Information for the User Diclofenac / Omeprazole Modified-Release
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Module 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods
CONFIDENTIAL 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods Module 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods Copyright 2012 ViiV Healthcare and the GlaxoSmithKline group of companies. All rights reserved. Unauthorized copying or use of this information is prohibited. 1 CONFIDENTIAL 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods TABLE OF CONTENTS PAGE ABBREVIATIONS ...........................................................................................................3 1. BACKGROUND AND OVERVIEW ...........................................................................4 1.1. Conclusions ..................................................................................................4 1.2. Formulation Development.............................................................................5 1.3. In Vitro Dissolution Data .............................................................................10 1.3.1. Comparative of 2 x 25 mg Clinical Tablets and 1 x 50 mg Clinical Tablets, Phase III Formulation.........................................10 1.3.2. Comparison of Phase III Clinical Image and Commercial Image Tablets..............................................................................13 1.4. Analytical Methods......................................................................................17 1.4.1. Validation.....................................................................................17 1.4.2. Summary of Within Study Quality -
Sulfinpyrazone 100Mg and 200Mg Tablets (Sulfinpyrazone)
Prescribing information sulfinpyrazone 100mg and 200mg tablets (sulfinpyrazone) Presentation: Coated tablets agents, sulphonamides, penicillin, theophylline, phenytoin, non- indication: Chronic, including tophaceous gout; recurrent gouty steroidal antirheumatic drugs. arthritis; hyperuricaemia Pregnancy and lactation: Used with caution in pregnant women, Dosage and administration: Route of administration: Oral. Adults: weighing the potential risk against the possible benefits. It is not known 100-200mg daily increasing gradually (over the first two or three whether the active substance or its metabolite(s) pass into breast milk. weeks) to 600mg daily (rarely 800mg), and maintained until the For safety reasons mothers should refrain from taking the drug. serum urate level has fallen within the normal range. Maintenance Undesirable effects: Mild transient gastro-intestinal upsets, such dose may be as low as 200mg daily. Children: Paediatric usage as nausea, vomiting, diarrhea, gastro-intestinal bleeding and not established. ulcers, acute renal failure, salt and water retention, allergic skin contraindications: Acute attacks of gout. Gastric and duodenal reactions, leucopenia, thrombocytopenia, agranulocytosis, aplastic ulcer. Known hypersensitivity to sulfinpyrazone and other pyrazolone anaemia, hepatic dysfunction, jaundice and hepatitis. derivatives. Contra-indicated in patients with asthma, urticaria, or (Please refer to the Summary of Product Characteristics for acute rhinitis, severe parenchymal lesions of the liver or kidneys, detailed information) porphyria, blood dyscrasias, haemorrhagic diatheses overdose: Nausea, vomiting, abdominal pains, diarrhoea, Precautions and warnings: Used with caution in patients with hypotension, cardiac arrhythmias, hyperventilation, respiratory hyperuricaemia or gout, episodes of urolithiasis or renal colic, disorders, impairment of consciousness, coma, epileptic seizures, ensure adequate fluid intake and alkalinisation of the urine during oliguria or anuria, acute renal failure, renal colic. -
Prevalence of Drug Interactions in Hospitalized Elderly Patients: a Systematic Review
Supplementary material Eur J Hosp Pharm Prevalence of drug interactions in hospitalized elderly patients: a systematic review Luciana Mello de Oliveira 1,2; Juliana do Amaral Carneiro Diel1; Alessandra Nunes3; Tatiane da Silva Dal Pizzol 1,2,3 1Programa de Pós-Graduação em Epidemiologia, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul. 2Programa de Pós-Graduação em Assistência Farmacêutica, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul. 3Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul. Corresponding author: Luciana Mello de Oliveira – [email protected] and Tatiane da Silva Dal Pizzol - [email protected] Supplementary Table 3: Number of patients with interaction, number of DDI per patient with at least one DDI, drugs or drug classes mostly involved with DDI and drug combinations mostly involved with DDI. In cases which prevalence were described, we reported the three drugs mostly involved with drug interactions or the three drug combinations (or drug classes) mostly involved with DDI. ACE: angiotensin-converting enzyme. NA: not available. NSAID: non-steroidal anti-inflammatory drugs. PPI: proton-pump inhibitors. # of patients with # of DDI per patient with First autor interactions interaction Drugs or drug classes mostly involved with DDI Drug combinations mostly involved with DDI Barak-Tsarfir O, et al (61) Unclear: around 56 patients NA NA NA Warfarin; digitoxin; prednisolone antithrombotic agents; non-steroidal anti- 70 (evaluated only serious or inflammatory agents; angiotensin converting enzyme Blix HS, et al (29) contraindicated DDI) NA inhibitors N/A Serious: chlorpromazine + promethazine; chlorpromazine + haloperidol; haloperidol + promethazine; diazepam + phenobarbital; risperidone + haloperidol; carbamazepine + ketoconazole; carbamazepine + chlorpromazine; haloperidol + ketoconazole; chlorpromazine + ketoconazole; chlorpromazine + sodium phosphate. -
Medication Guide Omeprazole Delayed-Release Capsules
MEDICATION GUIDE OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about omeprazole delayed-release capsules? Omeprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Omeprazole delayed-release capsules can cause serious side effects, including: z Diarrhea. Omeprazole delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. z Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take omeprazole delayed-release capsules. Omeprazole delayed-release capsules can have other serious side effects. See “What are the possible side effects of omeprazole delayed-release capsules?” What is omeprazole delayed-release capsule? Omeprazole delayed-release capsule is a prescription medicine called a proton pump inhibitor (PPI). -
New Zealand Data Sheet
NEW ZEALAND DATA SHEET 1 PRODUCT NAME DICLOFENAC SANDOZ 25mg enteric coated tablet 50mg enteric coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Diclofenac Sandoz 25 mg tablet contains Diclofenac Sodium 25mg Each Diclofenac Sandoz 50 mg tablet contains Diclofenac Sodium 50mg Tablets contain lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 25 mg Brown-yellow gastro-resistant film coated tablets, round, biconvex faced with a plain rim. Approximate tablet dimensions: diameter 6.1 to 6.3 mm; thickness 2.9 to 3.2 mm. Each tablet contains Diclofenac Sodium Ph Eur 25 mg. 50 mg Brown-yellow gastro-resistant film coated tablets, round, biconvex faced with a banded rim. Approximate tablet dimensions: diameter 8.0 to 8.3 mm; thickness 3.5 to 3.8 mm. Each tablet contains Diclofenac Sodium Ph Eur 50 mg. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of: • Inflammatory and degenerative forms of rheumatism - rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism; • Acute attacks of gout; • Post-traumatic and post-operative pain, inflammation, and swelling, e.g. following dental or orthopaedic surgery; • Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis; • As an adjuvant in severe painful inflammatory infections of the ear, nose, or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying Page 1 of 18 NEW ZEALAND DATA SHEET disease should be treated with basic therapy, as appropriate. Fever alone is not an indication. 4.2 Dose and method of administration Dosage Diclofenac Sandoz should only be prescribed when the benefits are considered to outweigh the potential risks. -
Nonsteroidal Antiinflammatory Drugs and Acute Renal Failure in Elderly Persons
American Journal of Epidemiology Vol. 151, No. 5 Copyright © 2000 by The Johns Hopkins University School of Hygiene and Public Health Printed In U.S.A. Ail rights reserved Nonsteroidal Antiinflammatory Drugs and Acute Renal Failure in Elderly Persons Marie R. Griffin,1'2 Aida Yared,3 and Wayne A. Ray1 Renal prostaglandin inhibition by nonsteroidal antiinflammatory drugs (NSAIDs) may decrease renal function, Downloaded from https://academic.oup.com/aje/article/151/5/488/117194 by guest on 27 September 2021 especially under conditions of low effective circulating volume. To evaluate the risk of important deterioration of renal function due to this effect, the authors performed a nested case-control study using Tennessee Medicaid enrollees aged £65 years in 1987-1991. Cases were patients who had been hospitalized with community- acquired acute renal failure; they were selected on the basis of medical record review of Medicaid enrollees with selected discharge diagnoses. Information on the timing, duration, and dose of prescription NSAIDs used, demographic factors, and comorbidity was gathered from computerized Medicaid-Medicare data files. Of the 1,799 patients with acute renal failure (4.51 hospitalizations per 1,000 person-years), 18.1% were current users of prescription NSAIDs as compared with 11.3% of 9,899 randomly selected population controls. After control for demographic factors and comorbidity, use of NSAIDs increased the risk of acute renal failure 58% (adjusted odds ratio = 1.58; 95% confidence interval (Cl): 1.34, 1.86). For ibuprofen, which accounted for 35% of NSAID use, odds ratios associated with dosages of £1,200 mg/day, >1,200-<2,400 mg/day, and £2,400 mg/day were 0.94 (95% Cl: 0.58, 1.51), 1.89 (95% Cl: 1.34, 2.67), and 2.32 (95% Cl: 1.45, 3.71), respectively (test for linear trend: p = 0.009). -
WO 2010/099522 Al
(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 2 September 2010 (02.09.2010) WO 2010/099522 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 45/06 (2006.01) A61K 31/4164 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 31/4045 (2006.01) A61K 31/00 (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/US2010/025725 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, 1 March 2010 (01 .03.2010) 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, TH, TJ, TM, TN, TR, (26) Publication Language: English TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/156,129 27 February 2009 (27.02.2009) 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): ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, HELSINN THERAPEUTICS (U.S.), INC. -
Guideline for Preoperative Medication Management
Guideline: Preoperative Medication Management Guideline for Preoperative Medication Management Purpose of Guideline: To provide guidance to physicians, advanced practice providers (APPs), pharmacists, and nurses regarding medication management in the preoperative setting. Background: Appropriate perioperative medication management is essential to ensure positive surgical outcomes and prevent medication misadventures.1 Results from a prospective analysis of 1,025 patients admitted to a general surgical unit concluded that patients on at least one medication for a chronic disease are 2.7 times more likely to experience surgical complications compared with those not taking any medications. As the aging population requires more medication use and the availability of various nonprescription medications continues to increase, so does the risk of polypharmacy and the need for perioperative medication guidance.2 There are no well-designed trials to support evidence-based recommendations for perioperative medication management; however, general principles and best practice approaches are available. General considerations for perioperative medication management include a thorough medication history, understanding of the medication pharmacokinetics and potential for withdrawal symptoms, understanding the risks associated with the surgical procedure and the risks of medication discontinuation based on the intended indication. Clinical judgement must be exercised, especially if medication pharmacokinetics are not predictable or there are significant risks associated with inappropriate medication withdrawal (eg, tolerance) or continuation (eg, postsurgical infection).2 Clinical Assessment: Prior to instructing the patient on preoperative medication management, completion of a thorough medication history is recommended – including all information on prescription medications, over-the-counter medications, “as needed” medications, vitamins, supplements, and herbal medications. Allergies should also be verified and documented. -
S Salsalate Tablets
SALSALATE TABLETS CARDIOVASCULAR EFFECTS renal disease. If SALSALATE TABLETS therapy must be initiated, Rx Only Cardiovascular Thrombotic Events close monitoring of the patient’s renal function is advisable. Cardiovascular Risk Clinical trials of several COX-2 selective and nonselective NSAIDs Anaphylactoid Reactions • NSAIDs may cause an increased risk of serious cardiovascular of up to three years duration have shown an increased risk of As with other NSAIDs, anaphylactoid reactions may occur in thrombotic events, myocardial infarction, and stroke, which can serious cardiovascular (CV) thrombotic events, myocardial patients without known prior exposure to SALSALATE TABLETS. be fatal. This risk may increase with duration of use. Patients infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 SALSALATE TABLETS should not be given to patients with the with cardiovascular disease or risk factors for cardiovascular selective and nonselective, may have a similar risk. Patients with aspirin triad. This symptom complex typically occurs in asthmatic disease may be at greater risk. (See WARNINGS and CLINICAL known CV disease or risk factors for CV disease may be at greater patients who experience rhinitis with or without nasal polyps, or TRIALS). risk. To minimize the potential risk for an adverse CV event in who exhibit severe, potentially fatal bronchospasm after taking • SALSALATE TABLETS is contraindicated for the treatment of patients treated with an NSAID, the lowest effective dose should be aspirin or other NSAIDs (see CONTRAINDICATIONS and perioperative pain in the setting of coronary artery bypass graft used for the shortest duration possible. Physicians and patients PRECAUTIONS - Preexisting Asthma). Emergency help should be (CABG) surgery (see WARNINGS Gastrointestinal Risk) should remain alert for the development of such events, even in sought in cases where an anaphylactoid reaction occurs. -
Jp Xvii the Japanese Pharmacopoeia
JP XVII THE JAPANESE PHARMACOPOEIA SEVENTEENTH EDITION Official from April 1, 2016 English Version THE MINISTRY OF HEALTH, LABOUR AND WELFARE Notice: This English Version of the Japanese Pharmacopoeia is published for the convenience of users unfamiliar with the Japanese language. When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic. The Ministry of Health, Labour and Welfare Ministerial Notification No. 64 Pursuant to Paragraph 1, Article 41 of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Law No. 145, 1960), the Japanese Pharmacopoeia (Ministerial Notification No. 65, 2011), which has been established as follows*, shall be applied on April 1, 2016. However, in the case of drugs which are listed in the Pharmacopoeia (hereinafter referred to as ``previ- ous Pharmacopoeia'') [limited to those listed in the Japanese Pharmacopoeia whose standards are changed in accordance with this notification (hereinafter referred to as ``new Pharmacopoeia'')] and have been approved as of April 1, 2016 as prescribed under Paragraph 1, Article 14 of the same law [including drugs the Minister of Health, Labour and Welfare specifies (the Ministry of Health and Welfare Ministerial Notification No. 104, 1994) as of March 31, 2016 as those exempted from marketing approval pursuant to Paragraph 1, Article 14 of the Same Law (hereinafter referred to as ``drugs exempted from approval'')], the Name and Standards established in the previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards established in the new Pharmacopoeia before and on September 30, 2017. -
Highlights of Prescribing Information
HIGHLIGHTS OF PRESCRIBING INFORMATION -----------------------------CONTRAINDICATIONS------------------------------------- These highlights do not include all the information needed to use Patients with known hypersensitivity to natural or recombinant hirudins, IPRIVASK safely and effectively. See full prescribing information for and in patients with active bleeding and/or irreversible coagulation IPRIVASK. disorders (4). IPRIVASK® 15 mg (desirudin for injection), for subcutaneous injection -----------------------WARNINGS AND PRECAUTIONS----------------------------- Initial U.S. approval: 2003 • Hemorrhage: Bleeding can occur at any site during therapy with WARNING: SPINAL/EPIDURAL HEMATOMAS Iprivask. An unexplained fall in hematocrit or blood pressure should See Full Prescribing Information for complete boxed warning. lead to a search for a bleeding site. Avoid intramuscular injection as When neuraxial anesthesia (epidural/spinal anesthesia) or local bleeding and hematoma formation may result. (5.3). spinal puncture is employed, patients anticoagulated or • Increased Risk of bleeding with Renal Impairment: Dose reductions scheduled to be anticoagulated with selective inhibitors of by factors of three and nine are recommended for patients with thrombin such as Iprivask may be at risk of developing an moderate and severe renal impairment respectively (2.2). In addition, epidural or spinal hematoma which can result in long-term or daily aPTT and serum creatinine monitoring are recommended for permanent paralysis (5.1). patients with moderate -
2021 Formulary List of Covered Prescription Drugs
2021 Formulary List of covered prescription drugs This drug list applies to all Individual HMO products and the following Small Group HMO products: Sharp Platinum 90 Performance HMO, Sharp Platinum 90 Performance HMO AI-AN, Sharp Platinum 90 Premier HMO, Sharp Platinum 90 Premier HMO AI-AN, Sharp Gold 80 Performance HMO, Sharp Gold 80 Performance HMO AI-AN, Sharp Gold 80 Premier HMO, Sharp Gold 80 Premier HMO AI-AN, Sharp Silver 70 Performance HMO, Sharp Silver 70 Performance HMO AI-AN, Sharp Silver 70 Premier HMO, Sharp Silver 70 Premier HMO AI-AN, Sharp Silver 73 Performance HMO, Sharp Silver 73 Premier HMO, Sharp Silver 87 Performance HMO, Sharp Silver 87 Premier HMO, Sharp Silver 94 Performance HMO, Sharp Silver 94 Premier HMO, Sharp Bronze 60 Performance HMO, Sharp Bronze 60 Performance HMO AI-AN, Sharp Bronze 60 Premier HDHP HMO, Sharp Bronze 60 Premier HDHP HMO AI-AN, Sharp Minimum Coverage Performance HMO, Sharp $0 Cost Share Performance HMO AI-AN, Sharp $0 Cost Share Premier HMO AI-AN, Sharp Silver 70 Off Exchange Performance HMO, Sharp Silver 70 Off Exchange Premier HMO, Sharp Performance Platinum 90 HMO 0/15 + Child Dental, Sharp Premier Platinum 90 HMO 0/20 + Child Dental, Sharp Performance Gold 80 HMO 350 /25 + Child Dental, Sharp Premier Gold 80 HMO 250/35 + Child Dental, Sharp Performance Silver 70 HMO 2250/50 + Child Dental, Sharp Premier Silver 70 HMO 2250/55 + Child Dental, Sharp Premier Silver 70 HDHP HMO 2500/20% + Child Dental, Sharp Performance Bronze 60 HMO 6300/65 + Child Dental, Sharp Premier Bronze 60 HDHP HMO