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Table 2. 2012 AGS Beers Criteria for Potentially
Table 2. 2012 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults Strength of Organ System/ Recommendat Quality of Recomm Therapeutic Category/Drug(s) Rationale ion Evidence endation References Anticholinergics (excludes TCAs) First-generation antihistamines Highly anticholinergic; Avoid Hydroxyzin Strong Agostini 2001 (as single agent or as part of clearance reduced with e and Boustani 2007 combination products) advanced age, and promethazi Guaiana 2010 Brompheniramine tolerance develops ne: high; Han 2001 Carbinoxamine when used as hypnotic; All others: Rudolph 2008 Chlorpheniramine increased risk of moderate Clemastine confusion, dry mouth, Cyproheptadine constipation, and other Dexbrompheniramine anticholinergic Dexchlorpheniramine effects/toxicity. Diphenhydramine (oral) Doxylamine Use of diphenhydramine in Hydroxyzine special situations such Promethazine as acute treatment of Triprolidine severe allergic reaction may be appropriate. Antiparkinson agents Not recommended for Avoid Moderate Strong Rudolph 2008 Benztropine (oral) prevention of Trihexyphenidyl extrapyramidal symptoms with antipsychotics; more effective agents available for treatment of Parkinson disease. Antispasmodics Highly anticholinergic, Avoid Moderate Strong Lechevallier- Belladonna alkaloids uncertain except in Michel 2005 Clidinium-chlordiazepoxide effectiveness. short-term Rudolph 2008 Dicyclomine palliative Hyoscyamine care to Propantheline decrease Scopolamine oral secretions. Antithrombotics Dipyridamole, oral short-acting* May -
Federal Register/Vol. 85, No. 178/Monday, September 14, 2020
Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices 56631 agreements. All non-confidential DEPARTMENT OF JUSTICE ADDRESSES: Written comments should written submissions will be available for be sent to: Drug Enforcement public inspection at the Office of the Drug Enforcement Administration Administration, Attention: DEA Federal Secretary and on EDIS. [Docket No. DEA–713] Register Representative/DPW, 8701 The Commission vote for these Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must determinations took place on September Importer of Controlled Substances Application: Cerilliant Corporation be sent to: Drug Enforcement 8, 2020. Administration, Attn: Administrator, The authority for the Commission’s AGENCY: Drug Enforcement 8701 Morrissette Drive, Springfield, determination is contained in section Administration, Justice. Virginia 22152. All request for a hearing 337 of the Tariff Act of 1930, as ACTION: Notice of application. should also be sent to: (1) Drug amended (19 U.S.C. 1337), and in Part SUMMARY: Cerilliant Corporation has Enforcement Administration, Attn: 210 of the Commission’s Rules of applied to be registered as an importer Hearing Clerk/OALJ, 8701 Morrissette Practice and Procedure (19 CFR part of basic class(es) of controlled Drive, Springfield, Virginia 22152; and 210). substance(s). Refer to Supplemental (2) Drug Enforcement Administration, Attn: DEA Federal Register By order of the Commission. Information listed below for further Representative/DPW, 8701 Morrissette Issued: September 8, 2020. drug information. DATES: Drive, Springfield, Virginia 22152. Lisa Barton, Registered bulk manufacturers of the affected basic class(es), and SUPPLEMENTARY INFORMATION: In Secretary to the Commission. applicants therefore, may file written accordance with 21 CFR 1301.34(a), this [FR Doc. -
Drugs to Avoid in Patients with Dementia
Detail-Document #240510 -This Detail-Document accompanies the related article published in- PHARMACIST’S LETTER / PRESCRIBER’S LETTER May 2008 ~ Volume 24 ~ Number 240510 Drugs To Avoid in Patients with Dementia Elderly people with dementia often tolerate drugs less favorably than healthy older adults. Reasons include increased sensitivity to certain side effects, difficulty with adhering to drug regimens, and decreased ability to recognize and report adverse events. Elderly adults with dementia are also more prone than healthy older persons to develop drug-induced cognitive impairment.1 Medications with strong anticholinergic (AC) side effects, such as sedating antihistamines, are well- known for causing acute cognitive impairment in people with dementia.1-3 Anticholinergic-like effects, such as urinary retention and dry mouth, have also been identified in drugs not typically associated with major AC side effects (e.g., narcotics, benzodiazepines).3 These drugs are also important causes of acute confusional states. Factors that may determine whether a patient will develop cognitive impairment when exposed to ACs include: 1) total AC load (determined by number of AC drugs and dose of agents utilized), 2) baseline cognitive function, and 3) individual patient pharmacodynamic and pharmacokinetic features (e.g., renal/hepatic function).1 Evidence suggests that impairment of cholinergic transmission plays a key role in the development of Alzheimer’s dementia. Thus, the development of the cholinesterase inhibitors (CIs). When used appropriately, the CIs (donepezil [Aricept], rivastigmine [Exelon], and galantamine [Razadyne, Reminyl in Canada]) may slow the decline of cognitive and functional impairment in people with dementia. In order to achieve maximum therapeutic effect, they ideally should not be used in combination with ACs, agents known to have an opposing mechanism of action.1,2 Roe et al studied AC use in 836 elderly patients.1 Use of ACs was found to be greater in patients with probable dementia than healthy older adults (33% vs. -
Nomination Background: Ketamine Hydrochloride (CASRN: 1867-66-9)
KETAMINE Nomination TABLE OF CONTENTS Page 1.0 BASIS OF NOMINATION 1 2.0 BACKGROUND INFORMATION 1 3.0 CHEMICAL PROPERTIES 2 3.1 Chemical Identification 2 3.2 Physico-Chemical Properties 3 3.3 Purity and Commercial Availability 4 4.0 PRODUCTION PROCESSES AND ANALYSIS 6 5.0 PRODUCTION AND IMPORT VOLUMES 7 6.0 USES 7 7.0 ENVIRONMENTAL OCCURRENCE 7 8.0 HUMAN EXPOSURE 7 9.0 REGULATORY STATUS 7 10.0 CLINICAL PHARMACOLOGY 7 11.0 TOXICOLOGICAL DATA 13 11.1 General Toxicology 13 11.2 Neurotoxicology 14 12.0 CONCLUSIONS 15 APPENDIX A 17 APPENDIX B 23 APPENDIX C 27 1 KETAMINE 1.0 BASIS OF NOMINATION Ketamine, a noncompetitive NMDA receptor blocker, has been used extensively off - label as a pediatric anesthetic for surgical procedures in infants and toddlers. Recently, Olney and coworkers have demonstrated severe widespread apoptotic degeneration throughout the rapidly developing brain of the 7-day-old rat after ketamine administration. Recent research at FDA has confirmed and extended Olney’s observations. These findings are cause for concern with respect to ketamine use in children. The issue of whether the neurotoxicity found in this animal model (rat) has scientific and regulatory relevance for the pediatric use of ketamine relies heavily upon confirmation of these findings that may be obtained from the conduct of an appropriate study in non-human primates. 2.0 BACKGROUND INFORMATION The issue of potential ketamine neurotoxicity in children surfaced as a result of FDA’s reluctance to approve an NIH pediatric clinical trial using this compound because of its documented neurotoxic effects in young rats (published in several papers over the last ten years by Olney and co-workers). -
The Anticholinergic Toxidrome
Poison HOTLINE Partnership between Iowa Health System and University of Iowa Hospitals and Clinics July 2011 The Anticholinergic Toxidrome A toxidrome is a group of symptoms associated with poisoning by a particular class of agents. One example is the opiate toxidrome, the triad of CNS depression, respiratory depression, and pinpoint pupils, and which usually responds to naloxone. The anticholinergic toxidrome is most frequently associated with overdoses of diphenhydramine, a very common OTC medication. However, many drugs and plants can produce the anticholinergic toxidrome. A partial list includes: tricyclic antidepressants (amitriptyline), older antihistamines (chlorpheniramine), Did you know …… phenothiazines (promethazine) and plants containing the anticholinergic alkaloids atropine, hyoscyamine and scopolamine (Jimson Weed). Each summer, the ISPCC receives approximately 10-20 The mnemonic used to help remember the symptoms and signs of this snake bite calls, some being toxidrome are derived from the Alice in Wonderland story: from poisonous snakes (both Blind as a Bat (mydriasis and inability to focus on near objects) local and exotic). Red as a Beet (flushed skin color) Four poisonous snakes can be Hot as Hades (elevated temperature) found in Iowa: the prairie These patients can sometimes die of agitation-induced hyperthermia. rattlesnake, the massasauga, Dry as a Bone (dry mouth and dry skin) the copperhead, and the Mad as a Hatter (hallucinations and delirium) timber rattlesnake. Each Bowel and bladder lose their tone (urinary retention and constipation) snake has specific territories Heart races on alone (tachycardia) within the state. ISPCC A patient who has ingested only an anticholinergic substance and is not specialists have access to tachycardic argues against a serious anticholinergic overdose. -
3 Drugs That May Cause Delirium Or Problem Behaviors CARD 03 19 12 JUSTIFIED.Pub
Drugs that May Cause Delirium or Problem Behaviors Drugs that May Cause Delirium or Problem Behaviors This reference card lists common and especially problemac drugs that may Ancholinergics—all drugs on this side of the card. May impair cognion cause delirium or contribute to problem behaviors in people with demena. and cause psychosis. Drugs available over‐the‐counter marked with * This does not always mean the drugs should not be used, and not all such drugs are listed. If a paent develops delirium or has new problem Tricyclic Andepressants Bladder Anspasmodics behaviors, a careful review of all medicaons is recommended. Amitriptyline – Elavil Darifenacin – Enablex Be especially mindful of new medicaons. Clomipramine – Anafranil Flavoxate – Urispas Desipramine – Norpramin Anconvulsants Psychiatric Oxybutynin – Ditropan Doxepin – Sinequan Solifenacin – VESIcare All can cause delirium, e.g. All psychiatric medicaons should be Imipramine – Tofranil Tolterodine – Detrol Carbamazepine – Tegretol reviewed as possible causes, as Nortriptyline – Aventyl, Pamelor Gabapenn – Neuronn effects are unpredictable. Trospium – Sanctura Anhistamines / Allergy / Leveracetam – Keppra Notable offenders include: Insomnia / Sleep Valproic acid – Depakote Benzodiazepines e.g. Cough & Cold Medicines *Diphenhydramine – Sominex, ‐Alprazolam – Xanax *Azelasne – Astepro Pain Tylenol‐PM, others ‐Clonazepam – Klonopin *Brompheniramine – Bromax, All opiates can cause delirium if dose *Doxylamine – Unisom, Medi‐Sleep ‐Lorazepam – Avan Bromfed, Lodrane is too high or -
Medicare Part D Excluded Drug List
MEDICARE PART D EXCLUDED DRUGS LIST 2016_updated July 2016 Reason: LIST = multiple reasons it's excluded; "not covered under Part D law" Reason: Not properly listed with FDA = CMS considers it best practice for Part D sponsors to consider the proper listing of a drug product with the FDA as a prerequisite for making a Part D drug coverage determination. The FDA is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage determination process by confirming that a prescription drug product national drug code (NDC) is properly listed with the FDA. Reason: DESI = Less Than Effective (LTE) drug for ALL indications Label Name Reason 1ST BASE CRE Bulk Ingredient 2-FUCCOSYLLA PAK LACTO-N Medical Food ABANEU-SL SUB Vitamin/Mineral ABLAVAR INJ 244MG/ML Diagnostic Agent ACACIA EXTRA SOL 1:20 Non-standardized allergenic ACCUCAINE INJ 1% LIST ACD FORMULA SOL A Blood Component ACD-A SOL Blood Component ACLARO PD EMU 4% Cosmetic ACREMONIUM SOL 20000PNU Non-standardized allergenic ACTCT FLEX 3 PAD 4"X4" Not properly listed with FDA ACTHREL INJ 100MCG Diagnostic Agent ACTI ANTIMIC PAD 2"X2" Not properly listed with FDA ACTI ANTIMIC PAD 4"X4" Not properly listed with FDA ACTICOAT 7 PAD 2"X2" Not properly listed with FDA ACTICOAT 7 PAD 4"X5" Not properly listed with FDA ACTICOAT ABS PAD 4"X5" Not properly listed with FDA ACTICOAT MOI PAD 2"X2" Surgical Supply/Medical ACTICOAT MOI PAD 4"X4" Surgical Supply/Medical ACTICOAT MOI PAD -
2 Spice English Presentation
Spice Spice contains no compensatory substances Специи не содержит компенсационные вещества Spice is a mix of herbs (shredded plant material) and manmade chemicals with mind-altering effects. It is often called “synthetic marijuana” because some of the chemicals in it are similar to ones in marijuana; but its effects are sometimes very different from marijuana, and frequently much stronger. It is most often labeled “Not for Human Consumption” and disguised as incense. Eliminationprocess • The synthetic agonists such as THC is fat soluble. • Probably, they are stored as THC in cell membranes. • Some of the chemicals in Spice, however, attach to those receptors more strongly than THC, which could lead to a much stronger and more unpredictable effect. • Additionally, there are many chemicals that remain unidentified in products sold as Spice and it is therefore not clear how they may affect the user. • Moreover, these chemicals are often being changed as the makers of Spice alter them to avoid the products being illegal. • To dissolve the Spice crystals Acetone is used endocannabinoids synhtetic THC cannabinoids CB1 and CB2 agonister Binds to cannabinoidreceptor CB1 CB2 - In the brain -in the immune system Decreased avtivity in the cell ____________________ Maria Ellgren Since some of the compounds have a longer toxic effects compared to naturally THC, as reported: • negative effects that often occur the day after consumption, as a general hangover , but without nausea, mentally slow, confused, distracted, impairment of long and short term memory • Other reports mention the qualitative impairment of cognitive processes and emotional functioning, like all the oxygen leaves the brain. -
Hyoscyamine, Atropine, Scopolamine, and Phenobarbital
PATIENT & CAREGIVER EDUCATION Hyoscyamine, Atropine, Scopolamine, and Phenobarbital This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. Brand Names: US Donnatal; Phenohytro What is this drug used for? It is used to treat irritable bowel syndrome. It is used to treat ulcer disease. It may be given to your child for other reasons. Talk with the doctor. What do I need to tell the doctor BEFORE my child takes this drug? If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had. If your child has any of these health problems: Heart problems due to bleeding, bowel block, enlarged colon, glaucoma, a hernia Hyoscyamine, Atropine, Scopolamine, and Phenobarbital 1/9 that involves your stomach (hiatal hernia), myasthenia gravis, slow-moving GI (gastrointestinal) tract, trouble passing urine, or ulcerative colitis. If your child has ever had porphyria. If your child has been restless or overexcited in the past after taking phenobarbital. If your child is addicted to drugs or alcohol, or has been in the past. This is not a list of all drugs or health problems that interact with this drug. Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. -
Introduced B.,Byhansen, 16
LB301 LB301 2021 2021 LEGISLATURE OF NEBRASKA ONE HUNDRED SEVENTH LEGISLATURE FIRST SESSION LEGISLATIVE BILL 301 Introduced by Hansen, B., 16. Read first time January 12, 2021 Committee: Judiciary 1 A BILL FOR AN ACT relating to the Uniform Controlled Substances Act; to 2 amend sections 28-401, 28-405, and 28-416, Revised Statutes 3 Cumulative Supplement, 2020; to redefine terms; to change drug 4 schedules and adopt federal drug provisions; to change a penalty 5 provision; and to repeal the original sections. 6 Be it enacted by the people of the State of Nebraska, -1- LB301 LB301 2021 2021 1 Section 1. Section 28-401, Revised Statutes Cumulative Supplement, 2 2020, is amended to read: 3 28-401 As used in the Uniform Controlled Substances Act, unless the 4 context otherwise requires: 5 (1) Administer means to directly apply a controlled substance by 6 injection, inhalation, ingestion, or any other means to the body of a 7 patient or research subject; 8 (2) Agent means an authorized person who acts on behalf of or at the 9 direction of another person but does not include a common or contract 10 carrier, public warehouse keeper, or employee of a carrier or warehouse 11 keeper; 12 (3) Administration means the Drug Enforcement Administration of the 13 United States Department of Justice; 14 (4) Controlled substance means a drug, biological, substance, or 15 immediate precursor in Schedules I through V of section 28-405. 16 Controlled substance does not include distilled spirits, wine, malt 17 beverages, tobacco, hemp, or any nonnarcotic substance if such substance 18 may, under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. -
Symptomatic Approach to Gas, Belching and Bloating 21
20 Osteopathic Family Physician (2019) 20 - 25 Osteopathic Family Physician | Volume 11, No. 2 | March/April, 2019 Gennaro, Larsen Symptomatic Approach to Gas, Belching and Bloating 21 Review ARTICLE to escape. This mechanism prevents the stomach from becoming IRRITABLE BOWEL SYNDROME (IBS) Symptomatic Approach to Gas, Belching and Bloating damaged by excessive dilation.2 IBS is abdominal pain or discomfort associated with altered with OMT Treatment Options Many patients with GERD report increased belching. Transient bowel habits. It is the most commonly diagnosed GI disorder lower esophageal sphincter (LES) relaxation is the major and accounts for about 30% of all GI referrals.7 Criteria for IBS is recurrent abdominal pain at least one day per week in the Carly Gennaro, DO1; Helaine Larsen, DO1 mechanism for both belching and GERD. Recent studies have shown that the number of belches is related to the number of last three months associated with at least two of the following: times someone swallows air. These studies have concluded that 1) association with defecation, 2) change in stool frequency, 1 Good Samaritan Hospital Medical Center, West Islip, NY patients with GERD swallow more air in response to heartburn and 3) change in stool form. Diagnosis should be made using these therefore belch more frequently.3 There is no specific treatment clinical criteria and limited testing. Common symptoms are for belching in GERD patients, so for now, physicians continue to abdominal pain, bloating, alternating diarrhea and constipation, treat GERD with proton pump inhibitors (PPIs) and histamine-2 and pain relief after defecation. Pain can be present anywhere receptor antagonists with the goal of suppressing heartburn and in the abdomen, but the lower abdomen is the most common KEYWORDS: ABSTRACT: Intestinal gas production is a normal physiologic progress. -
Substances in Penalty Group Two
Substances in Penalty Group Two Sec. 481.103. PENALTY GROUP 2. (a) Penalty Group 2 consists of: (1) any quantity of the following hallucinogenic substances, their salts, isomers, and salts of isomers, unless specifically excepted, if the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation: alpha-ethyltryptamine; 4-bromo-2, 5-dimethoxyamphetamine (some trade or other names: 4- bromo- 2, 5-dimethoxy-alpha-methylphenethylamine; 4-bromo-2, 5-DMA); 4-bromo-2, 5-dimethoxyphenethylamine; Bufotenine (some trade and other names: 3-(beta-Dimethylaminoethyl) - 5-hydroxyindole; 3-(2-dimethylaminoethyl)-5- indolol; N, N- dimethylserotonin; 5-hydroxy-N, N-dimethyltryptamine; mappine); Diethyltryptamine (some trade and other names: N, N-Diethyltryptamine, DET); 2, 5-dimethoxyamphetamine (some trade or other names: 2, 5- dimethoxy- alpha-methylphenethylamine; 2, 5-DMA); 2, 5-dimethoxy-4-ethylamphetamine ( trade or other name : DOET); 2, 5-dimethoxy-4-(n)-propylthiophenethylamine (trade or other name: 2C-T-7); Dimethyltryptamine ( trade or other name : DMT); Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved drug product (some trade or other names for Dronabinol: (a6aR-trans)-6a,7,8,10a-tetrahydro- 6,6, 9-trimethyl-3-pentyl-6H- dibenzo [b,d]pyran-1-ol or (-)-delta-9-(trans)- tetrahydrocannabinol); Ethylamine Analog of Phencyclidine (some trade or other names: N- ethyl-1-phenylcyclohexylamine, (1-phenylcyclohexyl) ethylamine,