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Parenteral Dilantin® (Phenytoin Sodium Injection, USP) WARNING
1 Parenteral Dilantin (Phenytoin Sodium Injection, USP) WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION The rate of intravenous Dilantin administration should not exceed 50 mg per minute in adults and 1-3 mg/kg/min (or 50 mg per minute, whichever is slower) in pediatric patients because of the risk of severe hypotension and cardiac arrhythmias. Careful cardiac monitoring is needed during and after administering intravenous Dilantin. Although the risk of cardiovascular toxicity increases with infusion rates above the recommended infusion rate, these events have also been reported at or below the recommended infusion rate. Reduction in rate of administration or discontinuation of dosing may be needed (see WARNINGS and DOSAGE AND ADMINISTRATION). DESCRIPTION Dilantin (phenytoin sodium injection, USP) is a ready-mixed solution of phenytoin sodium in a vehicle containing 40% propylene glycol and 10% alcohol in water for injection, adjusted to pH 12 with sodium hydroxide. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4- imidazolidinedione represented by the following structural formula: CLINICAL PHARMACOLOGY Mechanism of Action Phenytoin is an anticonvulsant which may be useful in the treatment of generalized tonic clonic status epilepticus. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited. Possibly by promoting sodium efflux from neurons, phenytoin tends to stabilize the threshold against hyperexcitability caused by excessive stimulation or environmental changes capable of reducing membrane sodium gradient. This includes the reduction of posttetanic potentiation at synapses. Loss of posttetanic potentiation prevents cortical seizure foci from detonating adjacent cortical areas. -
Dilantin (Phenytoin Sodium) Extended Oral Capsule Three Times Daily and the Dosage Then Adjusted to Suit Individual Requirements
Dilantin® (Phenytoin Sodium) 100 mg Extended Oral Capsule DESCRIPTION Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having the following structural formula: Each Dilantin— 100 mg Extended Oral Capsule—contains 100 mg phenytoin sodium. Also contains lactose monohydrate, NF; confectioner’s sugar, NF; talc, USP; and magnesium stearate, NF. The capsule body contains titanium dioxide, USP and gelatin, NF. The capsule cap contains FD&C red No. 28; FD&C yellow No. 6; and gelatin NF. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. CLINICAL PHARMACOLOGY Phenytoin is an antiepileptic drug which can be used in the treatment of epilepsy. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited. Possibly by promoting sodium efflux from neurons, phenytoin tends to stabilize the threshold against hyperexcitability caused by excessive stimulation or environmental changes capable of reducing membrane sodium gradient. This includes the reduction of posttetanic potentiation at synapses. Loss of posttetanic potentiation prevents cortical seizure foci from detonating adjacent cortical areas. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures. The plasma half-life in man after oral administration of phenytoin averages 22 hours, with a range of 7 to 42 hours. -
Studies on the Pharmacology of Conopharyngine, an Indole Alkaloid of the Voacanga Series
Br. J. Pharmac. Chemother. (1967), 30, 173-185. STUDIES ON THE PHARMACOLOGY OF CONOPHARYNGINE, AN INDOLE ALKALOID OF THE VOACANGA SERIES BY P. R. CARROLL AND G. A. STARMER From the Department of Pharmacology, University of Sydney, New South Wales, Australia (Received January 17, 1967) Conopharyngine, the major alkaloid present in the leaves of Tabernaemontana (Conopharyngia) pachysiphon var. cumminsi (Stapf) H. Huber was isolated and identified by Thomas & Starmer (1963). The same alkaloid has also been found in the stem bark of a Nigerian variety of the same species by Patel & Poisson (1966) and in the stem bark of Conopharyngia durissima by Renner, Prins & Stoll (1959). Conopharyn- gine is an indole alkaloid of the voacanga type, being 18-carbomethoxy-12,13- dimethoxyibogamine (Fig. 1) and is thus closely related to voacangine and coronaridine. Me.0OC Fig. 1. Conopharyngine (18-carbomethoxy-12,13-dimethoxyibogamine). Some confusion exists in that an alkaloid with an entirely different structure, but also named conopharyngine, was isolated from a cultivated variety of Conopharyngia pachysiphon by Dickel, Lucas & Macphillamy (1959). This compound was shown to be the 3-D-9-glucoside of 55-20a-amino-3 8-hydroxypregnene, and was reported to possess marked hypotensive properties. The presence of steroid alkaloids in the Tabernaemontaneae was hitherto unknown and it was suggested by Raffauf & Flagler (1960) and Bisset (1961) that the plant material was open to further botanical confir- mation. The roots of the conopharyngia species are used in West Africa to treat fever (Kennedy, 1936), including that of malaria (Watt & Breyer-Brandwijk, 1962). The only report on the pharmacology of conopharyngine is that of Zetler (1964), who included it in a study of some of the effects of 23 natural and semi-synthetic alkaloids 174 P. -
The Iboga Alkaloids
The Iboga Alkaloids Catherine Lavaud and Georges Massiot Contents 1 Introduction ................................................................................. 90 2 Biosynthesis ................................................................................. 92 3 Structural Elucidation and Reactivity ...................................................... 93 4 New Molecules .............................................................................. 97 4.1 Monomers ............................................................................. 99 4.1.1 Ibogamine and Coronaridine Derivatives .................................... 99 4.1.2 3-Alkyl- or 3-Oxo-ibogamine/-coronaridine Derivatives . 102 4.1.3 5- and/or 6-Oxo-ibogamine/-coronaridine Derivatives ...................... 104 4.1.4 Rearranged Ibogamine/Coronaridine Alkaloids .. ........................... 105 4.1.5 Catharanthine and Pseudoeburnamonine Derivatives .. .. .. ... .. ... .. .. ... .. 106 4.1.6 Miscellaneous Representatives and Another Enigma . ..................... 107 4.2 Dimers ................................................................................. 108 4.2.1 Bisindoles with an Ibogamine Moiety ....................................... 110 4.2.2 Bisindoles with a Voacangine (10-Methoxy-coronaridine) Moiety ........ 111 4.2.3 Bisindoles with an Isovoacangine (11-Methoxy-coronaridine) Moiety . 111 4.2.4 Bisindoles with an Iboga-Indolenine or Rearranged Moiety ................ 116 4.2.5 Bisindoles with a Chippiine Moiety ... ..................................... -
Management of Alcohol Withdrawal
Management of alcohol withdrawal Q2: What interventions are safe and effective for the management of alcohol withdrawal, including treatment for alcohol withdrawal seizures and prevention and treatment for acute Wernicke's encephalopathy? Background Alcohol withdrawal can be uncomfortable and occasionally life threatening. Pharmacological management of alcohol withdrawal is an essential component of alcohol dependence. Benzodiazepines (BZDs), non-sedating anticonvulsants and antipsychotics are commonly used in the treatment of alcohol withdrawal. Given that they are all potentially toxic medications, what is the evidence that the benefits of their use justify the risks? Which is more effective? Population/Intervention(s)/Comparison/Outcome(s) (PICO) Population: people with alcohol dependence commencing alcohol withdrawal Interventions: benzodiazepines anticonvulsants (non sedating i.e. non barbiturates and not chlormethiazole) antipsychotics Comparison: placebo and/or active treatment Outcomes: severity of withdrawal complications of withdrawal (seizures, delirium) completion of withdrawal death 1 Management of alcohol withdrawal List of the systematic reviews identified by the search process INCLUDED IN GRADE TABLES OR FOOTNOTES Ntais C et al (2005). Benzodiazepines for alcohol withdrawal. Cochrane Database of Systematic Review, (3):CD005063. Polycarpou A et al (2005). Anticonvulsants for alcohol withdrawal. Cochrane Database of Systematic Reviews, (3):CD005064. Mayo-Smith MF (1997). Pharmacological management of alcohol withdrawal. A -
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. -
Assessment Report for Zytiga (Abiraterone) Procedure
21 July 2011 EMA/CHMP/542871/2011 Committee for Medicinal Products for Human Use (CHMP) Assessment Report For Zytiga (abiraterone) Procedure No.: EMEA/H/C/002321 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimle +44 (0)20 7523 7455 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union TABLE OF CONTENTS 1. Background information on the procedure .............................................. 5 1.1. Submission of the dossier .................................................................................... 5 1.2. Steps taken for the assessment of the product........................................................ 5 2. Scientific discussion................................................................................ 6 2.1. Introduction....................................................................................................... 6 2.2. Quality aspects .................................................................................................. 8 2.2.1. Introduction.................................................................................................... 8 2.2.2. Active Substance ............................................................................................. 9 2.2.3. Finished Medicinal Product .............................................................................. 10 2.2.4. Discussion on chemical, pharmaceutical -
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 -
Honey, Not Tonight; I Have a Headache
FEMALE SEXUAL DYSFUNCTION: HOPE AND HELP FOR YOUR PATIENTS Kris Christiansen, MD Park Nicollet Sexual Medicine and Male Infertility St. Louis Park, MN March 28, 2019 DISCLOSURES • I have no financial disclosures to discuss. • Off-label use of medications will be discussed in this presentation. • The use of medications for conditions not approved by the FDA can be used by clinicians according to their discretion but needs to be disclosed to patients at the time of prescribing. OBJECTIVES • Discuss effective examples of how to take a sexual history • Review common female sexual dysfunctions • Learn about treatment options for female sexual problems 94% of U.S. adults feel sexual pleasure adds to quality of life • Brunk, Family Practice News & Internal Medicine News 5/10/2013. • C. Marwick, “Survey says patients expect little physician help on sex. • Laumann, A. Paik JAMA 1999; 281. PRINCIPLES FOR SEXUAL HISTORY TAKING • Patients prefer that health care provider initiate topic and advise (90%) • Use simple, direct language • Compassion, honesty, normalizing statements • Declare and demonstrate lack of embarrassment • Be aware of patient’s cultural background • Ensure confidentiality • Avoid judgement and assumptions Athanasiadis L, Papaharitou S, Salpiggidis G et al. J Sex Med 2006;3(1):47-55. Sadovsky R, Nusbaum M. J Sex Med. 2006;3(1);3-11. HOW TO CONDUCT THE INTERVIEW • Use words and body language that put the patient at ease • Open, non-defensive body posture • Sit and maintain eye contact • Avoid nervous gestures • Choose language appropriate to age, ethnicity, and culture of patients • Practice using sexual terminology • Ask open-ended questions • Use silences to allow patients to speak Athanasiadis L, Papaharitou S, Salpiggidis G et al. -
The Truth About Drug Fever Committee Met May 17, 2011
Volume 25, Number 6 June 2011 Drugs & Therapy B N U N L N L N E N T N I N N ADVERSE DRUG REACTIONS FORMULARY UPDATE The Pharmacy and Therapeutics The truth about drug fever Committee met May 17, 2011. 4 products were added in the Formu- t is estimated that about 3–7% of antimicrobials (median 6 days). Cardiac lary; 2 were deleted and designated I febrile episodes are attributed to drug and central nervous system medica- nonformulary and not available. 1 reactions; however, the true incidence is tions can induce fever at a much slower interchange was approved, while 3 unknown due to underreporting and fre- interval, median of 10 and 16 days after criteria for uses were changed. quent misdiagnosis.1 In the hospitalized initiation, respectively. patient, the most common presentation Fever patterns may present as a for drug fever is a patient with a resolv- continuous fever (temperature does not ing infection, on antimicrobial therapy, vary), remittent fever (where tempera- ◆ ADDED and after initial defervescence. Fever in tures vary, but are consistently elevat- Acetaminophen IV this patient can result in the over-utili- ed), intermittent fever (with normal (Ofirmev® by Cadence zation of antimicrobials and the addition temperatures in between), or the most Pharmaceuticals)* of agents to treat an infection that is not common: hectic fever (combination of 4 *Restricted present. This could potentially cause remittent and intermittent). Degree more adverse effects and further contrib- of pyrexia tends to range from 38.8°C Carglumic Acid ute to antimicrobial resistance. (102°F) to 40°C (104°F) but has been ® (Carbaglu by Orphan Europe) One study evaluating 51 episodes reported as high as 42.8°C (109°F). -
Bio-Guided Search of Active Indole Alkaloids from Tabernaemontana
Bioorganic Chemistry 85 (2019) 66–74 Contents lists available at ScienceDirect Bioorganic Chemistry journal homepage: www.elsevier.com/locate/bioorg Bio-guided search of active indole alkaloids from Tabernaemontana T catharinensis: Antitumour activity, toxicity in silico and molecular modelling studies Pauline Fagundes Rosalesa,b, Flavio Ferreira Marinhoa, Adriana Gowera, Marilda Chiarelloa, ⁎ Bianca Cancic, Mariana Roesch-Elyc, Favero Reisdorfer Paulad, Sidnei Mouraa, a Laboratory of Biotechnology of Natural and Synthetics Products, University of Caxias do Sul, Brazil b Federal Institute of Education, Science and Technology of Rio Grande do Sul, Campus Bento Gonçalves, Brazil c Laboratory of Genomics, Proteomics and DNA Repair, University of Caxias do Sul, Brazil d Laboratory of Research and Drugs Development, Federal University of Pampa, Brazil ARTICLE INFO ABSTRACT Keywords: Active plant metabolites have been used as prototype drugs. In this context, Tabernaemontana catharinensis Tabernaemontana catharinensis (Apocynaceae) has been highlighted because of the presence of active indole alkaloids. Thus, this study aims the A549 cell bio-guided search of T. catharinensis cytotoxic alkaloids. The chemical composition was identified by high-re- A375 cell solution mass spectrometry, and fractionation was performed by open column and preparative thin-layer Indole alkaloid chromatography, from plant stems. The enriched fractions were tested in vitro in tumour cells A375 (melanoma Toxicity cell line) and A549 (adenocarcinomic human alveolar basal epithelial cells), and non-tumour Vero cells (African green monkey kidney epithelial cells). The alkaloids identified as active were submitted to in silico toxicity prediction by ADME-Tox and OSIRIS programs and, also, to molecular docking, using topoisomerase I (PDB ID: 1SC7) by iGEMDOCK. -
Cover Next Page > Cover Next Page >
cover next page > Cover title: The Psychopharmacology of Herbal Medicine : Plant Drugs That Alter Mind, Brain, and Behavior author: Spinella, Marcello. publisher: MIT Press isbn10 | asin: 0262692651 print isbn13: 9780262692656 ebook isbn13: 9780585386645 language: English subject Psychotropic drugs, Herbs--Therapeutic use, Psychopharmacology, Medicinal plants--Psychological aspects. publication date: 2001 lcc: RC483.S65 2001eb ddc: 615/.788 subject: Psychotropic drugs, Herbs--Therapeutic use, Psychopharmacology, Medicinal plants--Psychological aspects. cover next page > < previous page page_i next page > Page i The Psychopharmacology of Herbal Medicine < previous page page_i next page > cover next page > Cover title: The Psychopharmacology of Herbal Medicine : Plant Drugs That Alter Mind, Brain, and Behavior author: Spinella, Marcello. publisher: MIT Press isbn10 | asin: 0262692651 print isbn13: 9780262692656 ebook isbn13: 9780585386645 language: English subject Psychotropic drugs, Herbs--Therapeutic use, Psychopharmacology, Medicinal plants--Psychological aspects. publication date: 2001 lcc: RC483.S65 2001eb ddc: 615/.788 subject: Psychotropic drugs, Herbs--Therapeutic use, Psychopharmacology, Medicinal plants--Psychological aspects. cover next page > < previous page page_ii next page > Page ii This page intentionally left blank. < previous page page_ii next page > < previous page page_iii next page > Page iii The Psychopharmacology of Herbal Medicine Plant Drugs That Alter Mind, Brain, and Behavior Marcello Spinella < previous page page_iii next page > < previous page page_iv next page > Page iv © 2001 Massachusetts Institute of Technology All rights reserved. No part of this book may be reproduced in any form by any electronic or mechanical means (including photocopying, recording, or information storage and retrieval) without permission in writing from the publisher. This book was set in Adobe Sabon in QuarkXPress by Asco Typesetters, Hong Kong and was printed and bound in the United States of America.