Preventive Generics Drug List
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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 -
Topically Applied Minoxidil in Baldness
Review Topically Applied Minoxidil in Baldness ERVIN NOVAK,M.D., THOMASJ. FRANZ, M.D., JOHN T. HEADINGTON,M.D., AND RONALD C. WESTER,PH.D. From the Upjohn Company, Kalamazoo, Michigan, School idil and its metabolites can be removed by hemodi- of Medicine, University of Washington, Seattle, alysis. Washington, Medical School, University of Michigan, Ann Fluid retention and hypertrichosis are the most Arbor, Michigan, and School of Medicine and School of Pharmacy, University of California, San Francisco, California commonly occurring side effects of minoxidil. Hair regrowth in a patient with male pattern baldness was described in a case report of a hypertensive patient treated twice daily with 20 mg oral minoxidil.6 The Minoxidil, an orally administered, peripheral va- extensive hair regrowth continued after 10 months sodilator used to treat hypertension, causes hypertri- of therapy. New and increased hair growth as a side chosis in more than 80% of users. The drug reduces effect was also detected in an early clinical study elevated blood pressure by decreasing peripheral involving five of eight patients on oral minoxidil vascular resistance. Chemically, minoxidil is 2,4-di- therapy for 2 month^.^ Zappacosta' reported reversal amino-6-piperidinopyrimidine-3-oxide; it is soluble in of baldness in a patient on minoxidil for the treatment water to the extent of approximately 2 mg/ml, is of hypertension. more readily soluble in propylene glycol or ethanol, After the third week of therapy with oral minoxidil, and is nearly insoluble in acetone, chloroform, or hypertrichosis usually appears between the eyebrows ethyl acetate. Following oral administration of minox- and the hair line, in the malar and temporal areas, idil and in association with the reduction in peripheral on the backs of the arms, on the shoulders, and on vascular resistance, cardiac output is augmented, salt the legs. -
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]. -
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. -
Health Reports for Mutual Recognition of Medical Prescriptions: State of Play
The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. Executive Agency for Health and Consumers Health Reports for Mutual Recognition of Medical Prescriptions: State of Play 24 January 2012 Final Report Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Acknowledgements Matrix Insight Ltd would like to thank everyone who has contributed to this research. We are especially grateful to the following institutions for their support throughout the study: the Pharmaceutical Group of the European Union (PGEU) including their national member associations in Denmark, France, Germany, Greece, the Netherlands, Poland and the United Kingdom; the European Medical Association (EMANET); the Observatoire Social Européen (OSE); and The Netherlands Institute for Health Service Research (NIVEL). For questions about the report, please contact Dr Gabriele Birnberg ([email protected] ). Matrix Insight | 24 January 2012 2 Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Executive Summary This study has been carried out in the context of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare (CBHC). The CBHC Directive stipulates that the European Commission shall adopt measures to facilitate the recognition of prescriptions issued in another Member State (Article 11). At the time of submission of this report, the European Commission was preparing an impact assessment with regards to these measures, designed to help implement Article 11. -
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. -
THE ROLE of CILOSTAZOL in ISCHEMIC STROKE
Since 1960 MedicineMedicine KoratKorat โรงพยาบาลมหาราชนครราชสีมา THE ROLE of CILOSTAZOL in ISCHEMIC STROKE PAWUT MEKAWICHAI MD DEPARTMENT of MEDICINE MAHARAT NAKHON RATCHASIMA HOSPITAL This presentation is supported by Thai Osuka CONTENT 1 Mechanism of cilostazol 2 Acute Ischemic Stroke (within 48h) 3 Secondary Prevention and Recurrence 4 Bleeding Complication CONTENT 1 Mechanism of cilostazol 2 Acute Ischemic Stroke (within 48h) 3 Secondary Prevention and Recurrence 4 Bleeding Complication Phosphodiesterase Inhibitor Increase cAMP → reduce platelet function Decrease cAMP → increase platelet function PDE enzyme change cAMP to 5-AMP Inhibit PDE enzyme → incrase cAMP → reduce platelet function Phosphodiesterase inhibitor Cilostazol Dipyridamole Classification of PDE Isozyme 9 family of PDE enzyme (PDE1-9) PDE-3 Site: platelet, heart, vascular SM, adipose tissue Inhibitor: Cilostazol PDE-5 Site: platelet, heart, vascular SM, corpus carvernosum Inhibitor: Dipyridamole, Sidenafil Distribution of PDE Isozyme Cell Platelet Heart Vascular Adipose SMC tissue Dominant III III III III Subordinate II V I II IV IV I II Inhibit PDE-3 antiplatelet action vasodilatation → headache ? inhibit vascular SMC proliferation tachycardia and palpitation increase HDL and decrease TG Which antiplatelet drug that can use in acute ischemic stroke? 1. ASA 81 mg 2. ASA 300 mg 3. Clopidogrel 4. Dipyridamole+ASA 5. Cilostazol CONTENT 1 Mechanism of cilostazol 2 Acute Ischemic Stroke (within 48h) 3 Secondary Prevention and Recurrence 4 Bleeding Complication ASPIRIN International Stroke Trial (IST) 1 ASA 300 mg-reduce mortality and recurrence in 2 wk) Chinese Acute Stroke Trial (CAST) 2 ASA 160 mg-reduce mortality and recurrence) reduce mortality rate 9/1,000 OR 0.92 (0.87-0.98) good functional outcome 7/1,000 OR 1.02 (1.01-1.04) increase severe bleeding (within 2-4 wk) 4/1,000 OR 1.69 (1.35-2.11) no evidence for difference dose of ASA 1.Lancet 1997; 349: 1569-81. -
Ace Inhibitors (Angiotensin-Converting Enzyme)
Medication Instructions Ace Inhibitors (Angiotensin-Converting Enzyme) Generic Brand Benazepril Lotensin Captopril Capoten Enalapril Vasotec Fosinopril Monopril Lisinopril Prinivil, Zestril Do not Moexipril Univasc Quinapril Accupril stop taking Ramipril Altace this medicine Trandolapril Mavik About this Medicine unless told ACE inhibitors are used to treat both high blood pressure (hypertension) and heart failure (HF). They block an enzyme that causes blood vessels to constrict. This to do so allows the blood vessels to relax and dilate. Untreated, high blood pressure can damage to your heart, kidneys and may lead to stroke or heart failure. In HF, using by your an ACE inhibitor can: • Protect your heart from further injury doctor. • Improve your health • Reduce your symptoms • Can prevent heart failure. Generic forms of ACE Inhibitors (benazepril, captopril, enalapril, fosinopril, and lisinopril) may be purchased at a lower price. There are no “generics” for Accupril, Altace Mavik, and of Univasc. Thus their prices are higher. Ask your doctor if one of the generic ACE Inhibitors would work for you. How to Take Use this drug as directed by your doctor. It is best to take these drugs, especially captopril, on an empty stomach one hour before or two hours after meals (unless otherwise instructed by your doctor). Side Effects Along with needed effects, a drug may cause some unwanted effects. Many people will not have any side effects. Most of these side effects are mild and short-lived. Check with your doctor if any of the following side effects occur: • Fever and chills • Hoarseness • Swelling of face, mouth, hands or feet or any trouble in swallowing or breathing • Dizziness or lightheadedness (often a problem with the first dose) Report these side effects if they persist: • Cough – dry or continuing • Loss of taste, diarrhea, nausea, headache or unusual fatigue • Fast or irregular heartbeat, dizziness, lightheadedness • Skin rash Special Guidelines • Sodium in the diet may cause you to retain fluid and increase your blood pressure. -
Cilostazol Protects Rats Against Alcohol‑Induced Hepatic Fibrosis Via Suppression of TGF‑Β1/CTGF Activation and the Camp/Epac1 Pathway
EXPERIMENTAL AND THERAPEUTIC MEDICINE 17: 2381-2388, 2019 Cilostazol protects rats against alcohol‑induced hepatic fibrosis via suppression of TGF‑β1/CTGF activation and the cAMP/Epac1 pathway KUN HAN, YANTING ZHANG and ZHENWEI YANG Department of Gastroenterology, Xi'an Central Hospital, Xi'an, Shaanxi 710003, P.R. China Received July 2, 2018; Accepted November 23, 2018 DOI: 10.3892/etm.2019.7207 Abstract. Alcohol abuse and chronic alcohol consump- Introduction tion are major causes of alcoholic liver disease worldwide, particularly alcohol‑induced hepatic fibrosis (AHF). Liver Liver fibrosis is a wound‑healing response to a variety of liver fibrosis is an important public health concern because of its insults, including excessive alcohol intake. Alcohol abuse and high morbidity and mortality. The present study examined chronic alcohol consumption are major causes of alcoholic the mechanisms and effects of the phosphodiesterase III liver disease (ALD) worldwide (1). Alcohol‑induced hepatic inhibitor cilostazol on AHF. Rats received alcohol infu- fibrosis (AHF) may cause serious hepatic cirrhosis, and is sions via gavage to induce liver fibrosis and were treated widely accepted as a milestone event in ALD (2). However, with colchicine (positive control) or cilostazol. The serum recent evidence indicates that liver fibrosis is reversible and alcohol dehydrogenase (ADH) and acetaldehyde dehydro- that the liver may recover from cirrhosis (3). Therefore, eluci- genase (ALDH) activities and the albumin/globulin (A/G), dation of the cellular and molecular mechanisms is urgently enzymes and hyaluronic acid (HA), type III precollagen required to prevent AHF. (PC III), laminin (LA), and type IV collagen (IV‑C) levels The exact mechanism remains unclear, but certain changes were measured using commercially available kits. -
Wo 2010/075090 A2
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 1 July 2010 (01.07.2010) WO 2010/075090 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 409/14 (2006.01) A61K 31/7028 (2006.01) kind of national protection available): AE, AG, AL, AM, C07D 409/12 (2006.01) A61P 11/06 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (21) International Application Number: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US2009/068073 HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (22) International Filing Date: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, 15 December 2009 (15.12.2009) ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (25) Filing Language: English SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, (26) Publication Language: English TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/122,478 15 December 2008 (15.12.2008) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, (71) Applicant (for all designated States except US): AUS- ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, PEX PHARMACEUTICALS, INC. -
PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. -
"Coaprovel, INN-Irbesartan+Hydrochlorothiazide"
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient with known effect: Each tablet contains 26.65 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1). 4.2 Posology and method of administration Posology CoAprovel can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: . CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; . CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg. CoAprovel 300 mg/25 mg may be administered in patients insufficiently controlled by CoAprovel 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended. When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).