ORUDIS KT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ORUDIS KT (ORUDIS KT).

How it works

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.

What the body does with it

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).

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for ORUDIS KT (ORUDIS KT).

Breastfeeding	Minimal excretion in breast milk; M/P ratio not well established. Use caution, especially in nursing infants with known NSAID sensitivity. Consider lowest effective dose.
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

Warnings & precautions

■ 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.

Side Effect Profile

Serious Effects

Absolute Contraindications

History of allergic-type reactions to aspirin or other NSAIDs, setting of coronary artery bypass graft (CABG) surgery, active peptic ulcer disease or gastrointestinal bleeding, advanced renal impairment, and in patients with severe uncontrolled heart failure.

Clinical Precautions

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).

Clinical Tips & Counseling

Drug interactions

Loading safety data…

ORUDIS KT

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ORUDIS KT (ORUDIS KT).

How it works

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.

What the body does with it

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).

Classification & Brands

Dosing & administration

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.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for ORUDIS KT (ORUDIS KT).

Breastfeeding	Minimal excretion in breast milk; M/P ratio not well established. Use caution, especially in nursing infants with known NSAID sensitivity. Consider lowest effective dose.
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