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ASHP INJECTABLE DRUG INFORMATION 1139

Multivitamins AHFS 88:28

Products E (dl-alpha tocopheryl acetate) 7 mg products for parenteral administration are avail- 20 mcg able in a variety of compositions and sizes. The following prod- Folic acid 140 mcg ucts are representative formulations. M.V.I. Adult is available as a package of 2 vials (labeled Vial 1 1 mcg and Vial 2) that are prepared for use by transferring the contents Phytonadione 200 mcg of Vial 1 into Vial 2 and mixing gently. After mixing, the product 1(5/07) contains: M.V.I. Pediatric also contains, in each vial, mannitol 375 Ascorbic acid 200 mg mg, polysorbate 80 50 mg, polysorbate 20 0.8 mg, butylated hydroxytoluene 58 mcg, butylated hydroxyanisole 14 mcg, and () 1 mg sodium hydroxide for pH adjustment.1(5/07) () 5 mcg Reconstitute the single-dose vial with 5 mL of sterile water for injection, dextrose 5%, or sodium chloride 0.9% and swirl (as hydrochloride) 6 mg gently. The solution is ready within 3 minutes. This solution (as ʹ5 -phosphate sodium) 3.6 mg must be further diluted for use; do not give it undiluted.1(5/07) Pyridoxine hydrochloride 6 mg Administration Niacinamide 40 mg Multivitamin infusion preparations are administered by intrave- Dexpanthenol 15 mg nous infusion only. They should not be given by direct intrave- nous injection. M.V.I. Adult is diluted in not less than 500 mL (dl-α tocopheryl acetate) 10 mg but preferably 1000 mL of intravenous infusion solution for 150 mcg administration. M.V.I. Pediatric should be added to at least 100 mL of a compatible intravenous infusion solution for adminis- Folic acid 600 mcg tration.1(5/07) Biotin 60 mcg Stability Vitamin B (cyanocobalamin) 5 mcg 12 Multivitamin products for infusion should be stored under refrig- eration and protected from light. Since some of the , The product also contains propylene glycol 30%, polysorbate especially A, D, and riboflavin, are light sensitive, light protec- 80 1.4%, citric acid, and sodium hydroxide and/or hydrochloric tion is necessary. After reconstitution of M.V.I. Pediatric, use of acid in water for injection. The concentrated vitamins must be the product without delay is recommended. However, if this is diluted for use; do not give undiluted.1(5/07) not possible, the manufacturer permits use within a maximum M.V.I.-12 has the same vitamin content as M.V.I. Adult except of 4 hours from the initial penetration of the closure.1(5/07) for the absence of vitamin K.1(5/07) Light Effects M.V.I. Pediatric is available as a lyophilized powder in vials containing a single dose. Each single dose contains:1(5/07) The effects of photoirradiation on a FreAmine II–dextrose 10% parenteral nutrition solution containing 1 mL/500 mL of multi- Ascorbic acid 80 mg vitamins (USV) were evaluated. During simulated continuous administration to an infant at 0.156 mL/min, the amino acids Vitamin A (retinol) 0.7 mg were stable when the bottle, infusion tubing, and collection Vitamin D (ergocalciferol) 10 mcg bottle were shielded with foil. Only 20 cm of tubing in the incu- bator was exposed to light. However, if the flow was stopped, Thiamine (as hydrochloride) 1.2 mg marked reductions in methionine (40%), tryptophan (44%), Riboflavin (as ʹ5 -phosphate sodium) 1.4 mg and histidine (22%) occurred in the solution exposed to light for 24 hours. In a similar solution without vitamins, only the tryp- Pyridoxine (as hydrochloride) 1 mg tophan concentration decreased. The difference was attributed Niacinamide 17 mg to the presence of riboflavin, a photosensitizer. The authors recommended administering the multivitamins separately and Dexpanthenol 5 mg shielding from light.833

DOI: 10.37573/9781585286850.276 1140 Multivitamins ASHP INJECTABLE DRUG INFORMATION

The stability of 5 was studied over 8 hours in essentially unchanged by exposure to sunlight through 12 hours. representative parenteral nutrition solutions exposed to fluo- The container material used to store the nutrition admixtures rescent light, indirect sunlight, or direct sunlight. One 5-mL vial affected the concentration of the vitamins as well. Losses were of multivitamin concentrate (Lyphomed) and 1 mg of folic acid greatest (10 to 25%) in PVC containers and were slightly better (Lederle) were added to a liter of parenteral nutrition solution in EVA and glass containers.2049 composed of amino acids 4.25% and dextrose 25% (Travenol) with standard electrolytes and trace elements. The 5 B vitamins Sorption were stable for 8 hours at room temperature when exposed to The following vitamins did not reveal significant sorption to a fluorescent light. In addition, folic acid and niacinamide were PVC plastic test strip in 24 hours:12 stable over 8 hours in direct or indirect sunlight. Exposure to Ascorbic acid indirect sunlight appeared to have little or no effect on thiamine Niacinamide hydrochloride and pyridoxine hydrochloride in 8 hours, but ribo- Pyridoxine hydrochloride flavin-5ʹ-phosphate lost 47%. Direct sunlight caused a 26% loss Riboflavin of thiamine hydrochloride and an 86% loss of pyridoxine hydro- Thiamine hydrochloride chloride in 8 hours. A 4-hour exposure of riboflavin-5ʹ-phos- Vitamin D phate to direct sunlight resulted in a 98% loss.842 Vitamin E acetate A parenteral nutrition solution in glass bottles exposed to sunlight was studied. Vitamin A decomposed rapidly, losing Riboflavin was shown not to exhibit sorption to PVC bags more than 50% in 3 hours. The decomposition could be slowed and tubing, polyethylene tubing, Silastic tubing, and polypro- 536 606 by covering the bottle with a light-resistant vinyl bag, resulting pylene syringes. in about a 25% loss in 3 hours. Vitamin E was stable in the paren- Vitamin A (as the acetate) (Sigma) 7.5 mg/L displayed 66.7% teral nutrition solution in glass bottles exposed to sunlight, with sorption to a PVC plastic test strip in 24 hours. The presence of no loss occurring during 6 hours of exposure.1040 dextrose 5% and sodium chloride 0.9% increased the extent of 12 Vitamin A rapidly and significantly decomposes when the sorption. exposed to daylight. The extent and rate of loss were dependent In another report, vitamin A acetate 3 mg/L displayed 78% on the degree of exposure to daylight which, in turn, depended sorption to 200-mL PVC containers after 24 hours at 25°C with on various factors such as the direction of the radiation, time of gentle shaking. The sorption was increased by 10% in sodium day, and climatic conditions. Delivery of less than 10% of the chloride 0.9% and by 20% in dextrose 5%.133 1047 expected amount was reported. In controlled light experi- However, vitamin A delivery is also reduced in glass intrave- ments, the decomposition initially progressed exponentially. nous containers. At a concentration of 10,000 units/L in glass Subsequently, the rate of decomposition slowed. This result was and PVC plastic containers protected from light with aluminum attributed to a protective effect of the degradation products on foil, 77 and 71%, respectively, of the vitamin A were delivered the remaining vitamin A. The presence of amino acids provided over a 10-hour period. Without light protection, 61% was deliv- greater protection. Compared to degradation rates in dextrose ered from glass and 49% from PVC plastic containers over a 5%, decomposition was reduced by up to 50% in some amino 10-hour period.290 acid mixtures.1048 In another test using multivitamin infusion (USV), 1 ampul per The stability of several water-soluble vitamins in dextrose 5% liter of sodium chloride 0.9% in glass and PVC plastic containers and sodium chloride 0.9% in polyvinyl chloride (PVC) and Clear- not protected from light, 69.4 and 67.9% of the vitamin A were Flex containers was evaluated. Thiamine, riboflavin, ascorbic delivered from glass and PVC containers, respectively, over a acid, and folic acid were stable at 23°C when protected from 10-hour period. The amount of vitamin A was constant over the light, exhibiting 10% or less loss in 24 hours. When exposed test period.282 to light, thiamine and folic acid were stable but ascorbic acid The delivery of vitamins A, D, and E from a parenteral nutri- was reduced by approximately 50 to 65% and riboflavin was tion solution composed of 3% solution (Phar- completely lost.1509 macia) in dextrose 10% with electrolytes, trace elements, The stability of phytonadione in a TPN solution containing vitamin K, , and was evaluated. To this solu- amino acids 2%, dextrose 12.5%, “standard” electrolytes, and tion was added 6 mL of multivitamin infusion (USV). The solu- M.V.I. Pediatric over 24 hours while exposed to light was evalu- tion was prepared in PVC bags (Travenol), and administration ated. Vitamin loss was about 7% in 4 hours and 27% in 24 hours. was simulated through a fluid chamber (Buretrol) and infusion Some loss was attributed to the light sensitivity of the phytona- tubing with a 0.5-μm filter at 10 mL/hr. During the first 60 to 1815 dione. 90 minutes, minimal delivery of the vitamins occurred. This Substantial loss of retinol all-trans palmitate and phytona- was followed by a rise and plateau in the delivered vitamins, dione was reported from both TPN and TNA admixtures due which were attributed to an increasing saturation of adsorptive to exposure to sunlight. In 3 hours of exposure to sunlight, binding sites in the tubing. The total amounts delivered over 24 essentially total loss of retinol and 50% loss of phytonadione hours were 31% for vitamin A, 68% for vitamin D, and 64% for had occurred. The presence or absence of did not affect vitamin E. Sorption of the vitamins was found in the PVC bag, stability. In contrast, concentrations remained fluid chamber, and tubing. Decomposition was not a factor.836