 |
| ketofan |
ketofan
- Traumatic injuries. week), by displacement from plasma proteins and/or decrease in renal clearance.
• Pain negandless of the origin such as cancer pain, dental pain, headache. Ketopnofen should be stopped at least 12 hours before methotreoatn treatment
- Primary dysmeeorrhea. and shoald not be administered for at least 12 hours after the end of methotreosfe
Ceeepesttlae: Adeewe Effaces: therapy.
Each 2 ml ampoule contains - Gastrointestinal manifestations: gastjalgia, abdominal pain, naasea, vomiting, Cambfeafiaeareqaetideegprscaeaflaeiarase:
Aceiee Caaetifaaeat:
constipation, and diannhea. Gastnitis, toniatitrs, narely colGis. The most serious - Diuretic: risk of acute mnal failune panticulaely In dehydnated patients due to a
Ketopnnfen 100mg udveese effects are: gastroduodenal tcnra0on, gastrointestinal hemornhage and decrease in glomerular filtration (reduced synthesis of renal prostuglandins).
Inactive Caeatiteeeta:
eucepnionully intestinal perforation. . Such patients should be rehydreted and renal function monitored at the start of
Anginire base (unhydnous), Darryl alcohol, Citric acid (ashydrovsj. Watenfar - headache, dizziness, blurred vision, taste perversion, linnitue, panestlrnsia, treatment.
inlection ‘ 00005lsiorn, somnolence, mood disorders, edema and weight gain, - Metlrntrexate at doses lower than 05 mgde’eek: during the first weeks of
Candiaaasculae Risk - Hypersersftlviry reactions of dermatological (urtiounia, nash, prunitus, angioedemu) combination therapy, blood count should be monitored weekly. Is cases of
- NSAIO5 may cause an increased risk of serious cardiovasculan thronnbotic and respiratory manifestations (possibtity of asthmatic attacks and bronchospasm, alIenatIon of renal functions or in elderly patients, monitoring should be more
events, enyocardial infarction (Ml), and steake, which can be natal. line ink especially, in patients allergic to aspirin and other NSAID5). Anaphylactic reoctions frequent.
may increase with duration of ose. Patients with caednovasculan disease or (including shock). - Peoeoviffnlline: increased risk or blneding. More frequent clinical and blending time
rIskfactors for cardiovascular disease may beat greaten risk. - In anemic patients, moderate fall In end cell court and a trw cases of moderate macironing Is required.
- Kotoproler is contraindicated for the treatment of peelopenasion pain’ir the leucopenia have been reported, thromhocytoponia and bate marrow aplasia. Cambiaatiaaa tabs taken iefa caaside,afiaaa: setting of coronary artery bypass graft (CABG) sungery - In patients with renal vascular dlseas, renal furction should be monitored: few -Aebotrpereeooiee (betablockers. angiztensiv convert/np enzinme inhibitors,
Gastralateafinat Risk cases of renal failure have been reported In this situation, interstitial eephnltls and diuretics): risk of reduction in aneihypertensive eIleen (due to inhibition of
vasodilafot pmstaglardins).
- NSAID5 cause an increased risk of serious gastrointestinal adverse events rephertic syndmmr.
ircluding bleeding, ulcerafiot, and perfotatios of the stomach on intestine, - Skin reactions: PhotosensitivIty alope a eaceptiosally bullous dermatosis. - Thrombzfe’tlcv: increased risk of bleeding,
which can be fatal These events can occur at any time during ass and - Local mactiers: pain at the site of injion. - Probenicid: marked redaction of plasma clearance of ketoprofen may occur.
without warnino symptoms. Elderly punients areas greater risk for serious Warelnis and Precerilians: . - Oemeproot. reduced efhcacy at Ormeprost may occur.
gastnoirtestinal (Cl) events. Warniogu. , Oeeellnsege:
___________________________________________________________________ Recause of the seriousness uf gonfrhin esninal manifestations particularly - Cases of overdosage have been reported with donut up to 2.5 got ketoproten. Ic
Pharrnacodyeaeric.: In patients Innated with articoagulants, sosr potlerts should be especially most iestances, the symptoms observed hove been benign and limited to lethargy,
Krtoprofen, an aryl carboxylic acid derivative, isa ton steroidal anti- monitored for the onset of gastroirtesninal symptoms. Discontinue nausea, vomiting and epigastric pain.
inflammotory. belonging to the propionic group It has anti-inflammatory, treatment In the event of gastrointestinal hemorrhage. - There are so specific antidotes to ketoprofan ouerdosages. In cases of massive
aetipynetics properties and has central aed peripheral analgesic activity, PrecautIons. oonrdoseges gastric lavage is recommended.
inhibits prostaglandin synthesis and platelet aggregation ‘History of gastroduodonal ulcer. J - Symptomatic and supportive treatment should be Irstituled to compensafe for
Phaemacobieetics’ -At the stan of treatment, careful mosltonirg of urine volume and renal function is dehydration, to monitor urinary excretion and to correct acidosis, if present. It
AhvaipbOn: required In patients with haag failure, sen cirrhosis, nephnitic syndrome, chronic meal failure is preseof, hamodialysis maybe useful to remove circulating drug.
- Successive measurements of serum levels after administration of a therapeutic renal insufficiency, in patients on diuretics, and particularly in the aldeety. Few Caetraindicalias::
dose show that ketoproner Is rapidly absorbed cases of renal InsuffIciency have been reported. - Proven allergy to kefoprofen and substances with a similar activity: asthma aOacks
- Peak serum concentrations are reached from 201030 minutes after istra-musculon - As with other NSAID5, in the presence p1 as infectious disease, it should be noted have beer observed in certain subjects, particularly to those with a hypersensihsity
administratios that the arq-inflammotcrj, analgesic and antipytetic properties of ketoprofen to aspirin.
Diotnibuhon’ might mask the usual signs of infectia pnogeessioe such as fever. - Active peptic ulceration.
-Ketopncfer diffuses into the synosial fluid and In ietra-aeticulan, capsular, synovial - In patients with abnormal liven function tests, on with a history of liver disease - Srnene hepatacellular or renal insufficiency.
and terdon tissues. transaminases levels should be evaluated periodically, parrlculanly during long- - Concomitant anticoagulant treatment (risk of hematuma us ton all injectable
- The gear plasma hap-life is from 1 b to 2 hours term therapy. Rare cases of (aunditei and hepatitis have been described with preparations by lU. route).
- 99% of hetoprofen administered binds with plasma pmtein. ketoprofer. Peeffececy. Rattleff Mothers & PedIatric Use.
- Ketoproten crosses the placental barrier and the blood brain barrier. - If visual disfonbarces such as blurred sian occur, treatment should be So not administer Injections preserved with beozyl alcohol to neonates, infants,
Motabolinm: - discontinued, pregnant women or canting methers. Beezyl alcohol has beer associated with
- Kefopnofrn is biotransformed according to 2 processes’ a very minor pathway Warnieff at Reazyl afothat: ,‘ serious adoense eyelets and death, particularly in pediatric patients. Injections
(hydrocylation) and a predominant pathway (glucuronic conjugation). - Ketofan ampovles contain benzril alcohffl Which Is potentially tcolc when preservative trot should bossed in these popalaOont.
- Less than 1% of the ketupnoten dose administered is found it the unchanged love administered locally to neural tissue. Donate and Mashed of Administeatitn:
in urien, whereas the glocunoconjugated metaboilfe represents around 60 to 85% - Ketofar umpoulos one corrraindicatednor use in premature infants because the hetofan is administered by deep lrtnamstculor injection at a daily dote sf100 to 200
of tire dose administered formulation contains benzyl alcohol. : mg, In two separate injfctions for a duretise 012-3 days.
Eucietizn’ Effect. on flea ability a delta an tparatwachlnaey: to eases of maintenance treatment, shift to the oral forms Is needed.
Eocretior, mainly urinary, is very rapid, since 50% Ofthe dose administered is Patients should bewarred of the risk Of izziness, somnolence orconvvlsions. Specialltattafetfoes: eliminated within 6 hours after dosing, whateser is the route of administration InteractIons with other mnedtcaftons: Patients wlOh impaired renal fvncti000 and eldedypatients:
lathe elderly ketspeofen absorption is rot modified The increased elimination Concomitant administeotiot of katorotmn with following products requires StriCt It inadvisable to reduce the initial dosage and to maintain fuch patients on the
half-life and the decreased total clearance may reflecto slower biotransformation - clielcal and laboratory monitoring. , minimal effective dote, Individual adjustments may be considered, only after
Patients with moat inovffIciency Plasma clearance ketoprolen Is dacreased and Cawbleaefon,etetreyommeeded: good ledividual tolerance has been ascertained (see Pharmucoklnetlcs section).
the elimination half-life ircr005nd correlated to thn teveniey of renal failure - Sitter. NS/4l0o, locludlog oalieylates aOhiyh dose.e increase in the rink of peptic Pat/nato with impaired hepatic functionv:
Patieneo urSA hepatic insufficiency There are no significant changes in the plasma olceration and gastrointestinal hemorrf(age by neortint an effect of potentiation. These patlenfs should be carefully monitored and dulls doses sf Ketofar kept at
clearaoceand elimination half-life However, she unboandfractlon isappnooimately - Oral anhcoagula000, hepanio by pareornral route and ticlupioe: increase in the minimal affecflse doses (see Phanmacokinetlcsand Precautions snction(.
doubled nisk of hemorrhage by Inhibiting the unCtiOt of the platelets aed irritating the Children: Therapeutic tndicatloer gastrointestinal mucosa. If concomitant treatment cannot be avoided, careful Safety and efficacy of ketoprofen hour rot been established
The indications of Ketofan are based on its aeti-ieflammttory, arraig es/c and clinIcal and laboratory monitoring (bleeding time) Is required. PicklE.:
antipyretic properties Ketolue is indicated for symptomatic treatment of- - Lithium: increase In plasma lithium lnnIs, up to toeie levels by medocirg the renal A carton boa contalring 3 ampoules, each of 2 ml e inner leaflet.
- Acute and chronic inflammafory rheumatic diseases, especially osttoarthtitis, secretion of lithium. If combination necasnarri. lithium blood levels ehesld Storaa:
rheumatoid arthritis, anlrylosing spondylOis, or other wlated syndromes be closely monitored In order to adapt the lithium dosage during concomitant Stone at a tempfrature not enceadlng 30 C, protected from light.
- Soft tissue injuries, acute painful shoulder, tendinitis, bursitis. tmeatmsnt and after NSAISt drscoetmnu4tion.
- Musculoskeletal pair toeictty of meshotreeate. in parliculor, hnn admnelstnred at high dotes (of 5 mg/ aearaeee veeeaa mc, AIIY& FORPHARPRACESFEICALINItRSTHIES - Low back pain. ‘ - Methotreoaee at doses more than t5mweetc incmeana in the nickel hematological ( aoed by:
AcWIIDIIIA. FOYPT 11111111
• Pain negandless of the origin such as cancer pain, dental pain, headache. Ketopnofen should be stopped at least 12 hours before methotreoatn treatment
- Primary dysmeeorrhea. and shoald not be administered for at least 12 hours after the end of methotreosfe
Ceeepesttlae: Adeewe Effaces: therapy.
Each 2 ml ampoule contains - Gastrointestinal manifestations: gastjalgia, abdominal pain, naasea, vomiting, Cambfeafiaeareqaetideegprscaeaflaeiarase:
Aceiee Caaetifaaeat:
constipation, and diannhea. Gastnitis, toniatitrs, narely colGis. The most serious - Diuretic: risk of acute mnal failune panticulaely In dehydnated patients due to a
Ketopnnfen 100mg udveese effects are: gastroduodenal tcnra0on, gastrointestinal hemornhage and decrease in glomerular filtration (reduced synthesis of renal prostuglandins).
Inactive Caeatiteeeta:
eucepnionully intestinal perforation. . Such patients should be rehydreted and renal function monitored at the start of
Anginire base (unhydnous), Darryl alcohol, Citric acid (ashydrovsj. Watenfar - headache, dizziness, blurred vision, taste perversion, linnitue, panestlrnsia, treatment.
inlection ‘ 00005lsiorn, somnolence, mood disorders, edema and weight gain, - Metlrntrexate at doses lower than 05 mgde’eek: during the first weeks of
Candiaaasculae Risk - Hypersersftlviry reactions of dermatological (urtiounia, nash, prunitus, angioedemu) combination therapy, blood count should be monitored weekly. Is cases of
- NSAIO5 may cause an increased risk of serious cardiovasculan thronnbotic and respiratory manifestations (possibtity of asthmatic attacks and bronchospasm, alIenatIon of renal functions or in elderly patients, monitoring should be more
events, enyocardial infarction (Ml), and steake, which can be natal. line ink especially, in patients allergic to aspirin and other NSAID5). Anaphylactic reoctions frequent.
may increase with duration of ose. Patients with caednovasculan disease or (including shock). - Peoeoviffnlline: increased risk or blneding. More frequent clinical and blending time
rIskfactors for cardiovascular disease may beat greaten risk. - In anemic patients, moderate fall In end cell court and a trw cases of moderate macironing Is required.
- Kotoproler is contraindicated for the treatment of peelopenasion pain’ir the leucopenia have been reported, thromhocytoponia and bate marrow aplasia. Cambiaatiaaa tabs taken iefa caaside,afiaaa: setting of coronary artery bypass graft (CABG) sungery - In patients with renal vascular dlseas, renal furction should be monitored: few -Aebotrpereeooiee (betablockers. angiztensiv convert/np enzinme inhibitors,
Gastralateafinat Risk cases of renal failure have been reported In this situation, interstitial eephnltls and diuretics): risk of reduction in aneihypertensive eIleen (due to inhibition of
vasodilafot pmstaglardins).
- NSAID5 cause an increased risk of serious gastrointestinal adverse events rephertic syndmmr.
ircluding bleeding, ulcerafiot, and perfotatios of the stomach on intestine, - Skin reactions: PhotosensitivIty alope a eaceptiosally bullous dermatosis. - Thrombzfe’tlcv: increased risk of bleeding,
which can be fatal These events can occur at any time during ass and - Local mactiers: pain at the site of injion. - Probenicid: marked redaction of plasma clearance of ketoprofen may occur.
without warnino symptoms. Elderly punients areas greater risk for serious Warelnis and Precerilians: . - Oemeproot. reduced efhcacy at Ormeprost may occur.
gastnoirtestinal (Cl) events. Warniogu. , Oeeellnsege:
___________________________________________________________________ Recause of the seriousness uf gonfrhin esninal manifestations particularly - Cases of overdosage have been reported with donut up to 2.5 got ketoproten. Ic
Pharrnacodyeaeric.: In patients Innated with articoagulants, sosr potlerts should be especially most iestances, the symptoms observed hove been benign and limited to lethargy,
Krtoprofen, an aryl carboxylic acid derivative, isa ton steroidal anti- monitored for the onset of gastroirtesninal symptoms. Discontinue nausea, vomiting and epigastric pain.
inflammotory. belonging to the propionic group It has anti-inflammatory, treatment In the event of gastrointestinal hemorrhage. - There are so specific antidotes to ketoprofan ouerdosages. In cases of massive
aetipynetics properties and has central aed peripheral analgesic activity, PrecautIons. oonrdoseges gastric lavage is recommended.
inhibits prostaglandin synthesis and platelet aggregation ‘History of gastroduodonal ulcer. J - Symptomatic and supportive treatment should be Irstituled to compensafe for
Phaemacobieetics’ -At the stan of treatment, careful mosltonirg of urine volume and renal function is dehydration, to monitor urinary excretion and to correct acidosis, if present. It
AhvaipbOn: required In patients with haag failure, sen cirrhosis, nephnitic syndrome, chronic meal failure is preseof, hamodialysis maybe useful to remove circulating drug.
- Successive measurements of serum levels after administration of a therapeutic renal insufficiency, in patients on diuretics, and particularly in the aldeety. Few Caetraindicalias::
dose show that ketoproner Is rapidly absorbed cases of renal InsuffIciency have been reported. - Proven allergy to kefoprofen and substances with a similar activity: asthma aOacks
- Peak serum concentrations are reached from 201030 minutes after istra-musculon - As with other NSAID5, in the presence p1 as infectious disease, it should be noted have beer observed in certain subjects, particularly to those with a hypersensihsity
administratios that the arq-inflammotcrj, analgesic and antipytetic properties of ketoprofen to aspirin.
Diotnibuhon’ might mask the usual signs of infectia pnogeessioe such as fever. - Active peptic ulceration.
-Ketopncfer diffuses into the synosial fluid and In ietra-aeticulan, capsular, synovial - In patients with abnormal liven function tests, on with a history of liver disease - Srnene hepatacellular or renal insufficiency.
and terdon tissues. transaminases levels should be evaluated periodically, parrlculanly during long- - Concomitant anticoagulant treatment (risk of hematuma us ton all injectable
- The gear plasma hap-life is from 1 b to 2 hours term therapy. Rare cases of (aunditei and hepatitis have been described with preparations by lU. route).
- 99% of hetoprofen administered binds with plasma pmtein. ketoprofer. Peeffececy. Rattleff Mothers & PedIatric Use.
- Ketoproten crosses the placental barrier and the blood brain barrier. - If visual disfonbarces such as blurred sian occur, treatment should be So not administer Injections preserved with beozyl alcohol to neonates, infants,
Motabolinm: - discontinued, pregnant women or canting methers. Beezyl alcohol has beer associated with
- Kefopnofrn is biotransformed according to 2 processes’ a very minor pathway Warnieff at Reazyl afothat: ,‘ serious adoense eyelets and death, particularly in pediatric patients. Injections
(hydrocylation) and a predominant pathway (glucuronic conjugation). - Ketofan ampovles contain benzril alcohffl Which Is potentially tcolc when preservative trot should bossed in these popalaOont.
- Less than 1% of the ketupnoten dose administered is found it the unchanged love administered locally to neural tissue. Donate and Mashed of Administeatitn:
in urien, whereas the glocunoconjugated metaboilfe represents around 60 to 85% - Ketofar umpoulos one corrraindicatednor use in premature infants because the hetofan is administered by deep lrtnamstculor injection at a daily dote sf100 to 200
of tire dose administered formulation contains benzyl alcohol. : mg, In two separate injfctions for a duretise 012-3 days.
Eucietizn’ Effect. on flea ability a delta an tparatwachlnaey: to eases of maintenance treatment, shift to the oral forms Is needed.
Eocretior, mainly urinary, is very rapid, since 50% Ofthe dose administered is Patients should bewarred of the risk Of izziness, somnolence orconvvlsions. Specialltattafetfoes: eliminated within 6 hours after dosing, whateser is the route of administration InteractIons with other mnedtcaftons: Patients wlOh impaired renal fvncti000 and eldedypatients:
lathe elderly ketspeofen absorption is rot modified The increased elimination Concomitant administeotiot of katorotmn with following products requires StriCt It inadvisable to reduce the initial dosage and to maintain fuch patients on the
half-life and the decreased total clearance may reflecto slower biotransformation - clielcal and laboratory monitoring. , minimal effective dote, Individual adjustments may be considered, only after
Patients with moat inovffIciency Plasma clearance ketoprolen Is dacreased and Cawbleaefon,etetreyommeeded: good ledividual tolerance has been ascertained (see Pharmucoklnetlcs section).
the elimination half-life ircr005nd correlated to thn teveniey of renal failure - Sitter. NS/4l0o, locludlog oalieylates aOhiyh dose.e increase in the rink of peptic Pat/nato with impaired hepatic functionv:
Patieneo urSA hepatic insufficiency There are no significant changes in the plasma olceration and gastrointestinal hemorrf(age by neortint an effect of potentiation. These patlenfs should be carefully monitored and dulls doses sf Ketofar kept at
clearaoceand elimination half-life However, she unboandfractlon isappnooimately - Oral anhcoagula000, hepanio by pareornral route and ticlupioe: increase in the minimal affecflse doses (see Phanmacokinetlcsand Precautions snction(.
doubled nisk of hemorrhage by Inhibiting the unCtiOt of the platelets aed irritating the Children: Therapeutic tndicatloer gastrointestinal mucosa. If concomitant treatment cannot be avoided, careful Safety and efficacy of ketoprofen hour rot been established
The indications of Ketofan are based on its aeti-ieflammttory, arraig es/c and clinIcal and laboratory monitoring (bleeding time) Is required. PicklE.:
antipyretic properties Ketolue is indicated for symptomatic treatment of- - Lithium: increase In plasma lithium lnnIs, up to toeie levels by medocirg the renal A carton boa contalring 3 ampoules, each of 2 ml e inner leaflet.
- Acute and chronic inflammafory rheumatic diseases, especially osttoarthtitis, secretion of lithium. If combination necasnarri. lithium blood levels ehesld Storaa:
rheumatoid arthritis, anlrylosing spondylOis, or other wlated syndromes be closely monitored In order to adapt the lithium dosage during concomitant Stone at a tempfrature not enceadlng 30 C, protected from light.
- Soft tissue injuries, acute painful shoulder, tendinitis, bursitis. tmeatmsnt and after NSAISt drscoetmnu4tion.
- Musculoskeletal pair toeictty of meshotreeate. in parliculor, hnn admnelstnred at high dotes (of 5 mg/ aearaeee veeeaa mc, AIIY& FORPHARPRACESFEICALINItRSTHIES - Low back pain. ‘ - Methotreoaee at doses more than t5mweetc incmeana in the nickel hematological ( aoed by:
AcWIIDIIIA. FOYPT 11111111
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