DOCSLIB.ORG

Glucosamine Chondroitin MSM

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Glucosamine Chondroitin MSM product monograph NPN: 80008779 3345-8 Class: Supplement Glucosamine Chondroitin MSM Ingredients (alphabetical) Medicinal: Chondroitin sulfate, glucosamine sulfate, MSM (methyl-sulfonyl-methane) Non-medicinal: Coating (dextrin, dextrose, lecithin, sodium carboxymethylcellulose, sodium citrate), croscarmellose sodium, microcrystalline cellulose, purified water, stearic acid, vegetable grade magnesium stearate Allergens Corn, shellfish, soy, starch Source Glucosamine from the hard shells of shell fish, Chondroitin sulfate from bovine trachea, MSM is a derivative of wood lignin. Uses Use as a symptomatic treatment for osteoarthritis. The more traditional glucosamine sulfate and chondroitin sulfate are used as restorative or anabolic agents for catilage [Bucci, 1994]. MSM provides some pain and anti-inflammatory relief, as well as sulfur for connective tissue enhancement. Recommended Amount Use 1 tablet TID. A workable reduced dosage can be tried for the maintenance phase based on the retention of treatment benefits. The dosage can gradually be reduced at the rate of 1 tablet per 3 months. Increase the dosage if pain returns. In the case of age-related osteoarthritis, it would probably be prudent to remain on at least 2 tablets per day indefinitely. Adverse Side Effects There are virtually no adverse side effects and no toxicity reported with glucosamine sulfate or chondroitin sulfate, both being endogenous to cartilage [Bucci, 1994]. Some have complained of initial gastric upset when using these substances, so recommend with meals. MSM is used at a reduced dose in this product compared to MSM used alone specifically for pain. MSM is not associated with adverse side effects. The overwhelming majority of people who have taken MSM have experienced no adverse effects. It has been taken in amounts greater than two grams for years without adverse effects [McCarty, 1994]. Taking too large an amount of MSM at one time can cause GI irritation with diarrhea and cramping, as well as minor headaches. This is resolved usually by dividing the daily amount or reducing the daily dose. Skin rashes have been reported with DMSO and therefore may be seen with MSM since it is a derivative of DMSO. Interactions There are no documented drug interactions with glucosamine sulfate salt or chondroitin sulfate. After many years of clinical use, MSM has not been found to adversely interact with any prescribed medication [McCarty, 1994]. DMSO has been found to counteract platelet aggregation. MSM as a derivative of DMSO has not been so studied but there is indication that it also will present a blood thinning effect. Those using coumadin or other blood thinning medication, including other natural blood thinning products like high doses of garlic, salmon oil, grape seed extract, and high doses of vitamin E, may be at risk of bleeding problems if using high doses of MSM. Precautions / Cautions The sulfate radical in the Glucosamine Sulfate salt is not as likely to cause allergy as is sulfite, but it may be possible, even FOR PROFESSIONAL USE ONLY. This information is provided for educational purposes only and is not intended for self-diagnosis or self-treatment of a condition that should be interpreted by a qualified health care provider. While the information in this document has been carefully reviewed and reflects current clinical and scientific knowledge, it is subject to change. UPDATED 10/01/2008 | Glucosamine Chondroitin MSM, 500/400/400 mg | NF0667T PAGE 1 OF 4 product monograph though sulfate is a metabolic necessity. The sulfate in chondroitin sulfate is covalently bound to the chondroitin and is not free to body fluids. Those allergic to shellfish have been concerned over a possible allergic reaction to glucosamine. Allergic reaction has not been reported as a practical concern, probably because the allergens are in the meat and the extraction process is able to denature any extraneous flesh protein. However, it must be recognized that individuals sometimes display profound sensitivity where it is not expected. If there is concern over possible allergic reaction, especially if anaphylactic reactions are possible, have the customer discuss the matter with their physician before commencing use. MSM has had a successful history of helping people without significant adverse effects. However, it is not yet fully known what might be the long-term effects in people using very large amounts. The experience of Dr Stanley W. Jacob, at the DMSO Clinic at the Oregon Health Sciences University in Portland, indicates that there are no special cautions [McCarty, 1994] other than those of prudent use associated with any substance that is still being explored and discovered without benefit of formal clinical trials. Concern has been expressed concerning those with a sulfa drug sensitivity, that a cross-sensitivity may be possible due to the sulfonyl group in MSM. Cross-sensitivity has not been widely reported but caution is advised. It is known that MSM will give false positive test results for elevated liver enzymes in liver function tests [McCarty, 1994]. Discontinuation of MSM should precede all liver testing by at least one week, with resumption following tests. Otherwise, MSM has been found to present no interference in blood chemistry tests. MSM has the potential for reducing platelet aggregation. See under Interactions. Clinical experience indicates that MSM is safe during pregnancy [McCarty, 1994]. However, it is recommended that pregnant women first discuss MSM with their physician before using MSM. Because MSM has the potential to raise one’s energy level, it is not recommended at bedtime. Contraindications None known. Pharmaceutical Commentary Glucosamine, itself, is a natural endogenous metabolite of cartilage and other connective tissue anabolic biochemistry. It is present in meat, fish, and poultry, but is only harvested commercially from the hard shells of shellfish, which are principally chitin (N-acetylglucosamine). Furthermore, humans are endowed with particular efficacy in absorbing glucosamine, as are other carnivorous mammals. These biological features constitute a straight forward and obvious rationale for using glucosamine supplementation in the clinical treatment of osteoarthritis. Indeed, early German clinical research, beginning in 1969, using glucosamine sulfate was predicated on the anabolic potential for cartilage renewal [McCarty, 1994]. Since these were uncontrolled studies they were not considered definitive. More impetus to pursue glucosamine became possible when an Italian pharmaceutical company introduced glucosamine sulfate in 500 mg tablets in the late 70s. Since its introduction in the early 1980s in commercial form, glucosamine has become highly regarded and a first-line treatment for osteoarthritis in many countries. International research has demonstrated that osteoarthritis could be arrested with glucosamine sulfate supplementation, if caught before the onset of irreversible joint damage. Significant reductions in joint pain, stiffness, tenderness, and swelling, as well as increased joint performance are the hallmarks of glucosamine sulfate. Even when researchers compared it to non-steroidal anti-inflammatory drug therapy (NSAID), like ibuprofen, glucosamine sulfate led to greater improvements in pain reduction and measurably better joint performance [Bucci, 1994] [McCarty, 1994]. Glucosamine hydrochloride has been introduced to offer an alternative approach. However, the sulfate moiety has important clinical value. Effective sulfur metabolism is imperative if osteoarthritis is to be arrested, and reversed where possible. Since reduced sulfur intake, and/or its synthesis into sulfate groups may be an important causative factor in a significant percent of arthritis, it seems prudent to use glucosamine sulfate with its preformed sulfate. Endogenously produced cartilage glycosaminoglycans (GAG’s), of which 66 percent is chondroitin sulfate, must be highly sulfated to electostatically bind water inside the cartilage. Cartilage hydration should be at 65 to 80 percent water. The first biochemical sign of failing cartilage is dehydration, and rehydration is integral to healing. Concerning chondroitin sulfate, because greater insights into the pathogenesis of osteoarthritis have revealed the critical role of the GAG’s and because chondroitin sulfate is a GAG, representing 66 percent of the GAG production, those seeking to FOR PROFESSIONAL USE ONLY. This information is provided for educational purposes only and is not intended for self-diagnosis or self-treatment of a condition that should be interpreted by a qualified health care provider. While the information in this document has been carefully reviewed and reflects current clinical and scientific knowledge, it is subject to change. UPDATED 10/01/2008 | Glucosamine Chondroitin MSM, 500/400/400 mg | NF0667T PAGE 2 OF 4 product monograph enhance the clinical work with chondroproective agents have turned to chondroitin sulfate. Chondroitin sulfate demonstrates considerable tolerability and therapeutic efficacy. GAG’s in vitro, generally are able to inhibit certain enzymes present in the synovial fluid such as elastase from leukocytes, and hyaluronidase, thus offering a greater opportunity for preserving cartilage anabolic success by reducing inordinate cartilage catabolism [Conte, 1995] [Pipitone, 1991]. Chondroitin sulfate has been shown to inhibit up to 60% of the enzymatic action of elastase. Furthermore, chondroitin sulfate has demonstrated in vitro anti- inflammatory action
Load more

Recommended publications
  • (12) STANDARD PATENT (11) Application No. AU 2010224615 B2 (19) AUSTRALIAN PATENT OFFICE
    (12) STANDARD PATENT (11) Application No. AU 2010224615 B2 (19) AUSTRALIAN PATENT OFFICE (54) Title Dietary supplement (51) International Patent Classification(s) A23K 1/175 (2006.01) A23K1/18 (2006.01) (21) Application No: 2010224615 (22) Date of Filing: 2010.02.12 (87) WIPONo: WO10/106351 (30) Priority Data (31) Number (32) Date (33) Country 0904584.0 2009.03.17 GB (43) Publication Date: 2010.09.23 (44) Accepted Journal Date: 2014.05.08 (71) Applicant(s) Calinnova Ltd (72) Inventor(s) Green, Malcolm Geoffrey (74) Agent / Attorney Davies Collison Cave, Level 14 255 Elizabeth Street, Sydney, NSW, 2000 (56) Related Art ARNBJERG, J. "Hypokalcaemi hos hest. En kasuistik med diskussion (Hypocalcemia in the horse. A case report)" Nord Vet Med, 1980, Volume 32, Issue 5 Pages 207-211 US 2003/0077254 A1 (RAMAEKERS) 24 April 2003 FR 2625415 A1 (UNICOR UNION COOP AGRICOLES) 07 July 1989 HUDSON, NPH et al., "Primary Hypothyroidism in Two Horses" Australian Veterinary Journal, 1999, Volume 77, Number 8, Pages 504-508 GRUBB, T.L. et al., "Hemodynamic Effects of Calcium Gluconate Administered to Conscious Horses" Journal of Veterinary Internal Medicine, 1996, Volume 10 Number 6 Pages 401-404 US 2008/0014304 A1 (ZELLER et al.) 17 January 2008 ANONYMOUS, "Finish Line Thia-cal" [Retrieved on 23 April 2013] Retrieved from internet <URL: http://www.doversaddlery.eom/finish-line-thia-cal-gallon/p/X1-22069/> published on 30 December 2005 ANONYMOUS, "Humavyte" [Retrieved on 23 April 2013] Retrieved from internet <URL: http://web.archive.org/web/20080719131829/http://www.ranvet.com.au/
    [Show full text]
  • Which Supplements Can I Recommend to My Osteoarthritis Patients?
    Rheumatology 2018;57:iv75iv87 RHEUMATOLOGY doi:10.1093/rheumatology/key005 Advance Access publication 1 March 2018 Which supplements can I recommend to my osteoarthritis patients? Downloaded from https://academic.oup.com/rheumatology/article-abstract/57/suppl_4/iv75/4916021 by Stellenbosch University user on 27 May 2019 Xiaoqian Liu1,2, Jillian Eyles1,2,3, Andrew J. McLachlan4 and Ali Mobasheri5,6 Abstract OA is a chronic and disabling joint disease with limited evidence-based pharmacological treatment op- tions available that improve outcomes for patients safely. Faced with few effective pharmacological treat- ments, the use has grown of dietary supplements and complementary medicines for symptomatic relief among people living with OA. The aim of this review is to provide a summary of existing evidence and recommendations supporting the use of supplements for OA. Systematic reviews and randomized con- trolled trials investigating oral supplements for treating OA were identified. Limited research evidence supports recommendations for the oral use of Boswellia serrata extract and Pycnogenol, curcumin and methylsulfonylmethane in people with OA despite the poor quality of the available studies. Few studies adequately reported possible adverse effects related to supplementation, although the products were generally recognized as safe. Further high quality trials are needed to improve the strength of evidence to support this recommendation and better guide optimal treatment of people living with OA. Key words: osteoarthritis, supplements, self-management, treatment, recommendations, complementary medicines Rheumatology key messages . Limited evidence supports the use Boswellia serrata extract, Pycnogenol, curcumin and methylsulfonylmethane for OA. Available evidence does not support some widely used supplements such as glucosamine and chondroitin for OA.
    [Show full text]
  • MSM) Levels in Human Plasma Ling Lin1,2*, Dejian Ma1, Richard J
    ition & F tr oo OPEN ACCESS Freely available online u d N f S o c l i e a n n c r e u s o J ISSN: 2155-9600 Journal of Nutrition & Food Sciences Research Article Development and Application of an LC-MS/MS Method for Determining Methylsulfonylmethane (MSM) levels in Human Plasma Ling Lin1,2*, Dejian Ma1, Richard J. Bloomer3, Matthew Butawan3 , Webb A. Smith4,5, Charles R. Yates6 1Department of Pharmaceutical Sciences, University of Tennessee College of Pharmacy, Memphis, TN, USA; 2Regenerative Medicine Research Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China; 3Center for Nutraceutical and Dietary Supplement Research, School of Health Studies, University of Memphis, Memphis, TN, USA Savar; 4Department of Pediatrics, University of Tennessee College of Medicine, Memphis, TN, USA; 5Children’s Foundation Research Institute, LeBonheur Children’s Hospital, Memphis, TN, USA; 6The National Center for Natural Products Research, Oxford, MS, USA ABSTRACT Methylsulfonylmethane (MSM) isan organosulfur phytochemical widely used as a dietary supplement carrying structure/function claims that includethe promotion of joint health. Untargeted metabolomics studies using nuclear magnetic resonance (NMR) have identified MSM in plasma and urine. However, MS-based methodology is more suitable for pharmacokinetic studies designed to explore MSM’s concentration-effect relationship for purposes of establishing dosing guidelines. To address this deficiency, an LC-MS/MS method using MSM, deuterated MSM (MSM-d6, internal standard), and liquid-liquid extraction was developed and validated in accordance with international guidelines. The method proved well-suited for determining MSM levels in human plasma following chronic oral administration (1, 2, or 3 grams daily) for four weeks.
    [Show full text]
  • Dietary Supplements for Osteoarthritis Philip J
    Dietary Supplements for Osteoarthritis PHILIP J. GREGORY, PharmD; MORGAN SPERRY, PharmD; and AmY FRIEdmAN WILSON, PharmD Creighton University School of Pharmacy and Health Professions, Omaha, Nebraska A large number of dietary supplements are promoted to patients with osteoarthritis and as many as one third of those patients have used a supplement to treat their condition. Glucosamine-containing supplements are among the most commonly used products for osteo- arthritis. Although the evidence is not entirely consistent, most research suggests that glucos- amine sulfate can improve symptoms of pain related to osteoarthritis, as well as slow disease progression in patients with osteoarthritis of the knee. Chondroitin sulfate also appears to reduce osteoarthritis symptoms and is often combined with glucosamine, but there is no reliable evi- dence that the combination is more effective than either agent alone. S-adenosylmethionine may reduce pain but high costs and product quality issues limit its use. Several other supplements are promoted for treating osteoarthritis, such as methylsulfonylmethane, Harpagophytum pro- cumbens (devil’s claw), Curcuma longa (turmeric), and Zingiber officinale (ginger), but there is insufficient reliable evidence regarding long-term safety or effectiveness. Am( Fam Physician. 2008;77(2):177-184. Copyright © 2008 American Academy of Family Physicians.) ietary supplements, commonly glycosaminoglycans, which are found in referred to as natural medicines, synovial fluid, ligaments, and other joint herbal medicines, or alternative structures. Exogenous glucosamine is derived medicines, account for nearly from marine exoskeletons or produced syn- D $20 billion in U.S. sales annually.1 These thetically. Exogenous glucosamine may have products have a unique regulatory status that anti-inflammatory effects and is thought to allows them to be marketed with little or no stimulate metabolism of chondrocytes.4 credible scientific research.
    [Show full text]
  • Dietary Supplements Compendium Volume 1
    2015 Dietary Supplements Compendium DSC Volume 1 General Notices and Requirements USP–NF General Chapters USP–NF Dietary Supplement Monographs USP–NF Excipient Monographs FCC General Provisions FCC Monographs FCC Identity Standards FCC Appendices Reagents, Indicators, and Solutions Reference Tables DSC217M_DSCVol1_Title_2015-01_V3.indd 1 2/2/15 12:18 PM 2 Notice and Warning Concerning U.S. Patent or Trademark Rights The inclusion in the USP Dietary Supplements Compendium of a monograph on any dietary supplement in respect to which patent or trademark rights may exist shall not be deemed, and is not intended as, a grant of, or authority to exercise, any right or privilege protected by such patent or trademark. All such rights and privileges are vested in the patent or trademark owner, and no other person may exercise the same without express permission, authority, or license secured from such patent or trademark owner. Concerning Use of the USP Dietary Supplements Compendium Attention is called to the fact that USP Dietary Supplements Compendium text is fully copyrighted. Authors and others wishing to use portions of the text should request permission to do so from the Legal Department of the United States Pharmacopeial Convention. Copyright © 2015 The United States Pharmacopeial Convention ISBN: 978-1-936424-41-2 12601 Twinbrook Parkway, Rockville, MD 20852 All rights reserved. DSC Contents iii Contents USP Dietary Supplements Compendium Volume 1 Volume 2 Members . v. Preface . v Mission and Preface . 1 Dietary Supplements Admission Evaluations . 1. General Notices and Requirements . 9 USP Dietary Supplement Verification Program . .205 USP–NF General Chapters . 25 Dietary Supplements Regulatory USP–NF Dietary Supplement Monographs .
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2012/0225053 A1 Dushenkov Et Al
    US 20120225053A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0225053 A1 Dushenkov et al. (43) Pub. Date: Sep. 6, 2012 (54) COMPOSITIONS AND METHODS FOR THE A6IP 9/02 (2006.01) PREVENTION AND TREATMENT OF A6IP 7/06 (2006.01) CONDITIONS ASSOCATED WITH A63L/7008 (2006.01) NFLAMATION A638/48 (2006.01) A6IR 36/287 (2006.01) (76) Inventors: Slavik Dushenkov, Fort Lee, NJ A 6LX 3L/75 (2006.01) (US); Patricia Lucas-Schnarre, A638/39 (2006.01) Metuchen, NJ (US); Julie Beth A6II 35/60 (2006.01) Hirsch, Branchburg, NJ (US); A636/906 (2006.01) David Evans, Belle Mead, NY A6IR 36/16 (2006.01) (US); Kitty Evans, legal A6IR 36/258 (2006.01) representative, Merritt Island, FL A636/87 (2006.01) (US) A636/76 (2006.01) A636/736 (2006.01) (21) Appl. No.: 11/920,973 A636/8 (2006.01) A6IP 29/00 (2006.01) (22) PCT Filed: May 24, 2006 (52) U.S. Cl. ........ 424/94.65: 514/456; 514/62; 424/771; (86). PCT No.: PCT/USO6/2O542 514/54: 514/17.2: 424/523; 424/756; 424/752: 424/728; 424/766; 424/769; 424/735; 424/760 S371 (c)(1), (2), (4) Date: May 2, 2012 (57) ABSTRACT Related U.S. Application Data The present invention provides methods for preventing, treat ing, managing and/or ameliorating a condition associated (60) Provisional application No. 60/684,487, filed on May with inflammation (e.g., an inflammatory disorder) or a 24, 2005. symptom thereof, the methods comprising administering to a subject in need thereof an effective amount of a theaflavin Publication Classification composition and an effective amount of one or more therapies (51) Int.
    [Show full text]
  • Glucosamine + Chondroitin + MSM Supports Joint Health*
    Jarrow® QUICKReference Guide FORMULAS healthy living through science & education Glucosamine + Chondroitin + MSM Supports Joint Health* Glucosamine + Chondroitin + MSM Combination provides efficacious quantities of Glucosamine Sulfate, Chondroitin Sulfate, and MSM combined with Vitamin C and Manganese for joint health.* PRODUCT CATEGORY Joint Who Can Benefit From this Product? Supplement Facts Serving Size 4 Capsules Anyone with suboptimal joint function who wants to promote joint Amount Per Serving % DV mobility, flexibility, and comfort may find this product beneficial.* Vitamin C 60 mg 100% Manganese 1 mg 50% Glucosamine Sulfate • 2 KCI 2000 mg * Yielding: Glucosamine Sulfate 1500 mg What Distinguishes this Product? Potassium Chloride 500 mg Chondroitin Sulfate (low molecular weight) 1200 mg * • Sodium-Free Glucosamine Sulfate (from 1333 mg Chondroitin Sulfate Sodium) Methylsulfonylmethane 300 mg * • 1.5 g Glucosamine Sulfate and 1.2 g Chondroitin Sulfate Per Serving (providing 102 mg of organic sulfur) - Quantities consistent with clinical research * Daily Value not established. • Also Contains Vitamin C and Manganese Other Ingredients - Needed in the synthesis of collagen and cartilage Magnesium stearate (vegetable source), cellulose, and silicon dioxide. Capsule consists of gelatin. Contains: Shellfish (shrimp). No wheat, no gluten, no soybeans, no dairy, no egg, How Does Each Active Ingredient Function in no fish, no peanuts/tree nuts. this Product? Suggested Usage Glucosamine Stimulates proteoglycan production found in joint Take 4 capsules per day, or as directed by your qualified health care consultant. Sulfate cartilage* Chondroitin Attracts shock-absorbing fluid to proteoglycans* Note MSM A sulfur source for inclusion in joints* Do NOT use if allergic to shellfish. If you have a medical condition, are pregnant, lactating, or trying Vitamin C Needed for synthesis of collagen* to conceive, are under the age of 18, or are taking medications, consult your health care practitioner Manganese Needed for synthesis of cartilage* before using this product.
    [Show full text]
  • Guideline for the Management of Knee and Hip Osteoarthritis Second Edition
    Guideline for the management of knee and hip osteoarthritis Second edition racgp.org.au Healthy Profession. Healthy Australia. Guideline for the management of knee and hip osteoarthritis. Second edition Disclaimer The information set out in this publication is current at the date of first publication and is intended for use as a guide of a general nature only and may or may not be relevant to particular patients or circumstances. Nor is this publication exhaustive of the subject matter. Persons implementing any recommendations contained in this publication must exercise their own independent skill or judgement or seek appropriate professional advice relevant to their own particular circumstances when so doing. Compliance with any recommendations cannot of itself guarantee discharge of the duty of care owed to patients and others coming into contact with the health professional and the premises from which the health professional operates. Whilst the text is directed to health professionals possessing appropriate qualifications and skills in ascertaining and discharging their professional (including legal) duties, it is not to be regarded as clinical advice and, in particular, is no substitute for a full examination and consideration of medical history in reaching a diagnosis and treatment based on accepted clinical practices. Accordingly, The Royal Australian College of General Practitioners Ltd (RACGP) and its employees and agents shall have no liability (including without limitation liability by reason of negligence) to any users of the information contained in this publication for any loss or damage (consequential or otherwise), cost or expense incurred or arising by reason of any person using or relying on the information contained in this publication and whether caused by reason of any error, negligent act, omission or misrepresentation in the information.
    [Show full text]
  • Product Data Douglas Laboratories® 04/2012 1
    PRODUCT DATA DOUGLAS LABORATORIES® 04/2012 1 MSM Fundamental Sulfur Capsules DESCRIPTION MSM (Fundamental Sulfur) provided by Douglas Laboratories®, contains 750 mg of methylsulfonylmethane (MSM) per capsule. MSM, a derivative of DMSO, is a naturally occurring compound of biologically available sulfur. FUNCTIONS Sulfur is an indispensable element in human nutrition. As part of the amino acids methionine and cysteine, sulfur is required for the structural integrity and function of almost every protein in the body, including enzymes, serum proteins, and the keratin of skin, hair, and nails. Sulfur is also an essential element for the glycosaminoglycans of connective tissues and cartilage, and assumes a major role in liver detoxification as part of the hepatic sulfur conjugation pathways. Proper detoxification of xenobiotics, such as phenols, and many endogenous and foreign food- or air-borne compounds depends on an adequate supply of biologically active sulfur. Dietary MSM serves as a versatile donor of metabolically active sulfur for the synthesis of numerous organosulfur compounds and proteins in the body. As such, MSM helps maintain normal immune response, lung function, connective tissue metabolism, and muscle contraction. MSM occurs naturally in a variety of foods, such as fruits, vegetables, cereal grains, milk, and fish. However, MSM is volatile and easily lost during cooking. MSM is very well absorbed by the intestinal tract and rapidly distributed within the body. INDICATIONS MSM may be a useful dietary supplement for individuals desiring support of joint/connective tissue function, hair and skin support, and liver health. FORMULA (#MSMC) One capsule contains: Methylsulfonylmethane (MSM)* .................................... 750 mg *OptiMSM (distilled methylsulfonylmethane) is a proprietary ingredient exceeding industry standards for optimal purity.
    [Show full text]
  • Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
    Updated June 07, 2021 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Three categories of bulk drug substances: • Category 1: Bulk Drug Substances Under Evaluation • Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Category 3: Bulk Drug Substances Nominated Without Adequate Support Updates to Categories of Substances Nominated for the 503B Bulk Drug Substances List1 • Add the following entry to category 2 due to serious safety concerns of mutagenicity, cytotoxicity, and possible carcinogenicity when quinacrine hydrochloride is used for intrauterine administration for non- surgical female sterilization: 2,3 o Quinacrine Hydrochloride for intrauterine administration • Revision to category 1 for clarity: o Modify the entry for “Quinacrine Hydrochloride” to “Quinacrine Hydrochloride (except for intrauterine administration).” • Revision to category 1 to correct a substance name error: o Correct the error in the substance name “DHEA (dehydroepiandosterone)” to “DHEA (dehydroepiandrosterone).” 1 For the purposes of the substance names in the categories, hydrated forms of the substance are included in the scope of the substance name. 2 Quinacrine HCl was previously reviewed in 2016 as part of FDA’s consideration of this bulk drug substance for inclusion on the 503A Bulks List. As part of this review, the Division of Bone, Reproductive and Urologic Products (DBRUP), now the Division of Urology, Obstetrics and Gynecology (DUOG), evaluated the nomination of quinacrine for intrauterine administration for non-surgical female sterilization and recommended that quinacrine should not be included on the 503A Bulks List for this use. This recommendation was based on the lack of information on efficacy comparable to other available methods of female sterilization and serious safety concerns of mutagenicity, cytotoxicity and possible carcinogenicity in use of quinacrine for this indication and route of administration.
    [Show full text]
  • 70596—Cool Command® Senior Horse Feed (Texturized)
    MULTI-FORM SENIOR TEXTURIZED Equine Supplement GUARANTEED ANALYSIS Crude Protein, min 14.0 % Phosphorus, min 0.5 % Lysine, min 0.79 % Copper, min 45 PPM Methionine, min 0.2 % Selenium, min 0.3 PPM Threonine, min 0.5 % Zinc, min 80 PPM Crude Fat, min 8.0 % Vitamin A, min 4,000 IU/LB Crude Fiber, max 20.0 % Vitamin D, min 400 IU/LB Acid Detergent Fiber, max 22.0 % Vitamin E, min 100 IU/LB Neutral Detergent Fiber, max 32.0 % Biotin, min 0.6 MG/LB Starch, max 13.0 % *Glucosamine HCL, min 500 MG/LB Sugars, max 7.2 % *Condroitin Sulfate, min 350 MG/LB Calcium, min 0.9 % *Methylsulfonylmethane, min 500 MG/LB Calcium, max 1.4 % *Not recognized as an essential dietary nutrient INGREDIENTS Grain products, roughage products, plant protein products, molasses products, forage products, processed grain by- products, vegetable oil, calcium carbonate, calcium phosphate, salt, L-lysine, glucosamine hydrochloride, methylsulfonylmethane, zinc proteinate, potassium chloride, vitamin E supplement, sodium carboxymethylcellulose, manganese proteinate, ascorbic acid, chondroitin sulfate, sodium sulfate, potassium sulfite, propylene glycol, copper proteinate, hydrolyzed yeast, natural flavor, artificial flavor, iron proteinate, propionic acid (a preservative), sorbic acid (a preservative), acetic acid (a preservative), benzoic acid (a preservative), selenium yeast, ferrous sulfate, calcium pantothenate, niacin supplement, mineral oil, zinc oxide, thiamine mononitrate, manganese sulfate, cobalt proteinate, riboflavin supplement, menadione nicotinamide bisulfite (source of vitamin K activity), vitamin A supplement, pyridoxine hydrochloride, copper sulfate, manganous oxide, vitamin B-12 supplement, folic acid, vitamin D-3 supplement, ethylenediamine dihydroiodide, biotin, menadione sodium bisulfite complex (source of vitamin K activity).
    [Show full text]
  • Blood MSM Concentrations Following Escalating Dosages of Oral MSM in Men and Women
    ition & F tr oo u d N f S o c Bloomer et al., J Nutr Food Sci 2019, 9:1 l i e a n n r c DOI: 10.4172/2155-9600.1000748 e u s o J Journal of Nutrition & Food Sciences ISSN: 2155-9600 Research Article Open Access Blood MSM Concentrations Following Escalating Dosages of Oral MSM in Men and Women Richard J Bloomer1*, Matthew Butawan1, Ling Lin2,3, Dejian Ma3 and Charles R Yates3 1Center for Nutraceutical and Dietary Supplement Research, School of Health Studies, University of Memphis, USA 2Regenerative Medicine Research Center, West China Hospital, Sichuan University, China 3Department of Pharmaceutical Sciences, University of Tennessee College of Pharmacy, USA Abstract Background: Methylsulfonylmethane (MSM) is an organosulfur compound used as a dietary supplement. We determined the plasma MSM concentration following four months of oral MSM supplementation at escalating dosages. Methods: 45 men and women (25 ± 5 years) participated in this study. Subjects were assigned to ingest either 1, 2, or 3 grams of MSM daily for 16 weeks. Blood was collected at baseline and following weeks 4, 8, 12, and 16 and analyzed for plasma MSM concentration using a LC-MS/MS method. Results: A group (p<0.0001), time (p<0.0001), and group x time (p=0.0005) interaction was noted. Values were higher for the 2 and 3 grams/day group as compared to the 1 gram/day group and were also higher for the 3 grams/day group as compared to the 2 grams/day group (p<0.05). Values at weeks 4, 8, 12, and 16 were higher as compared to baseline (p<0.05) but no differences were noted between weeks 4-16 (p>0.05).
    [Show full text]