COMPOSITION :
Dexketoprofen Trometamol Film coated tablet 25 mg, each film coated tablet contains : Dexketoprofen trometamol equivalent with Dexketoprofen 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.
OVERDOSAGE :
Drowsiness, vomiting and abdominal pain have been reported in some individuals after experiencing an acute overdose of this drug. In acute overdoses, common measures include rapid gastric emptying by stimulating vomiting or by washing the stomach, followed by supportive or symptomatic therapy.
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
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 :
Dexketoprofen Trometamol Film coated tablet 25 mg Box, 10 strips @ 10 film coated tablets
Reg. No. GKL2002363217A1
STORAGE :
STORE BELOW 30ºC, protect from light
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
