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PubMed1986

Reduction of pupillary constriction during cataract surgery using suprofen.

The efficacy of a new nonsteroidal anti-inflammatory agent, suprofen, for reducing pupillary constriction during cataract surgery was ascertained in a double-masked, multicenter, clinical study. Prior to surgery 1.0% suprofen or a placebo was instilled; the surgeon's normal regimen of mydriatics and cycloplegics was used. Suprofen (209 patients) was far more effective than the placebo (203 patients) in maintaining a dilated pupil prior to intraocular lens (IOL) implantation (or instillation of a miotic). The mean pupillary area prior to IOL implantation was 6.3 sq mm larger (20% larger) in patients treated with suprofen than in patients receiving the placebo. The investigators' subjective evaluations of the adequacy of pupil size for IOL implantation and of the difficulty of IOL implantation favored patients treated with suprofen over those receiving the placebo.

Adult↗
PubMed1988

Comparative bioavailability of suprofen after coadministration with food or milk.

Suprofen is a nonsteroidal analgesic with demonstrated efficacy in the treatment of mild to moderate pain associated with a variety of clinical conditions. Because nonsteroidal analgesic agents may cause gastrointestinal side effects, they are frequently prescribed with food or milk. The purpose of this study was to evaluate the effects of a standard meal and milk alone on the rate and extent of absorption of suprofen. In a randomized three-way cross-over study, 24 healthy volunteers each received a single 200-mg oral dose of suprofen in the fasted state half an hour after a standard meal or half an hour after an 8-ounce glass of milk. The influence of food and milk was greater on the rate than on the extent of absorption of suprofen as illustrated by a more pronounced effect on Cmax than on AUC. In addition, food had a greater influence on the bioavailability of suprofen than milk. Food decreased the mean Cmax to 44% and the mean AUC to 81% relative to the fasted state, whereas milk decreased the mean Cmax to 74% and the mean AUC to only 87% of the respective parameters in the fasted state. Symmetrical confidence intervals demonstrated that the mean AUCmilk was within only 19% and the mean AUCfood was within only 25% of the mean AUC in the fasted state, with 95% confidence.

Adult↗
PubMed1982

High-performance liquid chromatographic determination of suprofen in drug substance and capsules.

A rapid, simple, stability-indicating assay procedure for suprofen, a new analgesic agent, in suprofen drug substance and in capsules was developed using high-performance liquid chromatography. Suprofen was extracted from the sample matrix with methanol and diluted with internal standard solution, and an aliquot was chromatographed on a reversed-phased column using acetonitrile-pH 3.0 buffer solution as the mobile phase. The selectivity of te chromatographic system for intact suprofen was demonstrated by resolving suprofen from synthetic intermediates, potential impurities, and reaction products resulting from accelerated stress conditions. The method is linear, quantitative, and reproducible. Either peak height or peak area ratios can be used for quantitation.

Capsules↗
PubMed1986

Depressant effects of suprofen, a new non-steroidal anti-inflammatory drug on thalamic evoked neuronal firing in arthritic rats.

The effects of suprofen, a new non-steroidal anti-inflammatory drug, (NSAID), the activity of which is mainly antinociceptive, were compared with those of aspirin (as a reference drug) in a study of spontaneous and evoked firing of thalamic neurons (nucleus lateralis and ventrobasalis) in rats rendered arthritic by injection of Freund's adjuvant into the paw. Suprofen (3.7 mg/kg, i.v.) induced a marked decrease in the firing evoked in arthritic rats by ankle mobilization. This effect, after a rapid onset, lasted on the average for 60 min. A similar effect was obtained with aspirin, but with 54 mg/kg (i.v.) (14 times more than suprofen). With increasing doses of suprofen, it was possible to obtain an increased long-lasting inhibition of the evoked activity, with a significant dose-effect linear regression. The possibility that there are both CNS and peripheral effects of suprofen is discussed in relation to the possible role of aspirin (the reference standard for NSAIDs) in enhancing presynaptic inhibition, thus reducing the effectiveness of incoming sensory stimuli.

Animals↗
PubMed1985

Potent and selective effects of suprofen on uterine prostaglandin synthesis.

Suprofen is a non-narcotic, peripheral analgesic that exhibits potent prostaglandin (PG) synthesis inhibitory activities in a variety of subcellular tissue preparations and in vivo. The results of the present study show suprofen to be significantly more potent than either ibuprofen (6-fold) or aspirin (1000-fold) as an inhibitor of PG production by cell-free preparations of guinea pig uteri. It is selectively more potent against the production of PGF2 alpha and PGE2 than against the formation of 6-keto PGF1 alpha, the stable metabolite of prostacyclin. Suprofen is markedly more potent inhibiting the conversion of arachidonic acid to PGF2 alpha than is ibuprofen (30 times) or aspirin (1250 times). Taken together with the important role PGF2 alpha plays in the etiology of dysmenorrhea and the observation (Hahn et al., 1982) that suprofen is more potent and effective than a number of other PG synthesis inhibitors, including ibuprofen and aspirin, at reducing in vivo guinea pig uterine contractions induced by arachidonic acid, the results of the present study suggest a mechanism to support the clinical findings that suprofen is a very effective treatment for the signs and symptoms of dysmenorrhea.

Animals↗
PubMed1991

Allergic photocontact dermatitis due to suprofen. Photopatch testing and cross-reaction study.

We report 5 cases of photocontact dermatitis due to suprofen, a nonsteroidal anti-inflammatory drug introduced to the Japanese market in 1989, and available as a 1% ointment. The patients developed pruritic eczematous lesions after applying the ointment for from 2 weeks to 3 months. All 5 patients reacted positively to photopatch testing with ultraviolet A (UVA) and suprofen down to 0.1-0.01% pet., and 3 patients showed positive reactions with ultraviolet B (UVB) and suprofen down to 1.0-0.1%. Moreover, all patients showed a cross-reaction with tiaprofenic acid, which has a very similar chemical structure to suprofen. However, there was no cross-reaction between suprofen and ketoprofen. Prescribers should be aware of the existence of photocontact sensitivity due to these drugs.

Adolescent↗
PubMed1983

Long-term comparison of suprofen and propoxyphene in patients with osteoarthritis.

The analgesic efficacy and safety of suprofen, 200 mg q.i.d., and propoxyphene, 65 mg q.i.d., were compared in 114 patients with chronic pain due to osteoarthritis. Both analgesic agents decreased pain intensity after only 1 week of treatment and considerable pain relief was apparent by week 2 to week 3 of treatment. These beneficial effects persisted with long-term therapy and improvement continued throughout the 24-week treatment period. Overall, the response to suprofen and propoxyphene was good to excellent in most of the patients treated. Long-term administration of suprofen was at least as well tolerated as that of propoxyphene. Only 24% (13 of 55) of suprofen-treated patients and 34% (20 of 59) of propoxyphene-treated patients discontinued therapy, primarily due to gastrointestinal complaints. It was concluded that suprofen, 200 mg q.i.d., is comparable in terms of efficacy to propoxyphene, 65 mg q.i.d., in relieving pain due to osteoarthritis.

Aged↗
PubMed1983

Suprofen. An overview of long-term safety.

Suprofen, a new oral peripherally acting analgesic agent, has been shown to be effective in the relief of acute and chronic pain. This paper reviews data relative to long-term safety from more than 800 patients who received suprofen. Some of these patients were followed up to 2 years. Suprofen was generally found to be at least as safe and as well tolerated as reference drugs of aspirin, propoxyphene and propoxyphene combination. The discontinuance rate because of side effects was 17.7% for patients receiving suprofen and 23.9% for patients receiving reference drugs. Gastrointestinal side effects were the most frequently reported reasons for all patient dropout in all treatment groups. Fewer patients receiving suprofen discontinued due to gastrointestinal side effects (10.9%) than with reference drugs (17.2%).

Adult↗
PubMed1985

Suprofen. A review of its pharmacodynamic and pharmacokinetic properties, and analgesic efficacy.

Suprofen (sutoprofen) is a non-steroidal anti-inflammatory analgesic, closely related structurally to drugs such as ibuprofen, ketoprofen and naproxen. In patients with acute pain, single oral doses of suprofen are at least as effective as: usual therapeutic doses of aspirin; codeine alone or combined with aspirin; dextropropoxyphene alone or in various combinations; oxycodone combined with aspirin; dipyrone; pentazocine; paracetamol (acetaminophen); diflunisal; ibuprofen; indomethacin; or mefenamic acid. In chronic pain due to osteoarthritis, suprofen is as effective as usual dosages of aspirin or dextropropoxyphene during long term therapy, and as effective as diclofenac, ibuprofen, indomethacin and naproxen during short term treatment. As with other non-steroidal anti-inflammatory drugs, gastrointestinal complaints are the most frequently reported side effects, although discontinuation due to gastrointestinal effects may be necessary less frequently with suprofen than with aspirin, dextropropoxyphene or combinations of the two. Suprofen appears to be a useful alternative to mild analgesics, analgesic combinations or the older more established non-steroidal anti-inflammatory drugs in the treatment of patients with acute or chronic pain. However, further definition of its efficacy and tolerability is required, especially in comparison with newer non-steroidal anti-inflammatory analgesics.

Acute Disease↗
PubMed1984

Disposition of suprofen in rats following intravenous injection.

Distribution and excretion of DL-2-(4-(2-thienylcarbonyl)phenyl)propionic acid (suprofen) were evaluated in male and female rats following intravenous (i.v.) injection of labeled suprofen. The radiometric findings following i.v. administration of 2 mg/kg of 3H-suprofen to male and female rats showed similar patterns of blood level and excretion of the radioactivity. Elimination of 3H-suprofen from the blood was rapid; most of the radioactivity was excreted in the urine and a portion in the feces within 24 h after injection. After rats with biliary fistulas were given an i.v. dose of 2 mg/kg of 3H-suprofen, approximately half of the dose was excreted in the bile during 48 h. The only tissues with concentrations higher than that in the plasma were those involved in metabolism and excretion (liver and kidney); other tissue levels were all very low and there was no evidence of accumulation of drug-related material in any tissue.

Animals↗
PubMed1986

Controlled single-blind clinical study of suprofen syrup versus metamizole syrup.

The analgesic effect and the tolerability of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) syrup 200 mg and metamizole syrup 500 mg were compared in a randomized single-blind study including hospitalized patients with severe to moderate chronic pain. The 2 treatment groups consisted of 30 subjects each and were homogeneous as to the demographic data. Pain intensity was appreciated by the investigator prior to the treatment and on days 2, 3, and 5 of the study; pain relief was assessed on days 2, 3, and 5 of the therapy. Although pain intensity was on treatment with suprofen more markedly reduced than with metamizole, there was no statistically significant difference between the 2 treatment groups (chi 2-test). The Mann-Whitney test revealed that on days 3 and 5 pain relief with suprofen was significantly superior to that with metamizole. According to the investigator's final global evaluation, suprofen syrup 200 mg had very good to good effect in 70% of the cases, whereas the effectiveness of metamizole was rated good to very good in 44%. Side-effects manifesting themselves as gastric irritation and nausea were recorded for 3 patients on suprofen and 2 subjects on metamizole.

Adult↗
PubMed1986

Bioavailability and corneal anti-inflammatory effect of topical suprofen.

The bioavailability in rabbit cornea and aqueous humor of an ophthalmic formulation of suprofen, a nonsteroidal anti-inflammatory drug, was evaluated following topical administration of a single dose to the eye. The drug penetrated rapidly into the uninflamed cornea with intact epithelium; highest levels occurred during the first 30 to 45 min after instillation and decreased thereafter. The bioavailability of suprofen in cornea and aqueous humor following administration of a 1.0% concentration was twice that produced by a 0.5% concentration of the drug. Topical application of multiple doses of suprofen failed to suppress polymorphonuclear leukocyte invasion of the cornea if treatment was started after the induction of inflammation. Suprofen therapy initiated prior to the induction of corneal inflammation and maintained into the post-inflammation period did produce a significant (P less than 0.01) decrease in the numbers of PMNs that invaded the inflamed cornea. There was no significant difference (P greater than 0.05) in the corneal anti-inflammatory effect achieved by the 0.5% and 1.0% concentrations of suprofen when administered according to this regimen.

Animals↗
PubMed1983

[Experience with suprofen for acute and chronic pain in neurologic practice].

A single-dose, double-blind study included a total of 196 patients with neurologic pain. The subjects were subdivided into five groups and treated with alpha-methyl-4-(2-thienylcarbonyl) benzene acetic acid (suprofen, Suprol) 400 mg; suprofen 200 mg acetylsalicylic acid (ASA) 650 mg; ASA 650 plus codeine 60 mg; and placebo. The population was homogeneous as to age, sex, and body weight. About 95% of the patients rated the intensity of pain severe prior to treatment. The clinical effect was appreciated by investigator and patients after up to 6 h following administration of the single dose. It was demonstrated that the active substances all were significantly superior to placebo in all criteria tested. Statistical analysis of the parameters investigated revealed the following order of effectiveness of the test medications: Suprofen 400 and 200, respectively, = ASA 650 + codeine 60 greater than ASA 650 greater than placebo. The final overall patients appreciation of effectiveness showed good to very good results in 97.4% of the patients on suprofen 400; 65% of those on suprofen 200; 72.5% of those on ASA 650 + codeine 60; 13.5% of those on ASA 650; and 7.5% of those on placebo. During the treatment 26 patients experienced adverse reactions; of these, 18 subjects on ASA 650 + codeine 60 complained of fatigue or somnolence as the side effect experienced most frequently.

Acute Disease↗
PubMed1991

Stereoselective pharmacokinetics and inversion of suprofen enantiomers in humans.

The stereoselective pharmacokinetics of suprofen enantiomers has been studied in humans by means of stable isotope-labeled pseudoracemate-diastereomer methodology. After a single oral dose of a near equimolar mixture of unlabeled-(R)-(-)- and [2H3]-(S)-(+)-suprofen [or unlabeled-(S)- and [2H3]-(R)-suprofen] to three healthy male subjects, the plasma concentrations of drug were determined by a stereospecific gas chromatography-mass spectrometry method. Racemic [2H7]suprofen was used as an internal standard. The method involved chiral derivatization with (S)-(-)-1-(naphthyl)ethylamine to form the diastereomeric amide. The plasma concentrations were consistently higher for the (R)-isomer than the (S)-isomer. No significant difference in the elimination half-life of the enantiomers was observed. An average of 6.8% of an administered dose of the (R)-isomer was stereospecifically inverted to the (S)-isomer. There was no measurable inversion of the (S)- to (R)-isomer. The present stable isotope-labeled pseudoracemate-diastereomer methodology has made it possible to evaluate the pharmacokinetics of each enantiomer, including the estimation of chiral inversion after administration of the racemic mixture.

Administration, Oral↗
PubMed1985

Suprofen compared to dextropropoxyphene hydrochloride and paracetamol (Cosalgesic) after extraction of wisdom teeth under general anaesthesia.

In a randomised double-blind trial in postoperative ambulant day case dental patients suprofen 200 mg (29 patients) was compared with dextropropoxyphene hydrochloride 65 mg and paracetamol 650 mg (Cosalgesic, 28 patients) both available four times daily for 3 days. Suprofen was better than cosalgesic in the patients' opinion of initial (p = 0.01) and overall pain relief (p = 0.08) compared to Cosalgesic and the second night's sleep was better (p = 0.01). Side effects were reported in six suprofen patients and 10 cosalgesic patients (two suffering from vomiting withdrew). Suprofen, a non-steroidal anti-inflammatory drug is as good as, or better than, a widely used opioid-paracetamol mixture for ambulant patients with postoperative dental pain.

Acetaminophen↗
PubMed1983

Introduction to the pharmacology of suprofen.

A number of peripherally acting analgesics have become available in the past two decades for the treatment of mild to moderate pain of diverse etiology. The action of these agents is based on their putative ability to inhibit prostaglandin biosynthesis and attenuate hyperalgesia. Suprofen is a new and potent peripherally acting analgesic with anti-inflammatory and antipyretic properties which appears to inhibit prostaglandin synthetase in a tissue-selective manner. In preclinical studies, suprofen was shown to possess a wide separation of analgesic activity from gastrointestinal irritation. Suprofen appears to exert its pharmacological effect by inhibiting synthesis of prostaglandins from precursor arachidonic acid, inhibiting the pain induced by bradykinin, and by raising the threshold to pain induced by prostaglandins. The onset of action is rapid with peak analgesic effect reached in 1-2 h. Preclinical data suggest that suprofen may be an extremely valuable and versatile analgesic for the clinical management of pain.

Animals↗
PubMed1983

Comparison of fecal blood loss after use of aspirin and suprofen.

The effects of aspirin and suprofen on gastrointestinal blood loss were compared in a double-blind, crossover study of 20 healthy male subjects. Fecal blood loss was measured by 51Cr-labeled red cells. Subjects treated with aspirin (2,600 mg/day) experienced a mean fecal blood loss of 4.2 ml/day, compared with subjects treated with suprofen (800 mg/day) whose mean fecal blood loss was 1.8 ml/day. There was significantly greater (p less than 0.01) blood loss in the aspirin group than in the suprofen group. Mean fecal blood loss in the suprofen group did not differ appreciably from the fecal blood loss observed during the placebo period (0.4 ml/day).

Adult↗
PubMed1983

Double-blind evaluation of suprofen and aspirin in the treatment of periodontal pain.

A double-blind, randomized, parallel group, placebo-controlled study was carried out to compare the safety and efficacy of single doses of suprofen (200 mg and 400 mg) with aspirin (650 mg) and placebo in relieving pain. In patients with pain resulting from periodontal surgery, a single dose of suprofen 200 or 400 mg was significantly better than placebo in reducing pain intensity and providing pain relief. The superiority of both doses of suprofen over placebo was demonstrated in every parameter in which pain intensity or pain relief was calculated. In addition, both doses of suprofen were better than, or at least equivalent to, aspirin 650 mg in every efficacy measure including the patients' overall acceptability of treatment.

Acetaminophen↗