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Pharmaceutical Starting Materials/Essential Drugs
BULLETIN MNS October 2009 PHARMACEUTICAL STARTING MATERIALS MARKET NEWS SERVICE (MNS) BI -MONTHLY EDITION Market News Service Pharmaceutical Starting Materials/Essential Drugs October 2009, Issue 5 The Market News Service (MNS) is made available free of charge to all Trade Support Institutions and enterprises in Sub-Saharan African countries under a joint programme of the International Trade Centre and CBI, the Dutch Centre for the Promotion of Imports from Developing Countries (www.cbi.nl). Should you be interested in becoming an information provider and contributing to MNS' efforts to improve market transparency and facilitate trade, please contact us at [email protected]. This issue continues the series, started at the beginning of the year, focusing on the leading markets in various world regions. This issue covers the trends and recent developments in eastern European pharmaceutical markets. To subscribe to the report or to access MNS reports directly online, please contact [email protected] or visit our website at: http://www.intracen.org/mns. Copyright © MNS/ITC 2007. All rights reserved 1 Market News Service Pharmaceutical Starting Materials Introduction WHAT IS THE MNS FOR PHARMACEUTICAL STARTING MATERIALS/ESSENTIAL DRUGS? In 1986, the World Health Assembly laid before the Organization the responsibility to provide price information on pharmaceutical starting materials. WHA 39.27 endorsed WHO‟s revised drug strategy, which states “... strengthen market intelligence; support drug procurement by developing countries...” The responsibility was reaffirmed at the 49th WHA in 1996. Resolution WHA 49.14 requests the Director General, under paragraph 2(6) “to strengthen market intelligence, review in collaboration with interested parties‟ information on prices and sources of information on prices of essential drugs and starting material of good quality, which meet requirements of internationally recognized pharmacopoeias or equivalent regulatory standards, and provide this information to member states”. -
PENTOBARBITAL SODIUM- Pentobarbital Sodium Injection Akorn, Inc
PENTOBARBITAL SODIUM- pentobarbital sodium injection Akorn, Inc. ---------- Nembutal® Sodium Solution CII (pentobarbital sodium injection, USP) + novaplus TM Rx only Vials DO NOT USE IF MATERIAL HAS PRECIPITATED DESCRIPTION The barbiturates are nonselective central nervous system depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act (See “Drug Abuse and Dependence” section). The sodium salts of amobarbital, pentobarbital, phenobarbital, and secobarbital are available as sterile parenteral solutions. Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system (CNS) activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. NEMBUTAL Sodium Solution (pentobarbital sodium injection) is a sterile solution for intravenous or intramuscular injection. Each mL contains pentobarbital sodium 50 mg, in a vehicle of propylene glycol, 40%, alcohol, 10% and water for injection, to volume. The pH is adjusted to approximately 9.5 with hydrochloric acid and/or sodium hydroxide. NEMBUTAL Sodium is a short-acting barbiturate, chemically designated as sodium 5-ethyl-5-(1- methylbutyl) barbiturate. The structural formula for pentobarbital sodium is: The sodium salt occurs as a white, slightly bitter powder which is freely soluble in water and alcohol but practically insoluble in benzene and ether. CLINICAL PHARMACOLOGY Barbiturates are capable of producing all levels of CNS mood alteration from excitation to mild sedation, to hypnosis, and deep coma. Overdosage can produce death. In high enough therapeutic doses, barbiturates induce anesthesia. -
Benzodiazepines
Benzodiazepines Using benzodiazepines in Children and Adolescents Overview Benzodiazepines are group of medications used to treat several different conditions. Some examples of these medications include: lorazepam (Ativan®); clonazepam (Rivotril®); alprazolam (Xanax®) and oxazepam (Serax®). Other benzodiazepine medications are available, but are less commonly used in children and adolescents. What are benzodiazepines used for? Benzodiazepines may be used for the following conditions: • anxiety disorders: generalized anxiety disorder; social anxiety disorder; post-traumatic stress disorder (PTSD); panic attacks/disorder; excessive anxiety prior to surgery • sleep disorders: trouble sleeping (insomnia); waking up suddenly with great fear (night terrors); sleepwalking • seizure disorders (epilepsy) • alcohol withdrawal • treatment of periods of extreme slowing or excessive purposeless motor activity (catatonia) Your doctor may be using this medication for another reason. If you are unclear why this medication is being prescribed, please ask your doctor. How do benzodiazepines work? Benzodiazepines works by affecting the activity of the brain chemical (neurotransmitter) called GABA. By enhancing the action of GABA, benzodiazepines have a calming effect on parts of the brain that are too excitable. This in turn helps to manage anxiety, insomnia, and seizure disorders. How well do benzodiazepines work in children and adolescents? When used to treat anxiety disorders, benzodiazepines decrease symptoms such as nervousness, fear, and excessive worrying. Benzodiazepines may also help with the physical symptoms of anxiety, including fast or strong heart beat, trouble breathing, dizziness, shakiness, sweating, and restlessness. Typically, benzodiazepines are prescribed to manage anxiety symptoms that are uncomfortable, frightening or interfere with daily activities for a short period of time before conventional anti-anxiety treatments like cognitive-behavioural therapy or anti-anxiety takes effect. -
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. -
Deliberate Self-Poisoning with a Lethal Dose of Pentobarbital: Survival with Supportive Care
Deliberate self-poisoning with a lethal dose of pentobarbital: Survival with supportive care. (1) (1,2) Santosh Gone , Andis Graudins (1) Clinical Toxicology Service, Program of Emergency Medicine, Monash Health (2) Monash Emergency Research Collaboration, Clinical Sciences at Monash Health, Monash University Abstract 84 INTRODUCTION CASE REPORT (continued) DISCUSSION Pentobarbital (Nembutal) is short acting In the ED: Pentobarbital has been a banned substance for barbiturate sedative-hypnotic, currently widely GCS: 3/15, fixed dilated pupils, apnoeic and human use in Australia since 1998. However, it can used in veterinary practice for anesthesia and ventilated. be procured overseas or bought on the internet. euthanasia. Pulse: 116 bpm sinus tachycardia BP: 115/60 on epinephrine infusion. Pentobarbital is recommended as an effective It is also commonly recommended as a VBG: pH 7.03 pCO2 77 mmHg Bicarb 19 mmol/L agent for use in euthanasia due to its apparently euthanasia drug for assisted suicide and it is Lactate 8.8 mmol/L peaceful transition to death. unlikely that any resuscitative measures will be Activated charcoal (50g) given via an NG tube. attempted in such cases. Course in the Intensive Care Department: In a case series of 150 assisted suicides in Day-1 post-OD: Sweden, a 100% success rate was seen with Intentional overdose results in depression of - Absent brain stem reflexes and fixed dilated pupils for ingestion of 9 grams. Cardiovascular collapse was brain stem function and rapid onset respiratory five days. seen within 15 minutes in 30% of patients. It is rare depression and apnoea. Hypotension also - Diabetes insipidus developed with urine output of to see survival after intentional ingestion for develops, followed by cardiovascular collapse 300ml/hour. -
Pentobarbital Sodium
PENTobarbital Sodium Brand names Nembutal Sodium Medication error Look-alike, sound-alike drug names. Tall man letters (not FDA approved) are recommended potential to decrease confusion between PENTobarbital and PHENobarbital.(1,2) ISMP recommends the following tall man letters (not FDA approved): PENTobarbital.(30) Contraindications Contraindications: In patients with known hypersensitivity to barbiturates or any com- and warnings ponent of the formulation.(2) If an allergic or hypersensitivity reaction or a life-threatening adverse event occurs, rapid substitution of an alternative agent may be necessary. If pentobarbital is discontinued due to development of a rash, an anticonvulsant that is structurally dissimilar should be used (i.e., nonaromatic). (See Rare Adverse Effects in the Comments section.) Also contraindicated in patients with a history of manifest or latent porphyria.(2) Warnings: Rapid administration may cause respiratory depression, apnea, laryngospasm, or vasodilation with hypotension.(2) Should be withdrawn gradually if large doses have been used for prolonged periods.(2) Paradoxical excitement may occur or important symptoms could be masked when given to patients with acute or chronic pain.(2) May be habit forming. Infusion-related Respiratory depression and arrest requiring mechanical ventilation may occur. Monitor cautions oxygen saturation. If hypotension occurs, the infusion rate should be decreased and/or the patient should be treated with IV fluids and/or vasopressors. Pentobarbital is an alkaline solution (pH = 9–10.5); therefore, extravasation may cause tissue necrosis.(2) (See Appendix E for management.) Gangrene may occur following inadvertent intra-arterial injection.(2) Dosage Medically induced coma (for persistently elevated intracranial pressure (ICP) or refractory status epilepticus): Patient should be intubated and mechanically ventilated. -
Benzodiazepine Group ELISA Kit
Benzodiazepine Group ELISA Kit Benzodiazepine Background Since their introduction in the 1960s, benzodiazepines have been widely prescribed for the treatment of anxiety, insomnia, muscle spasms, alcohol withdrawal, and seizure-prevention as they are depressants of the central nervous system. Despite the fact that they are highly effective for their intended use, benzodiazepines are prescribed with caution as they can be highly addictive. In fact, researchers at NIDA (National Institute on Drug Abuse) have shown that addiction for benzodiazepines is similar to that of opioids, cannabinoids, and GHB. Common street names of benzodiazepines include “Benzos” and “Downers”. The five most encountered benzodiazepines on the illicit market are alprazolam (Xanax), lorazepam (Ativan), clonazepam (Klonopin), diazepam (Valium), and temazepam (Restori). The method of abuse is typically oral or snorted in crushed form. The DEA notes a particularly high rate of abuse among heroin and cocaine abusers. Designer benzodiazepines are currently offered in online shops selling “research chemicals”, providing drug abusers an alternative to prescription-only benzodiazepines. Data defining pharmacokinetic parameters, drug metabolisms, and detectability in biological fluids is limited. This lack of information presents a challenge to forensic laboratories. Changes in national narcotics laws in many countries led to the control of (phenazepam and etizolam), which were marketed by pharmaceutical companies in some countries. With the control of phenazepam and etizolam, clandestine laboratories have begun researching and manufacturing alternative benzodiazepines as legal substitutes. Delorazepam, diclazepam, pyrazolam, and flubromazepam have emerged as compounds in this class of drugs. References Drug Enforcement Administration, Office of Diversion Control. “Benzodiazepines.” http://www.deadiversion.usdoj.gov/drugs_concern/benzo_1. -
Pharmacology on Your Palms CLASSIFICATION of the DRUGS
Pharmacology on your palms CLASSIFICATION OF THE DRUGS DRUGS FROM DRUGS AFFECTING THE ORGANS CHEMOTHERAPEUTIC DIFFERENT DRUGS AFFECTING THE NERVOUS SYSTEM AND TISSUES DRUGS PHARMACOLOGICAL GROUPS Drugs affecting peripheral Antitumor drugs Drugs affecting the cardiovascular Antimicrobial, antiviral, Drugs affecting the nervous system Antiallergic drugs system antiparasitic drugs central nervous system Drugs affecting the sensory Antidotes nerve endings Cardiac glycosides Antibiotics CNS DEPRESSANTS (AFFECTING THE Antihypertensive drugs Sulfonamides Analgesics (opioid, AFFERENT INNERVATION) Antianginal drugs Antituberculous drugs analgesics-antipyretics, Antiarrhythmic drugs Antihelminthic drugs NSAIDs) Local anaesthetics Antihyperlipidemic drugs Antifungal drugs Sedative and hypnotic Coating drugs Spasmolytics Antiviral drugs drugs Adsorbents Drugs affecting the excretory system Antimalarial drugs Tranquilizers Astringents Diuretics Antisyphilitic drugs Neuroleptics Expectorants Drugs affecting the hemopoietic system Antiseptics Anticonvulsants Irritant drugs Drugs affecting blood coagulation Disinfectants Antiparkinsonian drugs Drugs affecting peripheral Drugs affecting erythro- and leukopoiesis General anaesthetics neurotransmitter processes Drugs affecting the digestive system CNS STIMULANTS (AFFECTING THE Anorectic drugs Psychomotor stimulants EFFERENT PART OF THE Bitter stuffs. Drugs for replacement therapy Analeptics NERVOUS SYSTEM) Antiacid drugs Antidepressants Direct-acting-cholinomimetics Antiulcer drugs Nootropics (Cognitive -
Calcium Current Block by (-)-Pentobarbital, Phenobarbital
The Journal of Neuroscience, August 1993, 13(E): 321 l-3221 Calcium Current Block by (-)-Pentobarbital, Phenobarbital, and CHEB but not (+)-Pentobarbital in Acutely Isolated Hippocampal CA1 Neurons: Comparison with Effects on GABA-activated Cl- Current Jarlath M. H. ffrench-Mullen,’ Jeffery L. Barker,* and Michael A. Rogawski3 ‘Department of Pharmacology, Zeneca Pharmaceuticals Group, Zeneca Inc., Wilmington, Delaware 19897 and *Laboratory of Neurophysiology, and 3Neuronal Excitability Section, Epilepsy Research Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland 20892 Block of a voltage-activated Ca*+ channel current by pheno- Ca*+ current, whereas the sedative effects that occur at high- barbital (PHB), 5-(2-cyclohexylideneethyl)-5-ethyl barbituric er concentrations could reflect stronger Ca2+ current block- acid (CHEB), and the optical R(-)- and S(+)-enantiomers of ade. The powerful sedative-hypnotic action of (-)-PB may pentobarbital (PB) was examined in freshly dissociated adult reflect greater maximal enhancement of GABA responses guinea pig hippocampal CA1 neurons; the effects of the in conjunction with strong inhibition of Ca2+ current. The barbiturates on GABA-activated Cl- current were also char- convulsant action of CHEB is unlikely to be related to its acterized in the same preparation. (-)-PB, PHB, and CHEB effects on the Ca*+ current. produced a reversible, concentration-dependent block of the [Key words: calcium channel, GABA receptor, (-)-pen- peak Ca*+ channel current (3 mM Ba2+ as the charge carrier) tobarbital, (+)-pentobarbital, phenobarbital, CHEB [S-(2-cy- evoked by depolarization from -80 to - 10 mV (I&,, values, clohexylideneethyl)-S-ethyl barbituric acid], CA 1 hippocam- 3.5, 72, and 118 PM, respectively). -
Execution by . . . Heroin?: Why States Should Challenge the FDA's Ban
N2_BERGS_UPDATED (DO NOT DELETE) 1/15/2017 9:55 AM Execution by . Heroin?: Why States Should Challenge the FDA’s Ban on the Importation of Sodium Thiopental Matthew C. Bergs* ABSTRACT: This Note traces the history of the lethal injection drug shortage and its impact on how states carry out the death penalty. Though this topic has received much attention in recent years, relatively little attention has been paid to the D.C. Circuit’s decision in Cook v. FDA, which exacerbated the shortage. In Cook, the D.C. Circuit enjoined the FDA from exercising its enforcement discretion to allow the importation of sodium thiopental, the primary anesthetic used by states in lethal injection executions. This decision is significant because it effectively required the FDA to ban the importation of sodium thiopental, forcing states to find other ways to carry out executions. Many states have turned to new drugs and manufacturers, while others have returned to past methods of execution. However, states’ use of alternative drugs and manufacturers has had disastrous consequences, and the return to old methods of execution constitutes an unacceptable regression towards inhumane and barbaric punishment. Thus, this Note argues that states should make every effort to obtain sodium thiopental. Potential avenues to obtain the drug include adhering to the FDA’s regulations or litigating against the FDA’s regulations. Renewed access to sodium thiopental will resolve many of the problems plaguing the administration of lethal injection. I. INTRODUCTION & BACKGROUND .................................................. 762 A. HISTORY OF LETHAL INJECTION AS A METHOD OF EXECUTION ... 763 B. DEVELOPMENT OF THE LETHAL INJECTION DRUG SHORTAGE .... -
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. -
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.