DOCSLIB.ORG

Zaltoprofen and Muscle Relaxant Combinations

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Zaltoprofen and Muscle Relaxant Combinations (19) TZZ Z_T (11) EP 2 977 045 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 27.01.2016 Bulletin 2016/04 A61K 31/135 (2006.01) A61K 31/27 (2006.01) A61K 31/38 (2006.01) A61K 31/421 (2006.01) (2006.01) (2006.01) (21) Application number: 15177490.8 A61K 31/445 A61K 31/704 A61K 31/138 (2006.01) A61K 31/197 (2006.01) (2006.01) (2006.01) (22) Date of filing: 20.07.2015 A61K 31/4178 A61K 31/423 A61K 31/433 (2006.01) A61K 31/49 (2006.01) A61K 31/5513 (2006.01) A61P 21/02 (2006.01) (84) Designated Contracting States: • TÜRKYILMAZ, Ali AL AT BE BG CH CY CZ DE DK EE ES FI FR GB 34460 Istanbul (TR) GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO • ILDES ERDEM, Ayse PL PT RO RS SE SI SK SM TR 34460 Istanbul (TR) Designated Extension States: • YILDIRIM, Ediz BA ME 34460 Istanbul (TR) Designated Validation States: • KARABULUT, Tutku Ceren MA 34460 Istanbul (TR) (30) Priority: 21.07.2014 TR 201408575 (74) Representative: Sevinç, Erkan Istanbul Patent A.S. (71) Applicant: Sanovel Ilac Sanayi ve Ticaret A.S. Plaza-33, Büyükdere Cad. No: 33/16 34460 Istanbul (TR) Sisli 34381 Istanbul (TR) (72) Inventors: • CIFTER, Ümit 34460 Istanbul (TR) (54) ZALTOPROFEN AND MUSCLE RELAXANT COMBINATIONS (57) The present invention relates to a novel pharmaceutical composition comprising zaltoprofen or a pharmaceu- tically acceptable salt thereof in combination with muscle relaxants with anti-inflammatory, analgesic and myorelaxant activity. EP 2 977 045 A1 Printed by Jouve, 75001 PARIS (FR) 1 EP 2 977 045 A1 2 Description or spasticity occurring in musculoskeletal and neuromus- cular disorders. Spasms are sudden alternating contrac- Technical Aspect tionsand relaxationsor sustainedcontractions of muscle. Antispasmodic drugs are used to treat musculoskeletal [0001] The present invention relates to a novel phar- 5 conditions or inflamation, which includes back pain. maceutical composition comprising zaltoprofen or a Spasticity is defined as an upper motor neuron disorder, pharmaceutically acceptable salt thereof in combination possibly caused by a conduction interruption in the nerve with muscle relaxant drugs with anti-inflammatory, anal- pathway. Antispastic drugs are primarily used to treat gesic and myorelaxant activity. neurological disorders, such as cerebral palsy. [0002] More specifically, this invention relates to a10 [0007] Tizanidine, dantrolene, thiocolchicoside and pharmaceutical composition comprising zaltoprofen or a carisoprodol are known muscle relaxant agents used in pharmaceutically acceptable salt thereof in combination the treatment of painful muscle spasms and spasticity with muscle relaxants with anti-inflammatory, analgesic occurring in musculoskeletal and neuromuscular disor- and myorelaxant activity administrated orally, parenter- ders and for treating contractures and inflammatory con- aly, intramuscularly or topicaly in the form of a tablet, 15 ditions that affect the muscular system. bilayer tablet, multilayer tablet, capsule, injectable pre- [0008] Tizanidine is an example for antispastic drugs. parat, suspension, syrup, sachet, ointment, cream or a Its chemical structure is shown in Formula II. gel form. Background of the Invention 20 [0003] Zaltoprofen is a propionic acid derivative, is a known NSAID (non-steroidal anti-inflammatory drug) with analgesic and anti-inflammatory activity. Its chemi- cal structure is shown in the Formula I. 25 30 [0009] Tizanidine is a α2-adrenergic agonist and acts mainly at spinal and supraspinal levels to inhibit excita- tory interneurones. It is used for the symptomatic relief of spasticity associated with multiple sclerosis or with spi- nal cord injury or disease. The recommended dose of 35 tizanidin is 2 mg, 4mg or 6 mg. [0010] Dantrolene is also an antispastic drug indicated in controlling the manifestations of clinical spasticity re- [0004] The chemical name of zaltoprofen is 2-(10-oxo- sulting from upper motor neuron disorders (e.g., spinal 10,11-dihydrodibenzo[b,f]thiepin-2-yl)propanoic acid. It cord injury, stroke, cerebral palsy, or multiple sclerosis). is a preferential COX-2 inhibitor. It selectively inhibits 40 Its chemical structure is shown in Formula III. PGE2 (Prostaglandin E2) that mediates the pain path- way. It inhibits bradykinin-induced pain responses with- out interfering with the bradykinin receptors. It is used in musculoskeletal and joint disorders such as osteoarthri- tis and rheumatoid arthritis and other chronic inflamma- 45 tory pain conditions or the treatment of lumbar pain, fro- zen shoulder, musculoskeletal pain, dental pain, post- operative pain, cervicobrachial syndrome, other pain and inflammatory conditions. It has also effect on post-sur- gery or post trauma chronic inflammation. 50 [0005] Muscle relaxants are used alone or in combi- nation with analgesics in the management of muscu- loskeletal and neuromuscular disorders. There are two [0011] The recommended dose of dantrolene is 25 mg main types; centrally acting relaxants and directly acting to 100 mg four times a day and at bedtime. relaxants. 55 [0012] Thiocolchicoside is an antispasmodic drug that [0006] Centrally acting relaxants generally have a se- is a gamma-aminobutiric acid receptor agonist. Its chem- lective action on the central nervous system (CNS) and ical structure is shown in Formula IV. are principally used for relieving painful muscle spasms 2 3 EP 2 977 045 A1 4 sitions in the treatment o a variety of skeletal muscle dis- orders including skeletal muscle spasm, certain ortho- pedic conditions, disk syndromes and low back pain. [0019] United Kingdom patent application GB 2 197 5 198 A1 (Sandoz Ltd.) 03.11.1986, describes to novel pharmaceutical preparations comprising ibuprofen and tizanidine with analgesic and myotonolytic activity as well as to methods of inducing analgesia and of treating con- ditions associated with increased muscle tone. 10 [0020] It is well known that drugs used in the same therapeutic area or even for treating the same indication cannot always be combined a priori with the expectation of at least additive therapeutic effects. The scientific lit- erature is full of examples wherein compounds of differ- 15 ent classes, which are used to treat the same indications, [0013] It has recently been shown that thiocoichico- cannot be combined into safe and efficacious dosage side’s activity can be ascribed to its ability of interacting forms thereby resulting in incompatible drug combina- withthe strychnine-sensitive glycinereceptors and there- tions. The reasons for this unexpected lack of compati- fore that compounds endowed with glycino-mimetic ac- bility are varied; however, it is often found that the incom- tivity can be used in the rheumatologic-orthopedic field 20 patibledrug combinations result in increasedside effects, for their muscle relaxant properties. unwanted drug interactions or additional side effects. [0014] The maximum recommended oral dose of Thi- More specifically, in the area of analgesia there are drug ocolchicoside is 8 mg every 12 hours; treatment duration combinations that are contraindicated for some or all of should be no more than 7 consecutive days. When given these very same reasons. intramuscularly, the maximum dose should be 4 mg eve- 25 [0021] Conventional analgesic and myorelaxant ther- ry 12 hours, for up to 5 days. apy generally involves administration of a pharmaceuti- [0015] In addition, Carisoprodol is an antispasmodic cal composition containing one or more different analge- drug indicated for the relief of discomfort associated with sic and muscle relaxant drugs. However, not all combi- acute, painful musculoskeletal conditions. Its chemical nations of analgesic drugs and muscle relaxant drugs structure is shown in Formula V. 30 are more suitable, in terms of safety or efficacy, than the administration of a single product. [0022] Thus, there is a need in the art for a pharma- ceutical composition or a dosage form comprising a com- bination of a zaltoprofen and a muscle relaxant, in par- 35 ticular tizanidine, thiocolchicoside, dantrolene or cariso- pradol. Detailed description of the invention 40 [0023] The present invention relates to a pharmaceu- [0016] The recommended dose of Carisoprodol is 250 tical composition comprising zaltoprofen or a pharma- mg to 350 mg three times a day and at bedtime. The ceutically acceptable salt thereof in combination with recommended maximum duration of Carisoprodol use is muscle relaxant drugs. up to two or three weeks. [0024] In one embodiment, pharmaceutical composi- [0017] Muscle relaxants have been evaluated alone or 45 tion comprising zaltoprofen or a pharmaceutically ac- in combination with conventional analgesics for the treat- ceptable salt thereof in combination with muscle relax- ment of pain. Mixed and unpredictable results have been ants with anti-inflammatory, analgesic and myorelaxant obtained in a pharmaceutical composition. But zaltopro- activity administrated orally, parenteraly, intramuscularly fen has not previously been combined with muscle re- or topicaly in the form of a tablet, bilayer tablet, multilayer laxantsin apharmaceutical compositionfor thetreatment 50 tablet, capsule, injectable preparat, suspension, syrup, of inflammatory, pain and musculoskeletal diseases. sachet, ointment, cream or a gel. [0018] PCT application WO 86/03681 A1 , relates gen- [0025] According to one embodiment, the present erally to novel pharmaceutical compositions of matter composition is in the form of a tablet, bilayer tablet, mul- comprising one or more non-steroidal
Load more

Recommended publications
  • What Are the Acute Treatments for Migraine and How Are They Used?
    2. Acute Treatment CQ II-2-1 What are the acute treatments for migraine and how are they used? Recommendation The mainstay of acute treatment for migraine is pharmacotherapy. The drugs used include (1) acetaminophen, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans and (5) antiemetics. Stratified treatment according to the severity of migraine is recommended: use NSAIDs such as aspirin and naproxen for mild to moderate headache, and use triptans for moderate to severe headache, or even mild to moderate headache when NSAIDs were ineffective in the past. It is necessary to give guidance and cautions to patients having acute attacks, and explain the methods of using medications (timing, dose, frequency of use) and medication use during pregnancy and breast-feeding. Grade A Background and Objective The objective of acute treatment is to resolve the migraine attack completely and rapidly and restore the patient’s normal functions. An ideal treatment should have the following characteristics: (1) resolves pain and associated symptoms rapidly; (2) is consistently effective; (3) no recurrence; (4) no need for additional use of medication; (5) no adverse effects; (6) can be administered by the patients themselves; and (7) low cost. Literature was searched to identify acute treatments that satisfy the above conditions. Comments and Evidence The acute treatment drugs for migraine generally include (1) acetaminophens, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans, and (5) antiemetics. For severe migraines including status migrainosus and migraine attacks refractory to treatment, (6) anesthetics, and (7) corticosteroids (dexamethasone) are used (Tables 1 and 2).1)-9) There are two approaches to the selection and sequencing of these medications: “step care” and “stratified care”.
    [Show full text]
  • Taking Muscle Relaxers Long Term
    Taking Muscle Relaxers Long Term Teeny and saltant Yankee sortes while inappreciable Gabriell razzes her curtailment apace and redeploy argumentatively. Interior-sprung Laurence hoarsens no electrodes quarrelled inscrutably after Puff participate currently, quite quick-witted. Scot gibbers untimely if step-up Torry palavers or overdid. Why you think properly and are already have been associated with multiple sclerosis, or cdc or glycerol injection. Neck pain is a muscle spasms or other muscle relaxers are taking a supervised detox. Signs of a Cyclobenzaprine Overdose? NSAIDs and acetaminophen in high doses, or if god for making long both, can cause serious side effects. Down Arrow keys to bloat or in volume. The serious risks associated with long-term NSAID benzodiazepine. Com is there a subsidiary of flexeril abuse was generally prescribed mainly because we may help manage your liver or trigger points on your doctor? Greenhouse treatment at risk when this medicine, if a long term. Muscle relaxants used at random have been shown to relieve immediate pain. Will i need something that she previously worked as long term treatment provider a long term rehab better if they work. They may have shown one is comprised of visits, dr leonard said, take it in the aim of? Pomona, NY: Barr Laboratories. Then research demonstrated that prolonged bedrest was use a bad repair It he no better and what worse than taking it secret for hour day his two. Flexeril without a prescription or using it in a manner utilize it is something intended example be used. Long-term Flexeril use can sure to withdrawal symptoms Learn better about the symptoms and surpass to safely quit taking study drug.
    [Show full text]
  • A Randomized, Placebo Controlled Trial of Ibuprofen + Metaxalone, Tizanidine, Or Baclofen for Acute Low Back Pain
    HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Ann Emerg Manuscript Author Med. Author Manuscript Author manuscript; available in PMC 2020 October 01. Published in final edited form as: Ann Emerg Med. 2019 October ; 74(4): 512–520. doi:10.1016/j.annemergmed.2019.02.017. A randomized, placebo controlled trial of ibuprofen + metaxalone, tizanidine, or baclofen for acute low back pain Benjamin W. Friedman, MD MS1, Eddie Irizarry, MD1, Clemencia Solorzano, PharmD2, Eleftheria Zias, RPh2, Scott Pearlman, MD1, Andrew Wollowitz, MD1, Michael P. Jones, MD1, Purvi D. Shah, MD MSc1, E. John Gallagher, MD1 1Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA 2Pharmacy Department, Montefiore, Bronx, NY, USA Abstract Background: Patients with low back pain (LBP) are often treated with non-steroidal antiinflammatory drugs (NSAID) and skeletal muscle relaxants (SMR). We compared functional outcomes and pain among acute LBP patients randomized to a one week course of ibuprofen + placebo versus ibuprofen + one of three SMRs: baclofen, metaxalone, or tizanidine. Methods: This was a randomized, double-blind, parallel group, 4-arm study conducted in two urban emergency departments (ED). Patients with non-radicular LBP for <=two weeks were eligible if they had a score >5 on the Roland-Morris Disability Questionnaire (RMDQ), a 24-item inventory of functional impairment due to LBP. All participants received 21 tablets of ibuprofen 600mg, to be taken TID, as needed. Additionally, they were randomized to baclofen 10mg, metaxalone 400mg, tizanidine 2mg, or placebo. Participants were instructed to take one or two of these capsules, TID, as needed. All participants received a 10 minute educational session.
    [Show full text]
  • Ibuprofen Plus Metaxolone, Tizandine, Or Baclofen for Low Back Pain. a Randomized Trial
    IRB NUMBER: 2017-7566 IRB APPROVAL DATE: 03/29/2017 Ibuprofen plus metaxolone, tizandine, or baclofen for low back pain. A randomized trial Ibuprofen plus metaxolone, tizanidine, or baclofen for LBP. A randomized trial Version 1 03272017 IRB NUMBER: 2017-7566 IRB APPROVAL DATE: 03/29/2017 Specific Aims Up to ½ of emergency department (ED) patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit.(1, 2) Skeletal muscle relaxants (SMR) are commonly used to treat LBP though evidence supporting efficacy is generally lower quality. We have demonstrated previously that two commonly used SMRs, cyclobenzaprine(1) and diazepam(2), when combined with an NSAID, do not improve LBP outcomes more than NSAIDs used alone. This proposal seeks to determine whether there is any benefit from other commonly used SMRs. The first SMR to be included in this study is baclofen. The precise mechanism of action of baclofen is unknown. Baclofen inhibits monosynaptic and polysynaptic reflexes at the spinal level, although actions at supraspinal sites may contribute to its clinical effect. Baclofen is an analog of the neurotransmitter GABA, but it is uncertain whether GABA is involved in its clinical effects. In a randomized, placebo controlled study, 200 patients with acute LBP were randomized to baclofen or placebo.(3) Patients randomized to baclofen reported modestly better outcomes four and ten days later. The second investigational SMR is tizanidine. Tizanidine is a centrally acting alpha-2-adrenergic agonist. It reduces muscle spasticity by increasing presynaptic inhibition of motor neurons. In a randomized, placebo controlled trial, 112 patients with acute LBP were randomized to tizanidine.
    [Show full text]
  • SKELAXIN® (Metaxalone) Tablets
    SKELAXIN® (Metaxalone) Tablets SKELAXIN TABLET DESCRIPTION ® SKELAXIN (metaxalone) is available as an 800 mg oval, scored pink tablet. Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, which corresponds to a molecular weight of 221.25. The structural formula is: Metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: alginic acid, ammonium calcium alginate, B-Rose Liquid, corn starch, and magnesium stearate. CLINICAL PHARMACOLOGY Mechanism of Action The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system (CNS) depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate, or the nerve fiber. Pharmacokinetics The pharmacokinetics of metaxalone have been evaluated in healthy adult volunteers after single dose administration of SKELAXIN under fasted and fed conditions at doses ranging from 400 mg to 800 mg. Absorption Peak plasma concentrations of metaxalone occur approximately 3 hours after a 400 mg oral dose under fasted conditions. Thereafter, metaxalone concentrations decline log-linearly with a terminal half-life of 9.0 ± 4.8 hours. Doubling the dose of SKELAXIN from 400 mg to 800 mg Reference ID: 4230551 results in a roughly proportional increase in metaxalone exposure as indicated by peak plasma concentrations (Cmax) and area under the curve (AUC). Dose proportionality at doses above 800 mg has not been studied.
    [Show full text]
  • Medication Alert
    Trade Name Generic Name Manufacturer Akineton Biperiden Knoll Muscle relaxing Analexin Phenyramidol Salicylate Neisler medications Anectine Succinycholine Chloride B.W. & Co. patients with Bancaps Acetaminophin, Mephenesin Butabarbital Sodium West Myasthenia Gravis Deprol Meprobamate & Benscyyzine Wallace should avoid. Dioloxl Mephensein Camrick Disipal Orphenadrine Hydrochloride Riker Norman A. David, MD, University of Oregon Medical Equagesic Meprobamate & Ethobeptazine Wyeth School Pharmacology Equanitrate Meproamate & Pentserythritol Wyeth Department Equanil Meprobamate Wyeth Flaxedil Has Curare Effect, Galiamine, Triethiodide Camrick Halabar Mephenesin & Butabarbital Camrick Kemadrin Procycllidine Hydrocholoride B.W. & Co. Maolate Chlorphenesin Carbamate Upjohn Meprospan Meprobamate Wallace Medigesic Mephenesin Medics Metubine Dimethyl Tubocurzine Loside Lilly Milpath Meprobamate Wallace Milprem Meprobamate + Conjugated Estrogens Wallace Miltown Meprobamate Wallace Miltrate Meprobamate + Pentserythritol Wallace Mylaxen Hexafluroenium Bromide – Cholinesterase Inhibitor Neisler Norflax Orphenadrine Citrate Riker Norgesic Orphenadrine + Aspirin + Phenacetin Riker Parglex Chlorzoxazone McNeil Parafon Forte Chlorzoxazone & Acetaminophen McNeil Phenoxene Chlorzoxazone Hydrochloride Pitman-Moore Quelicin Succinylcholine Abbott Quinine Several Different Salts Lilly Rela Carisoprodol Schering Robaxin Methocarbamal + Aspirin A.H. Robins Robaxisal Methocarbamal + Phenephen A.H. Robins Sinaxar Stramate Armor Skelaxin Metaxalone A.H. Robins Soma
    [Show full text]
  • S1 Table. List of Medications Analyzed in Present Study Drug
    S1 Table. List of medications analyzed in present study Drug class Drugs Propofol, ketamine, etomidate, Barbiturate (1) (thiopental) Benzodiazepines (28) (midazolam, lorazepam, clonazepam, diazepam, chlordiazepoxide, oxazepam, potassium Sedatives clorazepate, bromazepam, clobazam, alprazolam, pinazepam, (32 drugs) nordazepam, fludiazepam, ethyl loflazepate, etizolam, clotiazepam, tofisopam, flurazepam, flunitrazepam, estazolam, triazolam, lormetazepam, temazepam, brotizolam, quazepam, loprazolam, zopiclone, zolpidem) Fentanyl, alfentanil, sufentanil, remifentanil, morphine, Opioid analgesics hydromorphone, nicomorphine, oxycodone, tramadol, (10 drugs) pethidine Acetaminophen, Non-steroidal anti-inflammatory drugs (36) (celecoxib, polmacoxib, etoricoxib, nimesulide, aceclofenac, acemetacin, amfenac, cinnoxicam, dexibuprofen, diclofenac, emorfazone, Non-opioid analgesics etodolac, fenoprofen, flufenamic acid, flurbiprofen, ibuprofen, (44 drugs) ketoprofen, ketorolac, lornoxicam, loxoprofen, mefenamiate, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, pranoprofen, proglumetacin, sulindac, talniflumate, tenoxicam, tiaprofenic acid, zaltoprofen, morniflumate, pelubiprofen, indomethacin), Anticonvulsants (7) (gabapentin, pregabalin, lamotrigine, levetiracetam, carbamazepine, valproic acid, lacosamide) Vecuronium, rocuronium bromide, cisatracurium, atracurium, Neuromuscular hexafluronium, pipecuronium bromide, doxacurium chloride, blocking agents fazadinium bromide, mivacurium chloride, (12 drugs) pancuronium, gallamine, succinylcholine
    [Show full text]
  • Serotonin Syndrome Associated with Metaxalone and Venlafaxine Shreemayee De DO Lehigh Valley Health Network, [email protected]
    Lehigh Valley Health Network LVHN Scholarly Works Department of Medicine Serotonin Syndrome Associated with Metaxalone and Venlafaxine Shreemayee De DO Lehigh Valley Health Network, [email protected] Michael Kalil DO Lehigh Valley Health Network, [email protected] Follow this and additional works at: http://scholarlyworks.lvhn.org/medicine Part of the Medical Sciences Commons Published In/Presented At De, S., & Kalil, M. (2016, April 26). Serotonin Syndrome Associated with Metaxalone and Venlafaxine. Poster presented at LVHN Department of Medicine Research Day, Lehigh Valley Health Network, Allentown, PA. This Poster is brought to you for free and open access by LVHN Scholarly Works. It has been accepted for inclusion in LVHN Scholarly Works by an authorized administrator. For more information, please contact [email protected]. Serotonin Syndrome Associated with Metaxalone and Venlafaxine Shreemayee De, DO and Michael Kalil, DO Department of Medicine, Lehigh Valley Health Network, Allentown, PA Abstract Case Presentation Discussion Introduction: Metaxalone is a commonly prescribed muscle relaxant. However, due to its proposed Patient: 65-year-old male with history of cryptogenic cirrhosis had back pain • SS occurs when there is increased amount of serotonin neurotransmitters at synapses. SSRI drugs such as venlafaxine function by inhibiting reuptake of serotonin back into the mechanism of action as a weak monoamine oxidase inhibitor, it can interact with drugs with serotonergic resulting from a fall a week prior to his admission. Three days after his fall the patient presynaptic neurons. activity instigating a potentially deadly set of symptoms identified as serotonin syndrome. was prescribed with metaxalone 800 mg and was advised to take ½ to 1 tablet every 8 • Metaxalone has been correlated to SS, especially when given in addition to drugs with serotonergic activity.
    [Show full text]
  • Skeletal Muscle Relaxants Review 12/17/2008
    Skeletal Muscle Relaxants Review 12/17/2008 Copyright © 2007 - 2008 by Provider Synergies, L.L.C. All rights reserved. Printed in the United States of America. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage and retrieval system without the express written consent of Provider Synergies, L.L.C. All requests for permission should be mailed to: Attention: Copyright Administrator Intellectual Property Department Provider Synergies, L.L.C. 5181 Natorp Blvd., Suite 205 Mason, Ohio 45040 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to
    [Show full text]
  • Drug Class Review on Skeletal Muscle Relaxants
    Drug Class Review on Skeletal Muscle Relaxants Final Report Update 2 May 2005 Original Report Date: April 2003 Update 1 Report Date: January 2004 A literature scan of this topic is done periodically The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Roger Chou, MD Kim Peterson, MS Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Copyright © 2005 by Oregon Health & Science University Portland, Oregon 97201. All rights reserved. Note: A scan of the medical literature relating to the topic is done periodically (see http://www.ohsu.edu/ohsuedu/research/policycenter/DERP/about/methods.cfm for scanning process description). Upon review of the last scan, the Drug Effectiveness Review Project governance group elected not to proceed with another full update of this report. Some portions of the report may not be up to date. Prior versions of this report can be accessed at the DERP website. Final Report Update 2 Drug Effectiveness Review Project TABLE OF CONTENTS Introduction........................................................................................................................4 Scope and
    [Show full text]
  • Medicaid Drug Use Criteria
    Medicaid Drug Use Criteria Skeletal Muscle Relaxants ● Developed October 2008. ● Revised June 2020; May 2018; May 2016; September 2014; December 2012; March 2011. Information on indications for use or diagnosis is assumed to be unavailable. All criteria may be applied retrospectively; prospective application is indicated with an asterisk [*]. The information contained is for the convenience of the public. The Texas Health and Human Services Commission is not responsible for any errors in transmission or any errors or omissions in the document. Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Vendor Drug Program formulary coverage. Prepared by: ● Drug Information Service, UT Health San Antonio ● The College of Pharmacy, the University of Texas at Austin 1 Dosage 1.1 Adults The skeletal muscle relaxants (SMRs), carisoprodol, chlorzoxazone, cyclobenzaprine, methocarbamol, metaxalone, and orphenadrine, are FDA- approved for short-term use to manage discomfort associated with acute, painful musculoskeletal conditions such as strains, sprains, and other muscle injuries. These agents should be used as an adjunct to non-pharmacologic treatments, 1 including rest and physical therapy. The SMRs, baclofen, dantrolene, and tizanidine are FDA-approved for managing spasticity due to upper motor neuron disorders (e.g., spinal cord injury, cerebral palsy, multiple sclerosis, stroke). Maximum recommended dosages for SMRs are summarized in Table 1. Dosages exceeding these recommendations
    [Show full text]
  • Jp Xvii the Japanese Pharmacopoeia
    JP XVII THE JAPANESE PHARMACOPOEIA SEVENTEENTH EDITION Official from April 1, 2016 English Version THE MINISTRY OF HEALTH, LABOUR AND WELFARE Notice: This English Version of the Japanese Pharmacopoeia is published for the convenience of users unfamiliar with the Japanese language. When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic. The Ministry of Health, Labour and Welfare Ministerial Notification No. 64 Pursuant to Paragraph 1, Article 41 of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Law No. 145, 1960), the Japanese Pharmacopoeia (Ministerial Notification No. 65, 2011), which has been established as follows*, shall be applied on April 1, 2016. However, in the case of drugs which are listed in the Pharmacopoeia (hereinafter referred to as ``previ- ous Pharmacopoeia'') [limited to those listed in the Japanese Pharmacopoeia whose standards are changed in accordance with this notification (hereinafter referred to as ``new Pharmacopoeia'')] and have been approved as of April 1, 2016 as prescribed under Paragraph 1, Article 14 of the same law [including drugs the Minister of Health, Labour and Welfare specifies (the Ministry of Health and Welfare Ministerial Notification No. 104, 1994) as of March 31, 2016 as those exempted from marketing approval pursuant to Paragraph 1, Article 14 of the Same Law (hereinafter referred to as ``drugs exempted from approval'')], the Name and Standards established in the previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards established in the new Pharmacopoeia before and on September 30, 2017.
    [Show full text]