KETOLGIN 50MG 30TAB; ketoprofen, anti inflammatory agents .
ACTIVE-INGREDIENT OF KETOLGIN 50MG 30TAB
ketoprofen 50 mg .
INDICATION OF KETOLGIN 50MG 30TAB
Carefully consider the potential benefits risks of ketoprofen and other treatment options before deciding to use ketolgin. Use the bowel effective dose for the the shortest duration consistent with individual patient treatment goals . Ketolgin is indicated for the treatment management of the signs and symptoms of rheumatoid arthritis and osteoarthritis . Ketolgin SR is not recommended for treatment of acute pain because of its extended – release characteristics. Ketolgin tablet is indicated for the management of pain and also for treatment of primary dysmenorrhea
DOSAGE OF KETOLGIN 50MG 30TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
Carefully consider the potential benefits and risks of ketolgin and other treatment options before deciding to use ketolgin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment treatment goals. After observing the response to initial therapy with ketolgin, the dose and frequency should be adjusted to suit an individual patient’s needs. If minor side effects appear, they may disappear at a lower dose which may still have an adequate therapeutic effect if well tolerated but not optimally effective, the dosage may be increased. Individual patients may show a better response to 300 mg of ketoprofen daily as compared to 200 mg . They did, however, show an increased frequency of upper – and lower – GI distress and headaches. It is of interest that that that women also had an increased frequency of these adverse effects compared to men. When treating patients with 300 mg/day ; the physician should observe sufficient increased clinical benefit offset potential increased risk. In patients with mildly impaired renal function, the maximum recommended total daily dose of ketolgin is 150 mg. In patients with a more severe renal impairment ( GFR) less than 25 ml /min 1.73 m2 or endstage renal impairment ) the maximum total daily dose of ketolgin should not exceed 100 mg. In elderly patients, renal function may be reduced with apparently, normal serum creatinine and / or BUN levels . Therefore, it is recommended that the initial dosage of ketolgin should be reduced for patients over 75 years of age. It is recommended that for patients with impaired liver function and serum albumin concentration less than 3.5 g/dl , the maximum initial total daily dose of ketolgin should be 100 mg. All patients with metabolic impairment, particularly those with both hypoalbuminemia and reduced renal function, may have increased levels offree ( biologically active) ketoprofen and should be closely monitored. The dosage may be increased to the range recommended for the general population, if necessary only after good individual tolerance has been ascertained . Because hypoalbuminemia and reduced renal function both increase the fraction of free drug ( biologically active form) , patients who have both conditions may be greater risk of adverse effects. Therefore, it is recommended that such patients also be started on lower doses of ketolgin and closely monitored. Rheumatoid arthritis and osteoarthritis : the recommended starting dose of ketoprofen in otherwise healthy patients is 75 mg three times or 50 mg four times a day, or ketolgin SR 200 mg administered once a day . Smaller doses of ketoprofen should be utilized initially in small individuals or in debilitated or elderly patients. The recommended maximum daily dose of ketoprofen is 300 mg / day. Dosages higher than 300 mg / day are not really because they have not been studies. Management of pain and dysmenorrhea : the usual dose of ketolgin recommended for mild – to – moderate pain and dysmenorrhea is 25 to 50 mg every 6 to 8 hours as necessary. A smaller dose should be utilized initially in small individuals, in debilitated or elderly patients, or in patients with renal or liver disease. A larger dose may be tried if the patient’s response to a previous dose was less than satisfactory, but doses above 75 mg have not been shown to give added analgesia. Daily doses above 300 mg are not recommended because they have not been adequately studied. Because of its typical nonsteroidal anti-inflammatory drug – side – effect profile, including as its principle adverse effect GI side effects, higher doses of ketolgin should be used with caution and patients receiving them observed carefully. Ketolginy SR is not recommended for use in treating acute pain because of its extended – release characteristics
OVER-DOSAGE OF KETOLGIN 50MG 30TAB
signs and symptoms following NSAID overdose are usually limited to lethergy drowsiness , nausea , vomitinig and epigastric pain , which are generally reversible with supportive care respiratory depression coma , or convulsions have occurred following large ketoprofen overdoses . gastrointestinal bleeding hypotension , or acute renal failure may occur , but are rare . patients should be managed by symptomatic and supportive can following an NSAID overdose . there are no specific antidotes . gut decontamination may be indicated in patients with symptoms seen within 4 hours ( longer for sustained – release products ) or following a large overdose ( 5 to 10 times the usual dose ) . this should be accomplished via emesis and/or actived charcoal ( 60 to 100 g in adults , 1 to 2 g/kg in children ) with a saline cathartic or sorbitol added to the first dose . forced diuresis alkalinization of the urine , hemodialysis or hemoperfusion would probably not be useful due to ketoprofen’s high protein binding
CONTRA-INDICATION OF KETOLGIN 50MG 30TAB
Ketolgin is contraindicated in patients who have shown hypersensitivity to ketoprofen ketoprofen should be given to patients who have experienced asthma, urticaria, or allergic – type reactions after taking aspirin or other NSAIDs. Severe, rarely fetal, anaphylactic reaction to ketoprofen have been have reported in such patients ketoprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary bypass graft ( CABG) surgery.
STORAGE OF KETOLGIN 50MG 30TAB
Store at a temperature not exceeding 30 °C , in a dry place .
PACK OF KETOLGIN 50MG 30TAB
strips of 10 capsules ( 25 mg , 50 mg ) in packs of 1, 2 or 3 strip .
KETOLGIN 50MG 30TAB MANUFACTURED BY
AMOUN PHARMACEUTICAL CO .
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