Alcohol Withdrawal
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Methylphenidate Hydrochloride
Application for Inclusion to the 22nd Expert Committee on the Selection and Use of Essential Medicines: METHYLPHENIDATE HYDROCHLORIDE December 7, 2018 Submitted by: Patricia Moscibrodzki, M.P.H., and Craig L. Katz, M.D. The Icahn School of Medicine at Mount Sinai Graduate Program in Public Health New York NY, United States Contact: [email protected] TABLE OF CONTENTS Page 3 Summary Statement Page 4 Focal Point Person in WHO Page 5 Name of Organizations Consulted Page 6 International Nonproprietary Name Page 7 Formulations Proposed for Inclusion Page 8 International Availability Page 10 Listing Requested Page 11 Public Health Relevance Page 13 Treatment Details Page 19 Comparative Effectiveness Page 29 Comparative Safety Page 41 Comparative Cost and Cost-Effectiveness Page 45 Regulatory Status Page 48 Pharmacoepial Standards Page 49 Text for the WHO Model Formulary Page 52 References Page 61 Appendix – Letters of Support 2 1. Summary Statement of the Proposal for Inclusion of Methylphenidate Methylphenidate (MPH), a central nervous system (CNS) stimulant, of the phenethylamine class, is proposed for inclusion in the WHO Model List of Essential Medications (EML) & the Model List of Essential Medications for Children (EMLc) for treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) under ICD-11, 6C9Z mental, behavioral or neurodevelopmental disorder, disruptive behavior or dissocial disorders. To date, the list of essential medications does not include stimulants, which play a critical role in the treatment of psychotic disorders. Methylphenidate is proposed for inclusion on the complimentary list for both children and adults. This application provides a systematic review of the use, efficacy, safety, availability, and cost-effectiveness of methylphenidate compared with other stimulant (first-line) and non-stimulant (second-line) medications. -
Substance Abuse and Dependence
9 Substance Abuse and Dependence CHAPTER CHAPTER OUTLINE CLASSIFICATION OF SUBSTANCE-RELATED THEORETICAL PERSPECTIVES 310–316 Residential Approaches DISORDERS 291–296 Biological Perspectives Psychodynamic Approaches Substance Abuse and Dependence Learning Perspectives Behavioral Approaches Addiction and Other Forms of Compulsive Cognitive Perspectives Relapse-Prevention Training Behavior Psychodynamic Perspectives SUMMING UP 325–326 Racial and Ethnic Differences in Substance Sociocultural Perspectives Use Disorders TREATMENT OF SUBSTANCE ABUSE Pathways to Drug Dependence AND DEPENDENCE 316–325 DRUGS OF ABUSE 296–310 Biological Approaches Depressants Culturally Sensitive Treatment Stimulants of Alcoholism Hallucinogens Nonprofessional Support Groups TRUTH or FICTION T❑ F❑ Heroin accounts for more deaths “Nothing and Nobody Comes Before than any other drug. (p. 291) T❑ F❑ You cannot be psychologically My Coke” dependent on a drug without also being She had just caught me with cocaine again after I had managed to convince her that physically dependent on it. (p. 295) I hadn’t used in over a month. Of course I had been tooting (snorting) almost every T❑ F❑ More teenagers and young adults die day, but I had managed to cover my tracks a little better than usual. So she said to from alcohol-related motor vehicle accidents me that I was going to have to make a choice—either cocaine or her. Before she than from any other cause. (p. 297) finished the sentence, I knew what was coming, so I told her to think carefully about what she was going to say. It was clear to me that there wasn’t a choice. I love my T❑ F❑ It is safe to let someone who has wife, but I’m not going to choose anything over cocaine. -
Midazolam Injection, USP
Midazolam Injection, USP 2 mg per 2 mL | NDC 70860-600-02 50 mg per 10 mL | NDC 70860-601-10 ATHENEX AccuraSEETM PACKAGING AND LABELING BIG, BOLD AND BRIGHT — TO HELP YOU SEE IT, SAY IT AND PICK IT RIGHT DIFFERENTIATION IN EVERY LABEL, DESIGNED TO HELP REDUCE MEDICATION ERRORS PLEASE SEE FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING, FOR MIDAZOLAM INJECTION, USP, ENCLOSED. THE NEXT GENERATION OF PHARMACY INNOVATION To order, call 1-855-273-0154 or visit www.Athenexpharma.com Midazolam Injection, USP 2 5 mg NDC 70860-600-02 0 NDC 70860-601-10 2 mg per 2 mL mg 50 mg per 10 mL DESCRIPTION Glass Vial DESCRIPTION Glass Vial CONCENTRATION 1 mg per mL CONCENTRATION 5 mg per mL CLOSURE 13 mm CLOSURE 20 mm UNIT OF SALE 25 vials UNIT OF SALE 10 vials BAR CODED Yes BAR CODED Yes STORAGE Room Temp. STORAGE Room Temp. • AP RATED • PRESERVATIVE-FREE • AP RATED • NOT MADE WITH NATURAL RUBBER LATEX • NOT MADE WITH NATURAL RUBBER LATEX CHOOSE AccuraSEETM FOR YOUR PHARMACY Our proprietary, differentiated and highly-visible label designs can assist pharmacists in accurate medication selection. With a unique label design for every Athenex product, we’re offering your pharmacy added AccuraSEE. The idea is simple: “So what you see is exactly what you get.” Athenex, AccuraSEE and all label designs are copyright of Athenex. ©2020 Athenex. 000527 To order, call 1-855-273-0154 or visit www.Athenexpharma.com • Midazolam hydrochloride mufti-dose vial, is not intended for intrathecal or epidural • Anesthetic and sedation drugs are a necessary part of the care of children needing Midazolam Injection, USP administration, and is contraindicated for use in premature infants, because the formulation surgery, other procedures, or tests that cannot be delayed, and no specific medications INDICATIONS AND USAGE contains benzyl alcohol as a preservative. -
XANAX® Alprazolam Tablets, USP
XANAX® alprazolam tablets, USP CIV WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see Warnings, Drug Interactions]. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. DESCRIPTION XANAX Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is represented to the right: Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each XANAX Tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. XANAX Tablets, 2 mg, are multi-scored and may be divided as shown below: 1 Reference ID: 4029640 Inactive ingredients: Cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2. CLINICAL PHARMACOLOGY Pharmacodynamics CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereo specific receptors at several sites within the central nervous system. Their exact mechanism of action is unknown. Clinically, all benzodiazepines cause a dose-related central nervous system depressant activity varying from mild impairment of task performance to hypnosis. -
Prescription Medications: Misuse, Abuse, Dependence, and Addiction
Substance Abuse Treatment May 2006 Volume 5 Issue 2 ADVISORYNews for the Treatment Field Prescription Medications: Misuse, Abuse, Dependence, and Addiction How serious are prescription Older adults are particularly vulnerable to misuse and medication use problems? abuse of prescription medications. Persons ages 65 and older make up only 13 percent of the population but Development and increased availability of prescription account for one-third of all medications prescribed,3 drugs have significantly improved treatment of pain, and many of these prescriptions are for psychoactive mental disorders, anxiety, and other conditions. Millions medications with high abuse and addiction liability.4 of Americans use prescription medications safely and Data from the National Survey on Drug Use and Health responsibly. However, increased availability and vari- indicate that nonmedical use of prescription medications ety of medications with psychoactive effects (see Table was the second most common form of substance abuse 1) have contributed to prescription misuse, abuse, among adults older than 55.5 dependence, and addiction. In 2004,1 the number of Americans reporting abuse2 of prescription medications Use of prescription medications in ways other than was higher than the combined total of those reporting prescribed can have a variety of adverse health conse- abuse of cocaine, hallucinogens, inhalants, and heroin. quences, including overdose, toxic reactions, and serious More than 14.5 million persons reported having used drug interactions leading to life-threatening conditions, prescription medications nonmedically within the past such as respiratory depression, hypertension or hypoten- year. Of this 14.5 million, more than 2 million were sion, seizures, cardiovascular collapse, and death.6 between ages 12 and 17. -
The Emergence of New Psychoactive Substance (NPS) Benzodiazepines
Issue: Ir Med J; Vol 112; No. 7; P970 The Emergence of New Psychoactive Substance (NPS) Benzodiazepines. A Survey of their Prevalence in Opioid Substitution Patients using LC-MS S. Mc Namara, S. Stokes, J. Nolan HSE National Drug Treatment Centre Abstract Benzodiazepines have a wide range of clinical uses being among the most commonly prescribed medicines globally. The EU Early Warning System on new psychoactive substances (NPS) has over recent years detected new illicit benzodiazepines in Europe’s drug market1. Additional reference standards were obtained and a multi-residue LC- MS method was developed to test for 31 benzodiazepines or metabolites in urine including some new benzodiazepines which have been classified as New Psychoactive Substances (NPS) which comprise a range of substances, including synthetic cannabinoids, opioids, cathinones and benzodiazepines not covered by international drug controls. 200 urine samples from patients attending the HSE National Drug Treatment Centre (NDTC) who are monitored on a regular basis for drug and alcohol use and which tested positive for benzodiazepine class drugs by immunoassay screening were subjected to confirmatory analysis to determine what Benzodiazepine drugs were present and to see if etizolam or other new benzodiazepines are being used in the addiction population currently. Benzodiazepine prescription and use is common in the addiction population. Of significance we found evidence of consumption of an illicit new psychoactive benzodiazepine, Etizolam. Introduction Benzodiazepines are useful in the short-term treatment of anxiety and insomnia, and in managing alcohol withdrawal. 1 According to the EMCDDA report on the misuse of benzodiazepines among high-risk opioid users in Europe1, benzodiazepines, especially when injected, can prolong the intensity and duration of opioid effects. -
An Overview of Outpatient and Inpatient Detoxification
An Overview of Outpatient and Inpatient Detoxification Motoi Hayashida, M.D., Sc.D. lcohol detoxification can be defined as a period facility, where they reside for the duration of of medical treatment, usually including counsel- treatment, which may range from 5 to 14 days. A ing, during which a person is helped to overcome The process of detoxification in either setting initially physical and psychological dependence on alcohol (Chang involves the assessment and treatment of acute with- and Kosten 1997). The immediate objectives of alcohol drawal symptoms, which may range from mild (e.g., detoxification are to help the patient achieve a substance- tremor and insomnia) to severe (e.g., autonomic free state, relieve the immediate symptoms of withdrawal, hyperactivity, seizures, and delirium) (Swift 1997). and treat any comorbid medical or psychiatric conditions. Medications often are provided to help reduce a patient’s These objectives help prepare the patient for entry into withdrawal symptoms. Benzodiazepines (e.g., diazepam long-term treatment or rehabilitation, the ultimate goal of detoxification (Swift 1997). The objectives of long- and chlordiazepoxide) are the most commonly used term treatment or rehabilitation include the long-term drugs for this purpose, and their efficacy is well estab- maintenance of the alcohol-free state and the incor- lished (Swift 1997). Benzodiazepines not only reduce poration of psychological, family, and social interven- alcohol withdrawal symptoms but also prevent alcohol tions to help ensure its persistence (Swift 1997). withdrawal seizures, which occur in an estimated 1 to Alcohol detoxification can be completed safely and 4 percent of withdrawal patients (Schuckit 1995). -
The Waterloo Wellington Palliative Sedation Protocol
The Waterloo Wellington Palliative Sedation Protocol Waterloo Wellington Interdisciplinary HPC Education Committee; PST Task Force Chair: Dr. Deborah Robinson MD CCFP(F), Focused practice in Oncology and Palliative Care Co-chairs: Cathy Joy, Palliative Care Consultant, Waterloo Region Chris Bigelow, Palliative Care Consultant, Wellington County Revision due: November 2016 Last revised and activated: November 13, 2013 Committee responsible for revisions: WW Interdisciplinary HPC Education Committee Table of Contents Purpose and Definitions .................................................................................................................... 2 Indications for the use of PST .............................................................................................................. 3 Criteria for Initiation of PST ............................................................................................................... 4 Process ............................................................................................................................................. 4 Documentation for Initiation of PST .................................................................................................. 5 Medications ......................................................................................................................................... 6 1st Line (Initiating PST) ...................................................................................................................... 6 2nd Line (When 1st -
Benzodiazepine Abuse and Dependence: Misconceptions and Facts
CLINICAL REVIEW Benzodiazepine Abuse and Dependence: Misconceptions and Facts Michael G. Farnsworth, MD St Paul, Minnesota Benzodiazepines can be prescribed for a number of medical conditions. Many physi cians are reluctant to prescribe benzodiazepines out of fear of producing depen dence in patients and incurring the disapproval of their peers. Studies of psychotropic drug use and abuse demonstrate that individuals using benzodiazepines for treat ment of a medical illness rarely demonstrate tolerance to the therapeutic action of the medication or escalate the dose. Eighty percent of benzodiazepines are pre scribed for 6 months or less, and elderly women are the most common long-term users of low-dose benzodiazepines. In contrast, recreational use of benzodiazepines is associated with polysubstance abuse, lack of medical supervision, rapid tolerance to the euphoric or sedating side effect, and escalation of dose. Most recreational us ers of benzodiazepines are young men. Documentation of indication for use, collec tion of drug-abuse history, close monitoring, and drug holidays can improve the man agement of this class of medication. J Fam Pract 1990; 31:393-400. enzodiazepines, as a class of psychotherapeutic med barbiturates and meprobamate, introduced in 1955, re B ications, have enjoyed widespread use since their US mained as dominant anxiolytic drugs. Physicians, how introduction in the early 1960s. These medications are ever, were concerned with the propensity of barbiturates used to treat some of the most prevalent emotional and to induce tolerance, physical dependence, drug interac physical disorders seen in medical practice, which include tions, and potential for a lethal withdrawal syndrome. anxiety, insomnia, seizure disorders, muscle spasms, and Accordingly, chlordiazepoxide was synthesized and mar alcohol withdrawal. -
Midazolam Injection, USP
Midazolam Injection, USP Rx only PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION WARNING ADULTS AND PEDIATRICS: Intravenous midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted. Intravenous midazolam should be used only in hospital or ambulatory care settings, including physicians’ and dental offices, that provide for continuous monitoring of respiratory and cardiac function, i.e., pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured (see WARNINGS). For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedures. The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for older (over 60 years) or debilitated patients and in patients receiving concomitant narcotics or other central nervous system (CNS) depressants. The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and 1 allow an additional 2 or more minutes to fully evaluate the sedative effect. The dilution of the 5 mg/mL formulation is recommended to facilitate slower injection. Doses of sedative medications in pediatric patients must be calculated on a mg/kg basis, and initial doses and all subsequent doses should always be titrated slowly. -
Psychoactive Drugs Addiction the Role of Genes in Addiction
Drugs, Addiction and Reward Chapter 5 Psychoactive Drugs Addiction Garrett: Brain & Behavior 4e The Role of Genes in Addiction 1 Drugs, Addiction, and Reward Figure 5.1: Honore de Balzac died of heart attack after abusing coffee • A drug is any substance that changes the body or its functioning. • Agonists mimics or enhances a neurotransmitter. • Antagonists may reduce release of neurotransmitter or block receptors. • Psychoactive drugs are those that have psychological effects, such as anxiety relief or hallucinations. Garrett: Brain & Behavior 4e 2 Psychoactive Drugs Terms • Addiction is identified by: • preoccupation with obtaining a drug; • compulsive use of the drug in spite of adverse consequences; • a high tendency to relapse after quitting. • Withdrawal • negative reaction that occurs when drug use is stopped. • often include effects opposite of the drug itself • Tolerance: Garrett: Brain & Behavior 4e • Person becomes less responsive to the drug, requiring increasing amounts of the drug to produce the same results 3 • killed about ½ of heroin users in a long term study, and is a significant reason for overdose. Psychoactive Drugs An Overview • Opiates • Stimulants • Analgesic: pain relief; • Increased arousal and • Hypnotic: sleep- alertness inducing; • Euphoria • Euphoria: strong • Psychedelics feelings of happiness. • Perceptual distortions • Depressants and hallucinations • Sedation: calming, • MariJuana reduces agitation and • Temporary memory, irritability cognitive, and IQ • Anxiolytic: anxiety deficits; reduction • Impaired -
RPD1013 Understanding Addiction Test
RPD1013 Understanding Addiction Test Multiple Choice and True or False (circle one answer) 1. Research shows what percentage of those in jail or prison was involved with alcohol or other drugs, which contributed to their incarceration? a. 15% b. 30% c. Under 45% d. Over 50% e. 99% 2. Class materials said that future sessions will: a. Review the Ideas of 12 Step Recovery Groups (AA/NA/CA) b. Review the Ideas of Alternative Recovery Groups (SOS) c. Review Ideas on Recovery from Many Sources d. All of the Above e. Only B & C Above 3. Addiction May Be Better Understood by Defining: a. Physical Dependence b. Tolerance c. Psychological Dependence d. All of the Above e. None of the Above 4. A physical withdrawal reaction when someone stops drinking, smoking, or taking a drug means the body has developed physical dependence. a. True b. False 5. When a person takes the same dose of a drug over a period of time and finds that they get less and less of the effect they expect, we call this: a. Addiction b. Tolerance c. Relapse d. Recovery e. All of the Above Course RPD1013 Understanding Addiction Page 1 of 4 RPD1013 Understanding Addiction Test 6. Psychological dependence causes drug users to seek out more of the drug (drug-seeking behavior). a. True b. False 7. A first time user who took the same heroine dose as a user who had built up a heavy tolerance to a drug might overdose. a. True b. False 8. Denial is: a. A Powerful Defense Mechanism b.