Ketoprofen Enteric coated tablet 100 mg, each enteric coated tablet contains : Ketoprofen 100 mg.
Ketoprofen containing Ketoprofen as active ingredient is available in enteric coated tablet 100 mg.
- Chronic inflammatory rheumatism.
- Abarticular rheumatism.
- Attack of gout or chondrocalcinosis.
- Acute arthritis and polyarthritis.
- Sciatica and low back pain.
- Congestive exacerbation in osteoarthritis.
DOSAGE AND ADMINISTRATIONS :
1 or 2 tablets (100 – 200 mg) once daily, depending on patient weight and on severity of symptoms.
To be taken during meals, swallow whole, do not chew/crush.
Special population :
- Patient with impaired renal function and the elderly : It is advisable to reduce the initial dosage and to maintain such patients on the minimal effective dose. Individual adjustment may be consider, only after good individual tolerance has been ascertained.
- Patient with impaired hepatic function : These patients should be carefully monitored and daily dose of Ketoprofen kept at the minimal effective dosage.
- Children : Safety and effectiveness of Ketoprofen have not been established.
Cases of overdosage have been reported with doses up to 2.5 g of Ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain.
There are no specific antidotes to Ketoprofen overdosage. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present. If renal failure is present, hemodialysis may be useful to remove circulating drug.
This drug is contraindicated in the following cases :
- History of allergy or asthma triggered by taking of Ketoprofen and substances with a similar activity such as other NSAIDs or Acetosal.
- Active peptic ulcer.
- Severe hepatic insufficiency.
- Severe renal insufficiency.
- Third trimester of pregnancy.
- Rectitis or proctorrhagia history (rectal administration).
WARNINGS AND PRECAUTIONS :
- Cardiovascular Thrombotic Events
Clinical trials of severe COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increase risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have similar risk. Patients with known CV disease or risk factor for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the sign and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of Acetosal mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of Acetosal and an NSAID does increase the risk of serious GI events (see GI WARNINGS, Gastrointestinal (GI) Effect – Risk of GI Ulceration, Bleeding and Perforation).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain the first 10 – 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
NSAIDs, including Ketoprofen can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking Thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Ketoprofen, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment with Ketoprofen and throughout the course of therapy.
- Congestive Heart Failure and Edema
Fluid retention and edema have been observed in some patients taking NSAIDs, including Ketoprofen. Ketoprofen should be used with caution in patients with fluid retention or hearts failure.
GASTROINTESTINAL (GI) EFFECTS
- Risk of GI Ulceration, Bleeding and Perforation
NSAIDs, including Ketoprofen, can cause serious gastrointestinal events, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop serious upper GI adverse events of NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 – 6 months, and in about 2 – 4% of patients treated for one year. These trends with longer duration of use, increasing the like hood of developing a serious GI event at some time, during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should prescribed with extreme caution in patients with prior history of ulcer disease or gastrointestinal bleeding. Patients with prior history of ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed compared to patients with neither of these risk factor. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in the elderly or debilitated patients, and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, in patients treated with NSAIDs, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
DRUG INTERACTIONS :
Not recommended drug associations :
- Other NSAIDs (including high dose Salicylates) : Increased risk of gastrointestinal ulceration and bleeding.
- Oral anticoagulants, parenteral heparin and Ticlopidine : Increased risk of bleeding caused by platelet aggregation inhibition. If coprescription is unavoidable, patient should be closely monitored including laboratory tests (bleeding time).
- Lithium : Risk of elevation of Lithium plasma levels, sometimes reaching toxic levels, due to decreased Lithium renal excretion. Where necessary, plasma Lithium levels should be closely monitored and the Lithium dosage levels adjusted during and after NSAID’s therapy.
- Methotrexate ate doses greater than 15 mg/week : Increased risk of haematologic toxicity of Methotrexate, particularly if administered at high doses (>15 mg/week), possibly related to displacement of protein-bound Methotrexate and to its decreased renal clearance. In patients receiving previously Ketoprofen therapy, treatment by Ketoprofen should be interrupted for at least 12 hours before administration of Methotrexate. When Ketoprofen is to be administered following the end of Methotrexate therapy, a period of at least 12 hours also be observed before initiation of treatment.
Drug association requiring precautions for use :
- Diuretics : Patients and particularly dehydrated patients taking diuretic are at greater risk of developing renal failure secondary to a decrease in renal blood flow caused by prostaglandin inhibition. Such patients should be rehydrated before initiating coadministration therapy and renal function monitored when the treatment is started.
- Methotrexate at doses lower than 15 mg/week : During the first weeks of combination treatment, full blood count should be monitored weekly. If there is any alteration of the renal function, or if the patient is elderly, monitory should be more frequent.
- Pentoxifylline : There is an increased risk of bleeding. More frequent clinical and bleeding time monitoring is required.
Drug association to be taken into account :
- Antihypertensive agents (β-blockers, Angiotensin converting enzyme inhibitors, diuretics) : Risk of decrease antihypertensive potency (inhibition of vasodilator prostaglandins by NSAID’s).
- Thrombolytics : There is an increased risk of bleeding.
- Probenecid : Concomitant administration of Probenecid may markedly reduce the plasma clearance of Ketoprofen.
- Gemeprost : The efficacy of Gemeprost may be reduced.
- IUD : The efficacy of IUDs may be reduced and result in a pregnancy.
- During the first and second trimester : In mice and rats there is no evidence of teratogenic or embryotoxicity. In the rabbit slight embryotoxicity likely related to maternal toxicity has been reported. As the safety of Ketoprofen in pregnant women has not been evaluated, the use of Ketoprofen during the first and trimester of pregnancy should be avoided.
- During the third trimester of pregnancy : All prostaglandin synthetase inhibitors including Ketoprofen may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy, prolonged bleeding time in both mother and child, may occur. Therefore, Ketoprofen is contraindicated during the last trimester of pregnancy.
No data are available on excretion of Ketoprofen in human milk. Ketoprofen is not recommended in nursing mothers.
Effects on ability to drive and use machines :
Patients should be warned about the potential for somnolence, dizziness or convulsions, and advised not to drive or operate machinery if these symptoms occur.
ADVERSE REACTIONS :
- Dermatological reactions : Rash, pruritus, urticaria, angioedema.
- Respiratory reactions : Asthmatic attack, bronchospasm (particularly in patients with known hypersensitivity to other NSAIDs and Acetosal).
- Anaphylactic reactions (including shock).
- Skin reactions : Photosensitivity, alopecia, exceptionally bullous eruptions including Stevens-Johnson and Lyell syndrome.
- Peripheral and Central Nervous System : Dizziness, paresthesia, convulsions.
- Psychiatric disorders : Somnolence, mood disorders.
- Vision disorders : Visual disturbances such as blurred vision.
- Hearing disorders : Tinnitus.
- Renal system : Abnormal renal function tests, acute renal failure, interstitial nephritis, nephritic syndrome.
- Liver system : Elevations of transaminase levels, rare cases hepatitis.
- Haematology : Thrombocytopenia, anemia usually due to chronic bleeding, agranulocytosis, bone marrow aplasia.
- Cardiovascular system : Hypertension, vasodilation.
- Body as a whole : Headache, oedema, weight gain, taste perversion.
Ketoprofen Enteric coated tablet 100 mg Box, 10 blisters @ 10 enteric coated tablets
Reg. No. GKL0402336115B1
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
Sidoarjo – Indonesia