Ergoloid (Mesylates) Revision: 12/17/2017
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A Phase I Trial of Tamoxifen with Ribociclib (LEE011) in Adult Patients with Advanced ER+ (HER2 Negative) Breast Cancer
The TEEL Study: A Phase I Trial of Tamoxifen with Ribociclib (LEE011) in Adult Patients with Advanced ER+ (HER2 Negative) Breast Cancer NCT02586675 Version 12.0 September 14, 2016 TEEL Protocol- Tamoxifen +Ribociclib Page 1 TITLE PAGE The TEEL Study: A Phase I trial of Tamoxifen with Ribociclib (LEE011) in adult patients with advanced ER+ (HER2 negative) breast cancer. Protocol: MCC 18332 Chesapeake IRB Pro00015228 Principal Investigator: Co-Investigators: Statistician: Experimental Therapeutics Program H. Lee Moffitt Cancer Center 12902 Magnolia Drive Tampa, FL 33612 & Comprehensive Breast Program Moffitt McKinley Outpatient Center 10920 N. McKinley Dr. Tampa, FL 33612 Study Site Contact: Protocol Version 12 Date: September 14, 2016 TEEL Protocol- Tamoxifen +Ribociclib Page 2 TITLE PAGE .............................................................................................................................................. 1 SYNOPSIS ................................................................................................................................................... 5 Patient Population ................................................................................................................................. 5 Type of Study ......................................................................................................................................... 5 Prior Therapy......................................................................................................................................... 5 -
Potentially Harmful Drugs in the Elderly: Beers List
−This Clinical Resource gives subscribers additional insight related to the Recommendations published in− March 2019 ~ Resource #350301 Potentially Harmful Drugs in the Elderly: Beers List In 1991, Dr. Mark Beers and colleagues published a methods paper describing the development of a consensus list of medicines considered to be inappropriate for long-term care facility residents.12 The “Beers list” is now in its sixth permutation.1 It is intended for use by clinicians in outpatient as well as inpatient settings (but not hospice or palliative care) to improve the care of patients 65 years of age and older.1 It includes medications that should generally be avoided in all elderly, used with caution, or used with caution or avoided in certain elderly.1 There is also a list of potentially harmful drug-drug interactions in seniors, as well as a list of medications that may need to be avoided or have their dosage reduced based on renal function.1 This information is not comprehensive; medications and interactions were chosen for inclusion based on potential harm in relation to benefit in the elderly, and availability of alternatives with a more favorable risk/benefit ratio.1 The criteria no longer address drugs to avoid in patients with seizures or insomnia because these concerns are not unique to the elderly.1 Another notable deletion is H2 blockers as a concern in dementia; evidence of cognitive impairment is weak, and long-term PPIs pose risks.1 Glimepiride has been added as a drug to avoid. Some drugs have been added with cautions (dextromethorphan/quinidine, trimethoprim/sulfamethoxazole), and some have had cautions added (rivaroxaban, tramadol, SNRIs). -
Preventive Report Appendix
Title Authors Published Journal Volume Issue Pages DOI Final Status Exclusion Reason Nasal sumatriptan is effective in treatment of migraine attacks in children: A Ahonen K.; Hamalainen ML.; Rantala H.; 2004 Neurology 62 6 883-7 10.1212/01.wnl.0000115105.05966.a7 Deemed irrelevant in initial screening Seasonal variation in migraine. Alstadhaug KB.; Salvesen R.; Bekkelund SI. Cephalalgia : an 2005 international journal 25 10 811-6 10.1111/j.1468-2982.2005.01018.x Deemed irrelevant in initial screening Flunarizine, a calcium channel blocker: a new prophylactic drug in migraine. Amery WK. 1983 Headache 23 2 70-4 10.1111/j.1526-4610.1983.hed2302070 Deemed irrelevant in initial screening Monoamine oxidase inhibitors in the control of migraine. Anthony M.; Lance JW. Proceedings of the 1970 Australian 7 45-7 Deemed irrelevant in initial screening Prostaglandins and prostaglandin receptor antagonism in migraine. Antonova M. 2013 Danish medical 60 5 B4635 Deemed irrelevant in initial screening Divalproex extended-release in adolescent migraine prophylaxis: results of a Apostol G.; Cady RK.; Laforet GA.; Robieson randomized, double-blind, placebo-controlled study. WZ.; Olson E.; Abi-Saab WM.; Saltarelli M. 2008 Headache 48 7 1012-25 10.1111/j.1526-4610.2008.01081.x Deemed irrelevant in initial screening Divalproex sodium extended-release for the prophylaxis of migraine headache in Apostol G.; Lewis DW.; Laforet GA.; adolescents: results of a stand-alone, long-term open-label safety study. Robieson WZ.; Fugate JM.; Abi-Saab WM.; 2009 Headache 49 1 45-53 10.1111/j.1526-4610.2008.01279.x Deemed irrelevant in initial screening Safety and tolerability of divalproex sodium extended-release in the prophylaxis of Apostol G.; Pakalnis A.; Laforet GA.; migraine headaches: results of an open-label extension trial in adolescents. -
Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object. -
Randomized Controlled Pilot Trial of Cabergoline, Hydergine and Levodopa/Carbidopa: Los Angeles Cocaine Rapid Efficacy Screening
Blackwell Science, LtdOxford, UKADDAddiction1359-6357© 2005 Society for the Study of Addiction 100•••• Original Article Cabergoline, hydergine, levodopa/carbidopa Steven Shoptaw et al. RESEARCH REPORT Randomized controlled pilot trial of cabergoline, hydergine and levodopa/carbidopa: Los Angeles Cocaine Rapid Efficacy Screening Trial (CREST) Steven Shoptaw1, Donnie W. Watson2, Chris Reiber1, Richard A. Rawson1, Margaret A. Montgomery3, Maria D. Majewska3 & Walter Ling1 UCLA Integrated Substance Abuse Programs, Los Angeles, CA1 , Friends Research Institute, Inc., Los Angeles, CA2 and National Institute on Drug Abuse, Division of Treatment Research and Development, Bethesda, MD, USA3 Correspondence to: ABSTRACT Steven Shoptaw PhD UCLA/Integrated Substance Abuse Programs Aim This study tested three dopaminergic medications against a common 11075 Santa Monica Blvd unmatched placebo condition: hydergine 1 mg three times daily (n = 15); Suite 200 levodopa/carbidopa 25/100 mg three times daily (n = 15); cabergoline 0.5 mg Los Angeles per week (n = 15); and placebo three times daily (n = 15) as potential pharma- CA 90025 USA cotherapies for cocaine dependence. E-mail: [email protected] Design The four-parallel group, Cocaine Rapid Efficacy Screening Trial (CREST) design featured a 2-week baseline period followed by randomization to an 8-week medication condition that included 1 hour per week of cognitive RESEARCH REPORT behavioral drug counseling. A safety evaluation was conducted 4 weeks after termination. Measures Outcomes included cocaine metabolites measured in urine, reten- tion and self-reports for drug use, cocaine craving, clinical improvement, mood and HIV risk behaviors. Results Participants assigned to receive cabergoline provided more urine sam- ples negative for cocaine metabolites (42.4%) than those assigned to receive pla- cebo (25.0%), a statistically significant difference after controlling for baseline differences in self-reported cocaine use (F = 2.95, df = 3; P = 0.05). -
Suspension D'amm Des Médicaments Par Voie Orale Contenant
INFORMATION TRANSMISE SOUS L’AUTORITE DE L’ANSM Lettre aux professionnels de Santé Septembre 2013 Communication aux professionnels de santé concernant les restrictions d’indications des médicaments par voie orale contenant : dihydroergotamine, dihydroergocristine, dihydroergocryptine-caféine, nicergoline A destination des : neurologues, ophtalmologistes, cardiologues, chirurgiens vasculaires, phlébologues, angéiologues, gériatres, médecins généralistes, pharmaciens (ville + hôpital) , CRPV Madame, Monsieur, Cher Confrère, En accord avec l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) et l’Agence européenne du médicament (EMA), nous vous informons que les médicaments contenant de la dihydroergotamine, de la dihydroergocristine, de la dihydroergocryptine-caféine ou de la nicergoline ne devront plus être utilisés dans les indications suivantes : Dihydroergotamine (SEGLOR, TAMIK, IKARAN, DIHYDROERGOTAMINE AMDIPHARM): • Traitement de fond de la migraine. • Traitement de l’hypotension orthostatique. • Amélioration des symptômes en rapport avec l'insuffisance veinolymphatique (jambes lourdes, douleurs, impatience du primo-decubitus). Dihydroergocristine (ISKEDYL): • Traitement à visée symptomatique du déficit pathologique cognitif et neurosensoriel chronique du sujet âgé (à l’exclusion de la maladie d’Alzheimer et des autres démences). • Traitement d’appoint des baisses d’acuité visuelle et troubles présumés du champ visuel d’origine vasculaire. • Rétinopathies aigües d’origine vasculaire Dihydroergocryptine-caféine (VASOBRAL) : • Traitement d'appoint à visée symptomatique du déficit pathologique cognitif et neurosensoriel chronique du sujet âgé (à l'exclusion de la maladie d'Alzheimer et des autres démences). • Traitement d'appoint du syndrome de Raynaud. Nicergoline (SERMION, NICERGOLINE BIOGARAN, NICERGOLINE EG, NICERGOLINE MYLAN, NICERGOLINE TEVA): • Traitement d'appoint à visée symptomatique du déficit pathologique cognitif et neurosensoriel chronique du sujet âgé (à l'exclusion de la maladie d'Alzheimer et des autres démences). -
United States Patent (19) 11 Patent Number: 6,060,499 Plachetka (45) Date of Patent: *May 9, 2000
US006060499A United States Patent (19) 11 Patent Number: 6,060,499 Plachetka (45) Date of Patent: *May 9, 2000 54). ANTI-MIGRAINE METHODS AND Centonze, “Evaluation of the efficacy of oral Sumatriptan in COMPOSITIONS USING 5-HTAGONSTS the management of migraine attacks. Clinical Results' WITH LONG-ACTING NSAIDS (1995) La Clinica Teraputica, vol. 146(11), 721-728 (Article in the Italian language, Citation to English language 75 Inventor: John R. Plachetka, Chapel Hill, N.C. abstract only at 727). Dechant, “Sumatriptan. A review of its Pharmacodynamic 73 Assignee: Pozen, Inc., Chapel Hill, N.C. Properties, and Therapeutic Efficacy in the Acute Treatment of Migraine and Cluster Headache” (1992) Drugs, vol. 43(5) * Notice: This patent is Subject to a terminal dis 776-798. claimer. Klapper, “Toward a Standard Drug Formulary for the Treat ment of Headache” (1995) Headache, Apr., 1995, 225-227. 21 Appl. No.: 09/151,912 Oral Sumatriptan Group, “Sumatriptan-An Oral Dose-de fining Study” (1991) Eur: Neurol., vol. 31, 300–305. 22 Filed: Sep. 11, 1998 Thomson, “A Study to Compare Oral Sumatriptan with Oral Aspirin plus Oral Metoclopramide in the Acute Treatment of Related U.S. Application Data Migraine” (1992) Eur: Neurol., vol. 32, 177-184. 62 Division of application No. 08/907,826, Aug. 14, 1997, Pat. Todd, "Naproxen A reappraisal of its Pharmacology, and No. 5,872,145. Therapeutic Use in Rheumatic Diseases and pain States' 60 Provisional application No. 60/024,129, Aug. 16, 1996. (1990) Drugs, vol. 40(1), 91-137. Tokola, “Effects of migraine attack and metoclopramide on (51) Int. -
French Guidelines for the Diagnosis and Management of Migraine in Adults and Children
French Guidelines for the Diagnosis and Management of Migraine in Adults and Children Gilles Gkraud, MD,l Michel Lank-i-Minet, MD,’ Christian Lucas, MD,3 and Dominique Valade, MD,4 on behalf of the French Society for the Study of Migraine Headache (SFEMC) lDepartment of Neurology, Rangueil Hospital, Toulouse, 2Pain Centel; Pasteur Hospital, Nice, 3Depurtment of Neurology, Sulengro Hospital, Lille, and 4Heuduche Emergency Centel; Lur-iboisi&e Hospital, Paris, France ABSTRACT Background: The French Recommendations for Clinical Practice: Diagnosis and Therapy of Migraine are guidelines concerning the overall management of patients with migraine, including diagnostic and therapeutic strategies and assessment of disability Objective: This article summarizes the guidelines as they apply to adults and children, and proposes future direction for steps toward optimal treatment of migraine in patients in France. Methods: The recommendations were categorized into 3 levels of proof (A-C) according to the National Agency for Accreditation and Evaluation in Health (ANAES) methodology and were based on a professional consensus reached among members of the Working Group and the Guidelines Review Group of the ANAES. Results: The International Headache Society diagnostic criteria for migraine should be used in routine clinical practice. Recommended agents for the treatment of migraine in adults include nonsteroidal anti-inflammatory drugs, acetylsalicylic acid (ASA) monotherapy or in combination with metoclopramide, acetaminophen monotherapy, triptans, ergotamine tartrate, and dihydroergotamine mesylate. Patients should use the medication as early as possible after the onset of migraine headache. For migraine prophylaxis in adults, the following can be used: propranolol, metoprolol, oxetorone, or amitriptyline as first-line treatment, and pizotifen, flunarizine, valproate sodium, or topiramate as second-line treatment. -
Albert Hofmann's Pioneering Work on Ergot Alkaloids and Its Impact On
BIRTHDAY 83 CHIMIA 2006, 60, No. 1/2 Chimia 60 (2006) 83–87 © Schweizerische Chemische Gesellschaft ISSN 0009–4293 Albert Hofmann’s Pioneering Work on Ergot Alkaloids and Its Impact on the Search of Novel Drugs at Sandoz, a Predecessor Company of Novartis Dedicated to Dr. Albert Hofmann on the occasion of his 100th birthday Rudolf K.A. Giger* and Günter Engela Abstract: The scientific research on ergot alkaloids is fundamentally related to the work of Dr. Albert Hofmann, who was able to produce, from 1935 onwards, a number of novel and valuable drugs, some of which are still in use today. The complex chemical structures of ergot peptide alkaloids and their pluripotent pharmacological activity were a great challenge for Dr. Hofmann and his associates who sought to unravel the secrets of the ergot peptide alkaloids; a source of inspiration for the design of novel, selective and valuable medicines. Keywords: Aminocyclole · Bromocriptine Parlodel® · Dihydroergotamine Dihydergot® · Dihydro ergot peptide alkaloids · Ergobasin/ergometrin · Ergocornine · Ergocristine · α- and β-Ergocryptine · Ergolene · Ergoline · Ergoloid mesylate Hydergine® · Ergotamine Gynergen® · Ergotoxine · Lisuride · Lysergic acid diethylamide LSD · Methylergometrine Methergine® · Methysergide Deseril® · Paspalic acid · Pindolol Visken® · Psilocybin · Serotonin · Tegaserod Zelmac®/Zelnorm® · Tropisetron Navoban® Fig. 1. Albert Hofmann in 1943, 1979 and 2001 (Photos in 2001 taken by J. Zadrobilek and P. Schmetz) Dr. Albert Hofmann (Fig. 1), born on From the ‘Ergot Poison’ to *Correspondence: Dr. R.K.A. Giger January 11, 1906, started his extremely Ergotamine Novartis Pharma AG NIBR Global Discovery Chemistry successful career in 1929 at Sandoz Phar- Lead Synthesis & Chemogenetics ma in the chemical department directed The scientific research on ergot alka- WSJ-507.5.51 by Prof. -
2021 Formulary List of Covered Prescription Drugs
2021 Formulary List of covered prescription drugs This drug list applies to all Individual HMO products and the following Small Group HMO products: Sharp Platinum 90 Performance HMO, Sharp Platinum 90 Performance HMO AI-AN, Sharp Platinum 90 Premier HMO, Sharp Platinum 90 Premier HMO AI-AN, Sharp Gold 80 Performance HMO, Sharp Gold 80 Performance HMO AI-AN, Sharp Gold 80 Premier HMO, Sharp Gold 80 Premier HMO AI-AN, Sharp Silver 70 Performance HMO, Sharp Silver 70 Performance HMO AI-AN, Sharp Silver 70 Premier HMO, Sharp Silver 70 Premier HMO AI-AN, Sharp Silver 73 Performance HMO, Sharp Silver 73 Premier HMO, Sharp Silver 87 Performance HMO, Sharp Silver 87 Premier HMO, Sharp Silver 94 Performance HMO, Sharp Silver 94 Premier HMO, Sharp Bronze 60 Performance HMO, Sharp Bronze 60 Performance HMO AI-AN, Sharp Bronze 60 Premier HDHP HMO, Sharp Bronze 60 Premier HDHP HMO AI-AN, Sharp Minimum Coverage Performance HMO, Sharp $0 Cost Share Performance HMO AI-AN, Sharp $0 Cost Share Premier HMO AI-AN, Sharp Silver 70 Off Exchange Performance HMO, Sharp Silver 70 Off Exchange Premier HMO, Sharp Performance Platinum 90 HMO 0/15 + Child Dental, Sharp Premier Platinum 90 HMO 0/20 + Child Dental, Sharp Performance Gold 80 HMO 350 /25 + Child Dental, Sharp Premier Gold 80 HMO 250/35 + Child Dental, Sharp Performance Silver 70 HMO 2250/50 + Child Dental, Sharp Premier Silver 70 HMO 2250/55 + Child Dental, Sharp Premier Silver 70 HDHP HMO 2500/20% + Child Dental, Sharp Performance Bronze 60 HMO 6300/65 + Child Dental, Sharp Premier Bronze 60 HDHP HMO -
Conditions, Impairments Or Considerations That Would Disqualify a Proposed Insured from Approval
Nationwide YourLife CareMatters® Prequalification guide Conditions, impairments or considerations that would disqualify a proposed insured from approval In rare instances, there may be a history indicated for disqualification in this guide that you feel may qualify for a CareMatters® policy. These histories should be prescreened before an application is submitted. Histories not found in this prequalification guide will be given individual consideration. If you feel a history may be borderline for life and long-term care, please complete a prescreen with a CareMatters underwriter prior to submission of an application. For prescreens, call 1-855-381-5729. Include the prescreen reference number in the "Special Instructions Section" of the application, or prescreen via email at CMScreen@nationwide. com. Include a copy of the prescreen email reply with the application. The proposed insured must be a U.S. citizen or permanent green card holder (issued for 10 years or more) and be able to provide a copy of green card and Social Security/tax identification number card. Within the last five years, proposed insured has had, has been diagnosed as having or has been treated for: • Alcohol abuse or dependency • Cardiomyopathy • HIV positive, AIDS, ARC, severe • Paralysis, hemiplegia, paraplegia or • Cerebral palsy combined immunodeficiency, quadriplegia (excluding Bell's palsy) • Alzheimer's, dementia, senility, mild common variable immune • Cirrhosis of the liver • Parkinson's disease cognitive impairment (MCI), organic deficiency brain syndrome, -
EUROPEAN PHARMACOPOEIA 10.0 Index 1. General Notices
EUROPEAN PHARMACOPOEIA 10.0 Index 1. General notices......................................................................... 3 2.2.66. Detection and measurement of radioactivity........... 119 2.1. Apparatus ............................................................................. 15 2.2.7. Optical rotation................................................................ 26 2.1.1. Droppers ........................................................................... 15 2.2.8. Viscosity ............................................................................ 27 2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.2.9. Capillary viscometer method ......................................... 27 2.1.3. Ultraviolet ray lamps for analytical purposes............... 15 2.3. Identification...................................................................... 129 2.1.4. Sieves ................................................................................. 16 2.3.1. Identification reactions of ions and functional 2.1.5. Tubes for comparative tests ............................................ 17 groups ...................................................................................... 129 2.1.6. Gas detector tubes............................................................ 17 2.3.2. Identification of fatty oils by thin-layer 2.2. Physical and physico-chemical methods.......................... 21 chromatography...................................................................... 132 2.2.1. Clarity and degree of opalescence of