2021 Aetna Standard Plan
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Acetadote (Acetylcysteine) Injection Is Available As a 20% Solution in 30 Ml (200Mg/Ml) Single Dose Glass Vials
NDA 21-539/S-004 Page 3 Acetadote® (acetylcysteine) Injection Package Insert NDA 21-539/S-004 Page 4 RX ONLY PRESCRIBING INFORMATION ACETADOTE® (acetylcysteine) Injection For Intravenous Use DESCRIPTION Acetylcysteine injection is an intravenous (I.V.) medication for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine, NAC). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula: H CH3 N SH O COOH Acetadote is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetadote contains the following inactive ingredients: 0.5 mg/mL disodium edetate, sodium hydroxide (used for pH adjustment), and Sterile Water for Injection, USP. CLINICAL PHARMACOLOGY Acetaminophen Overdose: Acetaminophen is absorbed from the upper gastrointestinal tract with peak plasma levels occurring between 30 and 60 minutes after therapeutic doses and usually within 4 hours following an overdose. It is extensively metabolized in the liver to form principally the sulfate and glucoronide conjugates which are excreted in the urine. A small fraction of an ingested dose is metabolized in the liver by isozyme CYP2E1 of the cytochrome P-450 mixed function oxidase enzyme system to form a reactive, potentially toxic, intermediate metabolite. The toxic metabolite preferentially conjugates with hepatic glutathione to form nontoxic cysteine and mercapturic acid derivatives, which are then excreted by the kidney. -
The Promise of N-Acetylcysteine in Neuropsychiatry
Review The promise of N-acetylcysteine in neuropsychiatry 1,2,3,4 5,6 1 1,2,4 Michael Berk , Gin S. Malhi , Laura J. Gray , and Olivia M. Dean 1 School of Medicine, Deakin University, Geelong, Victoria, Australia 2 Department of Psychiatry, University of Melbourne, Parkville, Victoria, Australia 3 Orygen Research Centre, Parkville, Victoria, Australia 4 The Florey Institute of Neuroscience and Mental Health, Victoria, Australia 5 Discipline of Psychiatry, Sydney Medical School, University of Sydney, Sydney, Australia 6 CADE Clinic, Department of Psychiatry, Level 5 Building 36, Royal North Shore Hospital, St Leonards, 2065, Australia N-Acetylcysteine (NAC) targets a diverse array of factors with the pathophysiology of a diverse range of neuropsy- germane to the pathophysiology of multiple neuropsy- chiatric disorders, including autism, addiction, depression, chiatric disorders including glutamatergic transmission, schizophrenia, bipolar disorder, and Alzheimer’s and Par- the antioxidant glutathione, neurotrophins, apoptosis, kinson’s diseases [3]. Determining precisely how NAC mitochondrial function, and inflammatory pathways. works is crucial both to understanding the core biology This review summarises the areas where the mecha- of these illnesses, and to opening the door to other adjunc- nisms of action of NAC overlap with known pathophysi- tive therapies operating on these pathways. The current ological elements, and offers a pre´ cis of current literature article will initially review the possible mechanisms of regarding the use of NAC in disorders including cocaine, action of NAC, and then critically appraise the evidence cannabis, and smoking addictions, Alzheimer’s and Par- that suggests it has efficacy in the treatment of neuropsy- kinson’s diseases, autism, compulsive and grooming chiatric disorders. -
Clotrimazole Loaded Ufosomes for Topical Delivery: Formulation Development and In-Vitro Studies
molecules Article Clotrimazole Loaded Ufosomes for Topical Delivery: Formulation Development and In-Vitro Studies Pradeep Kumar Bolla 1 , Carlos A. Meraz 1, Victor A. Rodriguez 1, Isaac Deaguero 1, Mahima Singh 2 , Venkata Kashyap Yellepeddi 3,4 and Jwala Renukuntla 5,* 1 Department of Biomedical Engineering, College of Engineering, The University of Texas at El Paso, 500 W University Ave, El Paso, TX 79968, USA 2 Department of Pharmaceutical Sciences, University of the Sciences in Philadelphia, Philadelphia, PA 19104, USA 3 Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, UT 84112, USA 4 Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Salt Lake City, UT 84112, USA 5 Department of Basic Pharmaceutical Sciences, Fred Wilson School of Pharmacy, High Point University, High Point, NC 27240, USA * Correspondence: [email protected] Received: 9 August 2019; Accepted: 28 August 2019; Published: 29 August 2019 Abstract: Global incidence of superficial fungal infections caused by dermatophytes is high and affects around 40 million people. It is the fourth most common cause of infection. Clotrimazole, a broad spectrum imidazole antifungal agent is widely used to treat fungal infections. Conventional topical formulations of clotrimazole are intended to treat infections by effective penetration of drugs into the stratum corneum. However, drawbacks such as poor dermal bioavailability, poor penetration, and variable drug levels limit the efficiency. The present study aims to load clotrimazole into ufosomes and evaluate its topical bioavailability. Clotrimazole loaded ufosomes were prepared using cholesterol and sodium oleate by thin film hydration technique and evaluated for size, polydispersity index, and entrapment efficiency to obtain optimized formulation. -
TRP Mediation
molecules Review Remedia Sternutatoria over the Centuries: TRP Mediation Lujain Aloum 1 , Eman Alefishat 1,2,3 , Janah Shaya 4 and Georg A. Petroianu 1,* 1 Department of Pharmacology, College of Medicine and Health Sciences, Khalifa University of Science and Technology, Abu Dhabi 127788, United Arab Emirates; [email protected] (L.A.); Eman.alefi[email protected] (E.A.) 2 Center for Biotechnology, Khalifa University of Science and Technology, Abu Dhabi 127788, United Arab Emirates 3 Department of Biopharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, The University of Jordan, Amman 11941, Jordan 4 Pre-Medicine Bridge Program, College of Medicine and Health Sciences, Khalifa University of Science and Technology, Abu Dhabi 127788, United Arab Emirates; [email protected] * Correspondence: [email protected]; Tel.: +971-50-413-4525 Abstract: Sneezing (sternutatio) is a poorly understood polysynaptic physiologic reflex phenomenon. Sneezing has exerted a strange fascination on humans throughout history, and induced sneezing was widely used by physicians for therapeutic purposes, on the assumption that sneezing eliminates noxious factors from the body, mainly from the head. The present contribution examines the various mixtures used for inducing sneezes (remedia sternutatoria) over the centuries. The majority of the constituents of the sneeze-inducing remedies are modulators of transient receptor potential (TRP) channels. The TRP channel superfamily consists of large heterogeneous groups of channels that play numerous physiological roles such as thermosensation, chemosensation, osmosensation and mechanosensation. Sneezing is associated with the activation of the wasabi receptor, (TRPA1), typical ligand is allyl isothiocyanate and the hot chili pepper receptor, (TRPV1), typical agonist is capsaicin, in the vagal sensory nerve terminals, activated by noxious stimulants. -
PROVERA Medroxyprogesterone Acetate Tablets 2.5Mg, 5Mg, 10Mg, 100 Mg, 200 Mg Tablets
PROVERA Medroxyprogesterone acetate tablets 2.5mg, 5mg, 10mg, 100 mg, 200 mg tablets What is in this leaflet establish a regular menstrual breast cancer or breast lumps cycle not diagnosed by your doctor This leaflet answers some common bleeding or discharge from questions about PROVERA. It does certain types of cancer including your nipples not contain all the available cancer of the breast, kidney and information. It does not take the endometrium (the lining of the miscarriage place of talking to your doctor or womb). pharmacist. cancer of the womb or ovary PROVERA, in combination with an uncontrolled high blood estrogen containing medicine, is All medicines have risks and pressure. benefits. Your doctor has weighed used to relieve symptoms of the risks of you taking PROVERA menopause in women with an intact Do not take PROVERA if you are against the benefits it is expected to uterus. This is called hormone pregnant or intend to become have for you. replacement therapy (HRT). pregnant. PROVERA is used to protect the If you have any concerns about lining of the uterus while the PROVERA may affect your taking this medicine, ask your estrogens relieve the symptoms of developing baby if you take it doctor or pharmacist. Keep this menopause. PROVERA is not during pregnancy. leaflet with your medicine. suitable as a HRT treatment in women who have undergone a Do not take PROVERA if the You may need to read it again. hysterectomy. packaging is torn or shows signs of tampering. Do not take Your doctor may have prescribed PROVERA after the expiry date What PROVERA is PROVERA for another purpose. -
Liquid Spray Formulations for Buccal Delivery of Cannabinoids
(19) TZZ_¥__T (11) EP 1 361 864 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/08 (2006.01) A61K 9/107 (2006.01) 04.12.2013 Bulletin 2013/49 A61K 36/185 (2006.01) (21) Application number: 02712063.3 (86) International application number: PCT/GB2002/000620 (22) Date of filing: 14.02.2002 (87) International publication number: WO 2002/064109 (22.08.2002 Gazette 2002/34) (54) LIQUID SPRAY FORMULATIONS FOR BUCCAL DELIVERY OF CANNABINOIDS FLÜSSIGE SPRAY FORMULIERUNGEN ZUR BUCCALEN VERABREICHUNG VON CANNABINOIDEN PREPARATIONS DE SPRAY LIQUIDE POUR L’ADMINISTRATION BUCCALE DE CANNABINOIDES (84) Designated Contracting States: (74) Representative: Schiller, Dominic Christopher et AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU al MC NL PT SE TR Harrison Goddard Foote LLP Designated Extension States: 4th Floor, Merchant Exchange RO SI 17-19 Whitworth Street West Manchester M1 5WG (GB) (30) Priority: 14.02.2001 GB 0103638 30.03.2001 US 280044 P (56) References cited: 05.04.2001 US 827158 WO-A-00/25127 WO-A-01/66089 11.05.2001 GB 0111597 WO-A-95/25504 WO-A1-02/32420 07.09.2001 GB 0121715 WO-A1-02/069993 US-A- 3 560 625 12.09.2001 US 951022 • EITAN ALHANATY; ET AL.: "Osmotic fragility of (43) Date of publication of application: liposomes as affected by antihemolytic 19.11.2003 Bulletin 2003/47 compounds" BIOCHIMICA ET BIOPHYSICA ACTA, vol. 339, no. 1, 1974, pages 146-155, (60) Divisional application: XP008008726 10180611.5 / 2 286 793 • PATRICIA S. -
California Essential Drug List
California Essential Drug List The Essential Drug List (formulary) includes a list of drugs covered by Health Net. The drug list is updated at least monthly and is subject to change. All previous versions are no longer in effect. You can view the most current drug list by going to our website at www.healthnet.com. Refer to Evidence of Coverage or Certificate of Insurance for specific cost share information. For California Individual & Family Plans: Drug Lists Select Health Net Large Group – Formulary (pdf). For Small Business Group: Drug Lists Select Health Net Small Business Group – Formulary (pdf). NOTE: To search the drug list online, open the (pdf) document. Hold down the “Control” (Ctrl) and “F” keys. When the search box appears, type the name of your drug and press the “Enter” key. If you have questions or need more information call us toll free. California Individual & Family Plans (off-Exchange) If you have questions about your pharmacy coverage call Customer Service at 1-800-839-2172 California Individual & Family Plans (on-Exchange) If you have questions about your pharmacy coverage call Customer Service at 1-888-926-4988 Hours of Operation 8:00am – 7:00pm Monday through Friday 8:00am – 5:00pm Saturday Small Business Group If you have questions about your pharmacy coverage call Customer Service at 1-800-361-3366 Hours of Operation 8:00am – 6:00pm Monday through Friday Updated September 1, 2021 Health Net of California, Inc. and Health Net Life Insurance Company are subsidiaries of Health Net, LLC and Centene Corporation. Health Net is a registered service mark of Health Net, LLC Table of Contents What If I Have Questions Regarding My Pharmacy Benefit? ................................... -
(12) United States Patent (10) Patent No.: US 9,713,596 B2 Hong Et Al
USOO9713596B2 (12) United States Patent (10) Patent No.: US 9,713,596 B2 Hong et al. (45) Date of Patent: Jul. 25, 2017 (54) BAKUCHOL COMPOSITIONS FOR FOREIGN PATENT DOCUMENTS TREATMENT OF POST INFLAMMATORY DE 1900 435 7, 1970 HYPERPGMENTATION DE 3417234 A1 * 11, 1985 JP H1171231 A * 3, 1999 ............... A61K 7.00 (75) Inventors: Mei Feng Hong, Lacey, WA (US); Qi JP 2000-327581 A 11 2000 Jia, Olympia, WA (US); Lidia Alfaro JP 2005325 120 A 11/2005 KR 2000-0007648 A 2, 2000 Brownell, Tacoma, WA (US) WO 2006/122160 A2 11/2006 WO 2008. 140673 A1 11, 2008 (73) Assignee: Unigen, Inc., Lacey, WA (US) (*) Notice: Subject to any disclaimer, the term of this OTHER PUBLICATIONS patent is extended or adjusted under 35 Ohno, O. Watabe, T., Kazuhiko, N., Kawagoshi, M., Uotsu, N., U.S.C. 154(b) by 0 days. Chiba, T., Yamada, M., Yamaguchi, K., Yamada, K., Miyamoto, K., Uemura, D. Inhibitory Effects of Bakuchiol, Bavachin, an (21) Appl. No.: 13/365,172 Isobavachalcone Isolated from Piper loungum on Melainin Produc (22) Filed: Feb. 2, 2012 tion in B 16 Mouse Melanoma Cells. Biosci. Biotechnol. Biochem. 74 (7), 1504-1506 (2010).* Prior Publication Data Hiroyuki Haraguchi, Junji Inoue, Yukiyoshi Tamura and Kenji (65) Mizutani.Antioxidative Components of Psoralea corylifolia US 2012/O2O1769 A1 Aug. 9, 2012 (Leguminosae). Phytother. Res. 16, 539-544 (2002).* Petra Clara Arck, et al. Towards a “free radical theory of graying: melanocyte apoptosis in the aging human hair follicle is an indicator Related U.S. Application Data of oxidative stress induced tissue damage. -
Interactions with PBC Agents
www.hep-druginteractions.org Interactions with PBC Agents Charts created March 2020. Full information available at www.hep-druginteractions.org Page 1 of 4 Please note that if a drug is not listed it cannot automatically be assumed it is safe to coadminister. Obeticholic Ursodeoxycholic Obeticholic Ursodeoxycholic Obeticholic Ursodeoxycholic Acid Acid Acid Acid Acid Acid Anaesthetics & Muscle Relaxants Antibacterials (continued) Antidepressants Bupivacaine Cloxacillin Agomelatine Cisatracurium Dapsone Amitriptyline Isoflurane Delamanid Bupropion Ketamine Ertapenem Citalopram Nitrous oxide Erythromycin Clomipramine Propofol Ethambutol Desipramine Thiopental Flucloxacillin Desvenlafaxine Tizanidine Gentamicin Dosulepin Analgesics Imipenem Doxepin Aceclofenac Isoniazid Duloxetine Alfentanil Escitalopram Aspirin Levofloxacin Linezolid Fluoxetine Buprenorphine Fluvoxamine Lymecycline distribution. Celecoxib Imipramine Meropenem Codeine Lithium Methenamine Dexketoprofen Maprotiline Metronidazole Dextropropoxyphene Mianserin Moxifloxacin Diamorphine Milnacipran Diclofenac Nitrofurantoin only. Not for distribution. for only. Not Mirtazapine Diflunisal Norfloxacin Moclobemide Dihydrocodeine Ofloxacin Nefazodone Etoricoxib Penicillin V Nortriptyline Fentanyl Piperacillin Paroxetine Flurbiprofen Pivmecillinam Sertraline Hydrocodone use ersonal Pyrazinamide Tianeptine Hydromorphone Rifabutin Trazodone Ibuprofen Rifampicin -
210951Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 210951Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review CDTL review is complete and has been added to the NDA/BLA Multidisciplinary Review and Evaluation. My recommendation for this application is regular approval. Reference ID: 4220973 --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- CHANA WEINSTOCK 02/14/2018 Reference ID: 4220973 NDA/BLA Multi-Disciplinary Review and Evaluation NDA 210951 Erleada (apalutamide) NDA/BLA Multi-disciplinary Review and Evaluation Application Type NDA Application Number(s) 210951 Priority or Standard Priority Submit Date(s) October 09, 2017 Received Date(s) October 10, 2017 PDUFA Goal Date April 10, 2018 Division/Office DOP1/OHOP Review Completion Date February 13, 2018 Established Name Apalutamide (Proposed) Trade Name Erleada Pharmacologic Class Androgen receptor inhibitor Code name JNJ-56021927, ARN-509 Applicant Aragon Pharmaceuticals, Inc., represented by Janssen Research & Development, LLC. Formulation(s) 60 mg tablets Dosing Regimen 240 mg Applicant -
Does Your Patient Have Bile Acid Malabsorption?
NUTRITION ISSUES IN GASTROENTEROLOGY, SERIES #198 NUTRITION ISSUES IN GASTROENTEROLOGY, SERIES #198 Carol Rees Parrish, MS, RDN, Series Editor Does Your Patient Have Bile Acid Malabsorption? John K. DiBaise Bile acid malabsorption is a common but underrecognized cause of chronic watery diarrhea, resulting in an incorrect diagnosis in many patients and interfering and delaying proper treatment. In this review, the synthesis, enterohepatic circulation, and function of bile acids are briefly reviewed followed by a discussion of bile acid malabsorption. Diagnostic and treatment options are also provided. INTRODUCTION n 1967, diarrhea caused by bile acids was We will first describe bile acid synthesis and first recognized and described as cholerhetic enterohepatic circulation, followed by a discussion (‘promoting bile secretion by the liver’) of disorders causing bile acid malabsorption I 1 enteropathy. Despite more than 50 years since (BAM) including their diagnosis and treatment. the initial report, bile acid diarrhea remains an underrecognized and underappreciated cause of Bile Acid Synthesis chronic diarrhea. One report found that only 6% Bile acids are produced in the liver as end products of of British gastroenterologists investigate for bile cholesterol metabolism. Bile acid synthesis occurs acid malabsorption (BAM) as part of the first-line by two pathways: the classical (neutral) pathway testing in patients with chronic diarrhea, while 61% via microsomal cholesterol 7α-hydroxylase consider the diagnosis only in selected patients (CYP7A1), or the alternative (acidic) pathway via or not at all.2 As a consequence, many patients mitochondrial sterol 27-hydroxylase (CYP27A1). are diagnosed with other causes of diarrhea or The classical pathway, which is responsible for are considered to have irritable bowel syndrome 90-95% of bile acid synthesis in humans, begins (IBS) or functional diarrhea by exclusion, thereby with 7α-hydroxylation of cholesterol catalyzed interfering with and delaying proper treatment. -
(12) United States Patent (10) Patent No.: US 9.498,431 B2 Xu Et Al
USOO9498431B2 (12) United States Patent (10) Patent No.: US 9.498,431 B2 Xu et al. (45) Date of Patent: Nov. 22, 2016 (54) CONTROLLED RELEASING COMPOSITION 7,053,134 B2 * 5/2006 Baldwin et al. .............. 522,154 2004/0058056 A1 3/2004 Osaki et al. ................... 427.2.1 (76) Inventors: Jianjian Xu, Hefei (CN); Shiliang 2005/0037047 A1 2/2005 Song Wang, Hefei (CN); Manzhi Ding 2007/0055364 A1* 3/2007 Hossainy .................. A61F 2/82 s: s s 623, 1.38 Hefei (CN) 2008/0274194 A1* 11/2008 Miller .................... A61K 9.146 424/489 (*) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 FOREIGN PATENT DOCUMENTS U.S.C. 154(b) by 0 days. CN 1208.610 A 2, 1999 (21) Appl. No.: 13/133,656 EP O251680 A2 1, 1988 JP S63-22516. A 1, 1988 JP H1O-310518 A 11, 1998 (22) PCT Filed: Dec. 10, 2009 WO 96,10395 A1 4f1996 WO WO 2005.000277 A1 * 1, 2005 (86). PCT No.: PCT/CN2009/075468 WO 2007 115045 A2 10, 2007 WO 2008/OO2657 A2 1, 2008 S 371 (c)(1), WO 2008OO2657 A2 1, 2008 (2), (4) Date: Jun. 9, 2011 WO 2008041246 A2 4/2008 (87) PCT Pub. No.: WO2010/066203 OTHER PUBLICATIONS PCT Pub. Date: Jun. 17, 2010 Crowley and Zhang, Pharmaceutical Application of Hot Melt Extru (65) Prior Publication Data sion: Part I, Drug Development and Industrial Pharmacy, 2007. 33:909-926.* US 2011/024.4043 A1 Oct. 6, 2011 The Use of Poly (L-Lactide) and RGD Modified Microspheres as Cell Carriers in a Flow Intermittency Bioreactor for Tissue Engi (30) Foreign Application Priority Data neering Cartilage.