Combined Index to USP 43 and NF 38, Volumes 1–5
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Additions and Deletions to the Drug Product List
Prescription and Over-the-Counter Drug Product List 40TH EDITION Cumulative Supplement Number 09 : September 2020 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> AA STRIDES PHARMA 325MG;50MG;40MG A 203647 001 Sep 21, 2020 Sep NEWA ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE >D> AA WOCKHARDT BIO AG 120MG/5ML;12MG/5ML A 087006 001 Jul 22, 1981 Sep DISC >A> @ 120MG/5ML;12MG/5ML A 087006 001 Jul 22, 1981 Sep DISC TABLET;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE >A> AA NOSTRUM LABS INC 300MG;15MG A 088627 001 Mar 06, 1985 Sep CAHN >A> AA 300MG;30MG A 088628 001 Mar 06, 1985 Sep CAHN >A> AA ! 300MG;60MG A 088629 001 Mar 06, 1985 Sep CAHN >D> AA TEVA 300MG;15MG A 088627 001 Mar 06, 1985 Sep CAHN >D> AA 300MG;30MG A 088628 001 Mar 06, 1985 Sep CAHN >D> AA ! 300MG;60MG A 088629 001 Mar 06, 1985 Sep CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> @ CEROVENE INC 325MG;5MG A 211690 001 Feb 07, 2020 Sep CAHN >A> @ 325MG;7.5MG A 211690 002 Feb 07, 2020 Sep CAHN >A> @ 325MG;10MG A 211690 003 Feb 07, 2020 Sep CAHN >D> AA VINTAGE PHARMS 300MG;5MG A 090415 001 Jan 24, 2011 Sep DISC >A> @ 300MG;5MG A 090415 001 Jan 24, 2011 Sep DISC >D> AA 300MG;7.5MG A 090415 002 Jan 24, 2011 Sep DISC >A> @ 300MG;7.5MG A 090415 002 Jan 24, 2011 Sep DISC >D> AA 300MG;10MG A 090415 003 Jan 24, 2011 Sep DISC >A> @ 300MG;10MG A 090415 003 Jan 24, 2011 Sep DISC >D> @ XIROMED 325MG;5MG A 211690 -
Insomnia and Anxiety in Older People Sleeping Pills Are Usually Not the Best Solution
® Insomnia and anxiety in older people Sleeping pills are usually not the best solution lmost one-third of older people in the people who take one of United States take sleeping pills. These these medicines sleep medicines are also sometimes called only a little longer and A“sedative-hypnotics” or “tranquilizers.” They better than those who affect the brain and spinal cord. don’t take a medicine. Doctors prescribe some of these medicines Sleeping pills can for sleep problems. Some of these medicines have serious side effects. also can be used to treat other conditions, such All sedative-hypnotic medicines have special as anxiety or alcohol withdrawal. Sometimes, risks for older adults. Seniors are likely to be doctors also prescribe certain anti-depressants more sensitive to the medicines’ effects than for sleep, even though that’s not what they’re younger adults. And these medicines may designed to treat. stay in older people’s bodies longer. These Most older adults should first try to treat their medicines can cause confusion and memory insomnia without medicines. According to the problems that: American Geriatrics Society, there are safer and • Increase the risk of falls and hip fractures. better ways to improve sleep or reduce anxiety. These are common causes of hospital stays Here’s why: and death in older people. Sleeping pills may not help much. • Increase the risk of car accidents. Many ads say that sleeping pills help people get a full, restful night’s sleep. But studies show that this is not exactly true in real life. On average, The new “Z” medicines also have risks. -
Drug & Alcohol Testing Program
Pottawattmie County Drug & Alcohol Testing Program Appendix A Table of Contents POLICY STATEMENT ...................................................................................................................................... 3 SCOPE ............................................................................................................................................................ 4 EDUCATION AND TRAINING .......................................................................................................................... 4 DESIGNATED EMPLOYER REPRESENTATIVE (DER): ....................................................................................... 5 DUTY TO COOPERATE ................................................................................................................................... 5 EMPLOYEE ADMISSION OF ALCOHOL AND CONTROLLED SUBSTANCE USE: (49 CFR Part 382.121) ... 6 PROHIBITED DRUGS AND ILLEGALLY USED CONTROLLED SUBSTANCES: ..................................................... 7 PROHIBITED BEHAVIOR AND CONDUCT: ...................................................................................................... 8 DRUG & ALCOHOL TESTING REQUIREMENTS (49 CFR, Part 40 & 382) ............................................... 10 DRUG & ALCOHOL TESTING CIRCUMSTANCES (49 CFR Part 40 & 382) .............................................. 12 A. Pre-Employment Testing: .................................................................................................... 12 B. Reasonable Suspicion Testing: ......................................................................................... -
Compositions Comprising Drospirenone Molecularly
(19) & (11) EP 1 748 756 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/00 (2006.01) A61K 9/107 (2006.01) 29.04.2009 Bulletin 2009/18 A61K 9/48 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/14 (2006.01) (2006.01) (2006.01) (21) Application number: 05708751.2 A61K 9/70 A61K 31/565 (22) Date of filing: 10.03.2005 (86) International application number: PCT/IB2005/000665 (87) International publication number: WO 2005/087194 (22.09.2005 Gazette 2005/38) (54) COMPOSITIONS COMPRISING DROSPIRENONE MOLECULARLY DISPERSED ZUSAMMENSETZUNGEN AUS DROSPIRENON IN MOLEKULARER DISPERSION DES COMPOSITIONS CONTENANT DROSPIRENONE A DISPERSION MOLECULAIRE (84) Designated Contracting States: (72) Inventors: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR • FUNKE, Adrian HU IE IS IT LI LT LU MC NL PL PT RO SE SI SK TR D-14055 Berlin (DE) Designated Extension States: • WAGNER, Torsten AL BA HR MK YU 13127 Berlin (DE) (30) Priority: 10.03.2004 EP 04075713 (74) Representative: Wagner, Kim 10.03.2004 US 551355 P Plougmann & Vingtoft a/s Sundkrogsgade 9 (43) Date of publication of application: P.O. Box 831 07.02.2007 Bulletin 2007/06 2100 Copenhagen Ø (DK) (60) Divisional application: (56) References cited: 08011577.7 / 1 980 242 EP-A- 1 260 225 EP-A- 1 380 301 WO-A-01/52857 WO-A-20/04022065 (73) Proprietor: Bayer Schering Pharma WO-A-20/04041289 US-A- 5 569 652 Aktiengesellschaft US-A- 5 656 622 US-A- 5 789 442 13353 Berlin (DE) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. -
Drospirenone-Containing Birth Control Pills (Yaz, Yasmin, Ocella, Gianvi and Their Generics)
Drospirenone-Containing Birth Control Pills (Yaz, Yasmin, Ocella, Gianvi and their generics) Drospirenone is a progestin component of some birth control pills that does some blocking of testosterone (the "male hormone" that women have, too, and the hormone that can be a part of making acne worse). This is why drospirenone-containing birth control pills are especially good at helping acne (and why they can theoretically help hirsutism and female-pattern scalp hair loss as well). Drospirenone is also a mild diuretic and is why these birth control pills do not cause the water weight gain that some birth control pills can. Any birth control pill can theoretically help acne just by evening out hormonal fluctuations, but for many birth control pills, the effects on acne is very minimal. Which birth control pills are most likely to help acne? Some birth control pills are more like testosterone and some are less like testosterone. The ones that are less like testosterone can theoretically help acne more. The drospirenone-containing birth control pills go one step further by blocking testosterone, and may show the most benefit on clearing acne. Drospirenone is a progestin that is derived from 17-alpha-spironolactone and is chemically related to the diuretic spironolactone. Spironolactone is a diuretic (used for high blood pressure) that is sometimes used off-label for the treatment of acne, hirsutism or female-pattern hair loss. Often people say that a drospirenone-containing birth control pill may be equivalent to 25mg of spironolactone. Risks : Any estrogen-containing birth control pill increases the risk of a high blood pressure, stroke, or other life-threatening blood clot, and one study showed possibly a slightly higher risk with a drospirenone-containing birth control pill. -
Betamethasone Valerate Foam: a Look at the Clinical Data
Review: Clinical Trial Outcomes Betamethasone valerate foam: a look at the clinical data Clin. Invest. (2014) 4(3), 259–267 Topical corticosteroids and especially betamethasone valerate (BMV) have Avner Shemer1, Nicole Sakka1 & been used topically to relieve many inflammatory skin conditions such as Dov Tamarkin*2 psoriasis and atopic dermatitis. The vehicle used to deliver topical drugs 1Department of Dermatology, the Chaim Sheba Medical Center, Affiliated with the can influence the performance of these topical applications. BMV has Tel-Aviv University, Sackler School of Medicine, traditionally been available in creams, ointments, lotions and sprays. In Tel Hashomer, Israel the early 2000s, a topical hydroethanolic BMV foam became commercially 2Foamix Ltd., 2 Holzman Street, Weizmann available. Subsequently, alcohol-free emulsion- and petrolatum-based Science Park, Rehovot 76704, Israel foam formulations were also developed. This manuscript reviews the *Author for correspondence: Tel.: +972 52 457 5677 properties of BMV foams and clinical studies that have been conducted Fax: +972 8 853 1102 to assess their efficacy and safety as treatments for scalp and non-scalp [email protected] psoriasis, as well as other dermatological inflammatory conditions. Keywords: betamethasone valerate • foam • psoriasis • topical corticosteroids Topical corticosteroids have been ranked in four groups consisting of seven classes ranging from ultra-high potency preparations (class 1) to low-potency prepara- tions (class 7). Betamethasone valerate (BMV) is a mid-potency corticosteroid (class 3–5, depending on the dosage form), used topically to relieve inflammatory skin conditions. It is used as a treatment for psoriasis, atopic dermatitis and other corticosteroid-responsive dermatoses. The vehicle used to deliver topical drugs can influence the performance of these drugs. -
Albany-Molecular-Research-Regulatory
PRODUCT CATALOGUE API COMMERCIAL US EU Japan US EU Japan API Name Site CEP India API Name Site CEP India DMF DMF DMF DMF DMF DMF A Abiraterone Malta • Benztropine Mesylate Cedarburg • Adenosine Rozzano - Quinto de' Stampi • • * Betaine Citrate Anhydrous Bon Encontre • Betametasone-17,21- Alcaftadine Spain Spain • • Dipropionate Sterile • Alclometasone-17, 21- Spain Betamethasone Acetate Spain Dipropionate • • Altrenogest Spain • • Betamethasone Base Spain Amphetamine Aspartate Rensselaer Betamethasone Benzoate Spain * Monohydrate Milled • Betamethasone Valerate Amphetamine Sulfate Rensselaer Spain * • Acetate Betamethasone-17,21- Argatroban Rozzano - Quinto de' Stampi Spain • • Dipropionate • • • Atenolol India • • Betamethasone-17-Valerate Spain • • Betamethasone-21- Atracurium Besylate Rozzano - Quinto de' Stampi Spain • Phosphate Disodium Salt • • Bromfenac Monosodium Atropine Sulfate Cedarburg Lodi * • Salt Sesquihydrate • • Azanidazole Lodi Bromocriptine Mesylate Rozzano - Quinto de' Stampi • • • • • Azelastine HCl Rozzano - Quinto de' Stampi • • Budesonide Spain • • Aztreonam Rozzano - Valle Ambrosia • • Budesonide Sterile Spain • • B Bamifylline HCl Bon Encontre • Butorphanol Tartrate Cedarburg • Beclomethasone-17, 21- Spain Capecitabine Lodi Dipropionate • C • 2 *Please contact our Accounts Managers in case you are interested in this API. 3 PRODUCT CATALOGUE API COMMERCIAL US EU Japan US EU Japan API Name Site CEP India API Name Site CEP India DMF DMF DMF DMF DMF DMF Dexamethasone-17,21- Carbimazole Bon Encontre Spain • Dipropionate -
Neonatal Intensive Care Drug Therapy Update: a Bibliography
LWW/JPNN AS310-13 July 28, 2004 23:11 Char Count= 0 J Perinat Neonat Nurs Vol. 18, No. 3, pp. 292–306 c 2004 Lippincott Williams & Wilkins, Inc. Neonatal Intensive Care Drug Therapy Update: A Bibliography Jason Sauberan, PharmD BIBLIOGRAPHY I. Overview A. Clark RH, Bloom BT, Gerstmann DR Medications Used in Neonatal Intensive Care Units—A Descriptive Study [abstract 3047]. In: Program and abstracts of the 2004 Pediatric Academic Societies’ Annual Meeting, San Francisco, CA. B. Barr J, Brenner-Zada G, Heiman E, Pareth G, Bulkowstein M, Greenberg R, Berkovitch M. Unlicensed and off-label medication use in a neonatal intensive care unit: a prospective study. Am J Perinatol. 2002 Feb;19(2):67–72. C. O’Donnell CP, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics. 2002 Nov;110(5):e52. D. Committee on Drugs. American Academy of Pediatrics. Uses of drugs not described in the package insert (off-label uses). Pediatrics. 2002 Jul;110(1 Pt 1):181–3. II. Anti-infectives A. Linezolid 1. Deville JG, Adler S, Azimi PH, Jantausch BA, Morfin MR, Beltran S, Edge-Padbury B, Naberhuis-Stehouwer S, Bruss JB. Linezolid versus vancomycin in the treatment of known or suspected resistant gram-positive infections in neonates. Pediatr Infect Dis J. 2003 Sep;22(9 Suppl):S158–63. 2. Vo M, Cirincione BB, Rubino CM, Jungbluth GL. Pharmacokinetics of Linezolid in Neonates and Young Infants [abstract A-1409]. In: Program and abstracts of the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA. -
Effect of Aminophylline on Diaphragmatic Contractility in the Piglet
003 1-3998/90/2803-0196$02.00/0 PEDIATRIC RESEARCH Vol. 28, No. 3, 1990 Copyright 0 1990 International Pediatric Research Foundation, Inc. Printed in (I.S.A. Effect of Aminophylline on Diaphragmatic Contractility in the Piglet DENNIS E. MAYOCK, THOMAS A. STANDAERT, JON F. WATCHKO, AND DAVID E. WOODRUM1 University of Washington School of Medicine, Department of Pediatrics, Division of Neonatal and Respiratory Diseases, Seattle, Washington 98195 ABSTRACT. Minute ventilation, arterial blood gases, ar- of arterial oxygen > 8 kPa (60 torr) in room air, and a partial terial pH, cardiac output, and transdiaphragmatic force pressure of the arterial carbon dioxide 5 6.7 kPa (50 torr) were generation, both during spontaneous ventilation and in accepted for study. The animals were anesthetized with an i.v. response to phrenic nerve stiwulation during airway occlu- combination of chloralose (30 mg/kg) and urethane (1 50 mg/ sion at end expiration, were measured in nine anesthetized, kg) and studied in the supine position. Subsequent infusions of tracheostomized piglets before and 30 min after parenteral anesthetic were used if the piglet developed jaw clonus. A trache- infusion of 20 mg/kg aminophylline. Serum theophylline ostomy was placed and connected to a two-way nonrebreathing levels averaged 109 f 21 ~mol/L(19.7 f 3.7 ~g/mL)at valve (model 2384, Hans Rudolph, Inc., Kansas City, MO). 30 min postinfusion. No significant changes were noted in Inspiratory flow was detected by a hot-wire anemometer and pH, blood gases, blood Pressure, or ventilatory measures integrated to provide tidal volume. All animals breathed 50% after aminophylline. -
Aminophylline Catalog Number A1755 Storage
Aminophylline Catalog Number A1755 Storage Temperature –20 °C Replacement for Catalog Number 216895 CAS RN 317-34-0 Storage/Stability Synonyms: theophylline hemiethylenediamine complex; Aminophylline should be kept tightly closed to prevent 3,7-dihydro-1,3-demethyl-1H-purine-2,6-dione CO2 absorption from the atmosphere, which leads to compound with 1,2-ethanediamine (2:1); formation of theophylline and decreased solubility in 1,2 3 (theophylline)2 • ethylenediamine aqueous solutions. Stock solutions should be protected from light and prevented from contact with Product Description metals.2 Molecular Formula: C7H8N4O2 ·1/2 (C2H8N2) Molecular Weight: 210.3 References 1. The Merck Index, 12th ed., Entry# 485. Aminophylline is a xanthine derivative which is a 2. Martindale: The Extra Pharmacopoeia, 31st ed., combination of theophylline and ethylenediamine that is Reynolds, J. E. F., ed., Royal Pharmaceutical more water soluble than theophylline alone. Society (London, England: 1996), pp. 1651-1652. Aminophylline has been widely used as an inhibitor of 3. Data for Biochemical Research, 3rd ed., Dawson, cAMP phosphodiesterase.3 R. M. C., et al., Oxford University Press (New York, NY: 1986), pp. 316-317. Aminophylline has been shown to limit 4. Pelech, S. L., et al., cAMP analogues inhibit phosphatidylcholine biosynthesis in cultured rat phosphatidylcholine biosynthesis in cultured rat hepatocytes.4 It has been used in studies of acute hepatocytes. J. Biol. Chem., 256(16), 8283-8286 hypoxemia in newborn and older guinea pigs.5 The (1981). effect of various xanthine derivatives, including 5. Crisanti, K. C., and Fewell, J. E., Aminophylline aminophylline, on activation of the cystic fibrosis alters the core temperature response to acute transmembrane conductance regulator (CFTR) chloride hypoxemia in newborn and older guinea pigs. -
Rosemary)-Derived Ingredients As Used in Cosmetics
Safety Assessment of Rosmarinus Officinalis (Rosemary)-Derived Ingredients as Used in Cosmetics Status: Tentative Amended Report for Public Comment Release Date: March 28, 2014 Panel Meeting Date: June 9-10, 2014 All interested persons are provided 60 days from the above release date to comment on this safety assessment and to identify additional published data that should be included or provide unpublished data which can be made public and included. Information may be submitted without identifying the source or the trade name of the cosmetic product containing the ingredient. All unpublished data submitted to CIR will be discussed in open meetings, will be available at the CIR office for review by any interested party and may be cited in a peer-reviewed scientific journal. Please submit data, comments, or requests to the CIR Director, Dr. Lillian J. Gill. The 2014 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is Lillian J. Gill, D.P.A. This safety assessment was prepared by Monice M. Fiume, Assistant Director/Senior Scientific Analyst. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200♢ Washington, DC 20036 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected] TABLE OF CONTENTS Abstract ...................................................................................................................................................................................................................................... -
Antiluteogenic Effects of Serial Prostaglandin F2α Administration in Mares
ANTILUTEOGENIC EFFECTS OF SERIAL PROSTAGLANDIN F2α ADMINISTRATION IN MARES Thesis Presented in partial fulfillment of the requirements for the Master of Science in the Graduate School of The Ohio State University Elizabeth Ann Coffman Graduate ProGram in Comparative and Veterinary Medicine The Ohio State University 2013 Thesis committee: Carlos R.F. Pinto PhD, MV, DACT; Dissertation Advisor Marco A. Coutinho da Silva PhD, MV, DACT; Academic Advisor Christopher Premanandan PhD, DVM, DACVP Copyright by Elizabeth Ann Coffman 2013 Abstract For breedinG manaGement and estrus synchronization, prostaGlandin F2α (PGF) is one of the most commonly utilized hormones to pharmacologically manipulate the equine estrous cycle. There is a general supposition a sinGle dose of PGF does not consistently induce luteolysis in the equine corpus luteum (CL) until at least five to six days after ovulation. This leads to the erroneous assumption that the early CL (before day five after ovulation) is refractory to the luteolytic effects of PGF. An experiment was desiGned to test the hypotheses that serial administration of PGF in early diestrus would induce a return to estrus similar to mares treated with a sinGle injection in mid diestrus, and fertility of the induced estrus for the two treatment groups would not differ. The specific objectives of the study were to evaluate the effects of early diestrus treatment by: 1) assessing the luteal function as reflected by hormone profile for concentration of plasma progesterone; 2) determininG the duration of interovulatory and treatment to ovulation intervals; 3) comparing of the number of pregnant mares at 14 days post- ovulation. The study consisted of a balanced crossover desiGn in which reproductively normal Quarter horse mares (n=10) were exposed to two treatments ii on consecutive reproductive cycles.