COMPOSITION :
Dexfen® Film coated tablet 25 mg, each film coated tablet contains : Dexketoprofen trometamol equivalent with Dexketoprofen 25 mg.
DESCRIPTIONS :
Dexfen® contains Dexketoprofen trometamol (equivalent with Dexketoprofen) available in film coated tablet 25 mg.
INDICATIONS :
Treatment of symptoms with mild to moderate pain intensity, acute musculoskeletal pain, dysmenoria, toothache and pain after surgery.
DOSAGE AND ADMINISTRATIONS :
The speed of drug absorption is slowed by the presence of food, it is recommended that the drug is given 30 minutes before a meal, especially in the case of acute pain.
Usual dosage :
Depending on the condition and severity of pain.
In general the recommended dosage : 12.5 mg every 4 – 6 hours or 25 mg every 8 hours.
Pain after surgery, the recommended dosage : 25 mg every 8 hours.
The total daily dose should not exceed 75 mg.
Dexketoprofen trometamol is not used for a long time and therapy must be restricted to symptomatic period.
Elderly :
The recommended initial dose : The lowest dose of the dosage range (50 mg total daily dose).
The dosage can be increased according to the recommended dosage for general doses, only after it is confirmed that the drug is well tolerated by the patient.
Hepatic disorders :
Patients with mild to moderate hepatic disorders, treatment should start with small doses (total daily dose of 50 mg) and be closely monitored. Dexketoprofen trometamol should not be used in patients with severe hepatic disorders.
Renal disorders :
The initial dose should be reduced to a total daily dose of 50 mg in patients with mild renal disorders (creatinine clearance of 50 – 80 ml/minute). Dexketoprofen trometamol should not be used in patients with moderate to severe renal disorders.
Children :
Dexketoprofen trometamol is not permitted for use in children because there are no data regarding its efficacy and safety in children.
CONTRAINDICATIONS :
- Patients with a history of hypersensitivity to Dexketoprofen trometamol, other NSAIDs or additional ingredients in the preparation.
- Patients who have an asthma attack, urticaria or sensitivity reactions triggered by Acetosal or other NSAIDs.
- Patients with peptic ulcer/active stomach bleeding or new allegations or patients with a history of peptic ulcer/recurrent gastric bleeding.
- Patients with bleeding disorders.
- Pregnant and lactating women.
- Patients with moderate to severe renal disorders, severe hepatic disorders and severe heart failure.
- Dexketoprofen trometamol is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery (see WARNINGS AND PRECAUTIONS).
WARNINGS AND PRECAUTIONS :
CARDIOVASCULAR EFFECTS
Cardiovascular Thrombotic Events
Clinical trials with variety of COX-2 selective and nonselective NSAIDs of up to three years have shown an increase risk of serious cardiovascular (CV) thrombotic adverse events, myocardial infarction and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, can cause the similar risk. Patients with known CV disease or risk factor for CV disease may be at greater risk. To minimize the risk for CV adverse event in patients treated with NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should be alert for the adverse events, even in the absence of previous CV symptoms. Patients should be informed about the sign and/or symptoms of serious CV adverse events and the steps to take if they occur.
There is no evidence that concurrent use of Acetosal the increased risk of serious CV thrombotic events associated with NSAID use. The use of Acetosal and NSAID does increase the risk of serious GI adverse events (see WARNINGS, Gastrointestinal (GI) Effect – Risk of Ulceration, Bleeding and Perforation).
Two large and controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain the first 10 – 14 days following CABG surgery showed an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
Hypertension
NSAIDs, including Dexketoprofen trometamol can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV adverse events. Patients taking Thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Dexketoprofen trometamol, should be used caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment.
Congestive Heart Failure and Edema
Fluid retention and edema have been observed in some patients taking NSAIDs. Dexketoprofen trometamol should be used caution in patients with fluid retention or hearts failure.
GASTROINTESTINAL (GI) EFFECTS
Risk of Ulceration, Bleeding and Perforation
NSAIDs, including Dexketoprofen trometamol, can cause serious gastrointestinal adverse 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, only one in five patients, who have serious upper GI adverse events develop symptoms. Upper GI ulcers, 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. Prolonged use is likely to increase the incidence of serious GI adverse events. However, short-term therapy is not without risk.
NSAIDs should prescribed with extreme caution in patients who have a history of ulcer disease or gastrointestinal bleeding. Patients with a history of peptic ulcer and/or gastrointestinal bleeding using 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 of GI bleeding are concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAIDs therapy, smoking, use of alcohol, elderly patient and poor health status. Most spontaneous reports of fatal GI adverse events are in the elderly or debilitated patients. Therefore, special care should be taken in treating this population.
To reduce the risk of GI adverse events, in patients treated with NSAIDs, the lowest effective dose should be given in the shortest possible duration of treatment. Physicians and patients should be alert for signs and symptoms of ulceration and GI bleeding during therapy with NSAIDs and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. For high-risk patients, alternative therapies that do not involve NSAIDs should be considered.
- This drug must be used caution in patients with a history of allergic conditions, oesophagitis, gastritis.
- This drug must be used caution in patients who can be adversely affected by prolongation of bleeding time (for example in patients receiving anticoagulant therapy), because the drug can inhibit platelet function.
- As with other NSAIDs, urea nitrogen and plasma creatinine can increase. Some NSAIDs are associated with nephrotoxicity such as glomerulonephritis, interstitial nephritis and nephrotic syndrome. Prolonged NSAID administration can result in renal papillary necrosis and other renal injury.
- Increased serum concentration of SGPT and SGOT occur in patients receiving NSAIDs. Therapy must be stopped if signs or symptoms of a severe hepatic reaction appear.
- This drug must be used with caution in patients with hematopoietic disorders, systemic lupus erythematosus or mixed type connective tissue disease. The use of NSAIDs can mask the signs and symptoms of infection or other diseases.
- This drug is not recommended in patients with advanced renal disorders. If the drug is used in patients with severe renal disorders, it is recommended to closely monitor renal function.
- The safety of this drug in children is unknown.
- NSAIDs must be used with caution in elderly patients and dose reduction may be needed. Elderly patients are more prone to ulcers or gastrointestinal bleeding than other individuals. The use of NSAIDs in elderly patients is associated with an increased risk of developing heart failure.
DRUG INTERACTIONS :
- Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB) : Coadministration of NSAIDs with ACE inhibitors or ARB can reduce blood pressure response to antihypertensive drugs.
- Anticoagulants and thrombolytics : Coadministration of these drugs with anticoagulant or thrombolytic associated with increased risk of gastrointestinal bleeding compared to selfuse.
- Cardiac glycosides : Coadministration of these drugs with cardiac glycosides can increase the plasma concentration of cardiac glycosides.
- Diuretics : Patients who receive diuretics may have an increased risk of renal failure after a decrease in renal blood flow due to inhibition of prostaglandins by NSAIDs. There may be an increased risk of hyperkalemia with ACE inhibitors and some diuretics, including potassium sparing diuretics.
- Nonsteroidal anti-inflammatory : Coadministration of Acetosal with NSAIDs increase the serious effect of the gastrointestinal.
- Probenecid : Probenecid delays the excretion of this drug and decreases binding with proteins which results in increase the concentration of this drug in plasma.
- Methotrexate : Severe toxicity, sometimes fatal, occurs after the administration of NSAIDs that are used together with Methotrexate (especially in highdose therapy) in patients with various malignant neoplasms or rheumatoid arthritis. Toxicity associated with increased concentration and prolongation of Methotrexate in the blood.
- Lithium : NSAIDs have been reported to increase the concentration of Lithium in serum. NSAIDs can decrease the clearance of Lithium in the renal.
- Quinolones : Convulsions can occur due to interactions with quinolones.
- Zidovudine : There is an increased risk of hematotoxicity if Zidovudine is used together with NSAIDs.
- Mifepristone : NSAIDs can affect the efficacy of Mifepristone.
- Cyclosporin and tacrolimus : The risk of nephrotoxicity can increase if this drug is used together with Cyclosporin or tacrolimus.
- Phenytoin and sulfonylurea class of antidiabetic drugs : NSAIDs can increase the effects of sulfonylurea class of antidiabetic drugs.
ADVERSE REACTIONS :
- Effect on the cardiovascular : Peripheral edema, palpitations, hypertension, tachycardia, edema of the face, angioedema, hypotension, hot flushes.
- Effects on the gastrointestinal tract : Dyspepsia, gastrointestinal bleeding or perforation, peptic ulcer, nausea, diarrhea, abdominal pain, constipation, bloating, vomiting, anorexia, dry mouth, pancreatitis, gastritis.
- Effects on the nervous system : Headache, insomnia, anxiety, dizziness, malaise, drowsiness, fatigue, paresthesias, asthenia, vertigo.
- Effects on the renal, urinary tract and genitalia : Edema, increased blood urea nitrogen concentration and serum creatinine, menometrorrhagia, interstitial nephritis, nephrotic syndrome.
- Effects on the hepatic : Hepatic function disorders, increased serum concentration of SGPT or SGOT.
- Hematological effects : Anemia, purpura, agranulocytosis, thrombocytopenia, neutropenia.
- Dermatological effects : Rash, pruritus, urticaria, photosensitivity reactions, sweating, toxic epidermal necrolysis, Stevens-Johnson syndrome.
- Other side effects : Dyspnea, bronchospasm, pain, anaphylaxis, visual disturbances, tinnitus, aseptic meningitis.
PRESENTATION :
Dexfen® Film coated tablet 25 mg Box, 3 strips @ 10 film coated tablets
Reg. No. DKL2002363117A1
STORAGE :
STORE BELOW 30ºC, protect from light
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
