Overview
Dexketoprofen trometamol is a nonsteroidal anti-inflammatory drug (NSAID) and the water-soluble tromethamine salt of the active enantiomer (S-isomer) of ketoprofen. It provides rapid onset of analgesic and anti-inflammatory effects, typically within 30 minutes, and is used for short-term treatment of acute pain. It works by inhibiting cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis.
Mechanism of Action
Dexketoprofen trometamol is a nonselective inhibitor of cyclooxygenase (COX-1 and COX-2) enzymes, which are involved in the synthesis of prostaglandins from arachidonic acid. By inhibiting prostaglandin production, it reduces inflammation, pain, and fever. The trometamol salt enhances water solubility for faster absorption.
Indications
- Short-term treatment of acute mild to moderate pain
- Dysmenorrhea (menstrual pain)
- Postoperative pain
Dosage
Adults: Typically 12.5 mg to 25 mg every 4-8 hours as needed for pain, with a maximum daily dose of 75 mg. Should be taken with food or milk to minimize gastrointestinal irritation. Treatment duration should be as short as possible, generally not exceeding 7 days.
Black Box Warning
NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. NSAIDs are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a history of peptic ulcer disease and/or gastrointestinal bleeding are at greater risk for serious gastrointestinal events.
Contraindications
- Hypersensitivity to dexketoprofen, ketoprofen, other NSAIDs, or any component of the formulation
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Active peptic ulcer disease or gastrointestinal bleeding
- Severe heart failure
- Severe hepatic impairment
- Severe renal impairment
- Third trimester of pregnancy
- Concomitant use with other NSAIDs including COX-2 selective inhibitors
Side Effects
- Common: Nausea, dyspepsia, abdominal pain, diarrhea, headache, dizziness
- Less common: Vomiting, constipation, flatulence, gastritis, edema, hypertension, rash, pruritus
- Serious: Gastrointestinal bleeding/perforation, myocardial infarction, stroke, heart failure, renal impairment/failure, hepatic impairment/failure, anaphylaxis, severe skin reactions, bronchospasm
Interactions
- Anticoagulants (warfarin, heparin): Increased risk of bleeding
- Antiplatelet agents (aspirin, clopidogrel): Increased risk of bleeding
- Other NSAIDs: Increased risk of gastrointestinal and renal adverse effects
- ACE inhibitors/ARBs: Reduced antihypertensive effect and increased risk of renal impairment
- Diuretics: Reduced diuretic effect and increased risk of renal impairment
- Lithium: Increased lithium levels and toxicity risk
- Methotrexate: Increased methotrexate toxicity
- Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding
- Corticosteroids: Increased risk of gastrointestinal adverse effects