Renal and General Tolerability of Repeated Doses of Nimesulide in Normal Subjects

Warrington, S. J.; Ravic, Miroslav; Dawnay, A

doi:10.2165/00003495-199300461-00067

Cited by 19 publications

(12 citation statements)

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“…It should be noted here that our in vitro protocol for the combination of these two therapeutic modalities used clinically applicable doses of nimesulide (10 µmol L −1 for 72 h), ALA (1 mmol L −1 for 12 h), and light exposure (40 J cm −2 ). The maximum plasma concentration of nimesulide in normal humans has been reported to be about 10 mg L −1 or 30 µmol L −1 after oral administration of 200 mg to healthy adult volunteers, 30 which appear to be lower than the maximum tolerated dose 31 . The administration of nimesulide as an adjunct with ALA‐based PDT for patients with indications for PDT, including high‐risk patients, may well be feasible without compromising the quality of life in view of previously obtained favourable data on its use as an anti‐inflammatory drug.…”

Section: Discussionmentioning

confidence: 97%

“…The maximum plasma concentration of nimesulide in normal humans has been reported to be about 10 mg L )1 or 30 lmol L )1 after oral administration of 200 mg to healthy adult volunteers, 30 which appear to be lower than the maximum tolerated dose. 31 The administration of nimesulide as an adjunct with ALA-based PDT for patients with indications for PDT, including high-risk patients, may well be feasible without compromising the quality of life in view of previously obtained favourable data on its use as an anti-inflammatory drug. Exposures ranging from 25 to 300 J cm )2 light doses between 3 and 6 h after ALA application have also been indicated to be required for surface treatment with ALA-based PDT at 630-635 nm laser light.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Cyclooxygenase-2 is a possible target of treatment approach in conjunction with photodynamic therapy for various disorders in skin and oral cavity

Akita

Kozaki²,

Nakagawa³

et al. 2004

Br J Dermatol

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Cyclooxygenase-2 is a possible target of treatment approach in conjunction with photodynamic therapy for various disorders in skin and oral cavity

Akita

Kozaki²,

Nakagawa³

et al. 2004

Br J Dermatol

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“…A resulting decrease in the aldosterone plasma level probably contributed to the decreased potassium secretion. However, in a study involving 16 healthy men (Warrington et al 1993), nimesulide (200±300 mg twice daily) was well tolerated. At a dose of 400 mg (twice daily), laboratory tests and urine analysis did not show any adverse effects.…”

mentioning

confidence: 96%

Review Nimesulide: Some Pharmaceutical and Pharmacological Aspects—An Update

Singla

Chawla

Singh

2000

Journal of Pharmacy and Pharmacology

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Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), is administered orally or rectally twice daily for a variety of inflammation and pain states. This is a unique NSAID, not only because of its chemical structure but also because of its specific affinity to inhibit cyclooxygenase-2 (COX-2), thus exerting milder effects on the gastrointestinal mucosa. Current data on selective COX-2 inhibitors suggest that they may have an efficacy similar to that of standard NSAIDs. Initial general clinical experience with selective COX-2 inhibitors appears to show that they are particularly promising in individuals at risk because of renal diseases, hypertension or congestive heart failure. Various experimental models and clinical studies have demonstrated the anti-inflammatory efficacy of nimesulide. Nimesulide is superior, or at least comparable in efficacy, to other NSAIDs, but is better tolerated and has less potential for adverse reactions. Thus, selective COX-2 inhibitors should have anti-inflammatory effects devoid of side effects on the kidney and stomach. They may also demonstrate new important therapeutic benefits as anticancer agents as well as help prevention of premature labour and even retard the progression of Alzheimer's disease. No clinically significant drug interactions have been reported for nimesulide. Not much has been reported about the pharmaceutical aspects of nimesulide. Its poor aqueous solubility poses bioavailability problems in-vivo. This could be overcome by the formation of inclusion complexes with beta-cyclodextrin, as has been reported by various researchers. However, absence of any in-vivo data regarding the relative absorption of nimesulide from beta-cyclodextrin complex compared with that from conventional formulations of the drug makes the use of such fast-releasing complexes rather questionable. Only a limited number of assay procedures (HPLC, spectrophotometric, spectrofluorimetric) for the determination of nimesulide and its metabolite in plasma/urine samples or in dosage forms have been reported in the literature. The purpose of this review is to provide a concise overview of the pharmacological and pharmaceutical profile of nimesulide. Various investigations carried out recently are reported, although older references to research performed on nimesulide have also been included, where appropriate.

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“…In the previously reported clinical trials with nimesulide, only renal toxicity was observed with high doses. No liver impairment was recorded (3). Although this is an eventual, unexpected adverse effect, precautions should be observed until the Letter to the Editor frequency of this type of reaction can be more accurately quantified.…”

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confidence: 92%