Infuvite Pediatric
multiple vitamins injection · KIT · Sandoz Inc
Infuvite Pediatric is a kit containing multiple vitamins injection. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Infuvite Pediatric
- Generic Name
- multiple vitamins injection
- NDC Code (Product)
54643-5647- Manufacturer
- Sandoz Inc
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA021265
- Marketing Start
- 02/21/2001
Recall History
Sandoz, Inc
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • INFUVITE PEDIATRIC 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 PEDIATRIC is for administration by intravenous infusion after dilution ( 2.1 ) • Recommended daily dosage is based on patient’s actual weight ( 2.2 ): o INFUVITE PEDIATRIC Single Dose : ▪ Weight less than 1 kg : 1.2 mL of Vial 1 and 0.3 mL of Vial 2 ▪ Weight 1 kg to less than 3 kg : 2.6 mL of Vial 1 and 0.65 mL of Vial 2 ▪ Weight 3 kg or greater : 4 mL of Vial 1 and 1 mL of Vial 2 o INFUVITE PEDIATRIC Pharmacy Bulk Package : ▪ Weight less than 1 kg : 1.5 mL of combined content of Vials 1 and 2 ▪ Weight 1 kg to less than 3 kg : 3.25 mL of combined content of Vials 1 and 2 ▪ Weight 3 kg or greater : 5 mL of combined content of Vials 1 and 2. • Supplemental vitamin A may be required for low-birth weight infants ( 2.2 ) • INFUVITE PEDIATRIC is supplied as a single dose and as a pharmacy bulk package: o Single Dose consists of two vials labeled Vial 1 and Vial 2. Add one daily dose of Vial 1 and one dai…
Contraindications
4 CONTRAINDICATIONS INFUVITE PEDIATRIC is contraindicated in patients who have: • An existing hypervitaminosis, or • A history of hypersensitivity to any vitamins or excipients contained in this formulation. • Hypersensitivity to any of vitamins or excipients ( 4 ) • Existing hypervitaminosis ( 4 )
Drug Interactions
7 DRUG INTERACTIONS A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions. Effect of INFUVITE PEDIATRIC 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 PEDIATRIC: • Hydralazine, Isoniazid : Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements ( 7.2 ). • Phenytoin : May decrease folic acid concentrations ( 7.2 ) 7.1 Drug Interactions Affecting Co-Administered Drugs Warfarin : Vitamin K, a component of INFUVITE PEDIATRIC, antagonizes the anticoagulant action of warfarin. In patients who are co-administered warfarin and INFUVI…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections 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 PEDIATRIC. 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, 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.
Frequently Asked Questions
What is Infuvite Pediatric used for?
Infuvite Pediatric contains multiple vitamins injection. It is a kit taken as directed. Consult your doctor for specific uses.
Is Infuvite Pediatric a controlled substance?
Infuvite Pediatric is not classified as a controlled substance by the DEA.
What is the generic name for Infuvite Pediatric?
The generic name for Infuvite Pediatric is multiple vitamins injection. There are 2 other brand versions of multiple vitamins injection.
What is the NDC code for Infuvite Pediatric ?
The NDC (National Drug Code) for Infuvite Pediatric is 54643-5647, listed by Sandoz Inc.