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- Drugs and Lactation Database (LactMed) [BOOK]
- BOOKNational Library of Medicine (US): Bethesda (MD)
- Mispoprostol is a prostaglandin E1 analogue. Prostaglandin E1 and other prostaglandins appear normally in colostrum and milk. Because of the extremely low levels of misoprostol in breastmilk, amou...
Mispoprostol is a prostaglandin E1 analogue. Prostaglandin E1 and other prostaglandins appear normally in colostrum and milk. Because of the extremely low levels of misoprostol in breastmilk, amounts ingested by the infant are trivial and would not be expected to cause any adverse effects in breastfed infants. No special precautions are required.
- Objective Assessment of Cervical Stiffness after Administration of Misoprostol for Intrauterine Contraceptive Insertion. [Journal Article]
- UIUltrasound Int Open 2016; 2(2):E63-7
- CONCLUSIONS: The clinical value of the detected cervical softening after misoprostol administration remains unclear. Aspiration measurements could be helpful in searching for the ideal candidate, the appropriate route, dosage and interval of misoprostol intake prior to IUC insertion.
- Diclofenac/misoprostol during early pregnancy and the risk of miscarriage: a Danish nationwide cohort study. [Journal Article]
- AGArch Gynecol Obstet 2016; 294(2):245-50
- CONCLUSIONS: We found an increased risk of miscarriage after exposure to diclofenac/misoprostol during the early pregnancy. Women in the fertile age should not be treated with the combination of diclofenac/misoprostol if other options were available.
- Abortion after deliberate Arthrotec® addition to food. Mass spectrometric detection of diclofenac, misoprostol acid, and their urinary metabolites. [Case Reports]
- IJInt J Legal Med 2015; 129(4):759-69
- Arthrotec(®) (AT) is a combination of diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), and misoprostol (MP), a synthetic analogue of prostaglandin E1 (PGE1). MP is a lipophilic methyl ester...
Arthrotec(®) (AT) is a combination of diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), and misoprostol (MP), a synthetic analogue of prostaglandin E1 (PGE1). MP is a lipophilic methyl ester prodrug. It is readily metabolized to the biologically active misoprostol acid (MPA). During the last few years, medical studies exhibited MP to be an excellent abortive. In this paper, we describe a rare criminal case of MP abortion, initiated by the expectant father. After the abortion, samples of vomit and urine were collected. Systemic exposure to MP is difficult to prove, because both MP and the active metabolite MPA are hardly excreted in urine. Therefore, in addition to routine toxicological analysis, we used slightly modified, well-established liquid and gas chromatographic/tandem mass spectrometric (LC/MS/MS and GC/MS/MS) methods, for the direct and the indirect detection of MPA and its metabolites. In this case, we were able to demonstrate the presence of the major MP metabolites 2,3-dinor-MPA and 2,3,4,5-tetranor-MPA in the urine of the victim. We also detected paracetamol, 3-methoxyparacetamol and diclofenac-glucuronide in the urine. In the vomit of the victim, we detected diclofenac and MPA. These results, combined with the criminal investigations, showed that the accused had mixed MP into the food of his pregnant girlfriend. Finally, these investigations contributed to a confession of the accused.
- Do companion diagnostics make economic sense for drug developers? [Review]
- NBN Biotechnol 2012 Sep 15; 29(6):695-708
- Drug developers are grappling with the impact of personalized medicine on their portfolios. The combination of molecular diagnostics with targeted biologic therapies has been hailed as a recent innov...
Drug developers are grappling with the impact of personalized medicine on their portfolios. The combination of molecular diagnostics with targeted biologic therapies has been hailed as a recent innovation with few historical analogs to guide behavior. However, if the definition of companion diagnostics is broadened to include any drug whose FDA approved label requires diagnostic testing before prescription then over 50 drugs across multiple therapeutic areas arise. Most importantly for current drug developers, these drugs represent a wide variety of market situations and with sufficient historical data to evaluate different commercialization strategies for the combination. Included in these examples are drugs which were not initially launched with companion diagnostics but were required to implement companion diagnostics after they were on the market for a period of time. The historical case studies demonstrate that companion diagnostics are neither a universal panacea nor an unmitigated disaster for drug developers but require an understanding of specific situations to determine the utility of companion diagnostics. Numerous case studies highlight how companion diagnostics have been a boon to drug developers including Iressa, statins, Soriatane, Arthrotec, Promacta, Nplate, Letairis, and Tracleer. Other examples provide lessons on how to avoid pitfalls such as Accutane, Ticlid, Tegretol, Ziagen, Actigall and Clozaril. By carefully evaluating these case studies, drug developers can gain insight on the appropriate companion diagnostic strategy to implement for their specific situation and develop the elements of a successful companion diagnostic strategy.
- A case report of a 53-year-old female with rheumatoid arthritis and osteoporosis: focus on lab testing and CAM therapies. [Case Reports]
- AMAltern Med Rev 2011; 16(3):250-62
- A 53-year-old female presented with rheumatoid arthritis and osteoporosis. Additional conditions and symptoms included Raynaud syndrome, fatigue, irritable bowel syndrome associated constipation (IBS...
A 53-year-old female presented with rheumatoid arthritis and osteoporosis. Additional conditions and symptoms included Raynaud syndrome, fatigue, irritable bowel syndrome associated constipation (IBS-C), gastroesophageal reflux (GERD), menopausal symptoms, chronic urinary tract and upper respiratory infections, and weight gain. She was taking Arthrotec (a combination of diclofenac and misoprostol - for pain and inflammation), Fosamax Plus D (alendronate with vitamin D3 - recently prescribed because of low bone density), and Catapres (clonidine - for menopausal symptoms). Against the advice of her rheumatologist, she had recently discontinued taking Plaquenil (hydroxychloroquine), methotrexate, and prednisone due to significant side effects. Lab tests to identify underlying imbalances and to direct treatment were ordered. Treatment included dietary, nutritional, hormonal, and mind/body support. After one year of therapy, the patient experienced improvement with all of her presenting conditions and symptoms, which enabled her to discontinue several medications. She became versed in identifying and avoiding the environmental triggers of her disease, including foods (dairy, wheat, eggs, and soy), molds, and emotional stress. Antinuclear antibodies were normalized. She experienced a 7.5-percent improvement in left trochanteric bone density - comparable to bisphosphonate therapy. Mild improvements were also noted in the spine and bilateral femoral neck.
- Cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) for osteoarthritis and rheumatoid arthritis: a systematic review and economic evaluation. [Review]
- HTHealth Technol Assess 2008; 12(11):1-278, iii
- CONCLUSIONS: The COX-2 selective NSAIDs examined were found to be similar to non-selective NSAIDs for the symptomatic relief of RA and OA and to provide superior GI tolerability (the majority of evidence is in patients with OA). Although COX-2 selective NSAIDs offer protection against serious GI events, the amount of evidence for this protective effect varied considerably across individual drugs. The volume of trial evidence with regard to cardiovascular safety also varied substantially between COX-2 selective NSAIDs. Increased risk of MI compared to non-selective NSAIDs was observed among those drugs with greater volume of evidence in terms of exposure in patient-years. Economic modelling shows a wide range of possible costs per QALY gained in patients with OA and RA. Costs per QALY also varied if individual drugs were used in 'standard' or 'high'-risk patients, the choice of non-selective NSAID comparator and whether that NSAID was combined with a PPI. With reduced costs of PPIs, future primary research needs to compare the effectiveness and cost-effectiveness of COX-2 selective NSAIDs relative to non-selective NSAIDs with a PPI. Direct comparisons of different COX-2 selective NSAIDs, using equivalent doses, that compare GI and MI risk are needed. Pragmatic studies that include a wider range of people, including the older age groups with a greater burden of arthritis, are also necessary to inform clinical practice.
- Costs and effects of various analgesic treatments for patients with rheumatoid arthritis and osteoarthritis in the Netherlands. [Journal Article]
- VHValue Health 2008 Jul-Aug; 11(4):589-99
- CONCLUSIONS: Assuming a limit of 20,000 Euro per life-year gained, from an economic point of view, Arthrotec is the preferred treatment when all patients or medium-to-high-risk patients are considered. In high-risk patients, celecoxib is the preferred treatment strategy.
- Therapy switching and associated costs in elderly patients receiving COX-2 selective inhibitors or non-selective non-steroidal anti-inflammatory drugs in Quebec, Canada. [Journal Article]
- RRheumatology (Oxford) 2006; 45(7):903-10
- CONCLUSIONS: Compared with recipients of nsNSAIDs, coxib recipients were less likely to switch medications and had approximately half the adjusted costs for switching-related wasted resources per prescription.
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- Acetaminophen for osteoarthritis. [Review]
- CDCochrane Database Syst Rev 2006 Jan 25; (1):CD004257
- CONCLUSIONS: The evidence to date suggests that NSAIDs are superior to acetaminophen for improving knee and hip pain in people with OA. The size of the treatment effect was modest, and the median trial duration was only six weeks, therefore, additional considerations need to be factored in when making the decision between using acetaminophen or NSAIDs. In OA subjects with moderate-to-severe levels of pain, NSAIDs appear to be more effective than acetaminophen.