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( 12 ) United States Patent
US010376507B2 (12 ) United States Patent (10 ) Patent No. : US 10 , 376 , 507 B2 Srinivasan et al. (45 ) Date of Patent: Aug. 13 , 2019 CRESEMBA® ( isavuconazonium sulfate ) , Highlights of Prescrib (54 ) METHOD OF TREATING A PATIENT WITH ing Information , Label ; Patient Information approved by the U . S . A CYP3A4 SUBSTRATE DRUG Food and Drug Administration ; Astellas Pharma US , Inc. ( Licensed from Basilea Pharmaceutics International Ltd . ) , Illinois, USA , Ini (71 ) Applicant: Bow River LLC , Corona Del Mar , CA tial U . S . Approval: 2015 , Revised Mar. 2015 , Reference ID : 3712237, ( US ) 28 pages . DIFLUCAN® ( fluconazole ), Label ; Patient Information , Reference ( 72 ) Inventors : Sundar Srinivasan , Corona Del Mar, ID : 3650838 , Roerig , Division of Pfizer Inc ., New York , NY, Revised Mar. 2013 , 35 pages. CA (US ) ; Christina Chow , Seattle , WA NIZORAL® (ketoconazole )Label ; Patient Information approved by (US ) the U . S . Food and Drug Administration , Reference ID : 3458324 , Copyright 2014 Janssen Pharmaceuticals, Inc . , New Jersey, USA , ( 73 ) Assignee : BOW RIVER LLC , Corona del Mar , Revised Feb . 2014 , 23 pages . NOXAFIL® (posaconazole ) , Highlights of Prescribing Informa CA (US ) tion , Label ; Patient Information approved by the U . S . Food and Drug Administration ; Copyright © 2006 , 2010 , 2013 , 2014 Merck ( * ) Notice : Subject to any disclaimer , the term of this Sharp & Dohme Corp . , a subsidiary of Merck & Co ., Inc ., New patent is extended or adjusted under 35 Jersey , USA , Revised Sep . 2016 , Reference ID : 3983525, 37 pages . U . S . C . 154 (b ) by 0 days. ORAVIG® (miconazole ) , Highlights of Prescribing Information , Label ; Patient Information approved by the U . S . Food and Drug Administration ; Copyright 2012 Praelia Pharmaceuticals , Inc . , North (21 ) Appl. -
Anthem Blue Cross Drug Formulary
Erythromycin/Sulfisoxazole (generic) INTRODUCTION Penicillins ...................................................................... Anthem Blue Cross uses a formulary Amoxicillin (generic) (preferred list of drugs) to help your doctor Amoxicillin/Clavulanate (generic/Augmentin make prescribing decisions. This list of drugs chew/XR) is updated quarterly, by a committee Ampicillin (generic) consisting of doctors and pharmacists, so that Dicloxacillin (generic) the list includes drugs that are safe and Penicillin (generic) effective in the treatment of diseases. If you Quinolones ..................................................................... have any questions about the accessibility of Ciprofloxacin/XR (generic) your medication, please call the phone number Levofloxacin (Levaquin) listed on the back of your Anthem Blue Cross Sulfonamides ................................................................ member identification card. Erythromycin/Sulfisoxazole (generic) In most cases, if your physician has Sulfamethoxazole/Trimethoprim (generic) determined that it is medically necessary for Sulfisoxazole (generic) you to receive a brand name drug or a drug Tetracyclines .................................................................. that is not on our list, your physician may Doxycycline hyclate (generic) indicate “Dispense as Written” or “Do Not Minocycline (generic) Substitute” on your prescription to ensure Tetracycline (generic) access to the medication through our network ANTIFUNGAL AGENTS (ORAL) _________________ of community -
2021 National Formulary 3Rd Quarter Edition
2021 National Formulary 3rd Quarter Edition Last Revised: 08/18/2021 Version 2021Q3c Table of Contents OVERVIEW 4 CARDIOVASCULAR (HEART) DRUGS 14 Alpha & Beta Blockers 14 COVERAGE LIMITATION 4 Antihypertensive Combinations 14 Calcium Channel Blockers (CCBs) 14 COMPOUNDED DRUGS 4 ACE Inhibitors without & with Diuretics 15 DRUG PLACEMENT DETERMINATION 4 ACE Inhibitors / CCB Combinations 15 ARBs without & with Diuretics 15 PREFERRED BRAND PRODUCTS 5 ARB Combinations 15 Naprilysin Inhibitors 15 GENERIC SUBSTITUTION 5 Diuretics 15 Renin Inhibtors 16 SINGLE & DUAL SOURCE GENERICS 5 Antiarrhythmics/Anti-Ischemic 16 Cardiac Glycosides 16 PRIOR AUTHORIZATIONS, STEP EDITS & QTY LIMITS 6 Vasodilators, Coronary, Nitrates/Vasodilators, Sympatholytics 16 EXCLUDED DRUGS 6 Other Drugs 16 NON-LISTED DRUGS & DRUG CATEGORIES 7 ANTIHYPERLIPIDEMIC (CHOLESTEROL) DRUGS 17 Statins & Statin/CCB Combinations 17 FORMULARY MODIFICATIONS & CHANGES 7 Bile Acid Sequestrants, Liver Drugs 17 Fibrates 17 BIOSIMILARS 7 ACL Inhibitors 17 Other Drugs 17 MAJOR CHANGES TO THE PDL 7 PANCREATIC DRUGS 18 ANTIBIOTICS 8 Penicillins & Cephalosporins 8 KIDNEY & URINARY / UROLOGICAL DRUGS 18 Tetracyclines 8 Benign Prostate Hyperplasia 18 Macrolides & Clindamycins 8 Urologic Drugs / Other Drugs 18 Sulfonamides, Sulfones & Ketolides 8 Erectile Dysfunction Drugs 18 Quinolones 8 Gout Drugs – Purine Inhibitors 19 Miscellaneous Antibiotics 8 Urinary Ph Modifiers 19 Potassium & Electrolytes 19 ANTI-VIRALS 9 Phosphorus/Calcium/Electrolyte Depleters 19 General Antivirals 9 HIV Antiviral Drugs 9 OSTEOPOROSIS (BONE) DRUGS 20 HIV Pre-Exposure Propylaxis Drugs 9 ANTI-INFLAMMATORY / ANALGESIC (PAIN) DRUGS 20 ANTI-INFECTIVES 10 Anti-Inflammatory Drugs (NSAIDS) 20 Anaerobic Anti-Infectives 10 COX-II Drugs 21 Antiparasitics 10 Analgesics, Narcotics (Opioids) 21 Antimalarials & Antiprotozoals 10 Analgesics, Salicylates, Non-Salicylates, Other 21 Antihelmintic Drugs 10 CENTRAL NERVOUS SYSTEM DRUGS 22 ANTIEMETICS 10 Anti-Anxiety Drugs (Benzodiazepines) 22 Sedative/Sleeping Drugs 22 NEUROLOGIC DRUGS 11 A.D.D. -
Addyi Generic Name: Flibanserin Manufacturer
Brand Name: Addyi Generic Name: Flibanserin Manufacturer: Sprout Pharmaceuticals Drug Class: Central Nervous System Agent, Serotonin Agonist, Dopamine antagonist Uses: Labeled Uses: Indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. Unlabeled Uses: none. Mechanism of Action: The mechanism of action for flibanserin in the treatment of hypoactive sexual desire disorder is unknown. Flibanserin has high affinity for serotonin (5-hydroxytryptamine or 5-HT) 1A receptors, as an agonist, and 5-HT2A receptors, as an antagonist, and moderate affinity for 5- HT2B, 5-HT2C, and dopamine D4 receptors as an antagonist Pharmacokinetics: Absorption: Tmax 0.75 hours Vd 50L t ½ 11 hours Clearance Not reported Protein binding 98% (albumin) Bioavailability 33% Metabolism: Flibanserin is extensively metabolized primarily by CYP3A4 and, to a lesser extent, CYP2C19 to at least 35 metabolites, with most of the metabolites occurring in low concentrations in plasma. Elimination: Flibanserin is primarily excreted through the kidneys in to urine (44%) and feces (51%). Two metabolites could be characterized that showed plasma concentration similar to that achieved with flibanserin: 6,21-dihydroxy-flibanserin-6,21-disulfate and 6- hydroxy-flibanserin-6-sulfate. These two metabolites are inactive. Efficacy: Katz M, DeRogatis LR, Ackerman R, et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. J Sex Med. -
M2021: Pharmacogenetic Testing
Pharmacogenetic Testing Policy Number: AHS – M2021 – Pharmacogenetic Prior Policy Name and Number, as applicable: Testing • M2021 – Cytochrome P450 Initial Presentation Date: 06/16/2021 Revision Date: N/A I. Policy Description Pharmacogenetics is defined as the study of variability in drug response due to heredity (Nebert, 1999). Cytochrome (CYP) P450 enzymes are a class of enzymes essential in the synthesis and breakdown metabolism of various molecules and chemicals. Found primarily in the liver, these enzymes are also essential for the metabolism of many medications. CYP P450 are essential to produce many biochemical building blocks, such as cholesterol, fatty acids, and bile acids. Additional cytochrome P450 are involved in the metabolism of drugs, carcinogens, and internal substances, such as toxins formed within cells. Mutations in CYP P450 genes can result in the inability to properly metabolize medications and other substances, leading to increased levels of toxic substances in the body. Approximately 58 CYP genes are in humans (Bains, 2013; Tantisira & Weiss, 2019). Thiopurine methyltransferase (TPMT) is an enzyme that methylates azathioprine, mercaptopurine and thioguanine into active thioguanine nucleotide metabolites. Azathioprine and mercaptopurine are used for treatment of nonmalignant immunologic disorders; mercaptopurine is used for treatment of lymphoid malignancies; and thioguanine is used for treatment of myeloid leukemias (Relling et al., 2011). Dihydropyrimidine dehydrogenase (DPD), encoded by the gene DPYD, is a rate-limiting enzyme responsible for fluoropyrimidine catabolism. The fluoropyrimidines (5-fluorouracil and capecitabine) are drugs used in the treatment of solid tumors, such as colorectal, breast, and aerodigestive tract tumors (Amstutz et al., 2018). A variety of cell surface proteins, such as antigen-presenting molecules and other proteins, are encoded by the human leukocyte antigen genes (HLAs). -
Long-Term Administration of Tolvaptan to Patients with Decompensated
Int. J. Med. Sci. 2020, Vol. 17 874 Ivyspring International Publisher International Journal of Medical Sciences 2020; 17(7): 874-880. doi: 10.7150/ijms.41454 Research Paper Long-term administration of Tolvaptan to patients with decompensated cirrhosis Kengo Kanayama1, Tetsuhiro Chiba1, Kazufumi Kobayashi1, Keisuke Koroki1, Susumu Maruta1, Hiroaki Kanzaki1, Yuko Kusakabe1, Tomoko Saito1, Soichiro Kiyono1, Masato Nakamura1, Sadahisa Ogasawara1, Eiichiro Suzuki1, Yoshihiko Ooka1, Shingo Nakamoto1, Shin Yasui1, Tatsuo Kanda2, Hitoshi Maruyama3, Jun Kato1, Naoya Kato1 1. Department of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. 2. Department of Gastroenterology and Hepatology, Nihon University School of Medicine, 30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo 173-8610, Japan. 3. Department of Gastroenterology, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan. Corresponding author: Tetsuhiro Chiba, M.D., Ph.D. Department of Gastroenterology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. Telephone: +81-43-2262083, Fax: +81-43-2262088, E-mail: [email protected]. © The author(s). This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/). See http://ivyspring.com/terms for full terms and conditions. Received: 2019.10.24; Accepted: 2020.02.20; Published: 2020.03.15 Abstract Aim: Tolvaptan, an oral vasopressin-2 antagonist, sometimes improves hepatic edema including ascites in patients with decompensated cirrhosis. In this study, we examined the effectiveness and survival advantage in patients with the long-term administration of tolvaptan. -
Efficacy and Safety of Imiquimod for Verruca Planae: a Systematic Review
Global Dermatology Research Article ISSN: 2056-7863 Efficacy and safety of imiquimod for verruca planae: A systematic review Xin-rui Zhang#, Bi-huan Xiao#, Rui-qun Qi*, and Xing-hua Gao* Department of Dermatology, No 1 Hospital of China Medical University, Shenyang 110001, PR China #These authors contributed equally to this work Abstract Objective: To assess the efficacy and safety of imiquimod for treating verruca planae. Methods: We searched the Pubmed, Cochrane Register of Controlled Trials, EMbase, CBM, CNKI and Wanfang databases (Chinese) to collect randomized controlled trials (RCTs). We screened the retrieved studies according to the predefined inclusion and exclusion criteria, evaluated the quality of include studies, and performed meta-analyses using the Cochrane Collaboration’s RevMan 5.1. Software. Results: Twenty-six RCTs involving 2169 patients with verruca planae were included and assessed. At the end of the 6th and ≥8th week, the effective rate of topical imiquimod was obviously higher than that of control [ RR=1.42, 95%CI (1.27, 1.60), P <0.00001; RR=1.43, 95%CI (1.22,1.67), P<0.00001]. The effective rate of imiquimod cream was higher than tretinoin cream, tazarotene gel and other antiviral drugs. [RR=1.41, 95%CI (1.25, 1.59), P <0.00001; RR=1.76, 95%CI (1.48, 2.10), P<0.00001; RR=1.71, 95%CI (1.29, 2.26), P =0.0002]. However, the effectiverate of imiquimod cream was lower than 5-ALA-PDT (RR=0.6, 95%CI (0.5, 0.71), P<0.00001). Conclusions: The limited evidence demonstrates that topical imiquimod is safe and efficient. -
Treating the Oral Creeper: Herpes
ISSN: 2574-1241 Volume 5- Issue 4: 2018 DOI: 10.26717/BJSTR.2018.08.001639 Karthik D Yadav. Biomed J Sci & Tech Res Short Communication Open Access Treating the Oral Creeper: Herpes Yadav Karthik D1*, Pai Anuradha2, R Shesha Prasad3, Yaji Anisha4 1M.D.S - Master of Dental surgery, Department of oral medicine and radiology, Bangalore 2HOD & Professor, Department of oral medicine and radiology, The oxford dental college and research center, Bangalore 3M.D.S - Master of Dental surgery, Department of oral medicine and radiology, Senior lecturer, The oxford dental college and research center, Bangalore 4M.D.S – Master of Dental surgery, Department of oral medicine and radiology, Bangalore Received: August 19, 2018; Published: August 24, 2018 *Corresponding author: Karthik D Yadav, 10th Milestone, Bommanahalli, Hosur Road, Bangalore-560 102, India Short Communication combination of all these drugs is more effective in treating HSV The term “herpes” creates panic among the general population. infections than the anesthetic preparations alone. They are also Oral herpes simplex virus is most commonly seen affecting the oral soft tissue region the perioral area [1,2]. They have been categorized treating HSV. Further, ice can be used and lip materials containing into HSV -1 and HSV -2, wherein HSV-1 affects the orofacial region, used with systemic antiviral agents for increased efficacy while cocoa, lanolin and petroleum products have been recommended to most commonly above the waist region and HSV-2 affects the treat recurrent herpes [6]. genital region below the waist. However, change in sexual practices have been the basis for the variations of the virus, affecting the While the use of topical drugs has few adverse effects and are non-conventional regions of the body [3,4]. -
Medperform Low Formulary July 2017
MedPerform Low Formulary July 2017 Foreword FORMULARY This document represents the efforts of the MedImpact Healthcare Systems EXCLUDED THERAPEUTIC THERAPEUTIC DRUG CLASS Pharmacy and Therapeutics (P & T) and Formulary Committees to provide DRUGS physicians and pharmacists with a method to evaluate the safety, efficacy and cost- ALTERNATIVES effectiveness of commercially available drug products. A structured approach to the clindamycin/tretinoin, VELTIN ACNE AGENTS, TOPICAL drug selection process is essential in ensuring continuing patient access to rational ZIANA drug therapies. The ultimate goal of the MedPerform Formulary is to provide a morphine sulfate ER process and framework to support the dynamic evolution of this document to guide tablets, oxycodone ER, ANALGESICS, prescribing decisions that reflect the most current clinical consensus associated KADIAN with drug therapy decisions. NUCYNTA, NUCYNTA NARCOTICS ER This is accomplished through the auspices of the MedImpact P & T and Formulary ANALGESICS, BELBUCA BUTRANS PATCH Committees. These committees meet quarterly and more often as warranted to NARCOTICS ensure clinical relevancy of the Formulary. To accommodate changes to this ABSTRAL, document, updates are made accessible as necessary. FENTORA, ANALGESICS, LAZANDA, fentanyl citrate lozenge As you use this Formulary, you are encouraged to review the information and NARCOTICS provide your input and comments to the MedImpact P & T and Formulary ONSOLIS, Committees. SUBSYS immediate-release GRALISE ANTICONVULSANTS The MedImpact -
Herpes Simplex Virus
HSV Herpes simplex virus HSV (Herpes simplex virus) can be spread when an infected person is producing and shedding the virus. Herpes simplex can be spread through contact with saliva, such as sharing drinks. Symptoms of herpes simplex virus infection include watery blisters in the skin or mucous membranes of the mouth, lips or genitals. Lesions heal with ascab characteristic of herpetic disease. As neurotropic and neuroinvasive viruses, HSV-1 and -2 persist in the body by becoming latent and hiding from the immune system in the cell bodies of neurons. After the initial or primary infection, some infected people experience sporadic episodes of viral reactivation or outbreaks. www.MedChemExpress.com 1 HSV Inhibitors (Z)-Capsaicin 1-Docosanol (Zucapsaicin; Civamide; cis-Capsaicin) Cat. No.: HY-B1583 (Behenyl alcohol) Cat. No.: HY-B0222 (Z)-Capsaicin is the cis isomer of capsaicin, acts 1-Docosanol is a saturated fatty alcohol used as an orally active TRPV1 agonist, and is used in traditionally as an emollient, emulsifier, and the research of neuropathic pain. thickener in cosmetics, and nutritional supplement; inhibitor of lipid-enveloped viruses including herpes simplex. Purity: 99.96% Purity: ≥98.0% Clinical Data: Launched Clinical Data: Launched Size: 10 mM × 1 mL, 10 mg, 50 mg Size: 500 mg 2-Deoxy-D-glucose 20(R)-Ginsenoside Rh2 (2-DG; 2-Deoxy-D-arabino-hexose; D-Arabino-2-deoxyhexose) Cat. No.: HY-13966 Cat. No.: HY-N1401 2-Deoxy-D-glucose is a glucose analog that acts as 20(R)-Ginsenoside Rh2, a matrix a competitive inhibitor of glucose metabolism, metalloproteinase (MMP) inhibitor, acts as a inhibiting glycolysis via its actions on hexokinase. -
(Flibanserin) (Flibanserin) Tablets
™ MEDICATION GUIDE addyi ADDYI™ (add-ee) (flibanserin) (flibanserin) Tablets Read this Medication Guide before you start taking ADDYI™ and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor. What is the most important information I should know about ADDYI? Your risk of severe low blood pressure and fainting (loss of consciousness) is increased if you take ADDYI and: • drink alcohol. Do not drink alcohol if you take ADDYI. • take certain prescription medicines, over-the-counter medicines, or herbal supplements. Do not take or start taking any prescription medicines, over-the-counter medicines, or herbal supplements while taking ADDYI until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking ADDYI. • have liver problems. Do not take ADDYI if you have liver problems. If you take ADDYI and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you faint (lose consciousness). If you faint (lose consciousness), tell your doctor as soon as you can. ADDYI is only available through the ADDYI Risk Evaluation and Mitigation Strategy (REMS) Program because of the increased risk of severe low blood pressure and fainting (loss of consciousness) with alcohol use. You can only get ADDYI from pharmacies that are enrolled in the ADDYI REMS Program. For more information about the Program and a list of pharmacies that are enrolled in the ADDYI REMS Program, go to www.AddyiREMS.com or call 1-844-PINK-PILL (1-844- 746-5745). -
Subject: Samsca (Tolvaptan) Original Effective Date: 07/27/15
Subject: Samsca (tolvaptan) Original Effective Date: 07/27/15 Policy Number: MCP-252 Revision Date(s): Review Date(s): 12/15/2016; 6/22/2017 DISCLAIMER This Medical Policy is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a particular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusion(s) or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the CMS website. The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this Molina Clinical Policy (MCP) document and provide the directive for all Medicare members. SUMMARY OF EVIDENCE/POSITION This policy addresses the coverage of Samsca (tolvaptan) for the treatment of clinically significant hypervolemic and euvolemic hyponatremia when appropriate criteria are met.