Last update 01 Nov 2024

Alpha-tocopherol acetate/Ascorbic acid/Biotin/Cholecalciferol/Cyanocobalamin/Dexpanthenol/Folic acid/Niacinamide/Pyridoxine hydrochloride/Riboflavin 5'-phosphate sodium/Thiamine hydrochloride/Vitamin A palmitate/Vitamin K

Last update 01 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

Alpha-tocopherol acetate/Ascorbic acid/Biotin/Cholecalciferol/Cyanocobalamin/Dexpanthenol/Folic acid/Niacinamide/Pyridoxine hydrochloride/Riboflavin 5'-phosphate sodium/Thiamine hydrochloride/Vitamin A/Vitamin K, 醋酸α-生育酚/抗坏血酸/生物素/胆钙化醇/氰钴胺/右泛醇/叶酸/烟酰胺/盐酸吡哆醇/核黄素5'-磷酸钠/盐酸硫胺素/维生素A/维生素K, INFUVITE

Target-

Mechanism-

Therapeutic Areas

Endocrinology and Metabolic DiseaseOther Diseases

Active Indication

Dietary SupplementAvitaminosis

Inactive Indication-

Originator Organization

Sandoz Canada, Inc.

Active Organization

Sandoz Canada, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (18 May 2000),

Avitaminosis

Regulation-

Structure

Molecular FormulaC19H19N7O6

InChIKeyOVBPIULPVIDEAO-LBPRGKRZSA-N

CAS Registry59-30-3

View All Structures (12)

100 Clinical Results associated with Alpha-tocopherol acetate/Ascorbic acid/Biotin/Cholecalciferol/Cyanocobalamin/Dexpanthenol/Folic acid/Niacinamide/Pyridoxine hydrochloride/Riboflavin 5'-phosphate sodium/Thiamine hydrochloride/Vitamin A palmitate/Vitamin K

100 Translational Medicine associated with Alpha-tocopherol acetate/Ascorbic acid/Biotin/Cholecalciferol/Cyanocobalamin/Dexpanthenol/Folic acid/Niacinamide/Pyridoxine hydrochloride/Riboflavin 5'-phosphate sodium/Thiamine hydrochloride/Vitamin A palmitate/Vitamin K

100 Patents (Medical) associated with Alpha-tocopherol acetate/Ascorbic acid/Biotin/Cholecalciferol/Cyanocobalamin/Dexpanthenol/Folic acid/Niacinamide/Pyridoxine hydrochloride/Riboflavin 5'-phosphate sodium/Thiamine hydrochloride/Vitamin A palmitate/Vitamin K

Literatures (Medical) associated with Alpha-tocopherol acetate/Ascorbic acid/Biotin/Cholecalciferol/Cyanocobalamin/Dexpanthenol/Folic acid/Niacinamide/Pyridoxine hydrochloride/Riboflavin 5'-phosphate sodium/Thiamine hydrochloride/Vitamin A palmitate/Vitamin K

01 May 2003·Journal of Parenteral and Enteral NutritionQ2 · MEDICINE

New Food and Drug Administration requirements for inclusion of vitamin K in adult parenteral multivitamins

Q2 · MEDICINE

Review

Author: Bistrian, Bruce R. ; Helphingstine, Cynthia J.

The newly amended requirements by the Food and Drug Administration (FDA) for an effective adult parenteral multivitamin drug product increase the amounts of vitamins B1, B6, C, and folic acid currently in the product to better meet estimated needs, and specifies the inclusion of 150 microg of vitamin K. Infuvite Adult Multiple Vitamins for Infusion is the first adult parenteral multivitamin product to meet the revised FDA requirements. The inclusion of vitamin K in adult parenteral multivitamin products is intended to afford patients a consistent daily supply of vitamin K approximating usual levels of intake. This is a change to clinical practice in the United States, where vitamin K has not been included in adult parenteral vitamin preparations, and physicians prescribe vitamin K separately. The reformulation of adult parenteral multivitamins required by the FDA raises questions about the potential impact that inclusion of vitamin K will have on patient management. One clinical practice change is that patients on parenteral nutrition receiving Infuvite Adult should no longer need weekly subcutaneous (SC) or intramuscular (IM) vitamin K injections. In addition, the consistent and modest level of vitamin K provided by the reformulated adult parenteral multivitamins may make it easier for physicians to maintain the desired level of hypoprothrombinemia (low levels of prothrombin) in those patients also on anticoagulant therapy with warfarin. However, for physicians accustomed to administering vitamin K separately, it is important to highlight that it may be more difficult to titrate anticoagulant therapy, especially among patients receiving dual feeding or vitamin K from another source. If marketed globally, these clinical practice issues may be more pronounced outside of the United States, where dual feeding is common, and patients may receive vitamin K from other sources.

01 Apr 2002·Nutrition in Clinical Practice

Multivitamins for the Millennium

Author: Gordon S. Sacks

On October 15, 2001, Baxter Healthcare Corporation (Deerfield, IL) announced that it had received approval from the Food and Drug Administration (FDA) to market a new adult parenteral multivitamin product, INFUVITE Adult. This product, manufactured by the Canadian firm Sabex, Inc (Boucherville, Quebec, Canada), is the first to meet the FDA’s amended requirements for marketing of an “effective” adult parenteral multivitamin formulation. The new requirements for increased dosages of vitamins B1, B6, and C and folic acid, as well as addition of vitamin K, are based on the recommendations from a 1985 workshop sponsored jointly by the American Medical Association’s (AMA) Division of Personal and Public Health Policy and FDA’s Division of Metabolic and Endocrine Drug Products. Specific modifications of the previous formulation include increasing the provision of ascorbic acid (vitamin C) from 100 mg/d to 200 mg/d, pyridoxine (vitamin B6) from 4 mg/d to 6 mg/d, thiamine (vitamin B1) from 3 mg/d to 6 mg/d, folic acid from 400 g/d to 600 g/d, and addition of phylloquinone (vitamin K) at 150 g/d. The implications of these changes are important for all healthcare practitioners involved in the care of patients receiving parenteral nutrition (PN). The presence of phylloquinone can interfere with the hypothrombinemic effect of anticoagulant therapy such as warfarin; thus, patients receiving this medication may need to have their prothrombin time and international normalized ratio (INR) closely monitored. The impact on vitamin compatibility and stability should also be recognized when using this product. The package insert alludes to the presence of aluminum, although the specific amount is not disclosed. Previous work has demonstrated that certain patient populations may be extremely vulnerable to aluminum toxicity. Burn patients receiving large quantities of human serum albumin and calcium gluconate, both of which are contaminated with aluminum, may be at an even greater risk for aluminum toxicity if they require PN with daily multivitamins. Alterations in bone formation, mineralization, parathyroid hormone (PTH) secretion, and urinary calcium excretion have been attributed to aluminum toxicity in long-term PN patients or patients with renal impairment. Ascorbic acid is the least stable of all multivitamins, and degradation leading to loss of biological activity has been reported. The amount of ascorbic acid degraded has been shown to directly correlate with the amount of oxygen present in the compounded bag. Degradation by direct reaction with oxygen has been identified as the primary mechanism. Sources of oxygen include infusions containing dissolved air such as glucose, introduction of air during transfer of additives from bottle to PN bag, and residual air in the compounded bag after sealing. Although one would presume that this would support the need for a higher intake of ascorbic acid, limitations to the safe provision of vitamin C in PN formulations should be carefully reviewed. Because the ascorbic acid degradation pathway results in the production of oxalic acid, the potential for calcium oxalate precipitation in a PN bag exists. Since the advent of “hyperalimentation,” practitioners have learned that more is not necessarily better. Will providing higher intakes of vitamins translate into better outcomes for our patients? Only time will provide the answer.

International Journal of NanomedicineQ2 · MEDICINE

Preparation and Evaluation of Lipid Emulsion Containing 13 Vitamins for Injection Without Anaphylactoid Reactions

Q2 · MEDICINE

ArticleOA

Author: Ma, Yu-Fan ; Mi, Yan-Ni ; Cao, Yong-Xiao ; Hui, Min-Quan ; Chen, Tao

OBJECTIVEMultivitamins containing Tween 80 can cause anaphylactoid reactions. The objective of this study was to develop a new lipid emulsion containing 13 fat- and water-soluble vitamins for injection (13V-LE) that were simultaneously dissolved in one bottle and to evaluate the stability of and anaphylactoid reactions to 13V-LE.METHODSParticle size, ζ-potential, and polydispersity of 13V-LE were assayed with a Zetasizer Nano ZS. Entrapment efficiency of 13V-LE was determined with HPLC. Behavior, histamine, and blood pressure of beagle dogs were investigated by observation, fluorospectrophotometry, and sphygmomanometry.RESULTSThe 13V-LE with the smallest particles and highest entrapment efficiency with stable ζ-potential was composed of soybean oil, glycerin (2.25%, w:v), egg lecithin (1.2%, w:v), and purified water. There was no obvious change in characteristics of the 13V-LE samples in terms of appearance, size distribution, ζ-potential, pH value, or concentration over 6 months. In anaphylactoid reactions tests, when being administered with the multivitamin Infuvite Adult containing Tween 80, six beagles showed grade IV symptoms (P<0.01 vs control), low blood pressure, and high plasma-histamine concentrations (P<0.05 or P<0.01). However, there were no significant differences in behavior, blood pressure, or histamine concentration in the dogs before and after administration in the 13V-LE group.CONCLUSIONThe 13V-LE formulation is a suitable intravenous lipid emulsion without anaphylactoid reactions.

100 Deals associated with Alpha-tocopherol acetate/Ascorbic acid/Biotin/Cholecalciferol/Cyanocobalamin/Dexpanthenol/Folic acid/Niacinamide/Pyridoxine hydrochloride/Riboflavin 5'-phosphate sodium/Thiamine hydrochloride/Vitamin A palmitate/Vitamin K

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Dietary Supplement	US	Sandoz Canada, Inc.	21 Feb 2001
Avitaminosis	US	Sandoz Canada, Inc.	18 May 2000

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Alpha-tocopherol acetate/Ascorbic acid/Biotin/Cholecalciferol/Cyanocobalamin/Dexpanthenol/Folic acid/Niacinamide/Pyridoxine hydrochloride/Riboflavin 5'-phosphate sodium/Thiamine hydrochloride/Vitamin A palmitate/Vitamin K

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Translational Medicine

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