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Dietary Supplement Information for Physicians with Naturokinetics℠ Pantethine 300 mg Softgels Product Code: P0487 Category: Lipid Metabolism Support TECHNICAL SUMMARY Pantethine is the disulfide form of pantotheine, which in turn is the amide conjugate of pantothenic acid (vitamin B5) and cysteamine. Each molecule of pantethine provides two molecules of pantothenic acid and is more stable than the latter. Pantothenic acid in pantethine is already conjugated with cysteamine, which is the next metabolic step in the formation of coenzyme A. Chemical Name: D-Bis (N-pantothenyl-2aminoethyl)-disulfide. Structural Formula: Figure 1. Molecular Formula: C22H42N4O8S2 Molecular Weight: 554.72 Product Composition: Pantesin® Pantethine (Coenzyme A Precursor), Rice Bran Oil, Gelatin (capsule), Glycerin, Water, Carob, Beeswax and Lecithin. Delivery Form: Softgel. ROLE AS A NUTRIENT Fig. 1 Pantethine Essentiality: Pantethine is a derivative of pantothenic acid, which is an 1, 2 essential nutrient (vitamin B5) that serves as a precursor to Coenzyme A. Dietary Sources: Liver, kidney, yeast, egg yolk, tuna, cod, royal jelly, and fresh vegetables are typical dietary sources of 2 pantothenic acid. Typical Consumption: A typical 2,500 calorie diet from plant and animal sources provides approximately 10 mg of pantothenic acid. Recommended daily intake for adults is 4-7 mg; for children age 7-10 years old 4-5 mg; and for infants 2 2 mg. Prevalence of Nutrient Deficiency: In humans, pantothenic acid deficiency is rare and is generally associated with fatigue 2 and depression. 2 Methods of Evaluation: Pantothenic acid concentration can be assessed in blood and urine. Structural and Functional Role: As a Coenzyme A precursor, pantothenic acid plays an essential role in the synthesis of fatty acids and modifications of cellular proteins with acetyl or fatty acyl groups including microtubules, which are important to the cellular exoskeleton. It is also required for the synthesis of cholesterol, steroid hormones, dolichol, vitamin A, vitamin D, and all compounds formed from isoprenoid units. Pantethine is also well known for its ability to normalize lipid levels, 1, 2 positively affecting chronic conditions such as hyperlipidemia, fatty liver, and cardiovascular disease. Pantesin® is a registered trademark of Daiichi Fine Chemicals, Inc. Dietary Supplement Information for Physicians with Naturokinetics℠ RECOMMENDED USE Lipid Metabolism Support: The efficacy of pantethine in lipid metabolism support has been investigated in 28 clinical trials providing 3 a pooled population of 646 hyperlipidemic subjects. The average study sample size was 22.3 subjects with a mean age of 52.8 years. The average study trial length was 12.7 weeks with a median pantethine dosage of 900 mg/day. The mean percent decrease from baseline to 4 months was: For total serum cholesterol (TC) - 15.1% For low-density lipoprotein cholesterol (LDL) - 20.1% For serum triacylglycerols (TG) - 32.9% The mean percent increase for high-density lipoprotein cholesterol (HDL) was 8.4% In a one-year long clinical trial conducted in 24 patients (mean age 51 years old), the outcome of pantethine supplementation (900 mg/day) was dependent on the type of dyslipidemia. The most improvement 4 was achieved in the type IIB type of dyslipidemia (Figure 2). Figure 2: Total cholesterol concentrations in patients with dyslipidemia type IIA (●●●●) and IIB (— —) supplemented with pantethine. In the most recent randomized triple-blinded clinical trial, a total of 120 subjects with low to moderate CVD risk received either Pantesin® (600 mg/day weeks 1-8, 900 mg/day weeks 9-16) or placebo in conjunction with implementation of lifestyle changes. Pantethine supplementation 5 lowered TC and LDL better than the diet alone (P<0.05). NATUROKINETICS SM Liberation: Dissolution test is not available. P0487 Pantethine 300 mg passes the standard disintegration test in water (< 60min). Absorption: Pantethine is absorbed in the small intestine and results in a significant increase in plasma pantothenate concentration at 6 approximately 2.5h (Tmax) as shown in human volunteers (Figure 3). Figure 3: Plasma concentration of pantothenate Distribution: Pantothenic acid is distributed throughout the body after a single oral dose of pantethine (62 mg/kg). according to organ perfusion; cysteamine is predominantly found in the 1, 6 kidneys. Metabolism: Each molecule of pantethine provides 2 molecules of pantetheine, which can serve as a coenzyme A precursor 6 or can be further hydrolyzed into pantothenate and cysteamine. Excretion: Pantethine is excreted in urine as pantothenate and cysteamine. Elimination half-life (t1/2) of pantothenate is 28 6 hours. SAFETY INFORMATION Tolerability: Pantethine is generally very well tolerated. It has been clinically tested in doses ranging from 300 mg to 1,800 mg/day. Daily doses 1,500 mg/day or higher may result in occasional adverse effects that may include softening of stool, 2, 7 nausea, G.I. discomfort, and modest laxation. Contraindications: Pantethine has been shown to exhibit anti-platelet effects and could increase the risk of bleeding. 8 Individuals with bleeding disorders should be advised to use with caution. Pantesin® is a registered trademark of Daiichi Fine Chemicals, Inc. Dietary Supplement Information for Physicians with Naturokinetics℠ INTERACTIONS Drug Interactions: Concomitant use of pantethine with anti-coagulant/anti-platelet medications (such as Plavix®, 8 Coumadin® and aspirin) may increase the risk of bleeding. Supplement Interactions: Concomitant use with supplements that exhibit anti-platelet effects may increase the risk of 8 bleeding. This includes garlic, Ginkgo biloba, red clover, ginseng, and others. Interactions with Lab Tests: None known. Storage and Stability: Store in cool dry environment in a tightly sealed container. References 1. 2. 3. 4. 5. 6. 7. 8. Pantethine. Monograph. Altern Med Rev. Sep 2010; 15(3): 279-282. Pins JJ, Keenan JM. Dietary and nutraceutical options for managing the hypertriglyceridemic patient. Prog Cardiovasc Nurs. Spring 2006; 21(2): 89-93. Marc P M. Treatment of hyperlipoproteinemia with pantethine: A review and analysis of efficacy and tolerability. Nutrition Research. 2005; 25(4): 319-333. Arsenio L, Bodria P, Magnati G, Strata A, Trovato R. Effectiveness of long-term treatment with pantethine in patients with dyslipidemia. Clin Ther. 1986; 8(5): 537-545. Rumberger JA, Napolitano J, Azumano I, Kamiya T, Evans M. Pantethine, a derivative of vitamin B5 used as a nutritional supplement, favorably alters low-density lipoprotein cholesterol metabolism in low to moderate cardiovascular risk North American subjects: a triple-blinded placebo and diet-controlled investigation. Nutrition research (New York, N.Y.). 2011; 31(8): 608-615. Wittwer CT, Gahl WA, Butler JD, Zatz M, Thoene JG. Metabolism of pantethine in cystinosis. J Clin Invest. Oct 1985; 76(4): 1665-1672. Da Col PG CL, Fonda M. Pantethine in the treatment of hypercholesterolemia: a randomized double-blind trial versus tiadenol. Curr Ther Res 1984; 36: 314-22. Agrati AM AG, Ferraro G, Palmieri. Gemfibrozil efficacy vs pantethine in dyslipoproteinemic patients: a controlled study. Curr Ther Res 1989; 45: 650-653. Pantesin® is a registered trademark of Daiichi Fine Chemicals, Inc.