaxis, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia

Please see accompanying full Prescribing Information for Infuvite

Infuvite Adult Multiple Vitamins for Infusion

Indications

INFUVITE Adult is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition. INFUVITE Adult is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients.

Important Risk Information

INFUVITE Adult is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits.

• INFUVITE Adult contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
• Caution should be exercised when administering INFUVITE Adult 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.
• If this formulation is the only source of vitamins for a long period of time, blood concentrations of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring.
• Caution should be exercised when administering INFUVITE Adult due to possible physical incompatibilities and clinical interactions. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion and for specific vitamin-drug interactions.
• Ascorbic acid in the urine may cause false negative urine glucose determinations
• Safety and effectiveness in children below the age of 11 years have not been established
• There have been rare reports of anaphylactic reactions following parenteral multivitamin administration.

Infuvite Adult (Pharmacy Bulk Package)

Indications

INFUVITE Adult (Pharmacy Bulk Package) is a multivitamin indicated for prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition.

Important Risk Information

INFUVITE Adult (Pharmacy Bulk Package) is contraindicated in patients who have:

• Hypersensitivity to any of the vitamins in the product
• Existing hypervitaminosis
• This product contains aluminum that may be toxic
• Allergic reactions to thiamine may occur
• Hypervitaminosis A has been reported in patients with renal failure receiving
• 1.5 mg/day retinol and in patients with liver disease
• Vitamin K antagonizes the anticoagulant action of warfarin
• Interference with the diagnosis of megaloblastic anemia
• Blood vitamin concentrations should be periodically monitored to determine if
• deficiencies or excesses are developing
• Interference with urine glucose testing
• Incompatibility with intravenous fat emulsions
• There have been reports of the following types of reactions:
  • Allergic – anaphylactoid reactions following large intravenous doses of thiamine,
  • urticaria, shortness of breath, wheezing and angioedema
  • Dermatologic: rash, erythema, pruritis
  • CNS: headache, dizziness, agitation, anxiety
  • Ophthalmic: diplopia
• A number of interactions between vitamins and drugs have been reported.
• Pediatric Use: Safety and effectiveness in children below the age of 11 years have not been established.

Please see accompanying full Prescribing Information for Infuvite for Adult and Pediatric.