DOCSLIB.ORG

Chlordiazepoxide Oral Capsules for Treatment of Acute Alcohol Withdrawal Is to Be Reviewed for Use Within: Primary Care  Secondary Care 

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Chlordiazepoxide Oral Capsules for Treatment of Acute Alcohol Withdrawal Is to Be Reviewed for Use Within: Primary Care  Secondary Care  New Medicines Committee Briefing March 2016 Chlordiazepoxide oral capsules for treatment of acute alcohol withdrawal is to be reviewed for use within: Primary Care Secondary Care Summary: Chlordiazepoxide is an anxiolytic with a UK marketing authorisation for use in the management of acute alcohol withdrawal. Anxiolytics listed in the Joint Formulary for treatment of alcohol withdrawal include diazepam, escitalopram, lorazepam and propranolol. Chlordiazepoxide would provide an alternative to diazepam and lorazepam for patients who fail to respond to first line treatments. Chlordiazepoxide is more expensive than generic diazepam (Note: Diazepam 10mg ≡ Chlordiazepoxide 25mg) Chlordiazepoxide would provide a long acting alternative to the short acting agents when preventing withdrawal seizures. Chlordiazepoxide would contribute to a smoother withdrawal with fewer rebound symptoms. Chlordiazepoxide is less likely to be abused compared to rapid acting agents (diazepam and lorazepam). Chlordiazepoxide is a schedule 4 controlled drug (CD Benz POM). Page 1 of 14 Formulary application Consultant submitting application: Ediela Iliescu (Consultant Substance Misuse Pschyiatrist) (North Staffordshire Combined Healthcare Trust) Clinical Director supporting application: Derrett Watts (Consultant addiction Psychiatrist) (North Staffordshire, Combined Healthcare Trust) The application is a request for chlordiazepoxide to be considered for inclusion in the North Staffordshire Joint Formulary for the treatment of alcohol withdrawal. In support, the applicant states that chlordiazepoxide is well suited for the treatment of alcohol withdrawal and can be used as an alternative to diazepam. Dr Iliescu states that it is difficult to quantify the exact number of patients that commence detoxification in the community. However, based on the figures provided by One Recovery in South Staffordshire (Stafford, Tamworth, Burton and Cannock), it is estimated that approximately 500 hundred patients per year commence treatment for alcohol detoxification in the community. In addition to the above, Dr Iliescu states that as chlordiazepoxide is long acting, use will lead to a reduction in the number and length of hospital stays through effective symptom control. Furthermore, chlordiazepoxide has a lower potential for abuse than diazepam as it is less well known on the black market. Chlordiazepoxide is listed on the South Staffordshire Joint Formulary and is already prescribed by experienced and trained staff in the management of acute alcohol withdrawal. Background Alcohol withdrawal is a potentially life threatening condition which can develop when a patient stops drinking or significantly reduces their alcohol consumption after weeks, months or even years of heavy drinking. Patients can present with acute alcohol withdrawal or be admitted to hospital for another reason which leads to an unplanned alcohol withdrawal episode. Alternatively, a patient may present wishing to abstain from alcohol but has a high risk of acute alcohol withdrawal. Symptoms occur as heavy prolonged drinking disrupts the brains neurotransmitters. Initially, alcohol enhances the effect of Gamma-amino butyric acid (GABA) which promotes relaxation. However, eventually chronic alcoholism suppresses GABA activity which requires a greater amount of alcohol to produce the same desired effect (tolerance). In addition, to supressing GABA, alcohol also supresses the activity of glutamate, a neurotransmitter which produces excitatory feelings. When heavy drinkers stop suddenly, neurotransmitters previously supressed by alcohol are no longer supressed leading to patients experiencing a rebound response leading to effects commonly associated with alcohol withdrawal such as anxiety, irritability, agitation and seizures. Symptoms range from excessive sweating, restlessness, agitation, mild anxiety, feeling nervous and shaking to more severe complications such as anorexia, headache, nausea, vomiting, seizures and delirium tremens (DTs). Symptoms usually occur eight hours after a fall in blood alcohol levels and peak at day 2. Between 12 and 24 hours after stopping drinking, patients can experience auditory, visual or tactile hallucinations which collectively is termed alcoholic hallucinosis. Delirium tremens (DT) usually occur between 48 and 72 hours after stopping drinking and consist of rapid heartbeat, confusion and fever. By day 4-5, symptoms have significantly improved. Patients may also develop Page 2 of 14 Wernicke-korsakoff syndrome, depression and electrolyte disturbances as well as liver disorders such as cirrhosis. Management of acute alcohol withdrawal aims to prevent development of complications such as seizures and delirium tremens. Furthermore, treatment aims to make management of withdrawal more comfortable and produce an environment that allows abstinence to be produced and maintained. If symptoms are mild to moderate then patients may be treated as an outpatient. However, if withdrawal symptoms are severe, presence of seizures or delirium tremens, previous detoxifications, medical or psychiatric illness then hospital treatment may be necessary. The NICE guidelines for the management of acute alcohol withdrawal recommend a benzodiazepine, carbamazepine or alternatively, clomethiazole. Dosage regimens which should be considered are either a standard fixed dose or symptom-triggered. NICE advises that for community based withdrawal programmes, a fixed dose medication regimen is used whilst programmes for inpatient or residential settings can be either fixed dose or symptom-triggered regimens. Current formulary status 4.1.2 Anxiolytics Diazepam Escitalopram Restriction: For the treatment of Generalised Anxiety Disorder (GAD) only Lorazepam Propranolol Therapeutic class and mode of action Chlordiazepoxide is a benzodiazepine. Chlordiazepoxide acts on benzodiazepine allosteric sites that are part of the gamma-aminobutyric acid (GABA)A receptor/ion-channel complex which results in an increased binding of the inhibitory neurotransmitter GABA to the GABAA receptor thereby producing inhibitory effects on the central nervous system and body. Licensed indication Short term treatment of acute alcohol withdrawal. Dosage and administration The recommended dose for moderate alcohol withdrawal by mouth is 10 to 30 mg four times a day reducing gradually over 5-7 days as per local protocol for titration regimens. The recommended dose for acute alcohol withdrawal in severe dependence is 10-50mg four times a day and 10-40mg as required for the first 48 hours reducing gradually over the following 7-10 days as per local protocol. Maximum 250mg per day. 1 Page 3 of 14 Safety and adverse effects2 Contraindications Hypersensitivity to the active substance or to any of the excipients The use of chlordiazepoxide is contraindicated in: Patients with acute pulmonary insufficiency: respiratory depression: sleep apnoea. Patients with phobic and obsessional states Patients with chronic psychosis Patients with severe hepatic insufficiency Patients planning a pregnancy Patients with myasthenia gravis Patients with hyperkinesis. Adverse Events Reported adverse effects of chlordiazepoxide include light-headedness and drowsiness, sedation, unsteadiness and ataxia; these are usually dose related but, even after a single dose, may persist into the following day. The elderly are particularly sensitive to the effects of central depressant drugs and may experience confusion, especially if organic brain changes are present; the dosage of chlordiazepoxide should not exceed one-half that recommended for other adults. Other adverse effects include dependence, confusion, restlessness, agitation, irritability, aggressive outbursts, delusion, nightmares, hallucinations, inappropriate behaviour, tremor, dysarthria, salivation changes, incontinence, and thrombocytopenia / other blood disorders. Depressions and amnesia can result from high doses. Rare adverse effects include numbed emotions, reduced alertness, fatigue, headache, dizziness, muscle weakness, vertigo, blurred vision, hypotension, gastrointestinal upsets, skin rashes, visual disturbances, changes in libido, and urinary retention. Drug Interactions2 Potential for pharmacodynamic interactions with chlordiazepoxide Alcohol – chlordiazepoxide should not be used together with alcohol (enhanced sedative effects which affect the ability to drive or operate machinery). Antiepileptics – concurrent use with chlordiazepoxide may lead to side effects and toxicity. Sodium oxybate – chlordiazepoxide enhances the effect of sodium oxybate. Centrally acting drugs – enhancement of central depressive effect may occur if chlordiazepoxide is combined with neuroleptics, antipsychotics, tranquillisers, antidepressants, hypnotics, analgesics, anaesthetics, barbiturates and sedative antihistamines. Cytochrome P450 inhibitors – (e.g. ketoconazole, itraconazole, voriconazole, clarithromycin, nefazadone, saquinavir, nelfinavir, indinavir, atanazavir, and telithromycin) may reduce clearance of and potentiate the effect of chlordiazepoxide. Cytochrome P450 inducers – (e.g. bosentan, carbamazepine, efavirenz, phenobarbital and rifampicin) induce the clearance and reduce the effect of chlordiazepoxide. Page 4 of 14 Narcotic analgesics - Enhancement of the euphoria may occur when given with chlordiazepoxide leading to an increased psychological dependence. Other drugs enhancing the sedative effect of chlordiazepoxide: cisapride, lofexidine, nabilone, disulfiram, baclofen, tizanidine.
Load more

Recommended publications
  • Understanding Benzodiazephine Use, Abuse, and Detection
    Siemens Healthcare Diagnostics, the leading clinical diagnostics company, is committed to providing clinicians with the vital information they need for the accurate diagnosis, treatment and monitoring of patients. Our comprehensive portfolio of performance-driven systems, unmatched menu offering and IT solutions, in conjunction with highly responsive service, is designed to streamline workflow, enhance operational efficiency and support improved patient care. Syva, EMIT, EMIT II, EMIT d.a.u., and all associated marks are trademarks of General Siemens Healthcare Diagnostics Inc. All Drugs other trademarks and brands are the Global Division property of their respective owners. of Abuse Siemens Healthcare Product availability may vary from Diagnostics Inc. country to country and is subject 1717 Deerfield Road to varying regulatory requirements. Deerfield, IL 60015-0778 Please contact your local USA representative for availability. www.siemens.com/diagnostics Siemens Global Headquarters Global Siemens Healthcare Headquarters Siemens AG Understanding Wittelsbacherplatz 2 Siemens AG 80333 Muenchen Healthcare Sector Germany Henkestrasse 127 Benzodiazephine Use, 91052 Erlangen Germany Abuse, and Detection Telephone: +49 9131 84 - 0 www.siemens.com/healthcare www.usa.siemens.com/diagnostics Answers for life. Order No. A91DX-0701526-UC1-4A00 | Printed in USA | © 2009 Siemens Healthcare Diagnostics Inc. Syva has been R1 R2 a leading developer N and manufacturer of AB R3 X N drugs-of-abuse tests R4 for more than 30 years. R2 C Now part of Siemens Healthcare ® Diagnostics, Syva boasts a long and Benzodiazepines have as their basic chemical structure successful track record in drugs-of-abuse a benzene ring fused to a seven-membered diazepine ring. testing, and leads the industry in the All important benzodiazepines contain a 5-aryl substituent ring (ring C) and a 1,4–diazepine ring.
    [Show full text]
  • Analytical Methods for Determination of Benzodiazepines. a Short Review
    Cent. Eur. J. Chem. • 12(10) • 2014 • 994-1007 DOI: 10.2478/s11532-014-0551-1 Central European Journal of Chemistry Analytical methods for determination of benzodiazepines. A short review Review Article Paulina Szatkowska1, Marcin Koba1*, Piotr Kośliński1, Jacek Wandas1, Tomasz Bączek2,3 1Department of Toxicology, Faculty of Pharmacy, Collegium Medicum of Nicolaus Copernicus University, 85-089 Bydgoszcz, Poland 2Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Medical University of Gdańsk, 80-416 Gdańsk, Poland 3Institute of Health Sciences, Division of Human Anatomy and Physiology, Pomeranian University of Słupsk, 76-200 Słupsk, Poland Received 16 July 2013; Accepted 6 February 2014 Abstract: Benzodiazepines (BDZs) are generally commonly used as anxiolytic and/or hypnotic drugs as a ligand of the GABAA-benzodiazepine receptor. Moreover, some of benzodiazepines are widely used as an anti-depressive and sedative drugs, and also as anti-epileptic drugs and in some cases can be useful as an adjunct treatment in refractory epilepsies or anti-alcoholic therapy. High-performance liquid chromatography (HPLC) methods, thin-layer chromatography (TLC) methods, gas chromatography (GC) methods, capillary electrophoresis (CE) methods and some of spectrophotometric and spectrofluorometric methods were developed and have been extensively applied to the analysis of number of benzodiazepine derivative drugs (BDZs) providing reliable and accurate results. The available chemical methods for the determination of BDZs in biological materials and pharmaceutical formulations are reviewed in this work. Keywords: Analytical methods • Benzodiazepines • Drugs analysis • Pharmaceutical formulations © Versita Sp. z o.o. 1. Introduction and long). For this reason, an application of these drugs became broader allowing their utility to a larger extent, Benzodiazepines have been first introduced into medical and at the same time, problems related to drug abuse practice in the 60s of the last century.
    [Show full text]
  • Hsrs Alcohol and Other Drug Abuse Module
    WORKER ID (Field 1) OPTIONAL DEFINITION: The primary worker assigned to the client, or the person designated by the agency as having overall responsibility for the client or case. This is the person who will get information back about the client if any is requested. You may use a provider ID if you have delegated overall responsibility to a provider and you want them to get back all information about this client. PURPOSE: For local use to connect reports to specific case managers. MA NUMBER (Field 2) REQUIRED IF MEDICAL ASSISTANCE RECIPIENT CODES: Enter the client’s 10 digit MA Number. PURPOSE: For comparison with other databases (Medical Assistance; DWD employment data; Crime Information Bureau, etc.) CLIENT ID (Field 3) REQUIRED, COMPUTER GENERATED DEFINITION: An identifier that is computer generated for each individual reported on HSRS. Full legal name, birthdate, and sex are used to produce a 14 character ID which bears no resemblance to the client’s name. ENTER: May be left blank if name, birthdate, and sex are reported. OR Enter the 14 character HSRS client identification number. The ID will be generated and returned to you on the terminal screen. Copy it down or print the screen. Once the ID number is generated, use it on all future input. PURPOSE: To maintain client confidentiality while allowing reports to be produced on individual clients for audit purposes; to produce reports on multiple services to the same individual; to produce client number listings for recidivist clients. AODA - 1 NAME - LAST, FIRST, MIDDLE, SUFFIX (Fields 4a-d) REQUIRED TO GENERATE ID (THEN OPTIONAL) DEFINITION: The full legal name of the client.
    [Show full text]
  • 124.210 Schedule IV — Substances Included. 1
    1 CONTROLLED SUBSTANCES, §124.210 124.210 Schedule IV — substances included. 1. Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. 2. Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below: a. Not more than one milligram of difenoxin and not less than twenty-five micrograms of atropine sulfate per dosage unit. b. Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2- propionoxybutane). c. 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its salts, optical and geometric isomers and salts of these isomers (including tramadol). 3. Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation: a. Alprazolam. b. Barbital. c. Bromazepam. d. Camazepam. e. Carisoprodol. f. Chloral betaine. g. Chloral hydrate. h. Chlordiazepoxide. i. Clobazam. j. Clonazepam. k. Clorazepate. l. Clotiazepam. m. Cloxazolam. n. Delorazepam. o. Diazepam. p. Dichloralphenazone. q. Estazolam. r. Ethchlorvynol. s. Ethinamate. t. Ethyl Loflazepate. u. Fludiazepam. v. Flunitrazepam. w. Flurazepam. x. Halazepam. y. Haloxazolam. z. Ketazolam. aa. Loprazolam. ab. Lorazepam. ac. Lormetazepam. ad. Mebutamate. ae. Medazepam. af. Meprobamate. ag. Methohexital. ah. Methylphenobarbital (mephobarbital).
    [Show full text]
  • Calculating Equivalent Doses of Oral Benzodiazepines
    Calculating equivalent doses of oral benzodiazepines Background Benzodiazepines are the most commonly used anxiolytics and hypnotics (1). There are major differences in potency between different benzodiazepines and this difference in potency is important when switching from one benzodiazepine to another (2). Benzodiazepines also differ markedly in the speed in which they are metabolised and eliminated. With repeated daily dosing accumulation occurs and high concentrations can build up in the body (mainly in fatty tissues) (2). The degree of sedation that they induce also varies, making it difficult to determine exact equivalents (3). Answer Advice on benzodiazepine conversion NB: Before using Table 1, read the notes below and the Limitations statement at the end of this document. Switching benzodiazepines may be advantageous for a variety of reasons, e.g. to a drug with a different half-life pre-discontinuation (4) or in the event of non-availability of a specific benzodiazepine. With relatively short-acting benzodiazepines such as alprazolam and lorazepam, it is not possible to achieve a smooth decline in blood and tissue concentrations during benzodiazepine withdrawal. These drugs are eliminated fairly rapidly with the result that concentrations fluctuate with peaks and troughs between each dose. It is necessary to take the tablets several times a day and many people experience a "mini-withdrawal", sometimes a craving, between each dose. For people withdrawing from these potent, short-acting drugs it has been advised that they switch to an equivalent dose of a benzodiazepine with a long half life such as diazepam (5). Diazepam is available as 2mg tablets which can be halved to give 1mg doses.
    [Show full text]
  • Drugs of Abuse: Benzodiazepines
    Drugs of Abuse: Benzodiazepines What are Benzodiazepines? Benzodiazepines are central nervous system depressants that produce sedation, induce sleep, relieve anxiety and muscle spasms, and prevent seizures. What is their origin? Benzodiazepines are only legally available through prescription. Many abusers maintain their drug supply by getting prescriptions from several doctors, forging prescriptions, or buying them illicitly. Alprazolam and diazepam are the two most frequently encountered benzodiazepines on the illicit market. Benzodiazepines are What are common street names? depressants legally available Common street names include Benzos and Downers. through prescription. Abuse is associated with What do they look like? adolescents and young The most common benzodiazepines are the prescription drugs ® ® ® ® ® adults who take the drug Valium , Xanax , Halcion , Ativan , and Klonopin . Tolerance can orally or crush it up and develop, although at variable rates and to different degrees. short it to get high. Shorter-acting benzodiazepines used to manage insomnia include estazolam (ProSom®), flurazepam (Dalmane®), temazepam (Restoril®), Benzodiazepines slow down and triazolam (Halcion®). Midazolam (Versed®), a short-acting the central nervous system. benzodiazepine, is utilized for sedation, anxiety, and amnesia in critical Overdose effects include care settings and prior to anesthesia. It is available in the United States shallow respiration, clammy as an injectable preparation and as a syrup (primarily for pediatric skin, dilated pupils, weak patients). and rapid pulse, coma, and possible death. Benzodiazepines with a longer duration of action are utilized to treat insomnia in patients with daytime anxiety. These benzodiazepines include alprazolam (Xanax®), chlordiazepoxide (Librium®), clorazepate (Tranxene®), diazepam (Valium®), halazepam (Paxipam®), lorzepam (Ativan®), oxazepam (Serax®), prazepam (Centrax®), and quazepam (Doral®).
    [Show full text]
  • A Review of the Evidence of Use and Harms of Novel Benzodiazepines
    ACMD Advisory Council on the Misuse of Drugs Novel Benzodiazepines A review of the evidence of use and harms of Novel Benzodiazepines April 2020 1 Contents 1. Introduction ................................................................................................................................. 4 2. Legal control of benzodiazepines .......................................................................................... 4 3. Benzodiazepine chemistry and pharmacology .................................................................. 6 4. Benzodiazepine misuse............................................................................................................ 7 Benzodiazepine use with opioids ................................................................................................... 9 Social harms of benzodiazepine use .......................................................................................... 10 Suicide ............................................................................................................................................. 11 5. Prevalence and harm summaries of Novel Benzodiazepines ...................................... 11 1. Flualprazolam ......................................................................................................................... 11 2. Norfludiazepam ....................................................................................................................... 13 3. Flunitrazolam ..........................................................................................................................
    [Show full text]
  • Benzodiazepines Addiction & Treatment
    Benzodiazepines Addiction & Treatment Benzodiazepines are often used therapeutically to produce sedation, induce sleep, relieve anxiety and muscle spasms, and to prevent seizures. Benzodiazepines act as hypnotics in high doses, anxiolytics in moderate doses, and sedatives in low doses. Benzodiazepines effect the central nervous system functions and are classified as depressants. They are more commonly referred to as “benzos” or “benzies” and are ingestible in pill form or injected. Benzodiazepines can be found in many medications, including, but not limited to: Xanax (alprazolam), Valium (diazepam), Librium (chlordiazepoxide), Tranxene (clorazepate), Paxipam (Halazepam), Centrax (prazepam), Klonopin/Clonopin (Clonazepam), Serax (oxazepam), Restoril (temazepam), ProSom (estazolam), Dalmane (flurazepam) *Rohypnol (Flunitrazepam) is a benzodiazepine not manufactured or legally marketed in the United States; however it is often smuggled in by traffickers. This drug is often referred to as a “roofie” and is known as both a “party drug” and a “date rape” drug. It often is found to be popular among younger users. Effects of Benzodiazepines Benzodiazepine use can lead to amnesia, hostility, irritability, vivid or disturbing dreams, as well as tolerance and physical dependence. Use with alcohol or another depressant can lead to death, and often benzodiazepine abuse is particularly high among heroin and cocaine abusers. Lasting/Long-Term Effects Benzodiazepines target the emotional response system (limbic) of the brain, rather than the entire central nervous system. This leads to fewer long term effects than other drugs; however continued use can lead to physical and psychological dependence as well as addiction. Due to a tolerance developed to benzodiazepines, users must increase their doses in order to achieve the desired effects.
    [Show full text]
  • Formulary Benzodiazepine Anti-Anxiety Agents
    Alprazolam Shortage Recently, alprazolam has been in limited supply at both retail pharmacies and mail service facilities. Alprazolam is commercially manufactured as 0.25mg, 0.5mg, 1mg, and 2mg strength tablets. Retail pharmacies and mail order facilities may have alprazolam in stock but not necessarily all strengths. In response to the shortage of alprazolam, Xanax® (the branded product) has been temporarily added to the formulary. Xanax® XR, a recently approved sustained-release formulation of alprazolam, is not on the Highmark formulary. Although alprazolam quantities are available in limited supply, there are many other benzodiazepines available to treat anxiety. The following generic products in the table below are included on the Highmark formulary. Please consider these alternatives for patients who have difficulty obtaining Xanax or its generic. Formulary Benzodiazepine Anti-anxiety Agents Brandc Name Generic Name Approximate Dosage Range3 Equivalent (mg/day) Dosea, 1 b, 2 Short - Intermediate-acting benzodiazepines Xanax® alprazolam 0.5 mg 0.75 mg – 4 mg Ativan® lorazepam 1 mg 2 mg- 4 mg Serax® oxazepam 15 mg 30 mg – 120 mg b, 2Long-acting benzodiazepines Valium® diazepam 5 mg 4 mg – 40 mg Librium® chlordiazepoxide 10 mg 15 mg – 100 mg Tranxene® clorazepate 7.5 mg 15 mg – 60 mg a Elderly patients are treated with approximately one-half of dose listed b Based on effective half-life of parent drug and active metabolites c Brand products are non-formulary References 1. DiPiro, JT., et al. Pharmacotherapy: A Pathophysiologic Approach. 4th Edition, 1999; 1187 2. Shader RI, Greenblatt DJ. Use of Benzodiazepines in Anxiety Disorders. N Engl J Med 1993; 328: 1398-1405.
    [Show full text]
  • Apo-Bromazepam
    PRODUCT MONOGRAPH APO-BROMAZEPAM bromazepam 1.5 mg, 3 mg and 6 mg Tablets Anxiolytic - Sedative APOTEX INC. Date of Revision: 150 Signet Drive March 10, 2016 Toronto, Ontario M9L 1T9 Control No.: 192477 1 Table of Contents PART I: HEALTH PROFFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................. 3 INDICATIONS AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ........................................................................................................ 4 WARNINGS AND PRECAUTIONS ....................................................................................... 4 ADVERSE REACTIONS ......................................................................................................... 9 DRUG INTERACTIONS ....................................................................................................... 11 DOSAGE AND ADMINISTRATION ................................................................................... 12 OVERDOSAGE ...................................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY ................................................................. 15 STORAGE AND STABILITY ............................................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2006/0078604 A1 Kanios Et Al
    US 20060078604A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0078604 A1 Kanios et al. (43) Pub. Date: Apr. 13, 2006 (54) TRANSDERMAL DRUG DELIVERY DEVICE Related U.S. Application Data INCLUDING AN OCCLUSIVE BACKING (60) Provisional application No. 60/616,861, filed on Oct. 8, 2004. (75) Inventors: David Kanios, Miami, FL (US); Juan A. Mantelle, Miami, FL (US); Viet Publication Classification Nguyen, Miami, FL (US) (51) Int. Cl. Correspondence Address: A 6LX 9/70 (2006.01) DCKSTEIN SHAPRO MORN & OSHINSKY (52) U.S. Cl. .............................................................. 424/449 LLP (57) ABSTRACT 2101 L Street, NW Washington, DC 20037 (US) A transdermal drug delivery system for the topical applica tion of one or more active agents contained in one or more (73) Assignee: Noven Pharmaceuticals, Inc. polymeric and/or adhesive carrier layers, proximate to a non-drug containing polymeric backing layer which can (21) Appl. No.: 11/245,180 control the delivery rate and profile of the transdermal drug delivery system by adjusting the moisture vapor transmis (22) Filed: Oct. 7, 2005 sion rate of the polymeric backing layer. Patent Application Publication Apr. 13, 2006 Sheet 1 of 2 US 2006/0078604 A1 Fis ZZZZZZZZZZZZZZZZZZZ :::::::::::::::::::::::::::::::: Patent Application Publication Apr. 13, 2006 Sheet 2 of 2 US 2006/0078604 A1 3. s s 3. a 3 : 8 g US 2006/0078604 A1 Apr. 13, 2006 TRANSIDERMAL DRUG DELVERY DEVICE 0008. In the “classic' reservoir-type device, the active INCLUDING AN OCCLUSIVE BACKING agent is typically dissolved or dispersed in a carrier to yield a non-finite carrier form, Such as, for example, a fluid or gel.
    [Show full text]
  • PMDA Alert for Proper Use of Drugs When Using Benzodiazepine
    ■ PMDA Alert for Proper Use of Drugs https://www.pmda.go.jp/english/safety/info-services/drugs/properly- No. 11 March 2017 use-alert/0001.html PMDA Alert for Proper Use of Drugs Pharmaceuticals and Medical Devices Agency No. 11 March 2017 Dependence associated with Benzodiazepine Receptor Agonists [To Patients] This document is for healthcare professionals. If taking the drug, please consult with your physicians or pharmacists. Please don’t reduce the dosage or stop taking the drug on self-judgment. Benzodiazepine receptor agonists have a characteristic of developing physical dependence with long-term use even within an approved dose range, leading to various withdrawal symptoms on dose reduction or discontinuation. <Major withdrawal symptoms> insomnia, anxiety, feeling irritated, headache, queasy/vomiting, delirium, tremor, seizure, etc. Please pay careful attention to the following when using benzodiazepine receptor agonists as hypnotics-sedatives and anxiolytics. Healthcare professionals should avoid long-term use with chronic administration. - Dependence may occur with long-term use even within an approved dose range. - Therapeutic necessity should be carefully considered when continuing administration of the drug. Healthcare professionals should adhere to the dosage and confirm that there is no multiple prescription of similar drugs. - Long-term administration, high-dose administration, or multiple medications increase the risk of developing dependence. - Healthcare professionals should confirm that similar drugs are not prescribed by other medical institutions. Healthcare professionals should reduce the dose or discontinue carefully such as by gradual dose reduction or alternate-days administration when discontinuing the administration. - Sudden discontinuation will develop serious withdrawal symptoms in addition to aggravate primary diseases.
    [Show full text]