RUFEN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for RUFEN (RUFEN).

How it works

Non-selective cyclooxygenase (COX-1 and COX-2) inhibitor, decreasing prostaglandin synthesis.

What the body does with it

Metabolism	Hepatic metabolism primarily via CYP2C9; also undergoes glucuronidation.
Excretion	Primarily renal (approximately 90% as glucuronide conjugates and unchanged drug), with minor biliary/fecal elimination (<10%).
Half-life	Terminal elimination half-life is 2-4 hours; clinical context: short half-life requires frequent dosing for sustained analgesia.
Protein binding	>99% bound, primarily to albumin.
Volume of Distribution	0.1-0.2 L/kg; low Vd indicates limited extravascular distribution, consistent with high protein binding.
Bioavailability	Oral: ~80% (fasting); rectal: ~70%; topical: ~5-10% (systemic absorption minimal).
Onset of Action	Oral: 30 minutes; rectal: 60 minutes; topical: 2-4 hours.
Duration of Action	Oral/rectal: 4-6 hours; topical: 4-8 hours; note: analgesic effect often outlasts plasma levels.

Classification & Brands

Dosing & administration

400-800 mg orally three to four times daily; maximum 3200 mg/day.

Dosage form	TABLET
Renal impairment	GFR 30-60 mL/min: reduce dose by 50%; GFR <30 mL/min: avoid use.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use.
Pediatric use	5-10 mg/kg/dose every 6-8 hours; maximum 40 mg/kg/day.
Geriatric use	Initiate at lowest effective dose (e.g., 400 mg daily), increase cautiously; monitor renal function.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for RUFEN (RUFEN).

Breastfeeding	RUFEN (ibuprofen) is excreted into breast milk in very low concentrations (M/P ratio approximately 0.01). Considered compatible with breastfeeding; minimal risk to infant at recommended maternal doses.
Teratogenic Risk	First trimester: NSAIDs (including RUFEN) are associated with an increased risk of miscarriage and cardiac defects. Second trimester: Generally considered safer, but avoid prolonged use. Third trimester: Contraindicated due to risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment.

Warnings & precautions

■ FDA Black Box Warning

Non-steroidal 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 increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. RUFEN is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs","Perioperative pain in CABG surgery","Advanced renal disease","Active gastrointestinal bleeding or peptic ulcer disease"]

Clinical Precautions

Precautions

["Cardiovascular thrombotic events","Gastrointestinal bleeding, ulceration, and perforation","Hypertension","Heart failure","Renal toxicity","Anaphylactoid reactions","Serious skin reactions (e.g., Stevens-Johnson syndrome)"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

RUFEN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for RUFEN (RUFEN).

How it works

Non-selective cyclooxygenase (COX-1 and COX-2) inhibitor, decreasing prostaglandin synthesis.

What the body does with it

Metabolism	Hepatic metabolism primarily via CYP2C9; also undergoes glucuronidation.
Excretion	Primarily renal (approximately 90% as glucuronide conjugates and unchanged drug), with minor biliary/fecal elimination (<10%).
Half-life	Terminal elimination half-life is 2-4 hours; clinical context: short half-life requires frequent dosing for sustained analgesia.
Protein binding	>99% bound, primarily to albumin.
Volume of Distribution	0.1-0.2 L/kg; low Vd indicates limited extravascular distribution, consistent with high protein binding.
Bioavailability	Oral: ~80% (fasting); rectal: ~70%; topical: ~5-10% (systemic absorption minimal).
Onset of Action	Oral: 30 minutes; rectal: 60 minutes; topical: 2-4 hours.
Duration of Action	Oral/rectal: 4-6 hours; topical: 4-8 hours; note: analgesic effect often outlasts plasma levels.

Classification & Brands

Dosing & administration

400-800 mg orally three to four times daily; maximum 3200 mg/day.

Dosage form	TABLET
Renal impairment	GFR 30-60 mL/min: reduce dose by 50%; GFR <30 mL/min: avoid use.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use.
Pediatric use	5-10 mg/kg/dose every 6-8 hours; maximum 40 mg/kg/day.
Geriatric use	Initiate at lowest effective dose (e.g., 400 mg daily), increase cautiously; monitor renal function.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for RUFEN (RUFEN).

Breastfeeding	RUFEN (ibuprofen) is excreted into breast milk in very low concentrations (M/P ratio approximately 0.01). Considered compatible with breastfeeding; minimal risk to infant at recommended maternal doses.
Teratogenic Risk	First trimester: NSAIDs (including RUFEN) are associated with an increased risk of miscarriage and cardiac defects. Second trimester: Generally considered safer, but avoid prolonged use. Third trimester: Contraindicated due to risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment.