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At least 19 recordsLinked to original sources

PubMed1985

Clinical experience and results of treatment with suprofen in pediatrics. 2nd communication: Use of suprofen suppositories as an antipyretic in children with fever due to acute infections/A single-blind controlled study of suprofen versus paracetamol.

The present randomized single-blind trial was performed to study antipyretic effect and tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) suppositories versus paracetamol (acetaminophen) suppositories in pediatric patients with fever of various etiology. The study included a population of 120 patients ranging in age from 2 to 12 years; the subjects' mean rectal temperature was 39.3 degrees C in the beginning of the therapy. The dosage of the suppositories depended upon body weight; medication was applied up to 3 times a day. The temperatures were recorded 0.5, 1, 1.5, 2, 3, 4, 5, and 6 h after the preparation was first applied. Pulse rates and respiratory rates were measured at the same rating times. The antipyretic effect of suprofen in younger patients was from 1 through 6 h (except at 3 h) statistically significantly superior to that of paracetamol. In older children, the differences in favor of suprofen were statistically significant only at 1 and 2 h after application of the drug. After the treatment pulse and respiratory rate dropped in both age groups on either treatment. The means were within the normal range at all rating times. The only adverse reaction was vomiting; this phenomenon occurred in 4 cases, i.e., in 2 cases each on either drug.

Acetaminophen↗

PubMed1985

Clinical experience and results of treatment with suprofen in pediatrics. 1st communication: Suprofen dosage for children/An open and a double-blind study with suprofen syrup.

The antipyretic effect of single doses of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) syrup, administered at dose levels of 1, 2, 3, 4, 5, 7.5, and 10 mg/kg b.w., was tested in a randomized double-blind and a subsequent open study. The test populations consisted of 100 children in the double-blind study and 40 patients in the open test (20 subjects/group). The patients' age ranged from 2 to 12 years; the lowest initial rectal temperature was 39.0 degrees C. The treatment groups were homogeneous as to demographic data. The temperature was reduced in all treatment groups. In the double-blind study the mean value dropped under the subfebrile threshold of 38.0 degrees C only in the group on 5 mg/kg and remained then constant for up to 6 h following administration. No sufficient antipyretic effect was obtained with lower doses. The results of the additional open study with doses of 7.5 and 10 mg/kg indicated good antipyretic effect. This effect was not, however, superior to that obtained with 5 mg/kg. Pulse and respiratory rates returned to normal within 1.5 h following administration, except in patients on 1 mg/kg. A total of 10 patients, homogeneously distributed in the treatment groups, experienced vomiting as an adverse reaction. Short-term hypotonia was seen in one subject on 7.5 mg/kg. The results obtained show that single doses of suprofen upward of 5 mg/kg b.w. exert satisfactory, long-lasting, antipyretic effect on children.

Body Temperature↗

PubMed1986

Suprofen sustained release kinetics in healthy male volunteers. 1st communication: a single dose open crossover bioavailability study of suprofen sustained release tablets versus capsules.

An open crossover study was performed in 12 healthy male volunteers to compare the bioavailability of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) 600 mg sustained release tablets versus the suprofen capsule (2 X 200 mg). The pharmacokinetic profiles in plasma and urine were determined by a HPLC assay. In the dose range studied, the two suprofen formulations were not associated with any clinically significant effects on the blood pressure, heart rate or ECG. The results of the physical and neurological examinations showed no abnormal results. The results of haematology, clinical chemistry and urinalysis also showed no significant modifications. However, increased serum creatinine values were observed in some volunteers following suprofen administration. A drug relationship to this finding cannot be excluded with certainty. Two volunteers complained of nausea and vomiting following administration of two suprofen capsules. For this reason, volunteer no. 9 was withdrawn by the investigator from the study and replaced by an eligible substitute. In general, single doses of the two suprofen formulations investigated, were subjectively and objectively well tolerated. From the suprofen plasma-concentration time profiles, it was apparent that, whilst the elimination of suprofen was similar for both formulations, there was a marked delay in absorption of the tablet formulation. This formulation resulted in statistically significantly later maximum plasma levels and longer mean residence time (p less than 0.001). In comparison to the reference capsule formulation, the tablet had statistically significantly lower (75%) bioavailability. Measurement of suprofen concentrations in the urine indicated that less than 1% of the administered dose was excreted by this route.

Adolescent↗

PubMed1990

Determination of the enantiomers of suprofen and [2H3]suprofen in plasma by capillary gas chromatography-mass spectrometry.

A method for the stereoselective assay of the (+)- and (-)-enantiomers of suprofen and [2H3]suprofen in human plasma was developed using gas chromatography-mass spectrometry-selected-ion monitoring. (+/-)-[2H7]Suprofen was used as an internal standard. The method involved diethyl ether extraction and chiral derivatization with S-(-)-1-(naphthyl)ethylamine to form diastereomeric amide. The diastereoisomers were separated on a capillary gas chromatograph-mass spectrometer. Quantitation was achieved by selected-ion monitoring of the quasi-molecular ions of the diastereoisomers. The sensitivity, specificity, accuracy and reproducibility of the method were demonstrated to be satisfactory for application to pharmacokinetic studies of suprofen enantiomers.

Gas Chromatography-Mass Spectrometry↗

PubMed1986

Clinical experience and results of treatment with suprofen in pediatrics. 5th communication: a single-blind study on antipyretic effect and tolerability of suprofen syrup versus metamizole drops in pediatric patients.

In a single-blind study, 60 children in two age groups (30 patients: 6 months to 3 years; 30 patients: 3 years to 12 years), were orally treated with either alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol), syrup 10 mg/ml or metamizole drops 50% for a maximum period of 4 days, up to 4 times a day. The children presented with high fever due to bacterial or virus infections. Body temperature, pulse rate, and respiratory rate were evaluated at the beginning and then 30 min, 1, 1 1/2, 2, 3, 4, 5, and 6 h after the first administration of the respective drug. Significant differences between the drugs were found for all variables; this demonstrated that with suprofen the antipyretic effect set in more rapidly than with the reference drug. No side-effects were observed in children treated with suprofen syrup. Two patients showed adverse effects, i.e. sweating and hypotension, during the treatment with metamizole. Due to its good antipyretic effect and good tolerability, suprofen appears to be particularly useful for symptomatic treatment of pediatric patients with fever caused by bacterial or virus infections.

Adolescent↗

PubMed1985

Clinical experience and results of treatment with suprofen in pediatrics. 4th communication: Assessment of pain in babies and infants/Analgesic effect of suprofen syrup in otitis media.

In a study including a total of 175 children, ranging in age from 3 months to 3 years and suffering from otitis media, the analgesic effect of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) syrup was compared with that of lidocaine 0.03 g/6 g + phenazone (phenyl-dimethylpyrazolone) 0.03 g/6 g (L PDP) ear drops. The study was designed as an open controlled trial. The test medications were applied in single doses: suprofen 5-7.5 mg/kg b.w., orally; (L PDP) 1 drop, locally. The severity of pain was assessed in the beginning of the treatment and 2 h following administration of the drugs. The results were indicative of the fact that in children on suprofen syrup marked pain relief was obtained, whereas the painful condition of children on L PDP ear drops even deteriorated.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1985

Clinical experience and results of treatment with suprofen in pediatrics. 3rd communication: Antipyretic effect and tolerability of repeat doses of suprofen and paracetamol syrup in hospitalized children/A single-blind study.

Antipyretic effect and tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol), syrup and paracetamol (acetaminophen) were compared within the scope of the present randomized single-blind study; the test population included a total of 115 children ranging in age from 6 months to 12 years. All patients were admitted to the hospital with an average temperature of 39.3 degrees C, their disease being caused by bacterial or viral infections. The dose levels for treatment with syrup depended upon the children's age and body weight. Treatment was in most cases given for two days; a three-times-a-day schedule was used. The (rectal) temperature as well as pulse and respiratory rates were measured prior to treatment and 0.5, 1, 1.5, 2, 3, 4, 5, 6 h after first administration of the test preparations. The results showed that the antipyretic effect of suprofen was in both age groups at all rating times statistically significantly superior to that of paracetamol. Pulse and respiratory rates dropped in both age groups after treatment; the means were within the normal range at all rating times. Adverse drug reactions were seen in 5 patients on suprofen and in 3 cases on paracetamol. It is, however, questionable whether such reactions are drug-dependent.

Acetaminophen↗

PubMed1986

Suprofen sustained release kinetics in healthy male volunteers. 2nd communication: a multiple dose steady-state kinetics of suprofen sustained release tablets during 6 days in healthy male volunteers.

To 12 healthy male volunteers, who had given their consent, 11 administrations of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) sustained release tablets 600 mg were given twice a day with a dosage interval of 12 h. It could be demonstrated that suprofen given as multiple dose application of sustained release tablets was well tolerated. Effective mean plasma levels were reached after the second dosage. There was no indication of accumulation nor accelerated elimination during the 6-day period. There was no statistically significant difference between the mean plasma curve after the last administration of the 6-day period and the mean plasma curve after the 3rd application. Also the AUC's in the respective intervals turned out not to be statistically significantly different from each other. Clinical and laboratory tests showed no clinically relevant deviations from the normal range. No adverse reactions whatsoever were observed.

Adult↗

PubMed1975

Effects of suprofen, an inhibitor of prostaglandin biosynthesis, on platelet function, plasma coagulation and fibrinolysis. I. In vitro experiments.

?The effects of suprofen, an inhibitor of prostaglandin biosynthesis, on human platelet function, fibrinolysis, proteolysis and coagulation in vitro were compared to those of reference compounds. Platelet aggregation induced by collagen, adrenaline and arachidonic acid was inhibited by suprofen depending on its concentration. Suprofen and indomethacin proved to have an equally inhibitory effect on platelet aggregation induced by collagen. Thrombin-induced aggregation was more inhibited by suprofen than by indomethacin. While the primary wave of A.D.P.-induced aggregation remained unchanged, the rate of disaggregation was enhanced by both compounds. Experiments on platelet factor-4 and 14C-serotonin release showed that suprofen and indomethacin reduced the platelet release reaction. Based upon results from experiments on synergism of suprofen with other compounds, on inhibition of arachidonic acid-induced platelet reactions and of prostaglandin E2-release, it is suggested that suprofen by inhibiting the prostaglandin biosynthesis in platelets also inhibits the platelet release reaction. In contrast to indomethacin and flufenamic acid, suprofen did not affect fibrinolysis or thrombin clotting activity. Tryptic proteolysis of albumin, however, was reduced by suprofen in a concentration-dependent and a substrate-competitive way. Tryptic decompisition of a synthetic substrate, on the other hand, was not reduced by either suprofen, indomethacin or flufenamic acid. These findings suggest that the observed reduction of albumin proteolysis by suprofen is related to an effect on the protein substrate rather than on the proteolytic enzyme itself.

Adenosine Diphosphate↗

PubMedDate not supplied

The analgesic efficacy of suprofen in periodontal and oral surgical pain.

Suprofen is a new, orally effective nonsteroidal antiinflammatory analgesic of the propionic acid chemical class. Three separate single-dose studies were performed to evaluate the efficacy of suprofen in acute pain associated with periodontal surgery and removal of impacted third molars. Study medications were: A--suprofen 200 mg, codeine 60 mg, propoxyphene HCl 65 mg, and placebo; B--suprofen 400 mg and 200 mg, aspirin 650 mg, and placebo; C--suprofen 400 mg and 200 mg, aspirin 650 mg with codeine 60 mg, aspirin 650 mg alone, and placebo. Analgesic and side effect data were collected over a 6-hour period after patients medicated for moderate to severe pain. All studies were randomized, double-blinded, and parallel-group in design. Suprofen was significantly more effective than codeine 60 mg, propoxyphene HCl 65 mg, and aspirin 650 mg. Suprofen 400 mg appeared to be clinically more effective than the aspirin-codeine combination and the difference was statistically significant for most of the analgesic variables. Of the 224 patients who received suprofen in the 3 studies, 16 reported drowsiness and 1 reported constipation.

Adult↗

PubMed1988

Suprofen treatment of contact lens-associated giant papillary conjunctivitis.

This multicenter study of patients with contact lens-associated giant papillary conjunctivitis (GPC) was a randomized, double-masked comparison of a 1.0% suprofen solution versus the suprofen vehicle solution (placebo). Patients were given two drops of medication four times daily for up to 28 days and were clinically examined on days 0, 2, 7, 14, 21, and 28. The physicians' clinical judgments of the patients' responses to therapy significantly favored suprofen over placebo at day 21 (P = 0.02), while strongly favoring suprofen at day 14 (P = 0.057) and at day 28 (P = 0.067). The patients' opinions of their response to therapy significantly favored suprofen on day 14 (P = 0.03); a trend for suprofen was evident on day 28 (P = 0.1). Treatment with suprofen led to a greater overall reduction in ocular signs and symptoms than with placebo. Strong trends approaching statistically significant levels were found for reductions in the principal ocular sign, papillae, at day 28 (P = 0.068) and in mucus strands at days 14 and 28 (P = 0.09), which also favored suprofen.

Adult↗

PubMed1987

Suprofen versus paracetamol after oral surgery.

A randomized double-blind trial was performed to evaluate efficacy and tolerability of suprofen 200 mg (Suprocil) in comparison to paracetamol 500 mg after surgical extraction of a wisdom tooth. The study lasted 4 days per patient at the longest. Pain intensity and pain relief were evaluated by the patients using a visual analog scale. A total of 59 patients took part in the study; of these, 30 were on suprofen and 29 on paracetamol. The 30-min pain relief with paracetamol was superior to that obtained with suprofen. Roughly, the 90-min pain relief scores were somewhat higher for suprofen than for paracetamol. However, none of the differences were statistically significant. No significant difference was seen between the 2 treatment groups with respect to the frequency of the number of capsules taken per day. Broadly, the efficacy was good or excellent in 18 patients in each group. With suprofen, there were 8 moderate results and 4 insufficient ones. With paracetamol, 6 results were moderate and 5 insufficient or worse. No significant differences between the 2 treatments was seen. Tolerability was rated good by all but 1 patient in each treatment group; with suprofen, 1 result was moderate, while with paracetamol, 1 result was poor. Adverse reactions occurred in 3 patients on suprofen and in 2 patients on paracetamol, though these reactions could not be related to the use of the drug itself.

Acetaminophen↗

PubMed1992

Effects of suprofen on the isolated perfused rat kidney.

Although suprofen has been associated with the development of acute renal failure in greater than 100 subjects, the mechanism of damage remains unclear. The direct nephrotoxic effects of a single dose of 15 mg of suprofen were compared in the recirculating isolated rat kidney perfused with cell-free buffer with or without the addition of 5 mg/dL of uric acid. There were no significant differences in renal sodium excretion, oxygen consumption, or urinary flow rates in kidneys perfused with suprofen compared with the drug-free control groups. In contrast, a significant decline in glomerular filtration rate was found after the introduction of suprofen to the kidney perfused with uric acid; no changes were found with suprofen in the absence of uric acid. A significant decrease in the baseline excretion rate of uric acid was found in rats given suprofen, compared with drug-free controls. However, the fractional excretion of uric acid was unchanged between the groups over the experimental period. In summary, suprofen causes acute declines in renal function, most likely by directly altering the intrarenal distribution of uric acid.

Animals↗

PubMed1985

Local and systemic tolerability of suprofen. Experience with intravenous administration and infusion in healthy volunteers (1st comm.).

Local and systemic tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol 200 mg/ml intravenous injection and suprofen 200 mg/ml infusion were in the present single-blind crossover study assessed and compared with those of placebo i.v. 12 volunteers each were in random fashion assigned to one of the three treatment groups; for a period of 7 days the subjects received daily 2 intravenous injections or infusions of suprofen or placebo, respectively. Investigator and patients appreciation of local tolerability revealed that no pain or discomfort occurred in 98% of the subjects on suprofen and in 100% of those on placebo. The incidence of limited, moderate or mild, adverse reactions was in the suprofen group higher than in the placebo group. The laboratory tests for the treatment groups indicated no negative effects on either the hematopoietic organs or the liver function; no abnormal changes in ECG and cardiovascular parameters were observed during the treatment period. Tests of the renal parameters, i.e., creatinine clearance, creatinine, and urea (BUN), revealed negative shifts in the first two parameters, whereas BUN remained uninfluenced. On the basis of these results it can be stated that 200 mg/ml of suprofen, given either as intravenous injection or as infusion, were both locally and systemically well tolerated even on administration b.i.d. The more or less unfavorable shifts in the renal parameters, which occurred with placebo as well as with suprofen, require further investigation.

Adolescent↗

PubMed1975

Gastrointestinal effects and acute toxicity of suprofen.

The acute effects of orally administered, high doses of alpha-methyl-4-(2-thienylcarbonyl)benzeneacetic acid (suprofen) were studied in various tests, related to gastrointestinal functions. A decrease of the diarrheal stools in the castor oil test in rats was the first effect noted; the ED50 in this test was 40 mg/kg. This dose is 540 times higher than the ED50 of suprofen in the acetic acid-induced writhing test in rats (ED50 = 0.074 mg/kg). Temporarily decreased food consumption in rats was first noted after administration of 80 mg/kg. This is more than 1000 times the ED50 in the rat anti-writhing test. The appearance of gastrointestinal lesions was also studied in rats and a direct quantitative comparison was made with indometacin, acetyl-salicylic acid and ketoprofen. The dose of suprofen that produced lesions in 50% of the rats was 200 mg/kg, viz. 2700 times the ED50 in the rat anti-writhing test. Similarly obtained safety margins are 9.0 for indometacin, 78 for acetyl-salicylic acid and 102 for ketoprofen. The mortality after a single oral administration of suprofen was studied in mice, rats, guinea-pigs and dogs. LD50-values, based on mortality 7 days after administration, were 590 mg/kg, 353 mg/kg, 280 mg/kg and more than 160 mg/kg, respectively. Comparative LD50's in mice and rats were 14 and 19 mg/kg for indometacin, 280 and 70 mg/kg for ketoprofen. Therefore the safety margin in rats, with respect to the ED50 in the acetic acid-induced writhing test, is 4770 for suprofen, 156 for ketoprofen and 17.3 for indometacin. In guinea-pigs the safety margin of suprofen is 1470 with respect to the ED50 in UV-erythema and in dogs more than 250 with respect to the ED50 in urate-induced arthritis. From these data we may conclude that suprofen is comparatively safer than the reference compounds studied and that its effects on the gastrointestinal tract appear at doses far above those required for effectiveness in tests related to pain, fever and inflammation.

Animals↗

PubMed1989

Immune hemolytic anemia associated with tolmetin and suprofen.

This article reports the first case of immune hemolytic anemia possibly associated with the ingestion of suprofen. The patient suffered from massive hemoglobinuria and acute renal failure. Serologic studies of the patient's serum revealed suprofen-dependent red cell antibodies. However, tolmetin-dependent antibodies were also found in the serum, showing the same properties as the suprofen antibodies and an even higher titer. The patient not only had drug-dependent antibodies in the serum, but also had developed autoantibodies, a phenomenon that has been described for several other drugs. The working mechanism by which suprofen and tolmetin caused immune hemolysis had properties of both the immune complex model and the induction of autoimmunity. Although it was unclear whether the immune hemolytic anemia was the result of suprofen, tolmetin, or cross-reacting antibodies, we feel that suprofen should be added to the list of nonsteroidal anti-inflammatory drugs associated with a positive direct antiglobulin test.

Anemia, Hemolytic, Autoimmune↗

PubMed1984

Effect of (+/-)-2-[p-(2-thenoyl)phenyl] propionic acid (suprofen) on experimental allergic reactions.

The effects of (+/-)-2-[p-(2-thenoyl)phenyl] propionic acid (suprofen), a new anti-inflammatory agent, on experimental allergic reaction and antibody formation were examined. The action was compared with those of ketoprofen, ibuprofen, indomethacin, tranilast, chlorpheniramine, prednisolone and/or cyclophosphamide. Suprofen inhibited homologous PCA in rats, immunological histamine release from rat peritoneal mast cells and guinea pig lung tissues, Forssman cutaneous vasculitis (FCV) and the Arthus reaction in guinea pigs. The potency for inhibition of the PCA reaction was similar to that of ketoprofen and more potent than ibuprofen and trailast. As for the release of anaphylactic mediators, suprofen was less potent than tranilast in terms of histamine release, but not the release of the slow reacting substance of anaphylaxis (SRS-A). Suprofen inhibited FCA more potently than other nonsteroidal anti-inflammatory drugs (NSAID). The inhibition of the Arthus reaction by suprofen was similar to those of other NSAID and prednisolone. Suprofen hardly affected delayed hypersensitivity in guinea pigs and antibody (IgM or IgE) formation in mice or rats.

Animals↗

PubMedDate not supplied

Type I lipid photo-oxidation by the nonsteroidal anti-inflammatory drug suprofen: a possible key to its photosensitivity.

A nonsteroidal anti-inflammatory drug suprofen acted as a photosensitizer to oxidize lipids on ultraviolet A irradiation, that is, squalene and cholesterol in ethanol solution and phosphatidylcholine in liposome membranes. Photo-oxidation of squalene sensitized with suprofen was not repressed by the addition of sodium azide. Photo-oxidation of cholesterol sensitized with suprofen produced 7 alpha- and 7 beta-hydroperoxides but not 5 alpha-hydroperoxide of cholesterol. These findings are consistent with the type I mechanism but not the type II mechanism of photo-oxidation. Suprofen-sensitized photo-oxidation of membrane lipids of liposomes increased leakage of trapped glucose, suggesting photosensitized destabilization of the membrane structure. These results suggest that the photo-oxidation ability of suprofen by the type I mechanism is a possible key to the induction of suprofen photosensitivity.

Cholesterol↗