ORUDIS KT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ORUDIS KT (ORUDIS KT).
Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), thereby reducing prostaglandin synthesis, which mediates inflammation, pain, and fever.
| Metabolism | Hepatic metabolism primarily via glucuronidation; minor pathways include hydroxylation and conjugation. CYP450 involvement is minimal (CYP2C9 and CYP3A4). |
| Excretion | Renal (approximately 60-80% as metabolites, <10% unchanged); biliary/fecal (approximately 20-35%). |
| Half-life | Terminal elimination half-life: 2-4 hours (increased in elderly and renal impairment, up to 12 hours). |
| Protein binding | 99% bound to albumin. |
| Volume of Distribution | 0.15-0.25 L/kg (low, reflecting high protein binding and limited tissue distribution). |
| Bioavailability | Topical: approximately 5-10% (systemic absorption). Oral: 100%. |
| Onset of Action | Topical: 1-2 hours (local analgesic effect). Oral: 0.5-1 hour. |
| Duration of Action | Topical: 4-6 hours (local effect). Oral: 4-6 hours (analgesic/anti-inflammatory effect). |
| Molecular Weight | 254.28 |
50 mg orally three times daily or 75 mg orally twice daily; maximum 300 mg/day.
| Dosage form | TABLET |
| Renal impairment | GFR 30-89 mL/min: no adjustment. GFR <30 mL/min: reduce dose by 50% or avoid use. |
| Liver impairment | Child-Pugh Class A: no adjustment. Class B: reduce dose by 50%. Class C: avoid use. |
| Pediatric use | Not recommended for children under 16 years; dose for adolescents (>=16 years) same as adult. |
| Geriatric use | Initiate at lowest effective dose (50 mg/day) and titrate cautiously; maximum 200 mg/day. |
| 1st trimester | Avoid use due to risk of oligohydramnios and premature ductus arteriosus constriction; limited data suggest potential for miscarriage. |
| 2nd trimester | Avoid use due to risk of oligohydramnios and premature ductus arteriosus constriction; fetal renal impairment reported. |
| 3rd trimester | Contraindicated due to risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal renal dysfunction. |
Clinical note
Comprehensive clinical and safety monograph for ORUDIS KT (ORUDIS KT).
| Placental transfer | Readily crosses placenta; detected in fetal plasma and amniotic fluid. |
| Breastfeeding | Excretion into breast milk is minimal; however, due to potential for adverse effects in neonates (e.g., renal impairment), use with caution and avoid prolonged use. |
■ FDA Black Box Warning
Nonsteroidal anti-inflammatory drugs (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 in the setting of coronary artery bypass graft (CABG) surgery.
| Serious Effects |
History of allergic-type reactions to NSAIDs (e.g., aspirin triad)Active peptic ulcer disease or GI bleedingSevere renal impairment (CrCl <30 mL/min)Advanced hepatic diseaseThird trimester of pregnancyCerebrovascular bleeding or other bleeding disorders
| Precautions | Cardiovascular risk (including MI and stroke), gastrointestinal adverse events (bleeding, ulceration, perforation), renal toxicity, hepatic impairment, anaphylactoid reactions, serious skin reactions (e.g., Stevens-Johnson syndrome), and use in late pregnancy (risk of premature closure of ductus arteriosus). |
| Food/Dietary | No known food interactions with topical ketoprofen. However, patients taking oral NSAIDs should avoid alcohol due to increased risk of GI bleeding. |
Loading safety data…
| Lactation Rating |
| L2 (Possibly Compatible) |
| Teratogenic Risk | Pregnancy Category C (first and second trimesters) and Category D (third trimester). Avoid during third trimester due to risk of premature closure of ductus arteriosus and oligohydramnios. First and second trimester use only if clearly needed. |
| Fetal Monitoring | Monitor for oligohydramnios, ductus arteriosus constriction, and fetal renal function via ultrasound if prolonged use. Also monitor maternal bleeding time, renal function, and blood pressure. |
| Fertility Effects | Reversible inhibition of ovulation via prostaglandin synthesis; may delay conception. Discontinuation returns normal fertility. |
| Clinical Pearls | Orudis KT (ketoprofen) is a topical NSAID for short-term relief of acute musculoskeletal pain. Apply to intact skin only; avoid occlusive dressings. Not for use on open wounds or compromised skin. Limit application to 7 days. |
| Patient Advice | Apply a thin layer to the affected area only, 3-4 times daily. · Do not cover with bandages or plastic wrap unless directed by your doctor. · Wash hands after application unless treating hands. · Avoid contact with eyes, mucous membranes, or irritated skin. · Do not use with other NSAID-containing products (oral or topical). · Discontinue and seek medical attention if rash, persistent pain, or signs of gastrointestinal bleeding occur. |