Additions and Deletions to the Drug Product List

Total Page:16

File Type:pdf, Size:1020Kb

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 001 Feb 07, 2020 Sep CAHN >D> @ 325MG;7.5MG A 211690 002 Feb 07, 2020 Sep CAHN >D> @ 325MG;10MG A 211690 003 Feb 07, 2020 Sep CAHN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL OXYCODONE AND ACETAMINOPHEN >A> @ CEROVENE INC 325MG;5MG A 207574 001 Dec 13, 2016 Sep CAHN >D> @ XIROMED 325MG;5MG A 207574 001 Dec 13, 2016 Sep CAHN ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE;ORAL ACETAZOLAMIDE >A> AB MICRO LABS LTD INDIA 500MG A 207401 001 Oct 01, 2020 Sep NEWA TABLET;ORAL ACETAZOLAMIDE >A> MANKIND PHARMA 125MG A 214282 001 Oct 07, 2020 Sep NEWA >A> 250MG A 214282 002 Oct 07, 2020 Sep NEWA ACYCLOVIR CAPSULE;ORAL ACYCLOVIR >A> AB YILING 200MG A 212173 001 Sep 14, 2020 Sep NEWA OINTMENT;TOPICAL ACYCLOVIR >A> AB ANDA REPOSITORY 5% A 206437 001 Jul 31, 2017 Sep CAHN >D> AB TOLMAR 5% A 206437 001 Jul 31, 2017 Sep CAHN ALBUTEROL SULFATE AEROSOL, METERED;INHALATION ALBUTEROL SULFATE >A> AB2 LUPIN EQ 0.09MG BASE/INH A 209954 001 Aug 24, 2020 Sep CAHN >D> AB2 LUPIN ATLANTIS EQ 0.09MG BASE/INH A 209954 001 Aug 24, 2020 Sep CAHN Page 1 of 33 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMANTADINE HYDROCHLORIDE CAPSULE;ORAL AMANTADINE HYDROCHLORIDE >D> AB INVATECH 100MG A 210129 001 Mar 02, 2020 Sep CAHN >A> AB NOVELGENIX THERAPS 100MG A 210129 001 Mar 02, 2020 Sep CAHN TABLET, EXTENDED RELEASE;ORAL OSMOLEX ER >D> + OSMOTICA PHARM EQ 161MG BASE N 209410 004 Apr 22, 2020 Sep DISC >A> + @ EQ 161MG BASE N 209410 004 Apr 22, 2020 Sep DISC TABLET;ORAL AMANTADINE HYDROCHLORIDE >D> AB INVATECH 100MG A 210215 001 Mar 10, 2020 Sep CAHN >A> AB NOVELGENIX THERAPS 100MG A 210215 001 Mar 10, 2020 Sep CAHN AMILORIDE HYDROCHLORIDE TABLET;ORAL AMILORIDE HYDROCHLORIDE >A> AB ANDA REPOSITORY 5MG A 204180 001 Aug 07, 2015 Sep CAHN >D> AB WINDLAS HLTHCARE 5MG A 204180 001 Aug 07, 2015 Sep CAHN AMISULPRIDE SOLUTION;INTRAVENOUS BARHEMSYS >A> +! ACACIA 10MG/4ML (2.5MG/ML) N 209510 002 Sep 01, 2020 Sep NEWA AMLODIPINE BESYLATE TABLET;ORAL AMLODIPINE BESYLATE >D> AB HEBEI CHANGSHAN EQ 2.5MG BASE A 076692 001 Jul 20, 2007 Sep CAHN >D> AB EQ 5MG BASE A 076692 002 Jul 20, 2007 Sep CAHN >D> AB EQ 10MG BASE A 076692 003 Jul 20, 2007 Sep CAHN >D> AB HIKMA PHARMS EQ 2.5MG BASE A 077771 001 Apr 12, 2011 Sep DISC >A> @ EQ 2.5MG BASE A 077771 001 Apr 12, 2011 Sep DISC >D> AB EQ 5MG BASE A 077771 002 Apr 12, 2011 Sep DISC >A> @ EQ 5MG BASE A 077771 002 Apr 12, 2011 Sep DISC >D> AB EQ 10MG BASE A 077771 003 Apr 12, 2011 Sep DISC >A> @ EQ 10MG BASE A 077771 003 Apr 12, 2011 Sep DISC >A> AB YILING EQ 2.5MG BASE A 076692 001 Jul 20, 2007 Sep CAHN >A> AB EQ 5MG BASE A 076692 002 Jul 20, 2007 Sep CAHN >A> AB EQ 10MG BASE A 076692 003 Jul 20, 2007 Sep CAHN AMOXICILLIN; CLAVULANATE POTASSIUM TABLET, EXTENDED RELEASE;ORAL AMOXICILLIN AND CLAVULANATE POTASSIUM >D> AB SANDOZ 1GM;EQ 62.5MG BASE A 090227 001 Apr 21, 2010 Sep CHRS >A> AB ! 1GM;EQ 62.5MG BASE A 090227 001 Apr 21, 2010 Sep CHRS >A> ! 1GM;EQ 62.5MG BASE A 090227 001 Apr 21, 2010 Sep CTEC >D> AUGMENTIN XR >D> AB +! NEOPHARMA 1GM;EQ 62.5MG BASE N 050785 001 Sep 25, 2002 Sep DISC >A> + @ 1GM;EQ 62.5MG BASE N 050785 001 Sep 25, 2002 Sep DISC AMPHETAMINE SULFATE TABLET;ORAL AMPHETAMINE SULFATE >A> AA NOVAST LABS 5MG A 213763 001 Aug 24, 2020 Sep CAHN >A> AA 10MG A 213763 002 Aug 24, 2020 Sep CAHN >D> AA RICONPHARMA LLC 5MG A 213763 001 Aug 24, 2020 Sep CAHN >D> AA 10MG A 213763 002 Aug 24, 2020 Sep CAHN ANASTROZOLE TABLET;ORAL ANASTROZOLE >D> AB HIKMA 1MG A 078485 001 Jun 28, 2010 Sep DISC >A> @ 1MG A 078485 001 Jun 28, 2010 Sep DISC Page 2 of 33 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST APIXABAN TABLET;ORAL APIXABAN >A> AB INDOCO 2.5MG A 209898 001 Sep 11, 2020 Sep NEWA >A> AB 5MG A 209898 002 Sep 11, 2020 Sep NEWA ELIQUIS >D> + BRISTOL MYERS SQUIBB 2.5MG N 202155 001 Dec 28, 2012 Sep CTEC >A> AB + 2.5MG N 202155 001 Dec 28, 2012 Sep CTEC >D> +! 5MG N 202155 002 Dec 28, 2012 Sep CTEC >A> AB +! 5MG N 202155 002 Dec 28, 2012 Sep CTEC ASPIRIN; BUTALBITAL; CAFFEINE TABLET;ORAL BUTALBITAL, ASPIRIN AND CAFFEINE >D> AA ! HIKMA INTL PHARMS 325MG;50MG;40MG A 086162 002 Feb 16, 1984 Sep DISC >A> @ 325MG;50MG;40MG A 086162 002 Feb 16, 1984 Sep DISC >D> AA STRIDES PHARMA 325MG;50MG;40MG A 204195 001 Sep 22, 2016 Sep CHRS >A> AA ! 325MG;50MG;40MG A 204195 001 Sep 22, 2016 Sep CHRS >A> ! 325MG;50MG;40MG A 204195 001 Sep 22, 2016 Sep CTEC ATROPINE SULFATE SOLUTION;INTRAVENOUS ATROPINE SULFATE >A> +! ACCORD HLTHCARE 0.4MG/ML (0.4MG/ML) N 214652 001 Sep 29, 2020 Sep NEWA >A> +! 1MG/ML (1MG/ML) N 214652 002 Sep 29, 2020 Sep NEWA >D> +! HOSPIRA 1MG/10ML (0.1MG/ML) N 021146 005 Aug 17, 2017 Sep CFTG >A> AA +! 1MG/10ML (0.1MG/ML) N 021146 005 Aug 17, 2017 Sep CFTG >A> AA INTL MEDICATION SYS 1MG/10ML (0.1MG/ML) A 212461 001 Oct 05, 2020 Sep NEWA ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE >A> AA SPECGX LLC 2.5MG;0.025MG A 213335 001 Oct 06, 2020 Sep NEWA LOMOTIL >D> AA +! GD SEARLE LLC 0.025MG;2.5MG N 012462 001 Sep 15, 1960 Sep CAHN >A> AA +! PFIZER 0.025MG;2.5MG N 012462 001 Sep 15, 1960 Sep CAHN AZACITIDINE >A> TABLET;ORAL >A> ONUREG >A> + CELGENE CORP 200MG N 214120 001 Sep 01, 2020 Sep NEWA >A> +! 300MG N 214120 002 Sep 01, 2020 Sep NEWA AZELAIC ACID AEROSOL, FOAM;TOPICAL >A> AZELAIC ACID >A> AB TEVA PHARMS USA 15% A 210928 001 Oct 07, 2020 Sep NFTG FINACEA >D> +! LEO PHARMA AS 15% N 207071 001 Jul 29, 2015 Sep CFTG >A> AB +! 15% N 207071 001 Jul 29, 2015 Sep CFTG BENAZEPRIL HYDROCHLORIDE TABLET;ORAL BENAZEPRIL HYDROCHLORIDE >A> AB ANNORA PHARMA 5MG A 077128 001 Mar 08, 2006 Sep CAHN >A> AB 10MG A 077128 002 Mar 08, 2006 Sep CAHN >A> AB 20MG A 077128 003 Mar 08, 2006 Sep CAHN >A> AB 40MG A 077128 004 Mar 08, 2006 Sep CAHN >D> AB COREPHARMA 5MG A 077128 001 Mar 08, 2006 Sep CAHN >D> AB 10MG A 077128 002 Mar 08, 2006 Sep CAHN >D> AB 20MG A 077128 003 Mar 08, 2006 Sep CAHN >D> AB 40MG A 077128 004 Mar 08, 2006 Sep CAHN BETAMETHASONE DIPROPIONATE LOTION;TOPICAL BETAMETHASONE DIPROPIONATE >A> @ INVATECH EQ 0.05% BASE A 070274 001 Aug 12, 1985 Sep CAHN >D> @ PHARMADERM EQ 0.05% BASE A 070274 001 Aug 12, 1985 Sep CAHN Page 3 of 33 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE SUSPENSION;TOPICAL CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE >A> AB PERRIGO UK FINCO 0.064%;0.005% A 212367 001 Sep 11, 2020 Sep NEWA BETHANECHOL CHLORIDE TABLET;ORAL BETHANECHOL CHLORIDE >A> AA DISCOVERY THERAP 5MG A 040728 002 Oct 26, 2007 Sep CAHN >A> AA 10MG A 040728 003 Oct 26, 2007 Sep CAHN >A> AA 25MG A 040728 004 Oct 26, 2007 Sep CAHN >A> AA 50MG A 040728 001 Oct 26, 2007 Sep CAHN >D> AA ECI PHARMS LLC 5MG A 040728 002 Oct 26, 2007 Sep CAHN >D> AA 10MG A 040728 003 Oct 26, 2007 Sep CAHN >D> AA 25MG A 040728 004 Oct 26, 2007 Sep CAHN >D> AA 50MG A 040728 001 Oct 26, 2007 Sep CAHN BIVALIRUDIN INJECTABLE;INTRAVENOUS BIVALIRUDIN >D> AP CIPLA 250MG/VIAL A 091602 001 Jul 16, 2018 Sep CAHN >A> AP HONG KONG 250MG/VIAL A 091602 001 Jul 16, 2018 Sep CAHN BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE >A> AA BRECKENRIDGE 2MG/5ML;10MG/5ML;30MG/5ML A 203997 001 Sep 30, 2020 Sep NEWA >A> AA EYWA 2MG/5ML;10MG/5ML;30MG/5ML A 211170 001 Jun 16, 2020 Sep CAHN >D> AA WES PHARMA INC 2MG/5ML;10MG/5ML;30MG/5ML A 211170 001 Jun 16, 2020 Sep CAHN BUDESONIDE TABLET, EXTENDED RELEASE;ORAL BUDESONIDE >A> AB MYLAN 9MG A 208851 001 Sep 17, 2020 Sep NEWA BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL BUPROPION HYDROCHLORIDE >A> AB3 ADAPTIS 150MG A 211020 001 Jan 28, 2019 Sep CAHN >A> AB3 300MG A 211020 002 Jan 28, 2019 Sep CAHN >D> AB3 GRAVITI PHARMS 150MG A 211020 001 Jan 28, 2019 Sep CAHN >D> AB3 300MG A 211020 002 Jan 28, 2019 Sep CAHN CAFFEINE CITRATE SOLUTION;INTRAVENOUS CAFFEINE CITRATE >D> AP SUN PHARM EQ 30MG BASE/3ML (EQ 10MG A 090077 001 Sep 30, 2009 Sep DISC BASE/ML) >A> @ EQ 30MG BASE/3ML (EQ 10MG A 090077 001 Sep 30, 2009 Sep DISC BASE/ML) CAFFEINE; ERGOTAMINE TARTRATE
Recommended publications
  • 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.
    [Show full text]
  • P2 Receptors in Cardiovascular Regulation and Disease
    Purinergic Signalling (2008) 4:1–20 DOI 10.1007/s11302-007-9078-7 REVIEW P2 receptors in cardiovascular regulation and disease David Erlinge & Geoffrey Burnstock Received: 3 May 2007 /Accepted: 22 August 2007 /Published online: 21 September 2007 # Springer Science + Business Media B.V. 2007 Abstract The role of ATP as an extracellular signalling Introduction molecule is now well established and evidence is accumulating that ATP and other nucleotides (ADP, UTP and UDP) play Ever since the first proposition of cell surface receptors for important roles in cardiovascular physiology and pathophysi- nucleotides [1, 2], it has become increasingly clear that, in ology, acting via P2X (ion channel) and P2Y (G protein- addition to functioning as an intracellular energy source, the coupled) receptors. In this article we consider the dual role of purines and pyrimidines ATP, adenosine diphosphate ATP in regulation of vascular tone, released as a cotransmitter (ADP), uridine triphosphate (UTP) and uridine diphosphate from sympathetic nerves or released in the vascular lumen in (UDP) can serve as important extracellular signalling response to changes in blood flow and hypoxia. Further, molecules [3, 4] acting on 13 P2X homo- and heteromul- purinergic long-term trophic and inflammatory signalling is timer ionotropic and 8 P2Y metabotropic receptor subtypes described in cell proliferation, differentiation, migration and [5, 6] (Table 1). To terminate signalling, ectonucleotidases death in angiogenesis, vascular remodelling, restenosis and are present in the circulation and on cell surfaces, rapidly atherosclerosis. The effects on haemostasis and cardiac degrading extracellular ATP into ADP, AMP and adenosine regulation is reviewed. The involvement of ATP in vascular [7, 8].
    [Show full text]
  • Comparison of the Anti-Inflammatory Effects of Cilomilast, Budesonide
    Ratcliffe and Dougall BMC Pharmacology and Toxicology 2012, 13:15 http://www.biomedcentral.com/2050-6511/13/15 RESEARCH ARTICLE Open Access Comparison of the anti-inflammatory effects of Cilomilast, Budesonide and a p38 Mitogen activated protein kinase inhibitor in COPD lung tissue macrophages Marianne Jennifer Ratcliffe1* and Iain Gordon Dougall2 Abstract Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by a largely irreversible airflow obstruction and a persistent, excessive inflammatory response. Alveolar macrophages (AMs) are increased in the lungs of COPD patients, and act as orchestrators of the inflammatory response, releasing a range of mediators to coordinate recruitment and activation of leukocytes. Attempts to treat the inflammatory component of COPD with anti-inflammatory drugs such as steroids has met with limited success. In this study, we compared the ability of the phosphodiesterase IV (PDEIV) inhibitor Cilomilast, the steroid Budesonide, and the p38 mitogen activated protein kinase inhibitor BIRB-796 to inhibit tumour necrosis factor alpha (TNFα) and interleukin 6 (IL-6) releases from AMs isolated from COPD lung transplant tissue. All studies were carried out with appropriate ethical approval and written, informed consent was obtained from each subject. Cilomilast had little effect on cytokine release from AMs. There was considerable variability in the responsiveness of AMs to Budesonide, with a subset of AMs responding poorly to Budesonide. BIRB-796 inhibited TNFα release from all AM donors, including those that responded poorly to steroids. Treatment with BIRB-796 and Budesonide together gave an additive decrease in TNFa release. These results suggest that a p38 inhibitor may provide advantages over existing anti-inflammatory treatments for COPD, either as an add-on to existing therapy, or to treat patients who respond poorly to steroids.
    [Show full text]
  • Prasugrel Mylan 10 Mg Film-Coated Tablets Prasugrel
    Package leaflet: Information for the user Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets prasugrel Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Prasugrel Mylan is and what it is used for 2. What you need to know before you take Prasugrel Mylan 3. How to take Prasugrel Mylan 4. Possible side effects 5. How to store Prasugrel Mylan 6. Contents of the pack and other information 1. What Prasugrel Mylan is and what it is used for Prasugrel Mylan, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents. Platelets are very small cell particles that circulate in the blood. When a blood vessel is damaged, for example if it is cut, platelets clump together to help form a blood clot (thrombus). Therefore, platelets are essential to help stop bleeding. If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death.
    [Show full text]
  • Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations
    molecules Review Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations Deepak Gupta 1, Deepak Bhatia 2 ID , Vivek Dave 3 ID , Vijaykumar Sutariya 4 and Sheeba Varghese Gupta 4,* 1 Department of Pharmaceutical Sciences, School of Pharmacy, Lake Erie College of Osteopathic Medicine, Bradenton, FL 34211, USA; [email protected] 2 ICPH Fairfax Bernard J. Dunn School of Pharmacy, Shenandoah University, Fairfax, VA 22031, USA; [email protected] 3 Wegmans School of Pharmacy, St. John Fisher College, Rochester, NY 14618, USA; [email protected] 4 Department of Pharmaceutical Sciences, USF College of Pharmacy, Tampa, FL 33612, USA; [email protected] * Correspondence: [email protected]; Tel.: +01-813-974-2635 Academic Editor: Peter Wipf Received: 7 June 2018; Accepted: 13 July 2018; Published: 14 July 2018 Abstract: The physicochemical and biological properties of active pharmaceutical ingredients (APIs) are greatly affected by their salt forms. The choice of a particular salt formulation is based on numerous factors such as API chemistry, intended dosage form, pharmacokinetics, and pharmacodynamics. The appropriate salt can improve the overall therapeutic and pharmaceutical effects of an API. However, the incorrect salt form can have the opposite effect, and can be quite detrimental for overall drug development. This review summarizes several criteria for choosing the appropriate salt forms, along with the effects of salt forms on the pharmaceutical properties of APIs. In addition to a comprehensive review of the selection criteria, this review also gives a brief historic perspective of the salt selection processes. Keywords: chemistry; salt; water solubility; routes of administration; physicochemical; stability; degradation 1.
    [Show full text]
  • Application and Review of Pediatric Pharmacotherapy, Sample Chapter
    Application and Review of Pediatric Pharmacotherapy Chapter No. 1 Dated: 29/7/2010 At Time: 16:16:4 Section 1 Neonatal intensive care “Luck is where preparation meets opportunity.” This section consists of 16 medication orders followed by corresponding patient profiles representing pharmacotherapy associated with patients admit- ted to a neonatal intensive care unit. Each patient profile is followed by multiple-choice questions pertaining to the medication order and profile infor- mation. Choose the one best-lettered response to each item. The correct answers are provided at the end of this section. The reader is encouraged to attempt all questions for each case or for the entire section prior to referring to the answers. Moreover, where appropriate, the answer key provides a thor- ough explanation of the correct response and should serve as an additional learning tool for the reader. Application and Review of Pediatric Pharmacotherapy Chapter No. 1 Dated: 29/7/2010 At Time: 16:16:4 2 | Application and Review of Pediatric Pharmacotherapy Medication orders Physician order Patient weight: 2.5 kg Aminophylline 10 mg iv load, then begin 2.5 mg iv q 12 h Obtain theophylline concentration 1 h postinfusion of loading dose Date/time: 12/01/2100 Patient name: Baby Boy Turner Physician: John Craver Patient ID: 111222 Medical profile Patient: Baby Boy Turner Patient weight: 2.5 kg Age: 1d/o Present illness: Apneic episodes Allergies: None Medical history: 33 weeks gestation, Apgar 7 and 9 Labs: pending Medication profile Questions Q1 Which of the following is an acceptable definition of apnea of prematurity? 1 o cessation of breathing for less than 20 s 2 o cessation of breathing for at least 20 s 3 o cessation of breathing for less than 20 s when accompanied by bradycardia A o 1 only B o 3 only C o 1 and 3 only Application and Review of Pediatric Pharmacotherapy Chapter No.
    [Show full text]
  • Guanidine-Containing Polyhydroxyl Macrolides: Chemistry, Biology, and Structure-Activity Relationship
    molecules Review Guanidine-Containing Polyhydroxyl Macrolides: Chemistry, Biology, and Structure-Activity Relationship Xiaoyuan Song 1, Ganjun Yuan 1,* , Peibo Li 2 and Sheng Cao 1 1 College of Bioscience and Bioengineering, Jiangxi Agricultural University, Nanchang 330045, China; [email protected] (X.S.); [email protected] (S.C.) 2 School of Life Sciences, Sun Yat-sen University, 135 Xingang Road, Guangzhou 510275, China; [email protected] * Correspondence: [email protected]; Tel.: +86-0791-83813459 Academic Editor: Jesus Simal-Gandara Received: 7 October 2019; Accepted: 29 October 2019; Published: 30 October 2019 Abstract: Antimicrobial resistance has been seriously threatening human health, and discovering new antimicrobial agents from the natural resource is still an important pathway among various strategies to prevent resistance. Guanidine-containing polyhydroxyl macrolides, containing a polyhydroxyl lactone ring and a guanidyl side chain, can be produced by many actinomycetes and have been proved to possess many bioactivities, especially broad-spectrum antibacterial and antifungal activities. To explore the potential of these compounds to be developed into new antimicrobial agents, a review on their structural diversities, spectroscopic characterizations, bioactivities, acute toxicities, antimicrobial mechanisms, and the structure-activity relationship was first performed based on the summaries and analyses of related publications from 1959 to 2019. A total of 63 guanidine-containing polyhydroxyl macrolides were reported, including
    [Show full text]
  • Caffeine in the Treatment of Pain
    Rev Bras Anestesiol ARTIGOS DE REVISÃO 2012; 62: 3: 387-401 ARTIGOS DE REVISÃO Cafeína para o Tratamento de Dor Cristiane Tavares, TSA 1, Rioko Kimiko Sakata, TSA 2 Resumo: Tavares C, Sakata RK – Cafeína para o Tratamento de Dor. Justificativa e objetivos: A cafeína é uma substância amplamente consumida com efeitos em diversos sistemas e que apresenta farmacoci- nética e farmacodinâmica características, causando interações com diversos medicamentos. O objetivo deste estudo é fazer uma revisão sobre os efeitos da cafeína. Conteúdo: Nesta revisão, são abordados a farmacologia da cafeína, os mecanismos de ação, as indicações, as contraindicações, as doses, as interações e os efeitos adversos. Conclusões: Faltam estudos controlados, randomizados e duplos-cegos para avaliar a eficácia analgésica da cafeína nas diversas síndromes dolorosas. Em pacientes com dor crônica, é necessário ter cautela em relação ao desenvolvimento de tolerância, abstinência e interação medi- camentosa no uso crônico de cafeína. Unitermos: ANALGESIA; DOR; DROGAS, Alcaloide/cafeína. ©2012 Elsevier Editora Ltda. Todos os direitos reservados. INTRODUÇÃO Estrutura química A cafeína foi isolada em 1820, mas a estrutura correta des- A cafeína é um alcaloide presente em mais de 60 espécies ta metilxantina foi estabelecida na última década do século de plantas 4. Sua estrutura molecular pertence a um grupo XIX. Os efeitos não foram claramente reconhecidos até 1981, de xantinas trimetiladas que incluem seus compostos inti- quando o bloqueio de receptores adenosina foi correlacio- mamente relacionados: teobromina (presente no cacau) e nado às propriedades estimulantes da cafeína e de seus teofilina (presente no chá) 1. Quimicamente, esses alcaloides análogos 1. Provavelmente a cafeína é uma das substâncias são semelhantes a purinas, xantinas e ácido úrico, que são psicoativas mais utilizadas no mundo, promovendo efeitos compostos metabolicamente importantes 4.
    [Show full text]
  • A Comparative Study of Molecular Structure, Pka, Lipophilicity, Solubility, Absorption and Polar Surface Area of Some Antiplatelet Drugs
    International Journal of Molecular Sciences Article A Comparative Study of Molecular Structure, pKa, Lipophilicity, Solubility, Absorption and Polar Surface Area of Some Antiplatelet Drugs Milan Remko 1,*, Anna Remková 2 and Ria Broer 3 1 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Comenius University in Bratislava, Odbojarov 10, SK-832 32 Bratislava, Slovakia 2 Department of Internal Medicine, Faculty of Medicine, Slovak Medical University, Limbová 12, SK–833 03 Bratislava, Slovakia; [email protected] 3 Department of Theoretical Chemistry, Zernike Institute for Advanced Materials, University of Groningen, Nijenborgh 4, 9747 AG Groningen, The Netherlands; [email protected] * Correspondence: [email protected]; Tel.: +421-2-5011-7291 Academic Editor: Michael Henein Received: 18 February 2016; Accepted: 11 March 2016; Published: 19 March 2016 Abstract: Theoretical chemistry methods have been used to study the molecular properties of antiplatelet agents (ticlopidine, clopidogrel, prasugrel, elinogrel, ticagrelor and cangrelor) and several thiol-containing active metabolites. The geometries and energies of most stable conformers of these drugs have been computed at the Becke3LYP/6-311++G(d,p) level of density functional theory. Computed dissociation constants show that the active metabolites of prodrugs (ticlopidine, clopidogrel and prasugrel) and drugs elinogrel and cangrelor are completely ionized at pH 7.4. Both ticagrelor and its active metabolite are present at pH = 7.4 in neutral undissociated form. The thienopyridine prodrugs ticlopidine, clopidogrel and prasugrel are lipophilic and insoluble in water. Their lipophilicity is very high (about 2.5–3.5 logP values). The polar surface area, with regard to the structurally-heterogeneous character of these antiplatelet drugs, is from very large interval of values of 3–255 Å2.
    [Show full text]
  • Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate.
    [Show full text]
  • Health and Social Outcomes Associated with High-Risk Alcohol Use
    Manitoba Centre for Health Policy Health and Social Outcomes Associated with High-Risk Alcohol Use Summer 2018 Nathan C Nickel, MPH, PhD Jeff Valdivia, MNRM, CAPM Deepa Singal, PhD James Bolton, MD Christine Leong, PharmD Susan Burchill, BMus Leonard MacWilliam, MSc, MNRM Geoffrey Konrad, MD Randy Walld, BSc, BComm (Hons) Okechukwu Ekuma, MSc Greg Finlayson, PhD Leanne Rajotte, BComm (Hons) Heather Prior, MSc Josh Nepon, MD Michael Paille, BHSc This report is produced and published by the Manitoba Centre for Health Policy (MCHP). It is also available in PDF format on our website at: http://mchp-appserv.cpe.umanitoba.ca/deliverablesList.html Information concerning this report or any other report produced by MCHP can be obtained by contacting: Manitoba Centre for Health Policy Rady Faculty of Health Sciences Max Rady College of Medicine, University of Manitoba 4th Floor, Room 408 727 McDermot Avenue Winnipeg, Manitoba, Canada R3E 3P5 Email: [email protected] Phone: (204) 789-3819 Fax: (204) 789-3910 How to cite this report: Nathan C Nickel, James Bolton, Leonard MacWilliam, Okechukwu Ekuma, Heather Prior, Jeff Valdivia, Christine Leong, Geoffrey Konrad, Greg Finlayson, Josh Nepon, Deepa Singal, Susan Burchill, Randy Walld, Leanne Rajotte, Michael Paille. Health and Social Outcomes Associated with High-Risk Alcohol Use. Winnipeg, MB. Manitoba Centre for Health Policy, Summer 2018. Legal Deposit: Manitoba Legislative Library National Library of Canada ISBN 978-1-896489-90-2 ©Manitoba Health This report may be reproduced, in whole or in part, provided the source is cited. 1st printing (Summer 2018) This report was prepared at the request of Manitoba Health, Seniors and Active Living (MHSAL), a department within the Government of Manitoba, as part of the contract between the University of Manitoba and MHSAL.
    [Show full text]
  • Mediated Pulmonary Hypertension in Neonatal Rats: a Role for Products of Lipid Peroxidation
    0031-3998/00/4803-0289 PEDIATRIC RESEARCH Vol. 48, No. 3, 2000 Copyright © 2000 International Pediatric Research Foundation, Inc. Printed in U.S.A. Endothelin-1 and O2-Mediated Pulmonary Hypertension in Neonatal Rats: A Role for Products of Lipid Peroxidation ROBERT P. JANKOV, XIAOPING LUO, JUDY CABACUNGAN, ROSETTA BELCASTRO, HELENA FRNDOVA, STEPHEN J. LYE, AND A. KEITH TANSWELL Medical Research Council Group in Lung Development and Lung Biology Programme [R.P.J., X.L., J.C., R.B., H.F., A.K.T.], Hospital for Sick Children Research Institute, the MRC Group in Developmental and Fetal Health, Samuel Lunenfeld Research Institute, Mt. Sinai Hospital [S.J.L.], and the Departments of Obstetrics and Gynaecology [S.J.L.], Paediatrics [A.K.T.] and Physiology [A.K.T., S.J.L.], University of Toronto, Toronto, Ontario, M5S 1A8 Canada. ABSTRACT We hypothesized that reactive O2 species, or their interme- lung cell cultures. We conclude that reactive O2 species, or their diary products, generated during exposure to elevated O2 lead to bioactive intermediaries, are causative in O2-mediated pulmo- pathologic endothelin-1 expression in the newborn lung. Endo- nary hypertension and endothelin-1 up-regulation. It is likely that thelin-1 expression and 8-isoprostane content (an in vivo marker the bioactive lipid peroxidation product, 8-isoprostane, plays a of lipid peroxidation) were examined and found to be elevated key role in pathologic endothelin-1 expression and pulmonary (p Ͻ 0.05) in the lungs of newborn rats with abnormal lung hypertension during oxidant stress. (Pediatr Res 48: 289–298, morphology and pulmonary hypertension, as assessed by right 2000) ventricular hypertrophy, after a 14-d exposure to 60% O2.
    [Show full text]