NSAID Codes Used from Drug Programs Information Network (DPIN) Database
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Nsaids: Dare to Compare 1997
NSAIDs TheRxFiles DARE TO COMPARE Produced by the Community Drug Utilization Program, a Saskatoon District Health/St. Paul's Hospital program July 1997 funded by Saskatchewan Health. For more information check v our website www.sdh.sk.ca/RxFiles or, contact Loren Regier C/O Pharmacy Department, Saskatoon City Hospital, 701 Queen St. Saskatoon, SK S7K 0M7, Ph (306)655-8506, Fax (306)655-8804; Email [email protected] We have come a long way from the days of willow Highlights bark. Today salicylates and non-steroidal anti- • All NSAIDs have similar efficacy and side inflammatory drugs (NSAIDs) comprise one of the effect profiles largest and most commonly prescribed groups of • In low risk patients, Ibuprofen and naproxen drugs worldwide.1 In Saskatchewan, over 20 may be first choice agents because they are different agents are available, accounting for more effective, well tolerated and inexpensive than 300,000 prescriptions and over $7 million in • Acetaminophen is the recommended first line sales each year (Saskatchewan Health-Drug Plan agent for osteoarthritis data 1996). Despite the wide selection, NSAIDs • are more alike than different. Although they do Misoprostol is the only approved agent for differ in chemical structure, pharmacokinetics, and prophylaxis of NSAID-induced ulcers and is to some degree pharmacodynamics, they share recommended in high risk patients if NSAIDS similar mechanisms of action, efficacy, and adverse cannot be avoided. effects. week or more to become established. For this EFFICACY reason, an adequate trial of 1-2 weeks should be NSAIDs work by inhibiting cyclooxygenase (COX) allowed before increasing the dose or changing to and subsequent prostaglandin synthesis as well as another NSAID. -
Food and Drug Administration, HHS § 201.323
Food and Drug Administration, HHS § 201.323 liver damage or gastrointestinal bleed- calcium, choline salicylate, magnesium ing). OTC drug products containing in- salicylate, or sodium salicylate] or ternal analgesic/antipyretic active in- other pain relievers/fever reducers. [Ac- gredients may cause similar adverse ef- etaminophen and (insert one nonste- fects. FDA concludes that the labeling roidal anti-inflammatory analgesic/ of OTC drug products containing inter- antipyretic ingredient—including, but nal analgesic/antipyretic active ingre- not limited to aspirin, carbaspirin cal- dients should advise consumers with a cium, choline salicylate, magnesium history of heavy alcohol use to consult salicylate, or sodium salicylate] may a physician. Accordingly, any OTC cause liver damage and stomach bleed- drug product, labeled for adult use, ing.’’ containing any internal analgesic/anti- (b) Requirements to supplement ap- pyretic active ingredients (including, proved application. Holders of approved but not limited to, acetaminophen, as- applications for OTC drug products pirin, carbaspirin calcium, choline sa- that contain internal analgesic/anti- licylate, ibuprofen, ketoprofen, magne- pyretic active ingredients that are sub- sium salicylate, naproxen sodium, and ject to the requirements of paragraph sodium salicylate) alone or in combina- (a) of this section must submit supple- tion shall bear an alcohol warning ments under § 314.70(c) of this chapter statement in its labeling as follows: to include the required warning in the (1) Acetaminophen. ‘‘Alcohol Warn- product’s labeling. Such labeling may ing’’ [heading in boldface type]: ‘‘If you be put into use without advance ap- consume 3 or more alcoholic drinks proval of FDA provided it includes the every day, ask your doctor whether exact information included in para- you should take acetaminophen or graph (a) of this section. -
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. -
PACKAGE LEAFLET:INFORMATION for the USER Indocid Suppositories 100 Mg Indometacin
PACKAGE LEAFLET:INFORMATION FOR THE USER Indocid Suppositories 100 mg Indometacin Read all of this leaflet carefully before you start using 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. In this leaflet: 1. What Indocid Suppositories are and what they are used for 2. Before you use Indocid Suppositories 3. How to use Indocid Suppositories 4. Possible side effects 5, How to store Indocid Suppositories 6. Contents of the pack and other information 1. What Indocid Suppositories are and what they are used for Indocid Suppositories contain the active ingredient indometacin. This belongs to a group of medicines known as ‘non-steroidal anti-inflammatory agents’ or NSAlDs. These work by reducing the body’s ability to produce Inflammation, which may cause pain and discomfort. Your doctor has prescribed Indocid for you because you are suffering from one of the following: • Rheumatoid arthritis (disease mainly of the joints) • Osteoarthritis (disease of the joints) • Ankylosing spondylitis (a form of arthritis which mainly affects the back) • Pain, inflammation, and swelling following orthopaedic surgery. • Musculoskeletal disorders (muscles and bone disorders). • Period pain. • Low back pain. • Disease of the hip joint. -
Acute Renal Failure Associated with Diflunisal J. G. WHARTON D. 0
Postgrad Med J: first published as 10.1136/pgmj.58.676.104 on 1 February 1982. Downloaded from Postgraduate Medical Journal (February 1982) 58, 104-105 Acute renal failure associated with diflunisal J. G. WHARTON D. 0. OLIVER B.Sc., M.R.C.P. F.R.C.P., F.R.A.C.P. M. S. DUNNILL F.R.C.P., F.R.C.Path. Renal Unit, Churchill Hospital, and Department of Pathology, John Radcliffe Hospital, Oxford Summary eosinophils 224 x 106/1; ESR 30 mm/hr; urea 305 The case of a 44-year-old man with acute oliguric mmol/l; creatinine 1651 ,Lmol/l; potassium 6-43 renal failure due to tubulo-interstitial nephritis after mmol/l; serum amylase 88 Somogyi units; urine 3 months' diflunisal is reported. The possible mecha- contained no casts; no red cells but 10 neutrophils, nisms are discussed. no eosinophils and no growth. Antistreptolysin 0 titre 50 i.u./ml; IgG 16-5 g/l; IgA 3-8 g/l; IgM 1.1 g/l antinuclear factor negative; C3 122 mg/dl, C4 54Protected by copyright. Introduction mg/dl; hepatitis B surface antigen negative; chest Diflunisal has been reported as causing acute radiograph, cardiomegaly plus congestion; intra- allergic interstitial nephritis (Chan et al., 1980) venous urogram with tomograms, no obstruction, resulting in acute oliguric renal failure. A case of poor nephrogram. A renal biopsy showed tubulo- acute renal failure due to tubulo-interstitial nephritis interstitial nephritis with no eosinophil infiltrate. after 3 months of diflunisal is reported here. Recently, Diflunisal had been stopped 2 days before admission phenylakalonic acids with analgesic and anti- to this renal unit. -
Celecoxib, Celebrex, Celebra, Onsenal IUPAC- Name
Celecoxib Medical name: Celecoxib, Celebrex, Celebra, Onsenal IUPAC- name: 4-[5-(4-Methylphenyl)-3- (trifluoromethyl) pyrazol- 1-yl]benzenesulfonamide Formula: C17H14F3N3O2S (molar mass: 381,373 g/mol) Celecoxib, also known as Celebrex, is a non-steroidal anti-inflammatory drug (NSAID). It is used as long-term treatment of physical illnesses like osteoarthritis, chronic polyarthritis and Morbus Bechterew. The drug was developed by the US- American pharmacologist Philip Needleman and fielded by a pharmaceutical company called Pfizer. History: As vice president and manager of all chemical actions of the pharmaceutical and biotechnological company Pharmacia, Philip Needleman supervised the study of the experimental research of the enzyme Cyclooxygenase 2 (COX-2). The enzyme already was discovered by the Birmingham Young University in 1991. Its function is transmitting pain signals to the brain. Needleman’s ambition was to find a substance which is capable to inhibit the enzyme. On December, 31 in 1998 the research study lead to the NSAID drug Celecoxib. Rofecoxib, a similar drug which is able to inhibit COX-2 as well, has been taken off the market due to the fact that the drug caused strokes and heart attacks. As a consequence, an excessive demand for Celecoxib arose, despite of analogical adverse effects. Primary, the drug was created as a pain reliever for a long-term treatment with improved effects to the gastrointestinal passage compared to other NSAIDs. It is effective likewise ibuprofen and paracetamol. Celecoxib supposedly is “better in protecting the stomach from serious complications than other drugs”. The company Pharmacia and the concern Pfizer based their advertisement for Celecoxib on this statement. -
Non-Steroidal Anti-Inflammatory Drugs (Nsaids)* *See List of Prescription NSAID Nsaids Are Used to Treat Pain, Redness, Swelling, and Heat (Inflammation)
Medication Guide Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)* *see list of prescription NSAID NSAIDs are used to treat pain, redness, swelling, and heat (inflammation). medicines at the end of this guide WHAT IS THE MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT NSAIDS? NSAIDs can increase the risk of kidney failure, gastrointestinal damage, heart attack or stroke. Heart Kidney Gastrointestinal Attack Damage Damage (GI) Never use right before or You should not take NSAIDs Beware of life-threatening after coronary bypass graft if you have one of these ulcers and bleeding that may ! (CABG) surgery. ! high-risk conditions: ! happen without warning. Your risk† of heart attack or • Kidney disease Your GI risk increases with: stroke increases if: • Diabetes • Taking medicines called corticosteroids • You have heart disease • High blood pressure and anticoagulants • Even with short-term use • You take water pills or pills with • Old age or having poor health † • Smoking and drinking alcohol low dose aspirin does not pose this risk names that end in ‘pril’ or ‘sartan’ Your health risks increase the longer you take NSAIDs WHO SHOULD NOT TAKE NSAIDS? Do talk to your doctor if you: Do not take NSAIDs if you: • have medical conditions • have had an allergic reaction to aspirin or other NSAID • are breastfeeding • are a pregnant woman late in your pregnancy • take more than one medication: show your health provider a list of all of your medicines — some may cause serious side effects when combined with NSAIDs. WHAT ARE SERIOUS SIDE EFFECTS YOU -
Arthritis Treatment Comparison Arthritis Treatment Comparison
ARTHRITIS TREATMENT COMPARISON ARTHRITIS TREATMENT COMPARISON GENERIC OA of (BRAND) HOW SUPPLIED AS GA JIA JRA OA Knee PsA RA CHELATING AGENTS Penicillamine Cap: 250mg ✓ (Cuprimine) Penicillamine Tab: 250mg ✓ (Depen) CYCLIC POLYPEPTIDE IMMUNOSUPPRESSANTS Cyclosporine Cap: 25mg, 100mg; ✓ (Gengraf, Neoral) Sol: 100mg/mL CYCLOOXYGENASE-2 INHIBITORS Celecoxib Cap: 50mg, 100mg, ✓ ✓ ✓ ✓ (Celebrex) 200mg, 400mg DIHYDROFOLIC ACID REDUCTASE INHIBITORS Methotrexate Inj: 25mg/mL; ✓ ✓ Tab: 2.5mg Methotrexate Tab: 5mg, 7.5mg, ✓ ✓ (Trexall) 10mg, 15mg INTERLEUKIN RECEPTOR ANTAGONISTS Anakinra Inj: 100mg/0.67mL ✓ (Kineret) Tocilizumab Inj: 20mg/mL, ✓ ✓ (Actemra) 162mg/0.9mL GOLD COMPOUNDS Auranofin Cap: 3mg ✓ (Ridaura) Gold sodium thiomalate Inj: 50mg/mL ✓ ✓ (Myochrysine) HYALURONAN AND DERIVATIVES Hyaluronan Inj: 30mg/2mL ✓ (Orthovisc) Sodium hyaluronate Inj: 1% ✓ (Euflexxa) Sodium hyaluronate Inj: 10mg/mL ✓ (Hyalgan) Sodium hyaluronate Inj: 2.5mL ✓ (Supartz) HYLAN POLYMERS Hylan G-F 20 Inj: 8mg/mL ✓ (Synvisc, Synvisc One) KINASE INHIBITORS Tofacitinib Tab: 5mg ✓ (Xeljanz) MONOCLONAL ANTIBODIES Ustekinumab Inj: 45mg/0.5mL, ✓ (Stelara) 90mg/mL MONOCLONAL ANTIBODIES/CD20-BLOCKERS Rituximab Inj: 100mg/10mL, ✓ (Rituxan) 500mg/50mL (Continued) ARTHRITIS TREATMENT COMPARISON GENERIC OA of (BRAND) HOW SUPPLIED AS GA JIA JRA OA Knee PsA RA MONOCLONAL ANTIBODIES/TNF-BLOCKERS Adalimumab Inj: 20mg/0.4mL, ✓ ✓ ✓ ✓ (Humira) 40mg/0.8mL Golimumab Inj: 50mg/0.5mL, ✓ ✓ ✓ (Simponi) 100mg/mL Infliximab Inj: 100mg ✓ ✓ ✓ (Remicade) NON-STEROIDAL ANTI-INFLAMMATORY DRUGS -
The Challenge of Drug-Induced Aseptic Meningitis Revisited
Letters cardioverter-defibrillator generator replacements and upgrade procedures: brospinal fluid (CSF) findings and reviews added to the litera- results from the REPLACE registry. Circulation. 2010;122(16):1553-1561. ture from 1999 to date. Tables have been assembled from 6. Kramer DB, Buxton AE, Zimetbaum PJ. Time for a change: a new approach to information derived from 192 studies (these data are avail- ICD replacement. N Engl J Med. 2012;366(4):291-293. able from the authors on request). The Challenge of Drug-Induced Aseptic Results | Four groups of drugs continue to be associated Meningitis Revisited with DIAM (Table 1): nonsteroidal anti-inflammatory Cases of drug-induced aseptic meningitis (DIAM) are likely drugs (NSAIDs), antibiotics, immunosuppressive- underreported, and only a few reviews of the literature have immunomodulatory (IS-IM), and antiepileptic drugs.1 Prior been performed. We have updated (to February 2014) a pre- exposure to the associated drug was present in 26% to 35% vious review (1999)1 to identify newer agents associated with of cases (Table 1). The interval between exposure and men- DIAM, as well as distinctive new features. ingitis ranged from minutes to 5 months (Table 1). Most patients presented with headache, fever, meningismus, and Methods | Using the MEDLINE database, we searched the lit- mental status changes (Table 2). Underlying systemic disor- erature to February 2014 and included those cases with cere- ders were often present, particularly systemic lupus ery- Table 1. Drugs Involved in Drug-Induced -
B96i. Nsaids 2.1 Approximately 2 Million Prescription Items (13% of All NSAID Items) Per Year in Primary Care in England
Community Interest Company Non-steroidal anti-inflammatory drugs (NSAIDs) Over £70 million is spent annually on all non-steroidal anti-inflammatory drugs (NSAIDs), including cyclo-oxygenase II (COX-2) inhibitors, in England (ePACT Nov 14 - Jan 15). QIPP projects in this area focus on reducing prescribing of NSAIDs for cost and safety reasons, by adhering to current guidance. Recommendations • Regularly review the appropriateness of NSAID prescribing, especially in people who are at higher risk of both gastrointestinal (GI) and cardiovascular (CV) and renal morbidity and mortality, e.g. older people.1 Consider switching to a lower risk NSAID where appropriate. • Advise patients to exercise as a core treatment for osteoarthritis, to improve muscle strength and general aerobic fitness.2 • Consider paracetamol and/or topical NSAIDs (according to local formulary) before oral NSAIDs, COX- 2 inhibitors or opioids.2 • Choose the NSAID with the lowest CV, renal and/or GI risk, depending upon the individual patient’s risk factors.2 • Do not prescribe NSAIDs where contraindicated (CI). Only prescribe NSAIDs in patients at risk of renal impairment/failure (particularly the elderly) where unavoidable.3 • If an NSAID is needed then prescribe the lowest dose for the shortest duration,1-3 e.g. ibuprofen (≤1200mg daily in divided doses) or naproxen (≤1000mg daily in divided doses).1,3 These are associated with a lower CV risk than other NSAIDs.1,3 • COX-2 inhibitors, diclofenac (150mg daily) and ibuprofen (2.4g daily) are associated with an increased risk of thrombotic events. The increased risk for diclofenac is similar to that of licensed doses of etoricoxib.3 • Diclofenac has been associated with increased risk of recurrent myocardial infarction (MI) or death, from the beginning of treatment.4 • Co-prescribe a proton pump inhibitor (PPI) with lowest acquisition cost for gastroprotection in patients with a high risk of GI bleeds in: » Patients ≥65 years2 » Long term NSAID use, e.g. -
Product Monograph
PRODUCT MONOGRAPH NOVO–KETOROLAC (ketorolac tromethamine) 10 mg Tablets NSAID Analgesic Agent Novopharm Limited Date of Revision: Toronto, Canada August 02, 2007 Control Number 112565 PRODUCT MONOGRAPH NOVO–KETOROLAC (ketorolac tromethamine) 10 mg Tablets THERAPEUTIC CLASSIFICATION NSAID Analgesic Agent ACTION AND CLINICAL PHARMACOLOGY NOVO-KETOROLAC (ketorolac tromethamine) is a non-steroidal anti-inflammatory drug (NSAID) that has analgesic activity. It is considered to be a peripherally acting analgesic. It is thought to inhibit the cyclo-oxygenase enzyme system, thereby inhibiting the synthesis of prostaglandins. At analgesic doses it has minimal anti-inflammatory and antipyretic activity. The peak analgesic effect occurs at 2 to 3 hours post-dosing with no evidence of a statistically significant difference over the recommended dosage range. The greatest difference between large and small doses of administered ketorolac is in the duration of analgesia. Following oral administration, ketorolac tromethamine is rapidly and completely absorbed, and pharmacokinetics are linear following single and multiple dosing. Steady state plasma levels are achieved after one day of q.i.d. dosing. - 2 - Peak plasma concentrations of 0.7 to 1.1 µg/mL occurred at 44 minutes following a single oral dose of 10 mg. The terminal plasma elimination half-life ranged between 2.4 and 9 hours in healthy adults, while in the elderly subjects (mean age: 72 years) it ranged between 4.3 and 7.6 hours. A high fat meal decreased the rate but not the extent of absorption of oral ketorolac tromethamine, while antacid had no effect. In renally impaired patients there is a reduction in clearance and an increase in the terminal half- life of ketorolac tromethamine (See Table 1). -
DAYPRO ALTA™ (Oxaprozin Potassium) 600Mg Tablets Cardiovascular Risk • Nsaids May Cause an Increased Risk of Serious Cardiov
DAYPRO ALTA™ (oxaprozin potassium) 600mg tablets Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patient’s with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS). Daypro ALTA is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). Gastrointestinal Risk NSAID’s cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS). DESCRIPTION DAYPRO ALTA (oxaprozin potassium tablets) is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each blue, capsule-shaped tablet contains oxaprozin potassium (678mg equivalent to 600mg of oxaprozin) for oral administration. The chemical name for oxaprozin potassium is 4,5-diphenyl-2-oxazolepropionic acid, potassium salt. Its empirical formula is C18H14NO3K, and molecular weight is 331. Oxaprozin potassium is a white to off white powder with a melting point of 215°C. It is slightly soluble in alcohol and very soluble in water. The PK in water is 9.7. It has the following structural formula: Inactive ingredients in DAYPRO ALTA tablets include microcrystalline cellulose, hydroxypropyl methylcellulose, pregelatinized corn starch, stearic acid, colloidal silicon dioxide, polyethylene glycol, titanium dioxide, FD&C Blue #1 Aluminum Lake, and pharmaceutical glaze.