Infuvite Adult Multiple Vitamins by is a Prescription medication manufactured, distributed, or labeled by Sandoz Inc. Drug facts, warnings, and ingredients follow.
INFUVITE ADULT is a combination of vitamins indicated for prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition (1)
Adverse reactions have included anaphylaxis and anaphylactoid reactions including shortness of breath, wheezing and angioedema, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Effect of INFUVITE ADULT on other drugs:
Effects of other drugs on INFUVITE ADULT:
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 3/2016
INFUVITE ADULT is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12.
INFUVITE ADULT is supplied as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution.
INFUVITE ADULT Single Dose:
INFUVITE ADULT PharmacyBulk Package:
Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated. Some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the only source of vitamins.
Do not administer INFUVITE ADULT as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation.
INFUVITE ADULT Single Dose:
INFUVITE ADULT Pharmacy Bulk Package:
Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of vitamins for long periods of time.
INFUVITE ADULT Single Dose: is an injection for intravenous administration consisting of two vials labeled Vial 1 (5 mL) and Vial 2 (5 mL). For the vitamin strengths [see Description (11)].
INFUVITE ADULT Pharmacy Bulk Package: is an injection for intravenous administration consisting of two vials labeled Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial). The mixed solution (100 mL) will provide ten 10 mL single doses. For the vitamin strengths [see Description (11)].
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 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 (8.6, 8.7)].
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.
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.
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 (2.3)].
The following adverse reactions are discussed in greater detail in other section of the labeling.
The following adverse reactions have been identified during postapproval use of INFUVITE ADULT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dermatologic: rash, erythema, pruritis
CNS: headache, dizziness, agitation, anxiety
Ophthalmic: diplopia
A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions:
Warfarin: Vitamin K, a component of INFUVITE ADULT, antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and INFUVITE ADULT, blood levels of prothrombin/INR should be monitored to determine if dose of warfarin needs to be adjusted [see Warnings and Precautions (5.4)].
Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.
Bleomycin: Ascorbic acid and riboflavin inactivate bleomycin in vitro, thus the activity of bleomycin may be reduced.
Levodopa: Pyridoxine may increase the metabolism of levodopa (decrease blood levels of levodopa) and decrease its efficacy.
Phenytoin: Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in increased seizure activity.
Methotrexate: Folic acid may decrease a patient’s response to methotrexate therapy.
Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.
Phenytoin: Phenytoin may decrease serum folic acid concentrations.
Chloramphenicol: In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by chloramphenicol.
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.
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 (5.1, 5.3)].
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 (5.3)].
INFUVITE ADULT (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package, both intended for intravenous use for administration by intravenous infusion after dilution:
INFUVITE ADULT Single Dose- two 5 mL single-dose vials labeled Vial 1 and Vial 2.
INFUVITE ADULT Pharmacy Bulk Package- two vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial). The mixed solution (100 mL) will provide ten 10 mL single doses.
Each 5 mL of Vial 1 contains:
Ascorbic acid (Vitamin C) . . . . . . . . . . . . . . . . . . . . . . . . . . .200 mg
Vitamin A* (as palmitate) . . . . . . . . . . . . . . . . . . . . . . . . . .3,300 IU
Vitamin D3* (cholecalciferol) . . . . . . . . . . . . . . . . . . . . . . . . .200 IU
Thiamine (Vitamin B1) (as the hydrochloride) . . . . . . . . . . . . . 6 mg
Riboflavin (Vitamin B2)
(as riboflavin 5-phosphate sodium) . . . . . . . . . . . . . . . . . . . . .3.6 mg
Pyridoxine HCl (Vitamin B6) . . . . . . . . . . . . . . . . . . . . . . . . . . 6 mg
Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40 mg
Dexpanthenol
(as d-pantothenyl alcohol) . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 mg
Vitamin E* (dl-α-tocopheryl acetate) . . . . . . . . . . . . . . . . . . . 10 IU
Vitamin K1* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150 mcg
Inactive ingredients: 1.4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.
*Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K.
Each 5 mL of Vial 2 contains:
Folic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .600 mcg
Biotin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60 mcg
Vitamin B12 (cyanocobalamin) . . . . . . . . . . . . . . . . . . . . . . 5 mcg
Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection.
INFUVITE ADULT makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.
Contains no more than 70 mcg/L of aluminum (combined Vials 1 and 2).
How Supplied:
INFUVITE ADULT (multiple vitamins injection) is supplied as follows:
INFUVITE ADULT Single Dose:
INFUVITE ADULT Pharmacy Bulk Package:
Storage and Handling:
Minimize exposure of INFUVITE ADULT to light because vitamins A, D and riboflavin are light sensitive.
Store under refrigeration, 2-8°C (36-46°F).
Instruct patients (if age appropriate) and caregivers:
2A9018 NDC: 54643-5649-1
Baxter
INFUVITE® ADULT Multiple Vitamins Injection
For intravenous infusion after dilution only. Rx only
Sterile
Contains 5 each of Vial 1 (5 mL) and Vial 2 (5 mL).
One vial of each to be used for a single dose.
Store under refrigeration, 2-8°C (36-46°F).
2A9019 NDC: 54643-5650-2
Baxter
INFUVITE® ADULT
PHARMACY BULK PACKAGE
Multiple Vitamins Injection
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
For intravenous infusion after dilution only.
Sterile Rx only
Contents: Vial 1 (50 mL) and
Vial 2 (50 mL Fill in 100 mL Vial).
Both vials combined produce 10 single doses.
Store under refrigeration, 2-8°C (36-46°F).
INFUVITE ADULT MULTIPLE VITAMINS
ascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin-5 phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalamin injection, solution |
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INFUVITE ADULT MULTIPLE VITAMINS
ascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, riboflavin-5 phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin k1, folic acid, biotin, cyanocobalamin injection, solution |
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Labeler - Sandoz Manufacturing Inc (242254227) |