mobiflex and Arthritis

One-hundred and thirty-three clinical studies have been conducted with tenoxicam in patients with rheumatoid arthritis, osteoarthrosis, extra-articular rheumatism, ankylosing spondylitis and acute gouty arthritis. Its efficacy has been demonstrated in double-blind comparative studies against placebo, and dose-finding studies have found the optimal dose to be 20 mg. Most trials comparing tenoxicam with another NSAID have used piroxicam, an earlier oxicam derivative which also has a long half-life. In general, efficacy was similar in both drugs with a trend in favour of tenoxicam. The tolerability of tenoxicam has also been studied in detail. In short-term studies 11% of patients receiving 20 mg tenoxicam and 18% on 40 mg tenoxicam experienced side-effects (p less than 0.01), as did 20% treated with 20 mg piroxicam (p less than 0.01 against 20 mg tenoxicam). In long-term studies clinical tolerability of 20 mg tenoxicam was found to be superior to that of 20 mg piroxicam. The types of side-effects encountered were mainly gastrointestinal disturbances, followed in frequency by skin rashes. However, all side-effects were generally mild and reversible. The efficacy of tenoxicam is clearly established and its tolerability is acceptable with a 20 mg dose. Tenoxicam thus seems a promising drug and a useful addition to the therapeutic armamentarium.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Clinical Trials as Topic; Humans; Piroxicam; Rheumatic Diseases

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Piroxicam; Rheumatic Diseases

One-hundred and thirty-three clinical studies have been conducted with tenoxicam in patients with rheumatoid arthritis, osteoarthrosis, extra-articular rheumatism, ankylosing spondylitis and acute gouty arthritis. Its efficacy has been demonstrated in double-blind comparative studies against placebo, and dose-finding studies have found the optimal dose to be 20 mg. Most trials comparing tenoxicam with another NSAID have used piroxicam, an earlier oxicam derivative which also has a long half-life. In general, efficacy was similar in both drugs with a trend in favour of tenoxicam. The tolerability of tenoxicam has also been studied in detail. In short-term studies 11% of patients receiving 20 mg tenoxicam and 18% on 40 mg tenoxicam experienced side-effects (p less than 0.01), as did 20% treated with 20 mg piroxicam (p less than 0.01 against 20 mg tenoxicam). In long-term studies clinical tolerability of 20 mg tenoxicam was found to be superior to that of 20 mg piroxicam. The types of side-effects encountered were mainly gastrointestinal disturbances, followed in frequency by skin rashes. However, all side-effects were generally mild and reversible. The efficacy of tenoxicam is clearly established and its tolerability is acceptable with a 20 mg dose. Tenoxicam thus seems a promising drug and a useful addition to the therapeutic armamentarium.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Clinical Trials as Topic; Humans; Piroxicam; Rheumatic Diseases

Topics: Acute Disease; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Female; Gout; Humans; Male; Middle Aged; Piroxicam

Seventy-nine patients with arthrosis (40) or rheumatoid arthritis (39) were included in an open, non-comparative multicentric study. All the patients were treated by rectal route with a suppository form of tenoxicam (20 mg/day) during 6 weeks (in the first 3 days the dose was increased to 40 mg). The drug was administered once daily at evening. Clinical evaluation was performed before treatment and thereafter every 2 weeks. In the patients with arthrosis the parameters evaluated for efficacy were: pain on movement, pain at rest, tenderness, spontaneous pain, pain after 1 day of normal activity, flexion, functional status, and time to walk 10 metres. For patients with rheumatoid arthritis the parameters were: articular index, duration of morning stiffness, functional status, spontaneous pain and pain when moving. Efficacy was considered excellent or good in 22 patients with rheumatoid arthritis and moderate or poor in 17. In the group of patients with arthrosis the results were excellent or good in 28 and moderate or poor in 12. Side effects occurred in five cases.

Topics: Administration, Rectal; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Arthritis, Rheumatoid; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Piroxicam; Suppositories

Topics: Adult; Aged; Anti-Inflammatory Agents; Arthritis; Double-Blind Method; Female; Humans; Male; Middle Aged; Osteoarthritis; Piroxicam; Thiazines

Tenoxicam, a non-steroid anti-inflammatory of the oxicam type, has a molecular structure similar to that of piroxicam, but is more active and better tolerated. Several studies demonstrated that tenoxicam is a potent analgesic. It is completely absorbed after oral and intramuscular administration and slowly eliminated, the long half-life in tissues consenting once-daily administration. In the present study the pharmacokinetics of tenoxicam have been investigated during repeated parenteral administration, with or without loading dose, in order to establish the dose regime that produces constant tissue concentrations over time. Thirty-six patients of both sexes, suffering from acute pain due to arthritis of the spine, were enrolled in the study and divided into three equal groups. The first group was given 40 mg tenoxicam per day (single i.m. injection) for 2 days followed by 20 mg (single i.m. injection) for 10 days. The second group received 20 mg i.m. once a day for 12 days. The third group received 20 mg i.m. twice a day for two days followed by single 20 mg i.m. injections on the following days. Blood was sampled at 0, 0.5, 1,2,4,6,8,12,16 and 24 hours and at 3,5,7,9 and 12 days. Tenoxicam levels in the samples were assayed by an HPLC method. The results showed that single 40 mg loading doses for 2 days, followed by once-daily 20 mg maintenance administration, established the requisite steady-state tissue concentrations of tenoxicam after the second administration. Tenoxicam was very well tolerated in all three groups.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Drug Administration Schedule; Female; Humans; Male; Piroxicam

We have studied the pharmacokinetics of tenoxicam after single and multiple oral doses of 20 mg in five patients (2 men and 3 women) with end-stage renal disease undergoing haemodialysis. After a single dose, tenoxicam had a half-life (t1/2) of 33 h, an apparent clearance (CL.f-1) of 4.3 ml.min-1, and an apparent volume of distribution (Vz.f-1) of 11.81. The maximum tenoxicam concentration (Cmax) was 4.3 mg.l-1 at a median tmax of 1.7 h. There were no significant differences between the values calculated from the pre- or post-dialyser port plasma samples. Tenoxicam plasma concentrations measured during once daily dosing before and after haemodialysis showed that tenoxicam does not accumulate. Our findings suggest that dosage adjustment may not be required in patients with end-stage renal disease on haemodialysis taking tenoxicam.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Drug Administration Schedule; Female; Humans; Kidney Failure, Chronic; Male; Piroxicam; Renal Dialysis

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Humans; Piroxicam

Tenoxicam milk formulation is a new galenical form of a non-steroidal anti-inflammatory drug (NSAID). It is especially suitable for patients having compliance problems or difficulty in swallowing tablets. This formulation has proved to be a useful alternative oral treatment in various rheumatic conditions. Combining rapid onset of action and maintenance of active plasma levels, tenoxicam achieved good clinical efficacy and tolerability in the vast majority of the patients studied.

Topics: Administration, Oral; Animals; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Arthritis, Rheumatoid; Female; Humans; Male; Milk; Osteoarthritis; Pain Measurement; Periarthritis; Piroxicam

The antinociceptive action of tenoxicam, a new non-steroidal anti-inflammatory drug, has been investigated by exploring the spontaneous and evoked electrophysiological patterns of firing of thalamic neurons in arthritic rats. A marked decrease in the firing activity evoked by ankle mobilization has been found to be present at doses of tenoxicam of 0.6 mg/kg i.v. A similar effect is obtainable with aspirin (as reference drug) but with doses of 54 mg/kg i.v. On studying the effects of increasing doses of tenoxicam a progressively longer time-course inhibition has been found and the analysis confirmed a linear correlation. Findings are discussed postulating that the final antinociceptive effect of tenoxicam can be correlated with its anti-inflammatory activity.

Topics: Action Potentials; Animals; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Arthritis, Experimental; Male; Neurons; Nociceptors; Piroxicam; Rats; Rats, Inbred Strains; Thalamus

In view of the paucity of information of the synovial fluid pharmacokinetics of nonsteroidal anti-inflammatory drugs with a long half-life, we have compared the pharmacokinetics of tenoxicam (TILCOTIL, MOBIFLEX) in plasma and synovial fluid in six patients with polyarthritis causing knee effusion. Plasma and synovial fluid concentrations of tenoxicam were measured up to 96 hours after an oral dose of a single 40 mg tablet. A full pharmacokinetic analysis was performed. Tenoxicam passed into synovial fluid attaining a peak concentration significantly later than that for plasma. However, the mean half-life for synovial fluid (45 hours) was not significantly different from that for plasma (42 hours). Comparison of area under the curve (AUC) indicated the total exposure of the synovial fluid to tenoxicam was consistent in different patients, comprising 50-60% of the corresponding plasma levels in every case. In the case of tenoxicam, synovial fluid exhibits the pharmacokinetic properties of a peripheral "tissue" compartment.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Female; Half-Life; Humans; Kinetics; Male; Middle Aged; Piroxicam; Synovial Fluid