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(PRESCRIPTION REQUIRED)

INDICATIONS:

Indicated for the symptomatic treatment of acute pain of moderate to severe intensity when oral administration is not appropriate, such as:

  • Postoperative pain

  • Renal colic

  • Low back pain

Dexketoprofen Trometamol

Ketofenax

Non-Steroidal Anti-Inflammatory / Antirheumatic Product (Propionic Acid Derivative)

CONTENTS:

Each 2 mL ampoule contains:

  • 50 mg dexketoprofen (as dexketoprofen trometamol).

Each mL of solution contains:

  • 25 mg dexketoprofen (as dexketoprofen trometamol).​

  • 100 mg ethanol (96%) and 0.08 mmol sodium.

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PHP 2250 / box of 5 vials

DOSAGE:

The recommended dose is 50 mg every 8–12 hours. If necessary, administration may be repeated at 6-hour intervals.
The total daily dose should not exceed 150 mg.

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Ketofenax (Dexketoprofen as Trometamol) 50 mg/2 mL solution for injection or concentrate for solution for infusion is intended for short-term use only and should be limited to the acute symptomatic period (no more than 2 days). Patients should switch to oral analgesic treatment as soon as possible.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

 

Postoperative pain:
For moderate to severe postoperative pain, Ketofenax (Dexketoprofen as Trometamol) 50 mg/2 mL solution for injection or concentrate for solution for infusion can be used in combination with opioid analgesics, if indicated, at the same recommended doses for adults.
 

SPECIAL POPULATIONS:

Hepatic Dysfunction:
• Reduce the dose to a total daily dose of 50 mg in patients with mild tomoderate hepatic impairment (Child-Pugh score 5–9).
• Should not be used in patients with severe hepatic dysfunction (Child-Pugh score 10–15).
• Hepatic function should be closely monitored.

Renal Dysfunction:
• Reduce the dose to a total daily dose of 50 mg in patients with mildly impaired renal function (creatinine clearance 50–80 mL/min).
• Should not be used in patients with moderate to severe renal dysfunction (creatinine clearance <50 mL/min).

Elderly:
• No dosage adjustment is generally necessary.
• However, due to the physiological decline in renal function in elderly patients, a lower dose is recommended in cases of mild renal impairment (50 mg/min).

Pediatric Population:
• The safety and efficacy of Ketofenax (Dexketoprofen as Trometamol) 50 mg/2 mL solution for injection or concentrate for solution for infusion have not been established in children and adolescents. Therefore, it should not be used in these populations.

CONTRAINDICATIONS:

Ketofenax (Dexketoprofen as Trometamol) 50 mg/2 mL solution for injection or concentrate for solution for infusion must not be administered in the following cases:

• Hypersensitivity to the active substance or any excipients.
• Patients with a history of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria, or angioneurotic edema triggered by NSAIDs (e.g., acetylsalicylic acid).
• Patients with active or suspected peptic ulcer/hemorrhage, or a history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• Patients with chronic dyspepsia.
• Patients with gastrointestinal bleeding or other active bleeding disorders.
• Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy.
• Patients with Crohn’s disease or ulcerative colitis.
• Patients with severe heart failure.
• Patients with moderate to severe renal dysfunction (creatinine clearance <50 mL/min).
• Patients with severely impaired hepatic function (Child-Pugh score 10–15).
• Patients with hemorrhagic diathesis and other coagulation disorders.
• During the third trimester of pregnancy and the lactation period.
• For neuraxial (intrathecal or epidural) administration due to its ethanol content.

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