DOCSLIB.ORG

Identification and Determination of Antihypertonics from the Group of Angiotensin Ñ Convertase Inhibitors by Densitometric Method in Comparition with Hplc Method

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Identification and Determination of Antihypertonics from the Group of Angiotensin Ñ Convertase Inhibitors by Densitometric Method in Comparition with Hplc Method Acta Poloniae Pharmaceutica ñ Drug Research, Vol. 67 No. 2 pp. 137ñ143, 2010 ISSN 0001-6837 Polish Pharmaceutical Society IDENTIFICATION AND DETERMINATION OF ANTIHYPERTONICS FROM THE GROUP OF ANGIOTENSIN ñ CONVERTASE INHIBITORS BY DENSITOMETRIC METHOD IN COMPARITION WITH HPLC METHOD ELØBIETA WYSZOMIRSKA1*, KRYSTYNA CZERWI—SKA1 and ALEKSANDER P. MAZUREK1,2 1Department of Basic and Applied Pharmacy, National Medicines Institute, 30/34 Che≥mska St., 00-725 Warszawa, Poland 2Department of Drug Chemistry, Medical University of Warsaw, 1 Banacha St., 02-097 Warszawa, Poland Abstract: Conditions have been elaborated for the identification of all the compounds belonging to the group of angiotensin convertase inhibitors: lisinopril, quinapril, ramipril, spirapril, moexipril, trandolapril, benazepril, cilazapril, fosinopril, captopril, enalapril, imidapril and zofenopril by thin-layer chromatography. The selected conditions were used to design the densitometric method for the content determination of the above mentioned compounds in substances and medicines. The statistical data obtained for the designed method indicate ade- quate accuracy and precision. Keywords: lisinopril, quinapril, ramipril, spirapril, moexipril, trandolapril, benazepril, cilazapril, fosinopril, captopril, enalapril, imidapril, zofenopril, perindopril, antihypertonics, densitometric metod Arterial hypertension is one of the most com- the body they are subjected to hydrolysis into acids, mon cardiovascular disorders. Due to large inci- being capable of competitive inhibition of ACE dence of the disorder and the fact that it is an agent activity. that contributes to the development of arteriosclero- ACE inhibitors differ in terms of pharmacoki- sis and its clinical forms ñ coronary disease, cardiac netic properties and affinity for ACE. This is related infarction, cerebral stroke, it is considered to be a to the strength and time of their activity. social disease. At present, ACE inhibitors are the first-choice The principle action of hypotensive medicines medicines used in the treatment of hypertension. is based on controlling blood pressure in various They may also be used in the treatment of ischemia pressure points. Renin ñ angiotensin ñ aldosterone and heart failure. Their active metabolites created as system plays an important role in controlling blood a result of hydrolysis cause the fall in ACE activity, pressure and volume of body fluids. This has been a a decrease in releasing aldosterone, an increase in crucial agent in the necessity of searching for the the concentration of vaso-dialytic kinins and medicines inhibiting the renin ñ angiotensin activity, prostaglandins and indirectly reducing synthesis of including, among others, ACE (angiotensin convert- catecholamines and general sympathetic activity. ing enzyme) inhibitors. These inhibitors are dipep- This results in diastole of vessels and reduction of tides or compounds which are structurally very sim- circulating blood volume, which leads to the drop in ilar. One of the analogies is the presence of S-pro- blood pressure and reduction of peripheral resist- line in a cyclic molecule whose ring may be ance (1-3). replaced with another one, provided that configura- In the recent years, all medicines from the fol- tion S is maintained at C2. The SH group containing lowing group have been subjected to research: moiety, present in some ACE inhibitors, may be lisinopril, quinapril, ramipril, spirapril, moexipril, replaced with another one, e.g. with S-alanine. trandolapril, benazepril, cilazapril, fosinopril, capto- A majority of converting inhibitors are ethyl pril, enalapril, imidapril, zofenopril and perindopril. esters of appropriate acids. Esterases cause that in From the literature on the subject it can be conclud- * Corresponding author: e mail: [email protected] 137 138 ELØBIETA WYSZOMIRSKA et al. ed that in the recent years the following methods Imidapril HCl, Zofenopril Ca, Perindopril, Lisinopril ñ have been used for determination of these com- ratiopharm tablets 20 mg, Accupro 20 tablets 20 mg, pounds: HPLC with the use of various detectors, Tritace 10 tablets 10 mg, Quadropril tablets 6 mg, spectrofotometric and fluorometric methods, poten- Cardiotensin 7.5 tablets 7.5 mg, Gopten capsules 2 mg, tiometry, densitometry, gas chromatography and Lotensin tablets 10 mg, Inhibace coated tablets 1 mg, capillary electrophoresis. Monopril tablets 20 mg, Captopril tablets 12.5 mg, The HPLC method and spectrofotometric Enalapril tablets 20 mg, Tanatril tablets 20 mg, Zofenil detector as well as C18 column (4-14) was used for 30 coated tablets 30 mg . identification and determination of benazepril, tran- Analytically pure and high-purity reagents for dolapril, cilazapril, fosinopril, enalapril, quinapril HPLC, Merck HPTLC F254 pre-coated plates (glass), and moexipril, whereas C8 column (15-17) was Silica gel 60 layers (20 ◊ 10 cm), Camag used for determination of: ramipril, benazepril and Chromatographic chamber (20 ◊ 10 ◊ 5 cm), Hanau lisinopril. UV Lamp, Camag automatic applicator, Shimadzu CS The HPLC method with the use of mass spec- 9000 densitometer, Shimadzu liquid chromatograph trometry detector (18-27) was also used for identify- with SPD-10 AVVP spectrofotometric detector, SCL- ing and determining zofenopril, fosinopril, enalapril, 10 AVP auto-sampler, and LC-10 AT VP pump. quinapril, ramipril, trandolapril, cilazapril and imi- dapril. QUALITATIVE ANALYSIS Spectrofotometric determination was used for ramipril (28, 29) after transformation in colored Standard solutions were prepared as follows: derivatives, and cilazapril (30) and fosinopril (31) lisinopril, quinapril, ramipril, spirapril, moexipril, determined in two-element medicines with trandolapril, benazepril, cilazapril, fosinopril, capto- hydrochlorothiazide. pril, enalapril, imidapril and perindopril in methanol Fluorometric method was used for determina- as well as zofenopril in acid methanol (2 mL 85% o- tion of ramipril after derivatization (29). phosphoric acid in 100 mL of methanol) of the fol- Captopril was determined with potentiometric lowing concentrations: 2, 0.1, 0.01 and 0.001 method using enantioselective electrodes (32-33). mg/mL. Quantities of 10, 5, 2.5, 1, 0.5, 0.25, 0.1, Gas chromography method was used for determin- 0.05, 0.025, 0.01 and 0.005 µg of active substances ing moexipril with the use of capillary column DB- were put as spots on glass chromatoplates HPTLC 1 (34), whereas benazepril with hydrochlorothiazide GF254 (2 cm from the bottom of the plate and 2 cm was determined by densitometric method (35). from edges) and unrolled up to 1 cm from the top of Capillary electrophoresis method was used for the plate in 6 various mobile phases:1) ethyl acetate determining cilazapril (36) and its active metabolite ñ methylene chloride ñ methanol ñ ammonia 25% ñ cilazaprilat, isolated from urine. Available litera- (30 : 25 :2 : 1, v/v), 2) toluene ñ glacial acetic acid ture does not comprise any publications on deter- (30 : 10, v/v) with saturation, 3) chloroform ñ mining spirapril. methanol ñ glacial acetic acid (30 : 5 : 1, v/v), 4) The HPLC method, widely used for analysis of toluene ñ glacial acetic acid ñ methanol (75 : 25 : 10, compounds from the group of convertase inhibitors, v/v) with saturation, 5) benzene ñ glacial acetic acid requires expensive equipment and high purity (3 : 1, v/v) with saturation, 6) n-butanol ñ glacial reagents, which significantly increase the cost of acetic acid ñ water (3 : 1 : 1, v/v). determination. Therefore, an attempt has been made After drying the plates with air, the position of to develop a sensitive, less expensive and time con- spots was determined under UV light with wave- suming method of identification and determination length of 254 nm, and then the plates were exposed of lisinopril, quinapril, ramipril, spirapril, moexipril, to iodine vapors. In qualitative analyses, Rf values trandolapril, benazepril, cilazapril, fosinopril, capto- were determined and detection limits were estab- pril, enalapril, imidapril, zofenopril and perindopril lished for all compounds investigated in all systems. in medicines. The results have been presented in Tables 1 and 2. EXPERIMENTAL QUANTITATIVE ANALYSIS Determination of the content by densitometric Materials and apparatus method Lisinopril 2 H2O, Quinapril HCl, Ramipril, For captopril, enalapril and spirapril ñ mobile Spirapril HCl, Moexipril HCl, Trandolapril, Benazepril, phase 3, for ramipril, quinapril, lisinopril, moexipril, Cilazapril, Fosinopril Na, Captopril, Enalapril Maleate, trandolapril, benazepril, cilazapril, fosinopril and Identification and determination of antihypertonics from the group of angiotensin convertase inhibitors by... 139 Table 1. Rf values for the tested compounds (grey fields refer to the mobile phase selected for the quantitative determination of a given compound). Tested Mobile Mobile Mobile Mobile Mobile compound phase 2 phase 3 phase 4 phase 5 phase 6 Lisinopril 0 0 0 0 0.29 Quinapril 0 0.91 0.05 0 0.85 Ramipril 0.06 0.84 0.06 0.06 0.82 Spirapril 0 0.84 0.05 0 0.84 Moexipril 0.06 0.84 0.12 0.11 0.82 Trandolapril óó 0.76 óó- 0.36 0.87 Benazepril 0.12 0.76 0.18 0.22 0.89 Cilazapril 0.06 0.83 0.09 0.08 0.82 Fosinopril 0.57 0.85 0.59 0.71 0.63 Captopril 0.29 0.74 0.29 0.32 0.71 Enalapril 0.04 0.63 0.02 0.04 0.66 Imidapril 0 0.52 0.15 0 0.58 Zofenopril 0.45 0.95 0.88 0.55 0.85 Mobile phases: 1) ethyl acetate : dichloromethane : methanol : 25% ammonia (30:25:2:1, v/v) ñ Rf = 0 for all tested compounds; 2)
Load more

Recommended publications
  • Cardioprotective Role of Zofenopril in Patients with Acute
    Open Heart: first published as 10.1136/openhrt-2014-000220 on 8 September 2015. Downloaded from Coronary artery disease Cardioprotective role of zofenopril in patients with acute myocardial infarction: a pooled individual data analysis of four randomised, double- blind, controlled, prospective studies Claudio Borghi,1 Stefano Omboni,2 Giorgio Reggiardo,3 Stefano Bacchelli,1 Daniela Degli Esposti,1 Ettore Ambrosioni,1 on behalf of the SMILE Working Project To cite: Borghi C, Omboni S, ABSTRACT et al KEY QUESTIONS Reggiardo G, . Background: Early administration of zofenopril Cardioprotective role of following acute myocardial infarction (AMI) proved to zofenopril in patients with What is already known about this subject? be prognostically beneficial in the four individual acute myocardial infarction: a ▸ Use of ACE inhibitors has been shown to be pooled individual data randomised, double-blind, parallel-group, prospective beneficial in preventing major cardiovascular analysis of four randomised, SMILE (Survival of Myocardial Infarction Long-term complications in several large randomised, pro- double-blind, controlled, Evaluation) studies. In the present analysis, we spective early and late intervention trials in prospective studies. Open evaluated the cumulative efficacy of zofenopril by patients with post-acute myocardial infarction Heart 2015;2:e000220. pooling individual data from the four SMILE studies. (AMI). doi:10.1136/openhrt-2014- Methods: 3630 patients with AMI were enrolled and 000220 treated for 6–48 weeks with zofenopril 30–60 mg/day What does this study add? (n=1808), placebo (n=951), lisinopril 5–10 mg/day ▸ Zofenopril is an ACE inhibitor with a proven effi- (n=520) or ramipril 10 mg/day (n=351).
    [Show full text]
  • “Captopril” [Mesh
    BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s) Open Heart PubMed: 1. (“dose comparison” OR “dose” OR “low dose” OR “high dose” OR “dosage*”) 2. (“captopril” [mesh] OR “Benazepril” OR “Enalapril” [mesh] OR “Enalapril” OR “Cilazapril” [mesh] OR “Cilazapril” OR “Delapril” OR “Imidapril” OR “Lisinopril” [mesh] OR “Lisinopril” OR “Moexipril” OR “Perindopril” [mesh] OR “Perindopril” OR “Quinapril” OR “Ramipril” [mesh] “Ramipril” OR “Spirapril” OR “Temocapril” OR “Trandolapril” OR “Zofenopril” OR “Enalaprilat” [mesh] OR “Enalaprilat” OR “Fosinopril” [mesh] OR “Fosinopril” OR “Teprotide” [mesh] OR “Teprotide” OR “Angiotensin-Converting Enzyme Inhibitors” [mesh] OR “Angiotensin-Converting Enzyme Inhibitors” OR “Angiotensin Converting Enzyme Inhibitors” OR “Inhibitors, Kininase II” OR “Kininase II Antagonists” OR “Kininase II Inhibitors” OR “Angiotensin I-Converting Enzyme Inhibitors” OR “Angiotensin I Converting Enzyme Inhibitors” OR “Antagonists, Angiotensin- Converting Enzyme” OR “Antagonists, Angiotensin Converting Enzyme” OR “Antagonists, Kininase II” OR “Inhibitors, ACE” OR “ACE Inhibitors” OR “Inhibitors, Angiotensin-Converting Enzyme” OR “Enzyme Inhibitors, Angiotensin-Converting” OR “Inhibitors, Angiotensin Converting Enzyme” OR “Angiotensin-Converting Enzyme Antagonists” OR “Angiotensin Converting Enzyme Antagonists” OR “Enzyme Antagonists, Angiotensin-Converting”) 3. (“Heart failure” [mesh] OR “heart failure” OR “Cardiac Failure” OR “Heart Decompensation” OR “Decompensation, Heart” OR “Heart Failure, Right-Sided” OR “Heart Failure, Right Sided” OR “Right-Sided Heart Failure” OR “Right Sided Heart Failure” OR “Myocardial Failure” OR “Congestive Heart Failure” OR “Heart Failure, Congestive” OR “Heart Failure, Left-Sided” OR “Heart Failure, Left Sided” OR “Left-Sided Heart Failure” OR “Left Sided Heart Failure” OR “chronic heart failure” OR "chronic heart" OR (CHF)) 4.
    [Show full text]
  • ACE Inhibitors
    ACE Inhibitors This sheet talks about exposure to ACE inhibitors in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider. What is an ACE inhibitor? Angiotensin-converting-enzyme (ACE) inhibitor is the name used to describe a group of medications used to treat high blood pressure. They have also been used for treating problems with the heart and kidneys. ACE inhibitors are sold under many names, such as: benazepril (Lotensin®), captopril (Capoten®), cilazapril (Inhibace®), enalapril (Vasotec ®, Renitec®), fosinopril, imidapril (Tanatril®), lisinopril (Listril®, Lopril®, Novatec®, Prinivil®, Zestril®), moexipril (Univasc®), perindopril (Aceon®), quinapril (Accupril®), ramipril (Altace®, Prilace®, Ramace®, Ramiwin®, Triatec®, Tritace®), trandolapril (Gopten®, Mavik®, Odrik®) and zofenopril. I take an ACE inhibitor. Can it make it harder for me to get pregnant? Studies have not been done to see if ACE inhibitors could make it harder to get pregnant. I just found out I am pregnant. Should I stop taking my ACE inhibitor? Talk with your healthcare providers before making any changes to how you take your medication(s). They will work with you to determine the most appropriate way to treat your blood pressure. It is important to maintain a healthy blood pressure. Can high blood pressure during my pregnancy cause problems? Uncontrolled high blood pressure that starts before pregnancy or before the 20th week of pregnancy can cause slow growth, low birth weight, or preterm delivery (birth before 37 weeks of pregnancy). Some people develop elevated blood pressure after the 20th week of pregnancy (known as preeclampsia). Treatment depends on how high the blood pressure is and other factors.
    [Show full text]
  • Recommendation to Restrict the Combined Use of Medicines Affecting the Renin-Angiotensin (Ras) System
    HPRA page August2014_medbook 12/07/2014 14:23 Page iv Recommendation to RestRict the combined use of medicines affecting the Renin-angiotensin (Ras) system The European Medicines Agency’s Pharmacovigilance Risk individual studies, that the likely benefits from dual Assessment Committee (PRAC) has reviewed the risks of blockade are limited to a reduction in hospital admissions combining different classes of medicines that act on the for heart failure among people with pre-existing heart renin-angiotensin (RAS) system. These medicines, which failure, and highlights some important safety concerns are called RAS-acting agents, belong to three classes: associated with dual therapy. Based on the totality of the 1. Angiotensin-receptor blockers (ARBs) for example evidence, the PRAC has recommended that dual therapy candesartan, telmisartan, valsartan, losartan, should be restricted to limited situations under specialist olmesartan and irbesartan*, supervision after careful consideration of the likely risks and benefits. 2. Angiotensin-converting enzyme inhibitors (ACE inhibitors) for example captopril, enalapril, lisinopril, Following this review, harmonised implementation of these ramipril, perindopril and zofenopril*, recommendations into product information has begun in 3. Direct renin inhibitors such as aliskiren*, which is the order to reflect the available information and adequately only authorised substance in its class. manage the concerns identified with regards to dual RAS blockade therapy and the overall conclusion that dual The PRAC has advised that combining medicines from any blockade of the renin angiotensin system with an ACE two of these classes should not be recommended, and in inhibitor plus an angiotensin receptor blocker (ARB) has particular that patients with diabetic nephropathy should only a limited place in treatment e.g.
    [Show full text]
  • IMPACT of DIFFERENT ANGIOTENSIN-CONVERTING INHIBITORS on OUTCOMES of POST-MYOCARDIAL INFARCTION PATIENTS DOI: 10.36740/Wlek202003129
    © Wydawnictwo Aluna Wiadomości Lekarskie 2020, tom LXXIII, nr 3 ORIGINAL ARTICLE PRACA ORYGINALNA IMPACT OF DIFFERENT ANGIOTENSIN-CONVERTING INHIBITORS ON OUTCOMES OF POST-MYOCARDIAL INFARCTION PATIENTS DOI: 10.36740/WLek202003129 Marian V. Hrebenyk, Larysa Yu. Bidovanets I. HORBACHEVSKY TERNOPIL NATIONAL MEDICAL UNIVERSITY, TERNOPIL, UKRAINE ABSTRACT The aim: To compare the long-term effects of different angiotensin-converting enzyme inhibitors in post-myocardial infarction (MI) patients. Materials and methods: Of 445 consecutive patients with myocardial infarction, 76 (17%) patients had co-morbid conditions, as well as were found to be compliant with secondary prevention treatment and eligible for follow-up. These patients were assigned to ramipril, perindopril or zofenopril groups in complex management of post-MI period. Subsequently, the patients were followed-up prospectively for a period of up to 24 months. Results: Patients of zofenopril group performed better in terms of post-MI biventricular remodeling and left ventricular function recovery. Also, patients receiving zofenopril showed benefits in terms of short-term and long-term mortality as compared with patients of ramipril and perindopril groups. Conclusion: Zofenopril may have advantages over perindopril and ramipril in the complex management of post-MI patients in terms of prevention of negative myocardial remodeling, onset of congestive heart failure and major adverse events. KEY WORDS: myocardial infarction; angiotensin-converting enzyme inhibitors; myocardial remodeling; co-morbidities; secondary prevention Wiad Lek. 2020;73(3):555-560 INTRODUCTION MATERIALS AND METHODS Myocardial infarcion (MI) is one of the most dramatic A total of 455 patients (342 [75,16%] – males) with ST-eleva- manifestations of coronary artery disease characterized by tion acute MI aged 62,7±1,07 years gave informed consent for high mortality rates due to fatal arrhythmias, cardiogenic participation in the study.
    [Show full text]
  • Preclinical Profile of Zofenopril: an Angiotensin Converting Enzyme Inhibitor with Peculiar Cardioprotective Properties
    Cardiovascular Drug Reviews Vol. 17, No. 2, pp. 115–133 © 1999 Neva Press, Branford, Connecticut Preclinical Profile of Zofenopril: An Angiotensin Converting Enzyme Inhibitor with Peculiar Cardioprotective Properties A. Subissi, S. Evangelista and A. Giachetti Preclinical Development, Menarini Ricerche S.p.A., Firenze, Italy. Key Words: Angiotensin-converting enzyme inhibitor—Cardioprotection—Hypertension— Sulfhydryl—Zofenopril. INTRODUCTION The discovery of captopril, the prototype of orally active angiotensin-converting en- zyme inhibitors (ACEIs), represented a major breakthrough in the treatment of cardio- vascular diseases. Currently, captopril has four important indications: hypertension, con- gestive heart failure, acute myocardial infarction, and diabetic nephropathy. After the discovery of captopril, several new ACEIs were developed and introduced into medical practice. These new ACEIs are neither chemically nor pharmacologically identical; they differ in their chemical structure, functional groups (sulfhydryl in captopril, carboxyl in enalapril, or phosphinyl in fosinopril), active moiety (some are prodrugs), potency, an- cillary pharmacology, and pharmacokinetics. These and other important characteristics differentiate ACEIs and influence their ability to inhibit the enzyme in various organs. Since ACEIs appear to work by inhibiting angiotensin-converting enzyme (ACE) in critical tissues, tissue selectivity is one of the most important properties that varies with the individual ACEIs. An important question is whether different tissue-selectivity profiles of ACEIs in ani- mal experiments are clinically relevant. Although the clinical relevance is not yet firmly established, the emerging evidence indicates that some differences among ACEIs are clinically significant (4,6,28,43). The latest ACE inhibitor to reach the European market is zofenopril calcium. By February 1999, it was registered in all 15 European Community countries.
    [Show full text]
  • Estonian Statistics on Medicines 2013 1/44
    Estonian Statistics on Medicines 2013 DDD/1000/ ATC code ATC group / INN (rout of admin.) Quantity sold Unit DDD Unit day A ALIMENTARY TRACT AND METABOLISM 146,8152 A01 STOMATOLOGICAL PREPARATIONS 0,0760 A01A STOMATOLOGICAL PREPARATIONS 0,0760 A01AB Antiinfectives and antiseptics for local oral treatment 0,0760 A01AB09 Miconazole(O) 7139,2 g 0,2 g 0,0760 A01AB12 Hexetidine(O) 1541120 ml A01AB81 Neomycin+Benzocaine(C) 23900 pieces A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+Thymol(dental) 2639 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+Cetylpyridinium chloride(gingival) 179340 g A01AD81 Lidocaine+Cetrimide(O) 23565 g A01AD82 Choline salicylate(O) 824240 pieces A01AD83 Lidocaine+Chamomille extract(O) 317140 g A01AD86 Lidocaine+Eugenol(gingival) 1128 g A02 DRUGS FOR ACID RELATED DISORDERS 35,6598 A02A ANTACIDS 0,9596 Combinations and complexes of aluminium, calcium and A02AD 0,9596 magnesium compounds A02AD81 Aluminium hydroxide+Magnesium hydroxide(O) 591680 pieces 10 pieces 0,1261 A02AD81 Aluminium hydroxide+Magnesium hydroxide(O) 1998558 ml 50 ml 0,0852 A02AD82 Aluminium aminoacetate+Magnesium oxide(O) 463540 pieces 10 pieces 0,0988 A02AD83 Calcium carbonate+Magnesium carbonate(O) 3049560 pieces 10 pieces 0,6497 A02AF Antacids with antiflatulents Aluminium hydroxide+Magnesium A02AF80 1000790 ml hydroxide+Simeticone(O) DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 34,7001 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 3,5364 A02BA02 Ranitidine(O) 494352,3 g 0,3 g 3,5106 A02BA02 Ranitidine(P)
    [Show full text]
  • Reseptregisteret 2014–2018 the Norwegian Prescription Database 2014–2018
    LEGEMIDDELSTATISTIKK 2019:2 Reseptregisteret 2014–2018 The Norwegian Prescription Database 2014–2018 Reseptregisteret 2014–2018 The Norwegian Prescription Database 2014–2018 Christian Lie Berg Kristine Olsen Solveig Sakshaug Utgitt av Folkehelseinstituttet / Published by Norwegian Institute of Public Health Område for Helsedata og digitalisering Avdeling for Legemiddelstatistikk Juni 2019 Tittel/Title: Legemiddelstatistikk 2019:2 Reseptregisteret 2014–2018 / The Norwegian Prescription Database 2014–2018 Forfattere/Authors: Christian Berg, redaktør/editor Kristine Olsen Solveig Sakshaug Acknowledgement: Julie D. W. Johansen (English text) Bestilling/Order: Rapporten kan lastes ned som pdf på Folkehelseinstituttets nettsider: www.fhi.no / The report can be downloaded from www.fhi.no Grafisk design omslag: Fete Typer Ombrekking: Houston911 Kontaktinformasjon / Contact information: Folkehelseinstituttet / Norwegian Institute of Public Health Postboks 222 Skøyen N-0213 Oslo Tel: +47 21 07 70 00 ISSN: 1890-9647 ISBN: 978-82-8406-014-9 Sitering/Citation: Berg, C (red), Reseptregisteret 2014–2018 [The Norwegian Prescription Database 2014–2018] Legemiddelstatistikk 2019:2, Oslo, Norge: Folkehelseinstituttet, 2019. Tidligere utgaver / Previous editions: 2008: Reseptregisteret 2004–2007 / The Norwegian Prescription Database 2004–2007 2009: Legemiddelstatistikk 2009:2: Reseptregisteret 2004–2008 / The Norwegian Prescription Database 2004–2008 2010: Legemiddelstatistikk 2010:2: Reseptregisteret 2005–2009. Tema: Vanedannende legemidler / The Norwegian
    [Show full text]
  • Combined Use of Medicines Affecting the Renin-Angiotensin System (RAS) to Be Restricted – CHMP Endorses PRAC Recommendation EMA/294911/2014 Page 2/4
    23 May 2014 EMA/294911/2014 Combined use of medicines affecting the renin- angiotensin system (RAS) to be restricted – CHMP endorses PRAC recommendation The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed restrictions on combining different classes of medicines that act on the renin-angiotensin system (RAS), a hormone system that controls blood pressure and the volume of fluids in the body. These medicines (called RAS-acting agents) belong to three main classes: angiotensin-receptor blockers (ARBs, sometimes known as sartans), angiotensin-converting enzyme inhibitors (ACE- inhibitors) and direct renin inhibitors such as aliskiren. Combination of medicines from any two of these classes is not recommended and, in particular, patients with diabetes-related kidney problems (diabetic nephropathy) should not be given an ARB with an ACE-inhibitor. Where combination of these medicines (dual blockade) is considered absolutely necessary, it must be carried out under specialist supervision with close monitoring of kidney function, fluid and salt balance and blood pressure. This would include the licensed use of the ARBs candesartan or valsartan as add- on therapy to ACE-inhibitors in patients with heart failure who require such a combination. The combination of aliskiren with an ARB or ACE-inhibitor is strictly contraindicated in those with kidney impairment or diabetes. The CHMP opinion confirms recommendations made by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) in April 2014, following assessment of evidence from several large studies in patients with various pre-existing heart and circulatory disorders, or with type 2 diabetes. These studies found that combination of an ARB with an ACE-inhibitor was associated with an increased risk of hyperkalaemia (increased potassium in the blood), kidney damage or low blood pressure compared with using either medicine alone.
    [Show full text]
  • [NAME] 30 Mg /12.5 Mg Film-Coated Tablets (Zofenopril Calcium / Hydrochlorothiazide)
    Package leaflet: Information for the user [NAME] 30 mg /12.5 mg film-coated tablets (zofenopril calcium / hydrochlorothiazide) 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. 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 include any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What [NAME] is and what it is used for 2. What you need to know before you take [NAME] 3. How to take [NAME] 4. Possible side effects 5. How to store [NAME] 6. Content of the pack and other information 1. What [NAME] is and what it is used for [NAME] contains zofenopril calcium 30 mg and hydrochlorothiazide 12.5 mg as the active ingredients. Zofenopril calcium is a cardiovascular drug which belongs to a group of blood pressure lowering medicines called angiotensin converting enzyme (ACE) inhibitors. Hydrochlorothiazide is a diuretic, that acts by increasing the amount of urine you produce. [NAME] is used to treat mild to moderate high blood pressure (hypertension), when this is not adequately controlled by taking zofenopril alone. 2. What you need to know before you take [NAME] Do not take [NAME] if you: are more than 3 months pregnant (It is also better
    [Show full text]
  • Zofenopril Mylan Film-Coated Tablet ENG Smpc
    SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Invented name> 30mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30mg of zofenopril calcium, equivalent to 28.7 mg of zofenopril For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White, round, film-coated tablets with break line on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Hypertension Zofenopril is indicated for the treatment of mild to moderate essential hypertension. Acute Myocardial Infarction Zofenopril is indicated for the treatment initiated within the first 24 hours of patients with acute myocardial infarction with or without signs and symptoms of heart failure, who are haemodynamically stable and have not received thrombolytic therapy. 4.2 Posology and method of administration Posology Hypertension The need for dosage titration should be determined by measurement of blood pressure just before the next dose. The dose should be increased at an interval of four weeks. Page 1 Patients without volume or salt depletion Treatment should be started with 15mg once daily and titrated upwards to achieve optimal blood pressure control. The usual effective dose is 30mg once daily. The maximum dose is 60mg per day administered in a single or two divided doses. In case of inadequate response, other antihypertensive agents such as diuretics may be added (see sections 4.3, 4.4, 4.5 and 5.1). Patients suspected of volume or salt depletion First-dose hypotension may occur in high risk patients (see section 4.4).
    [Show full text]
  • Summary of Product Characteristics
    SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zofenopril / Hydrochlorothiazide Mylan 30 mg / 12.5 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 30 mg of zofenopril calcium (equivalent to 28.7 mg zofenopril) and 12.5 mg hydrochlorothiazide. Excipient with known effect: Each film-coated tablet contains 47.50 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Beige, film-coated, round, biconvex tablet debossed with “M” on one side of the tablet and “Z” over the score and “H” below the score on the other side of the tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of mild to moderate essential hypertension. This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on zofenopril alone. 4.2 Posology and method of administration Posology Zofenopril / Hydrochlorothiazide Mylan should be used once daily. Dose titration with the individual components (i.e. zofenopril and hydrochlorothiazide) is recommended before changing to the fixed dose combination. When clinically appropriate direct change from monotherapy to the fixed combination may be considered. Adults (18 to 65 years of age) Patients without volume or salt depletion The usual effective dose is one tablet once daily. Patients suspected of volume or salt depletion The use of zofenopril / hydrochlorothiazide is not recommended. Older people (over 65 years) In older people with normal creatinine clearance no dose adjustment is necessary.
    [Show full text]