DOCSLIB.ORG

Comparison of Effects Ofcalcium Carbasalate and Aspirin On

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Comparison of Effects Ofcalcium Carbasalate and Aspirin On Gut 1996; 38: 11-14 11 Comparison of effects of calcium carbasalate and aspirin on gastroduodenal mucosal damage in human volunteers Gut: first published as 10.1136/gut.38.1.11 on 1 January 1996. Downloaded from F E Murray, N Hudson, J C Atherton, A T Cole, F Scheck, C J Hawkey Abstract substantial morbidity and mortality from Calcium carbasalate is a therapeutically peptic ulcer disease. Effervescent calcium active salicylate which seems to cause less carbasalate (ECC) is a calcium urea chelate of gastroduodenal mucosal damage than two aspirin molecules, formed by replacing the aspirin in laboratory animals. This endo- two molecules of water in crystalline calcium scopist-blinded, randomised, cross over acetyl salicylate by a molecule of urea. It forms trial aimed to compare acute gastric a stable and very soluble complex. In solution, mucosal damage in 20 healthy volunteers the complex immediately releases aspirin in the treated with acetyl salicylic acid (ASA) form of acetyl salicylate ion. When adminis- (650 mg three times daily) and efferves- tered orally, the acetyl salicylate is readily cent calcium carbasalate (ECC) (826.8 mg absorbed and has similar analgesic, antipyretic, three times daily) bioequivalent to 650 mg and anti-inflammatory properties to aspirin. ASA over a five day period. Endoscopy Studies using intramucosal potential difference was performed immediately before treat- and gastrointestinal bleeding have suggested ment and on day 5 of each treatment. that ECC may be less damaging to the human Serum salicylate, thromboxane B2, and gastrointestinal tract. 14 gastric mucosal prostaglandin E2 (PGE2) We now report a direct comparison of concentrations were measured after gastroduodenal injury, assessed endoscopi- endoscopy. ECC caused fewer gastric cally, caused by plain ASA for five days and mucosal erosions than ASA. The total effervescent calcium carbasalate (826.8 mg number of gastric erosions was 23.8 (16.1) three times daily, equivalent to 650 mg ASA in the ASA treated subjects compared three times daily for five days). with 9.1 (8.7) in ECC treated subjects (p=0.004). Differences between ASA and http://gut.bmj.com/ ECC were significant for both the gastric Patients and methods antrum and body, and for both haemor- This was a randomised, endoscopist-blind, rhagic and non-haemorrhagic erosions. cross over trial comparing the effects of effer- The mean gastric body Lanza score for vescent calcium carbasalate (ECC) and plain mucosal damage was lower after ECC ASA on gastroduodenal mucosal injury in than ASA (p=0.003). The visual analogue healthy volunteers. Healthy volunteers of score for gastric body damage was lower either sex, aged between 18 and 45, within on September 25, 2021 by guest. Protected copyright. for ECC (16.9 mm (15.9)) than for ASA 15% of their desirable weight (according to (32.7 mm (20.8)) p=0.008. Serum salicy- Metropolitan Life tables), were recruited. late concentrations were similar after After giving written informed consent, subjects both preparations (ASA: 66 (23) mgIl, were screened to enter this study. versus ECC: 58 (17) mgll, NS). Serum Subjects underwent a medical examination thromboxane B2 was similarly reduced with haematological and biochemical screen- using both preparations - 97.2 (3.5)% inhi- ing and a screening endoscopy before the start bition with ASA, 95.2 (5.5)% inhibition of the study. The main exclusion criteria with calcium carbasalate (NS). Suppres- included asthma, peptic ulcer disease, aspirin sion of gastric mucosal PGE2 synthesis intolerance, and the presence of more than was similar with both preparations (ASA: three erosions at screening endoscopy. 83.4 (17.1)%; ECC 84.3 (12.9)%; NS). It is Volunteers were instructed to refrain from Division of concluded that ECC causes significantly drugs (except oral contraceptives), alcohol, Gastroenterology, Department of less gastroduodenal mucosal damage than and spicy food during the study. They were Therapeutics, ASA administered at bioequivalent doses randomised to receive either 325 mg plain University Hospital, as judged by serum salicylate, serum ASA (Aspirin, Bayer) or ECC containing 413 Nottingham NG7 2UH and mucosal values. F E Murray thromboxane, PGE2 mg acetyl salicylate (Redupsan, UPSA, Rueil N Hudson ECC may therefore be a less harmful Malmaison, France) first. During the active J C Atherton alternative treatment to plain ASA. treatment period, subjects were instructed to A T Cole 38: take two tablets 20 minutes before each meal F Scheck (Gut 1996; 11-14) C J Hawkey (breakfast, lunch, and dinner) for four days Keywords: calcium carbasalate, acetyl salicylic acid, and one dose on the fifth day. There was a Correspondence to: gastric mucosal damage. 16 to Professor C J Hawkey, wash out period of 23 days between Division of Gastroenterology, active treatments. University Hospital, Nottingham NG7 2UH. Before treatment and on day 5, subjects Accepted for publication Acetyl salicylic acid (ASA) causes acute underwent evaluation ofsymptoms and adverse 12 July 1995 gastroduodenal mucosal injury, resulting in events, endoscopic evaluation, and had blood 12 Murray, Hudson, Atherton, Cole, Scheck, Hawkey TABLE I Modified Lanza samples taken from serum salicylate and significant. The results were expressed as mean scale thromboxane B2 (TxB2) measurement. (SD) (as well as mean and interquartile range Score Endoscopic appearances Endoscopy was performed without sedation. (IQR) for efficacy criteria) for quantitative The number of erosions (both haemorrhagic parameters and frequencies and percentages 0 Normal mucosa and non-haemorrhagic), intramucosal haemor- for qualitative parameters. Data regarding the 1 Mucosal erythema Gut: first published as 10.1136/gut.38.1.11 on 1 January 1996. Downloaded from 1 1-5 Erosions rhages, and superficial and deep ulcers in the Lanza scale are expressed as median (IQR). 3 6-10 Erosions 4 > 10 Erosions or an oesophagus, stomach, and duodenum were The two randomised groups were compared ulcer counted. These data were used to derive a for demographic parameters using the modified Lanza score of mucosal damage Pearson's x2 test for qualitative parameters and (Table I). A visual analogue score (100 mm) of the Student's t test for quantitative parameters. mucosal damage was also used to evaluate The efficacy analysis was performed in three gastric antrum, body, and duodenal damage. steps. Firstly, the presence of residual effects Endoscopic biopsy was performed in the gastric was investigated using the paired sample t test body to determine PGE2 synthesis. After with- for quantitative parameters and the initial drawal of the endoscope, blood was taken for assessments at the first visit and the third visit estimation of serum salicylate by high perfor- (baseline evaluations before each sequence mance liquid chromatography (HPLC). Serum under active treatment). Secondly, within TxB2 and mucosal prostaglandin E2 (PGE2) treatment effects were tested using the same were assayed as previously described.5 6 Briefly, tests to compare initial and final assessment mucosal biopsy specimens were washed in 0. 15 within each treatment, pooling the subjects of ml ofTris-saline and vortexed in 500 ,ul ofTris- the two sequences. Thirdly, the two treatments saline for one minute at room temperature. The were compared using a two way analysis of biopsy specimens were then removed and variance model (testing treatments effect, washed and the supematant stored at -70°C sequence effect and sequence by treatment until assayed. PGE2 was measured in unex- interaction) for quantitative parameters and a tracted supernatant using a validated specific modified x2 test (Cochran Mantel-Haenszel radioimmunoassay (RIA), and expressed as test) to compare the frequencies of qualitative pg/mg wet weight ofgastric mucosa. The serum parameters adjusting for the sequence. TxB2 concentration was measured in separated serum using RIA. Results STATISTICAL METHODS PATIENT POPULATION From previous data, we estimated an average Twenty two volunteers were screened to enter total number of erosions with aspirin of 11.2 the study. One subject was not included in the and aimed for the power to detect reduction of study because ofthe presence of a baseline bio- http://gut.bmj.com/ mucosal damage by two erosions (29% reduc- chemical abnormality (raised serum creati- tion a=0 05, 1-p=09). As a result of sample nine) and did not receive either treatment. One size calculation in log transformed values this other subject who had been randomised to led to 20 subjects being recruited to complete plain ASA dropped out before the end of the the study. first treatment period because she was unwill- Statistical analysis was done using the SAS ing to undergo further endoscopy. She did not and the Statexact packages. All tests were two complain of any symptom while taking the on September 25, 2021 by guest. Protected copyright. tailed; p values below 0.05 were considered treatment and reported no adverse event. Thus 20 subjects (16 men and 4 women, TABLE II Comparison ofgastroduodenal damage associated withfive days' treatment with aged 23.95 (3.6) years (range 19-35), and acetyl salicylic acid (ASA) or effervescent calcium carbasatate (ECC) (values mean weight 73 kg (8)) completed the entire study (SD)) and were evaluated. Eleven subjects received Total no oferosions ASA as the first treatment and ECC as the ECC p Value second treatment; nine subjects received ECC ASA as the first treatment and ASA as the second Gastric body: Total erosions and ulcers 12-4 (9-7) 5-0 (7-3) 0-005 treatment. Haemorrhagic erosions 11-8 (9 6) 4-6 (6-9) 0.004 Non-haemorrhagic erosions 0-7 (1-5) 0-4 (1-0) Lanza score (IQR) 3 (2-4) 2 (0-2) 0-003 VAS (mm) 32-7 (20-8) 16-9 (15-9) 0-008 COMPARISON OF EFFECTS OF ASA AND ECC ON Gastric antrum: GASTRIC MUCOSAL DAMAGE Total erosions and ulcers 11-4 (9-4) 4-1 (4-1) 0-002 Haemorrhagic erosions 5-7 (6-9) 2-2 (2.7) 0-006 There was no difference in the number of Non-haemorrhagic erosions 5-5 (5-8) 1-9 (3-0) 0-01 erosions at baseline in the two groups.
Load more

Recommended publications
  • Pharmacokinetics of Salicylic Acid Following Intravenous and Oral Administration of Sodium Salicylate in Sheep
    animals Article Pharmacokinetics of Salicylic Acid Following Intravenous and Oral Administration of Sodium Salicylate in Sheep Shashwati Mathurkar 1,*, Preet Singh 2 ID , Kavitha Kongara 2 and Paul Chambers 2 1 1B, He Awa Crescent, Waikanae 5036, New Zealand 2 School of Veterinary Sciences, College of Sciences, Massey University, Palmerston North 4474, New Zealand; [email protected] (P.S.); [email protected] (K.K.); [email protected] (P.C.) * Correspondence: [email protected]; Tel.: +64-221-678-035 Received: 13 June 2018; Accepted: 16 July 2018; Published: 18 July 2018 Simple Summary: Scarcity of non-steroidal anti-inflammatory drugs (NSAID) to minimise the pain in sheep instigated the current study. The aim of this study was to know the pharmacokinetic parameters of salicylic acid in New Zealand sheep after administration of multiple intravenous and oral doses of sodium salicylate (sodium salt of salicylic acid). Results of the study suggest that the half-life of the drug was shorter and clearance was faster after intravenous administration as compared to that of the oral administration. The minimum effective concentration required to produce analgesia in humans (16.8 µL) was achieved in sheep for about 0.17 h in the current study after intravenous administration of 100 and 200 mg/kg body weight of sodium salicylate. However, oral administration of these doses failed to achieve the minimum effective concentration as mentioned above. This study is of significance as it adds valuable information on pharmacokinetics and its variation due to breed, species, age, gender and environmental conditions.
    [Show full text]
  • Aspirin Therapy in Primary Prevention of ASCVD
    Aspirin Therapy in Primary Prevention of ASCVD ✖ The use of aspirin in primary prevention of atherosclerotic cardiovascular disease (ASCVD) has faced increasing controversy. ✖ A recently published four-trial series evaluating the use of aspirin therapy in the primary prevention of ASCVD has yielded potential challenges to decades-old research as reflected in the current U.S. Preventive Services PROBLEM Task Force guidelines. • In three of the four trials, aspirin failed to show benefit of primary cardiovascular prevention, while suggesting potential harm including higher all-cause mortality and major hemorrhage with reduced disability- free survival. • A fourth trial showed modest reduction in serious vascular events which were “largely counterbalanced” by the observed rate of major bleeding events within the trial. ✔ Low-dose aspirin SHOULD NOT be routinely administered for primary prevention of ASCVD to individuals >70 years of age and those at increased risk of bleeding GENERALLY NO SOLUTION irrespective of age (risk may outweigh benefit), or <40 years of age (insufficient data for determining risk-to-benefit). OCCASIONALLY YES ✔ Low-dose aspirin MAY be considered for primary prevention of ASCVD among adults aged 40-70 years who possess higher ASCVD risk but remain at low probability for bleeding events. LOW-DOSE ASPIRIN USE IN PRIMARY PREVENTION OF ASCVD Study Patient Population Benefit Harm (Aspirin vs. Placebo) ASCEND Diabetes without ASCVD iIn MACE hRisk of major bleeding 8.5% vs. 9.6% 4.1% vs. 3.2% (rate ratio 0.88, CI 0.79-0.97) (rate ratio 1.29, CI 1.09-1.52) ASPREE Elderly: ≥ 70 years of age No reduction all-cause mortality hRisk of major hemorrhage OR 5.9% vs.
    [Show full text]
  • Antipyretic Efficacy of an Initial 30-Mg/Kg Loading Dose of Acetaminophen Versus a 15-Mg/Kg Maintenance Dose
    Antipyretic Efficacy of an Initial 30-mg/kg Loading Dose of Acetaminophen Versus a 15-mg/kg Maintenance Dose Jean Marc Tre´luyer, MD, PhD*; Sylvie Tonnelier, PharmD*; Philippe d’Athis‡; Beatrice Leclerc§; Isabelle Jolivet-Landreau, MD§; and Ge´rard Pons, MD, PhD* ABSTRACT. Objective. To compare the antipyretic comfort.1 Among the available antipyretic agents, efficacy of an initial 30-mg/kg acetaminophen loading acetaminophen is one of the most widely used be- dose versus a 15-mg/kg maintenance dose. cause it has an antipyretic efficacy equivalent to the Methods. A double-blind, parallel-group, random- other antipyretic drugs and a good safety profile.2–4 ized clinical trial was conducted. A total of 121 febrile Acetaminophen antipyretic efficacy is dose-depen- (rectal temperature between 39°C and 40°C) but other- dent.5,6 The recommended dose is 15 mg/kg every 6 wise healthy outpatients who were 4 months to 9 years of 2 age and weighed 4 to 26 kg were assigned randomly to 1 hours. Following this dosing schedule, it usually -takes several hours after the first acetaminophen ad ؍ and 30 mg/kg (n (62 ؍ of the dose groups: 15 mg/kg (n 59). ministration to obtain the maximal clinical efficacy of Results. In an “intention to treat” analysis, the time to the drug.7 Therefore, Mahar et al8 suggested a phys- obtain a temperature lower than 38.5°C was significantly ical “cold therapy” at the initiation of the chemical shorter in the 30-mg/kg than in the 15-mg/kg group treatment to decrease the time course to antipyretic minutes vs 139 ؎ 113 minutes).
    [Show full text]
  • Clinical Report—Fever and Antipyretic Use in Children Abstract
    Guidance for the Clinician in Rendering Pediatric Care Clinical Report—Fever and Antipyretic Use in Children Janice E. Sullivan, MD, Henry C. Farrar, MD, and the abstract SECTION ON CLINICAL PHARMACOLOGY AND THERAPEUTICS, and COMMITTEE ON DRUGS Fever in a child is one of the most common clinical symptoms managed by pediatricians and other health care providers and a frequent cause KEY WORDS fever, antipyretics, children of parental concern. Many parents administer antipyretics even when ABBREVIATIONS there is minimal or no fever, because they are concerned that the child NSAID—nonsteroidal anti-inflammatory drug must maintain a “normal” temperature. Fever, however, is not the The guidance in this report does not indicate an exclusive primary illness but is a physiologic mechanism that has beneficial course of treatment or serve as a standard of medical care. effects in fighting infection. There is no evidence that fever itself wors- Variations, taking into account individual circumstances, may be ens the course of an illness or that it causes long-term neurologic appropriate. complications. Thus, the primary goal of treating the febrile child This document is copyrighted and is property of the American Academy of Pediatrics and its Board of Directors. All authors should be to improve the child’s overall comfort rather than focus on have filed conflict of interest statements with the American the normalization of body temperature. When counseling the parents Academy of Pediatrics. Any conflicts have been resolved through or caregivers of a febrile child, the general well-being of the child, the a process approved by the Board of Directors.
    [Show full text]
  • New Zealand Data Sheet 1
    New Zealand Data Sheet 1. PRODUCT NAME NAXEN® 250 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each NAXEN 250 mg tablet contains 250 mg of Naproxen For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM NAXEN 250 mg tablets are yellow, biconvex, round tablet of 11 mm diameter with one face engraved NX250 and having a bisecting score. 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 NAXEN is indicated in adults for the relief of symptoms associated with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendonitis and bursitis, acute gout and primary dysmenorrhoea. NAXEN is indicated in children for juvenile arthritis. 4.2. Dose and method of administration After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used (see Section 4.4). During long-term administration the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration. In patients who tolerate lower doses well, the dose may be increased to 1000 mg per day when a higher level of anti-inflammatory/analgesic 1 | P a g e activity is required. When treating patients with naproxen 1000 mg/day, the physician should observe sufficient increased clinical benefit to offset the potential increased risk. Dose Adults For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis Initial therapy: The usual dose is 500-1000 mg per day taken in two doses at 12 hour intervals.
    [Show full text]
  • Using Aspirin for the Primary Prevention of Cardiovascular Disease
    Partnership for HEALTH Heart and Circulation Clinician Fact Sheet Using Aspirin for the Primary Prevention of Cardiovascular Disease Your patients rely on you for accurate, up-to-date preventive health information. This fact sheet for clinicians provides information about the use of aspirin to prevent first myocardial infarctions in men and first ischemic strokes in women. It is designed to complement the patient brochures: y Talk With Your Health Care y Talk With Your Health Care Provider About: Taking Aspirin Provider About: Taking to Prevent Heart Attacks— Aspirin to Prevent Strokes— for Men for Women Who should take aspirin to prevent How do I determine benefit? cardiovascular disease? An individual’s potential clinical benefit The US Preventive Services Task Force (USPSTF) recommends the use of aspirin from aspirin depends on his or her for the primary prevention of cardiovascular disease (CVD) when a net benefit baseline risk. is present. A net benefit means that the potential benefit from taking aspirin outweighs the harms, mainly gastrointestinal (GI) bleeding. Specifically, MI Risk Factors for Men y Aspirin is recommended for men age 45–79 to reduce risk of myocardial y Age infarction (MI) when a net benefit is present. y Diabetes y Total cholesterol level y Aspirin is recommended for women age 55–79 to reduce risk of ischemic y HDL cholesterol level stroke when a net benefit is present. y High blood pressure The USPSTF recommends AGAINST the use of aspirin for the primary prevention of y Smoking MI in men less than age 45 or stroke in women less than age 55.
    [Show full text]
  • Lodine 600 Mg SR Tablets Etodolac
    Package Leaflet : Information for the patient Lodine 600 mg SR Tablets etodolac 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, please 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 you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Lodine is and what it is used for 2. What you need to know before you take Lodine 3. How to take Lodine 4. Possible side effects 5. How to store Lodine 6. Contents of the pack and other information 1. What Lodine is and what it is used for Lodine is used to treat the symptoms of rheumatoid arthritis and osteoarthritis by reducing inflammation, swelling, stiffness, and joint pain. Each tablet contains 600mg of the active ingredient etodolac. In this tablet, the medicine is released slowly which means that you only have to take one tablet each day. Lodine is one of a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs) which are usually taken to relieve the pain, stiffness, inflammation and swelling which is often associated with arthritis. 2. What you need to know before you take Lodine DO NOT take Lodine if you: • are allergic to etodolac or any of the other ingredients of this medicine (listed in section 6) • have severe heart failure • have a peptic ulcer (a small erosion or hole in the stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.
    [Show full text]
  • The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances
    WHO/PSM/QSM/2006.3 The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances 2006 Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines Medicines Policy and Standards The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
    [Show full text]
  • Pharmacological Evaluation of Novel Dimers of an Arylpropionic Acid Class of Non-Selective Cyclooxygenase Inhibitors
    Halimi et al Tropical Journal of Pharmaceutical Research February 2017; 16 (2): 327-336 ISSN: 1596-5996 (print); 1596-9827 (electronic) © Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, 300001 Nigeria. All rights reserved. Available online at http://www.tjpr.org http://dx.doi.org/10.4314/tjpr.v16i2.10 Original Research Article Pharmacological evaluation of novel dimers of an arylpropionic acid class of non-selective cyclooxygenase inhibitors Syed Muhammad Ashhad Halimi1*, Muhammad Saeed1, Safiullah1 and Khalid Muhammed Khan2 1Department of Pharmacy, University of Peshawar, Peshawar 25120, 2H.E.J. International Centre for Chemical and Biological Sciences (ICCBS), University of Karachi, Karachi 75270, Pakistan *For correspondence: Email: [email protected]; Tel: +92 91 9216750; Fax: +92 91 9218318 Received: 4 August 2016 Revised accepted: 5 January 2017 Abstract Purpose: To explore and identify cyclooxygenase (COX) inhibitors with optimal potency and efficacy using an arylpropionic acid class of drugs as lead molecules. Methods: The selected lead molecules were dimerised through chemical processes (reflux condensation) and characterised in terms of structural properties using infrared, proton nuclear magnetic resonance, electron impact mass spectrometry, and elemental analysis techniques. The molecules were evaluated pharmacologically for acute toxicity and anti-inflammatory (carrageenan- induced paw oedema test), analgesic (acetic acid-induced writhing test in mice), and antipyretic (Brewer’s yeast-induced pyrexia test in mice) activities against control (normal saline) and relevant reference standard drugs. Docking analyses were also performed to assess possible protein–ligand interactions. Results: The test compounds were non-toxic at doses of 50, 100 and 150 mg/kg body weight, ip.
    [Show full text]
  • For Voltaren® Gel
    HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Voltaren® Gel ------------------------------WARNINGS AND PRECAUTIONS--------------------------- safely and effectively. See full prescribing information for Voltaren® Gel. • Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment. The lowest possible dose Voltaren® Gel (diclofenac sodium topical gel), For topical use only of Voltaren® Gel should be used in patients with known CV disease or risk factors Initial U.S. Approval: 1988 for CV disease. (5.1) WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK • NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse See full prescribing information for complete boxed warning. events including inflammation, bleeding, ulceration, and perforation. Voltaren® Cardiovascular Risk Gel should be prescribed with caution in those with a prior history of ulcer • Non steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of disease or gastrointestinal bleeding. (5.2) serious cardiovascular thrombotic events, myocardial infarction, and stroke, • Elevation of one or more liver tests may occur during therapy with diclofenac. which can be fatal. (5.1) Voltaren® Gel should be discontinued immediately if abnormal liver tests persist • Voltaren® Gel is contraindicated for the treatment of peri-operative pain in the or worsen. (5.3) setting of coronary artery bypass graft (CABG) surgery. • Long-term administration of NSAIDs can result in renal papillary necrosis and Gastrointestinal Risk (4, 5.1) other renal injury. Voltaren® Gel should be used with caution in patients at greatest • Nonsteroidal anti-inflammatory drugs (NSAIDs), including Voltaren® Gel, risk of this reaction, including the elderly, those with impaired renal function, heart cause an increased risk of serious gastrointestinal adverse events including failure, liver dysfunction, and those taking diuretics and ACE inhibitors.
    [Show full text]
  • Different Techniques for Analysis of Aspirin, Caffeine, Diclofenac Sodium and Paracetamol: Review Article
    ISSN 2692-4374 Pharmaceutical Sciences | Review Article Different techniques for Analysis of Aspirin, Caffeine, Diclofenac Sodium and Paracetamol: Review Article Mahmoud M. Sebaiy1*, Sobhy M. El-Adl1, and Amr A. Mattar1&2 1 Medicinal Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt. 2 Pharmaceutical Medicinal Chemistry Department, Faculty of Pharmacy, Egyptian Russian University, Badr City, Cairo 11829, Egypt. *Аuthоrcоrrеspоndеncе: Е-mаil: mmsеbаiу@zu.еdu.еg; sеbаiуm@gmаil.cоm.Tеl: 01062780060. Fаx: 0552303266 Submitted: 27 April 2020 Approved: 11 May 2020 Published: 14 May 2020 How to cite this article: Sebaiy MM, El-Adl SM, Mattar AA. Different techniques for Analysis of Aspirin, Caffeine, Diclofenac Sodium and Paracetamol: Review Article. G Med Sci. 2020; 1(1): 013-031. https://www.doi.org/10.46766/thegms.pharma.20042701 Copyright: © 2020 Mahmoud MS. This is an open access article distributed under the Creative Commons Attribution License, which permits unre- stricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTracT Early treatment of pain is of a great importance as unrelieved pain can have profound psychological effects on the patient, and acute pain that is poorly managed initially can degenerate into chronic pain, which may prove to be much more difficult to treat. It is important to assess and treat the article,mental weand will emotional shed the aspects light on of different the pain waysas well of assome its physicalanalgesic aspects. drugs monitoring Although drug and therapyanalysis isusing a mainstay different of techniques pain treatment, in addition physical to methodsthe most such as physiotherapy (including massage and the application of heat and cold), surgery, and drug monitoring are also very valuable.
    [Show full text]
  • Clinical Outcomes of Aspirin Interaction with Other Non-Steroidal Anti- Inflammatory Drugs: a Systematic Review
    J Pharm Pharm Sci (www.cspsCanada.org) 21, 48s – 73s, 2018 Clinical Outcomes of Aspirin Interaction with Other Non-Steroidal Anti- Inflammatory Drugs: A Systematic Review Zuhair Alqahtani and Fakhreddin Jamali Faculty of Pharmacy and Pharmaceutical Science, University of Alberta, Edmonton, Alberta, Canada. Received, March 16, 2018; Revised, March 30, 2018; Accepted, April 25, 2018; Published, April 27, 2018. ABSTRACT - Purpose: Concomitant use of some non-Aspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) reduces the extent of platelet aggregation of Aspirin (acetylsalicylic acid). This is while many observational studies and clinical trials suggest that Aspirin reduces cardiovascular (CV) risk attributed to the use of NANSAIDs. Thus, the therapeutic outcome of the interaction needs to be assessed. Methods: We searched various databases up to October 2017 for molecular interaction studies between the drugs and long-term clinical outcomes based on randomized clinical trials and epidemiological observations that reported the effect estimates of CV risks (OR, RR or HR; 95% CI) of the interacting drugs alone or in combinations. Comparisons were made between outcomes after Aspirin alone, NANSAIDs alone and Aspirin with naproxen, ibuprofen, celecoxib, meloxicam, diclofenac or rofecoxib. Results: In total, 32 eligible studies (20 molecular interactions studies and 12 observational trials) were found. Conflicting in vitro/in vivo/ex vivo platelet aggregation data were found for ibuprofen, naproxen and celecoxib. Nevertheless, for naproxen, the interaction at the aggregation level did not amount to a loss of cardioprotective effects of Aspirin. Similarly, for ibuprofen, the results overwhelmingly suggest no negative clinical CV outcomes following the combination therapy. Meloxicam and rofecoxib neither interacted with Aspirin at the level of platelet aggregation nor altered clinical outcomes.
    [Show full text]