Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new cataflam research articles will be listed here shortly after becoming available to us.
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Medical research on cataflam
J Oral Maxillofac Surg. 2004 Jul; 62(7): 806-15
Zuniga JR, Phillips CL, Shugars D, Lyon JA, Peroutka SJ, Swarbrick J, Bon C
PURPOSE: The purpose of this single-blind, placebo-controlled, 3-arm parallel, randomized study was to compare the analgesic efficacy and tolerability of a single dose of 100 mg diclofenac potassium (Cataflam; Novartis, Stein, Switzerland), 100 mg diclofenac sodium softgel, and placebo in patients experiencing moderate to severe postoperative pain after third molar extraction. PATIENTS AND METHODS: Seventy-five patients (67% female with a mean age of 23, age range 18 to 34.5 years) participated in the study following removal of at least 1 impacted mandibular third molar. Patients received a single dose of study medication when their postoperative pain reached a moderate or severe intensity. Analgesic efficacy measures included the time to meaningful pain relief measured using a stopwatch and time to rescue medication. Pain relief (PR) and Pain intensity (PI) ratings were recorded at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, and 24 hours postdosing. Summary analgesic measures, including Summed Pain Relief Score (TOTPAR) and Summed Pain Intensity Differences (SPID), were calculated from the 0.25- to 6-hour responses. The time between pain relief and rescue and a global evaluation for the effectiveness of the study medications were recorded at the end of the study. Seven scheduled blood samples were collected from each patient for determining plasma concentrations of diclofenac anion. RESULTS: Both diclofenac sodium softgel and Cataflam were significantly more effective than placebo (P
Cataflam-induced esophageal ulceration.
Am J Gastroenterol. 2001 Apr; 96(4): 1300-1
Isler M, Bahceci M
Arzneimittelforschung. 2000 Jan; 50(1): 43-7
Marzo A, Dal Bo L, Verga F, Ceppi Monti N, Abbondati G, Tettamanti RA, Crivelli F, Uhr MR, Ismaili S
This paper reports the results of a pharmacokinetic study involving 24 healthy volunteers and designed to characterise the rate and extent of diclofenac absorption after the administration of a single dose of diclofenac (CAS 15307-86-5) potassium salt 50 mg in sachet (Voltfast) and tablet (Cataflam) formulations. Timed plasma concentrations of diclofenac during a 12-h-period after dosing were measured by means of HPLC with UV detection at 275 nm and a quantification limit of 10 ng/ml; the method was fully validated for pharmacokinetic purposes. These plasma concentrations were used to calculate Cmax, tmax, trapezoidal AUC0-t and AUC0-infinity and t1/2 by means of noncompartmental analysis. Cmax and tmax are the parameters expressing the rate of absorption, whereas the AUCs reflect the extent of absorption. The rate of absorption with the sachets proved to be very fast, reaching peak values at 10 min in seven subjects and at 15 min in the remaining subjects: mean time was 13.68 min, with concentrations at 5 min being 38% of Cmax. The average time to peak concentration with the tablets was 53.10 min. The extent of absorption of the sachets and tablets was similar, with AUC0-infinity values of respectively 1362 and 1214 ng.ml-1.h, and a 90% confidence interval 1.05-1.20. The highly soluble potassium salt of diclofenac was rapidly absorbed, especially in its sachet formulation, and thus appears to be an invaluable analgesic agent that is particularly useful for quick pain relief.
[Comparative study of the analgesic effect of Apranax and Cataflam after oral surgical procedures]
Fogorv Sz. 1999 Dec; 92(12): 374-8
Ujpál M, Biczó A, Huszár L, Temesvári A, Tóthfalusi L, Szabó G
After oral- and maxillo-facial surgical interventions both Apranax and Cataflam proved to be satisfying against pain. Though there is no difference in the kinetics of the effect, we found Apranax more effective to relieve postoperative pain. Besides the fast elimination of pain the medicine significantly mitigate the symptoms of inflammation.
Comparative bioavailability of two different diclofenac formulations in healthy volunteers.
Arzneimittelforschung. 1999 Nov; 49(11): 920-4
Silva LC, Simões IG, Lerner FE, Belém GR, de Moraes ME, De Nucci G
The aim of the study was to assess the bioequivalence of two different diclofenac (CAS 15307-86-5) formulations (diclofenac free acid suspension as test formulation and diclofenac resinate suspension, Cataflam, as reference formulation) in 24 healthy volunteers. After an overnight fast, the volunteers received a single oral dose (50 mg) of each formulation, following an open, randomized, two-period crossover design, with a fourteen-day washout interval between doses. Serum samples were obtained over a 24-h interval post-dosing, and were analysed for their diclofenac content by HPLC-UV. No adverse effect was reported for any of the formulations administered. Geometric mean test/reference individual ratios were: 92.8% for AUC(0-24 h), 93.2% for AUC(0-infinity), 117.2% for Cmax, 131.0% for Ke and 76.2% for T1/2. The variability of Cmax parameter expressed as CV was greater than 25%. Since the 90% CI for AUC(0-24 h) mean ratio were within the 80-125% interval proposed by the Food and Drug Administration, it can be concluded that diclofenac free acid formulation is bioequivalent to diclofenac resinate formulation for the extent of absorption. Since the European Community Agency accepts a 90% CI for Cmax of 70-143%, it can be concluded that diclofenac free acid formulation is bioequivalent to diclofenac resinate formulation for both the rate and the extent of absorption after single dose administration.
Afr J Med Med Sci. 1998 Sep-Dec; 27(3-4): 243-6
Ebong PE, Eyong EU, Udosen EO
The effects of graded doses of aspirin (acetylsalicylic acid) and cataflam (potassium diclofenac) on serum aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, 5'Nucleotidase, methaemoglobin, total and conjaged bilirubin were investigated in wistar rats. Results showed a significant increase (P < 0.05) in the levels of alanine animotransferase, aspartate amino transferase, methaemoglobin, total and conjugated bilirubin upon treatment of animals with both drugs. Aspirin significantly decreased (P < 0.05, P < 0.00) the activity of alkaline phsophatase but increased the activity of 5'ucleotidase while cataflam significantly increased the activity of alkaline phosphatase (P < 0.001) and 5'nucletodase (P < 0.05). These effects were however dose dependent and the biochemical implications of these results are discussed.
Int J Clin Pharmacol Ther. 1994 Mar; 32(3): 131-5
Mendes GB, Franco LM, Moreno RA, Fernandes AG, Muscara MN, de Nucci G
The bioavailability of two suspension formulations of potassium diclofenac (Flogan, Merck and Cataflam, Ciba-Geigy) were compared in eighteen healthy male volunteers who received a single dose of 7 ml of each suspension (equivalent to 105 mg of potassium diclofenac) in an open randomized two period crossover design, with a fourteen-day washout period between doses. Serum samples were obtained over a 24 hour interval and diclofenac concentrations were determined by HPLC with ultraviolet detection. From the serum diclofenac concentration vs time curves, AUC[0-24] (area under the concentration vs time curves from 0-24 h), Cmax (maximum achieved concentration), Tmax (time to achieve Cmax) and Ke (terminal first order elimination constant) were obtained. Overlapping of Tmax intervals for both formulations was observed, but the important inter-subject variation observed in Cmax ratios did not allow equivalence conclusion for the rate of absorption. Equivalence in the extent of bioavailability between both potassium diclofenac suspension brands was concluded from the analysis of AUC[0-24] ratios.