Ketofenax

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

CONTENTS:

Each ampoule of 2mL contains 50mg dexketoprofen (as dexketoprofen trometamol).
Each mL of the solution contains 25mg dexketoprofen (as dexketoprofen trometamol).
Each mL of the solution contains 100mg ethanol (96%) and 0.08 mmol sodium.

INDICATIONS:

Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain.

PHP 2250 / box of 5 vials

DOSAGE:

The recommended dose is 50 mg every 8-12 hours. If necessary, the administration can be repeated 6 hours apart. The total daily dose should not exceed 150 mg.

Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion is intended for short term use and the treatment must be limited to the acute symptomatic period (no more than 2 days). Patients should be switched to an oral analgesic treatment when possible.

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

In case of moderate to severe postoperative pain, Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion can be used in combination with opioid analgesics, if indicated, at the same recommended doses in adults.

Hepatic dysfunction

The dosage should be reduced to 50mg total daily dose in patients with mild to moderate (Child-Pugh score 5-9) hepatic impairment and hepatic function should be closely monitored. Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion should not be used in patients with severe hepatic dysfunction (Child-Pugh score 10-15).

Renal dysfunction

The dosage should be reduced to 50mg total daily dose in patients with mildly impaired renal function (creatinine clearance 50-80ml /min). Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion should not be used in patients with moderate to severe renal dysfunction (creatinine clearance <50ml/min).

Elderly

No dosage adjustment is generally necessary in elderly patients. However, because of the physiological decline in renal function in elderly patients a lower dose is recommended in case of mild renal function impairment: 50 mg / min).

Pediatric population

The safety and efficacy of Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion have not been established and therefore should not be used in children and adolescents.

CONTRAINDICATIONS:

Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion must not be administered in the following cases:

Hypersensitivity to the active substance or to any of the excipients
Patients in whom substances with a similar action (e.g. acetylsalicylic acid and other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema.
Patients with active or suspended peptic ulcer/hemorrhage or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding) or chronic dyspepsia.
Patients who have gastrointestinal bleeding or other active bleeding disorders
Patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs 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 hemorrhage diathesis and other coagulation disorders
During the third trimester of pregnancy and lactation period
For neuraxial (intrathecal or epidural) administration due to its ethanol content