Infuvite Adult

• Tell all of your health care providers that you take Infuvite Adult. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• If you have high blood sugar (diabetes), talk with your doctor about which glucose tests are best to use.
• Use with care in newborns. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Infuvite Adult while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time after being added to fluids.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Infuvite Adult or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Infuvite Adult. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Infuvite Adult is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition.

The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

Important Dosage Instructions

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:

• Provides one daily dose of 10 mL (5 mL of Vial 1 plus 5 mL of Vial 2) which must be diluted prior to intravenous administration [see Dosage and Administration (2.2)].

Infuvite Adult PharmacyBulk Package:

• Provides ten 10 mL daily doses when the content of vial 1 is transferred into the content of vial 2. One 10 mL dose is then added directly to intravenous fluid. Pharmacy bulk package of Infuvite Adult is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion [see Dosage and Administration (2.2)].

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.

Preparation and Administration Instructions

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:

• Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). • Add 5 mL of Vial 1 and 5 mL of Vial 2 to at least 500 mL to 1000 mL, of intravenous dextrose or saline solutions. • Discard unused portion. • Visually inspect for particulate matter and discoloration prior to administration. • After Infuvite Adult is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution. • Minimize exposure to light because some of the vitamins in Infuvite Adult, particularly A, D and riboflavin, are light sensitive.

Infuvite Adult Pharmacy Bulk Package:

• Use only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). • Transfer the contents of Vial 1 into the contents of Vial 2 to provide ten 10 mL single doses. • Each bulk vial closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. • Once the closure system has been penetrated, complete dispensing from the pharmacy bulk vial should be completed within 4 hours. The mixed solution may be refrigerated and stored for up to 4 hours. • Discard unused portion. • Visually inspect for particulate matter and discoloration prior to administration. • One daily 10 mL dose should be added directly to at least 500 mL to 1000 mL, of intravenous dextrose, saline or similar infusion solutions. • After Infuvite Adult is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution. • Minimize exposure to light because some of the vitamins in Infuvite Adult, particularly A, D and riboflavin, are light sensitive.

Monitoring Vitamin Blood Levels

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.

Drug Incompatibilities

• Infuvite Adult is not physically compatible with moderately alkaline solutions such as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide sodium. • Folic acid is unstable in the presence of calcium salts such as calcium gluconate. • Vitamin A and thiamine in Infuvite Adult may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfate. • Do not add Infuvite Adult directly to intravenous fat emulsions. • Consult appropriate references for additional listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion when needed. If incompatibilities are identified, avoid admixture or Y-site administration with vitamin solutions.

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)].

Aluminum Toxicity

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 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. 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

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)].

Decreased Anticoagulant Effect of Warfarin

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.

Interference with Diagnosis of Megaloblastic Anemia

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.

Potential to Develop Vitamin Deficiencies or Excesses

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)].

Interference with Urine Glucose Testing

Infuvite Adult contains vitamin C which is also known as ascorbic acid. Ascorbic acid in the urine may cause false negative urine glucose results.

Pregnancy

Pregnancy Category C

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.

Nursing Mothers

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.

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 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)].

Hepatic Impairment

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)].