infuvite adult

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 K 1 , folic acid, biotin, and vitamin B 12 ( 2.1 ) • INFUVITE ADULT is for administration by intravenous infusion after dilution ( 2.1 ) • Recommended daily dosage is 10 mL ( 2.1 ) • INFUVITE ADULT is supplied as a single dose and as a pharmacy bulk package. o Single Dose : Add one daily dose of 10 mL (5 mL from Vial 1 and 5 mL from Vial 2) to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. ( 2.2 ) o Pharmacy Bulk Package : Add the contents of Vial 1 to the contents of Vial 2. This provides ten 10 mL daily doses. Take 10 mL from Vial 2 and add to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. ( 2.2 ) • After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately. Use solution within 24 hours after dilution ( 2.2 ) • Monitor blood vitamin concentrations ( 2.3 ) • See Full Prescribing Information for drug incompatibilities ( 2.4 ) 2.1 Important Dosage Instructions INFUVITE ADULT is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide,…

The following adverse reactions are discussed in greater detail in other section of the labeling. • Allergic reactions to thiamine [see Warnings and Precautions ( 5.2 )] • Hypervitaminosis A [see Warnings and Precautions ( 5.3 )] 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 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 .

INFUVITE ADULT is contraindicated in patients who have • An existing hypervitaminosis, or • A history of hypersensitivity due to any vitamins or excipients contained in this formulation. • Hypersensitivity to any of the vitamins or excipients ( 4 ) • Existing hypervitaminosis ( 4 )

Signs and symptoms of acute or chronic overdosage may be those of individual INFUVITE ADULT component toxicity. In post-marketed surveillance, overdosage with INFUVITE ADULT at two times the prescribed dose did not result in toxicity.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions: Effect of INFUVITE ADULT on other drugs: • Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin ( 7.1 ) • Bleomycin: Ascorbic acid and riboflavin may reduce the activity of bleomycin ( 7.1 ) • Levodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease ( 7.1 ) • Phenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure activity ( 7.1 ) • Methotrexate: Folic acid may decrease response to methotrexate ( 7.1 ) Effects of other drugs on INFUVITE ADULT: • Hydralazine, Isoniazid: Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements ( 7.2 ). • Phenytoin: May decrease folic acid concentrations ( 7.2 ) • Chloramphenicol : In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited ( 7.2 ) 7.1 Drug Interactions Affecting Co-Administered Drugs 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. 7.2 Drug Interactions Affecting Vitamin Levels 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 B 12 therapy may be inhibited by chloramphenicol.