DUEXIS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DUEXIS (DUEXIS).

How it works

DUEXIS is a combination of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, and famotidine, a histamine H2-receptor antagonist that decreases gastric acid secretion. Famotidine mitigates the risk of NSAID-induced gastric ulcers.

What the body does with it

Metabolism	Ibuprofen is primarily metabolized by CYP2C9, with minor contributions from CYP2C8. Famotidine is metabolized via the liver with minimal first-pass effect, but specific CYP enzymes are not significantly involved; elimination is mainly renal.
Excretion	Ibuprofen: ~1% unchanged in urine, 14% as conjugated metabolites, remainder as oxidative metabolites; <1% excreted in feces. Famotidine: 65-70% unchanged in urine, 30-35% metabolized hepatic; <10% fecal.
Half-life	Ibuprofen: 2-4 hours (terminal); requires every 6-8 hour dosing. Famotidine: 2.5-3.5 hours (normal renal function); prolonged to 20 hours or more in severe renal impairment (CrCl < 30 mL/min).
Protein binding	Ibuprofen: >99% bound to albumin. Famotidine: 15-20% bound to plasma proteins.
Volume of Distribution	Ibuprofen: 0.1-0.2 L/kg. Famotidine: 1.0-1.5 L/kg.
Bioavailability	Ibuprofen: 80-100% oral. Famotidine: 40-50% oral.
Onset of Action	Pain relief: 30-60 minutes after oral administration. Antipyretic effect: 1-2 hours.
Duration of Action	Pain relief: 4-6 hours. Antipyretic: 6-8 hours. Acid suppression with famotidine: up to 12 hours.

Classification & Brands

Dosing & administration

One tablet (800 mg ibuprofen/26.6 mg famotidine) orally three times daily.

Dosage form	TABLET
Renal impairment	Contraindicated in patients with CrCl <30 mL/min. For CrCl 30-60 mL/min: maximum dose one tablet twice daily.
Liver impairment	No specific adjustment recommended, but caution in severe hepatic impairment (Child-Pugh C) due to potential hepatotoxicity.
Pediatric use	Safety and efficacy not established in pediatric patients.
Geriatric use	Use lowest effective dose; consider increased risk of gastrointestinal bleeding and renal impairment; 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 DUEXIS (DUEXIS).

Breastfeeding	Ibuprofen transfers minimally into breast milk (M/P ratio ~0.02-0.07); famotidine M/P ratio ~0.31-0.78. Ibuprofen is generally considered compatible with breastfeeding. Use with caution due to potential gastric acid suppression in infant.
Teratogenic Risk	DUEXIS (ibuprofen/famotidine) contains ibuprofen, an NSAID. Avoid during third trimester due to risk of premature closure of ductus arteriosus and oligohydramnios. First and second trimester use associated with increased risk of cardiac defects and gastroschisis; use only if clearly needed.

Warnings & precautions

■ FDA Black Box Warning

NSAIDs increase the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use and in patients with cardiovascular risk factors. DUEXIS is contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs also cause an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to ibuprofen, famotidine, or any component; history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; perioperative pain in CABG surgery; active peptic ulcer disease or gastrointestinal bleeding; severe renal impairment; advanced liver disease.

Clinical Precautions

Precautions

Cardiovascular thrombotic events; gastrointestinal bleeding, ulceration, and perforation; hypertension; congestive heart failure; renal toxicity; anaphylactic reactions; skin reactions (e.g., Stevens-Johnson syndrome); hematologic effects (e.g., thrombocytopenia); interaction with aspirin; masking of fever and inflammation; pregnancy risk (avoid in third trimester); renal papillary necrosis.

Clinical Tips & Counseling

Drug interactions

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DUEXIS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for DUEXIS (DUEXIS).

How it works

What the body does with it

Metabolism	Ibuprofen is primarily metabolized by CYP2C9, with minor contributions from CYP2C8. Famotidine is metabolized via the liver with minimal first-pass effect, but specific CYP enzymes are not significantly involved; elimination is mainly renal.
Excretion	Ibuprofen: ~1% unchanged in urine, 14% as conjugated metabolites, remainder as oxidative metabolites; <1% excreted in feces. Famotidine: 65-70% unchanged in urine, 30-35% metabolized hepatic; <10% fecal.
Half-life	Ibuprofen: 2-4 hours (terminal); requires every 6-8 hour dosing. Famotidine: 2.5-3.5 hours (normal renal function); prolonged to 20 hours or more in severe renal impairment (CrCl < 30 mL/min).
Protein binding	Ibuprofen: >99% bound to albumin. Famotidine: 15-20% bound to plasma proteins.
Volume of Distribution	Ibuprofen: 0.1-0.2 L/kg. Famotidine: 1.0-1.5 L/kg.
Bioavailability	Ibuprofen: 80-100% oral. Famotidine: 40-50% oral.
Onset of Action	Pain relief: 30-60 minutes after oral administration. Antipyretic effect: 1-2 hours.
Duration of Action	Pain relief: 4-6 hours. Antipyretic: 6-8 hours. Acid suppression with famotidine: up to 12 hours.

Classification & Brands

Dosing & administration

One tablet (800 mg ibuprofen/26.6 mg famotidine) orally three times daily.

Dosage form	TABLET
Renal impairment	Contraindicated in patients with CrCl <30 mL/min. For CrCl 30-60 mL/min: maximum dose one tablet twice daily.
Liver impairment	No specific adjustment recommended, but caution in severe hepatic impairment (Child-Pugh C) due to potential hepatotoxicity.
Pediatric use	Safety and efficacy not established in pediatric patients.
Geriatric use	Use lowest effective dose; consider increased risk of gastrointestinal bleeding and renal impairment; 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 DUEXIS (DUEXIS).

Breastfeeding	Ibuprofen transfers minimally into breast milk (M/P ratio ~0.02-0.07); famotidine M/P ratio ~0.31-0.78. Ibuprofen is generally considered compatible with breastfeeding. Use with caution due to potential gastric acid suppression in infant.
Teratogenic Risk	DUEXIS (ibuprofen/famotidine) contains ibuprofen, an NSAID. Avoid during third trimester due to risk of premature closure of ductus arteriosus and oligohydramnios. First and second trimester use associated with increased risk of cardiac defects and gastroschisis; use only if clearly needed.