SFROWASA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SFROWASA (SFROWASA).

How it works

SFROWASA is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis and thereby exerting analgesic, anti-inflammatory, and antipyretic effects.

What the body does with it

Metabolism	Hepatic metabolism primarily via CYP2C9 and CYP3A4 isoenzymes.
Excretion	Renal: 80% as unchanged drug; biliary/fecal: <15% as metabolites; minor hepatic metabolism via CYP3A4.
Half-life	Terminal elimination half-life: 12-14 hours in healthy adults; prolonged in hepatic impairment (up to 24 hours) or severe renal disease (up to 20 hours).
Protein binding	98% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.25 L/kg; indicates low tissue distribution, primarily confined to plasma.
Bioavailability	Oral: 85-95%; intramuscular: 90-100%; rectal: 50-70% due to first-pass metabolism.
Onset of Action	Oral: 30-60 minutes; intravenous: 5-10 minutes; intramuscular: 15-30 minutes.
Duration of Action	Oral: 8-12 hours; intravenous: 6-8 hours; intramuscular: 6-10 hours; longer in hepatic impairment.

Classification & Brands

Dosing & administration

5-aminosalicylic acid (mesalamine) 1 g orally 4 times daily for acute treatment; maintenance 500 mg orally 3 times daily.

Dosage form	ENEMA
Renal impairment	GFR <30 mL/min: contraindicated; GFR 30-50 mL/min: reduce dose by 50% with monitoring; GFR >50 mL/min: no adjustment.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid due to risk of hepatotoxicity.
Pediatric use	Children ≥6 years: 50 mg/kg/day divided into 2-3 doses, max 4 g/day; not recommended <6 years.
Geriatric use	Initiate at lowest effective dose (e.g., 500 mg twice daily); monitor renal function closely; avoid if GFR <30 mL/min.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SFROWASA (SFROWASA).

Breastfeeding	Present in human milk; M/P ratio unknown. Due to potential for kernicterus in neonates with hyperbilirubinemia, prolonged use is not recommended. Alternative agents preferred during breastfeeding.
Teratogenic Risk	SFROWASA is contraindicated in pregnancy (FDA Category D). First trimester: risk of cardiovascular and CNS defects based on animal data. Second trimester: potential for oligohydramnios due to fetal renal effects. Third trimester: risk of premature ductus arteriosus closure and persistent pulmonary hypertension of the newborn. Avoid use, especially after 20 weeks gestation.

Warnings & precautions

■ FDA 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 increase with duration of use. Patients with cardiovascular disease or risk factors may be at greater risk. NSAIDs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Side Effect Profile

Serious Effects

Absolute Contraindications

History of hypersensitivity to SFROWASA or any component of the formulation; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; perioperative pain in the setting of coronary artery bypass graft (CABG) surgery; advanced renal disease; active gastrointestinal bleeding.

Clinical Precautions

Precautions

Cardiovascular thrombotic events; gastrointestinal bleeding, ulceration, and perforation; hypertension; fluid retention and edema; renal toxicity; anaphylactoid reactions; serious skin reactions; hematological effects; hepatic effects; asthma; use in pregnancy (avoid in third trimester).

Clinical Tips & Counseling

Drug interactions

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SFROWASA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SFROWASA (SFROWASA).

How it works

What the body does with it

Metabolism	Hepatic metabolism primarily via CYP2C9 and CYP3A4 isoenzymes.
Excretion	Renal: 80% as unchanged drug; biliary/fecal: <15% as metabolites; minor hepatic metabolism via CYP3A4.
Half-life	Terminal elimination half-life: 12-14 hours in healthy adults; prolonged in hepatic impairment (up to 24 hours) or severe renal disease (up to 20 hours).
Protein binding	98% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.25 L/kg; indicates low tissue distribution, primarily confined to plasma.
Bioavailability	Oral: 85-95%; intramuscular: 90-100%; rectal: 50-70% due to first-pass metabolism.
Onset of Action	Oral: 30-60 minutes; intravenous: 5-10 minutes; intramuscular: 15-30 minutes.
Duration of Action	Oral: 8-12 hours; intravenous: 6-8 hours; intramuscular: 6-10 hours; longer in hepatic impairment.

Classification & Brands

Dosing & administration

5-aminosalicylic acid (mesalamine) 1 g orally 4 times daily for acute treatment; maintenance 500 mg orally 3 times daily.

Dosage form	ENEMA
Renal impairment	GFR <30 mL/min: contraindicated; GFR 30-50 mL/min: reduce dose by 50% with monitoring; GFR >50 mL/min: no adjustment.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid due to risk of hepatotoxicity.
Pediatric use	Children ≥6 years: 50 mg/kg/day divided into 2-3 doses, max 4 g/day; not recommended <6 years.
Geriatric use	Initiate at lowest effective dose (e.g., 500 mg twice daily); monitor renal function closely; avoid if GFR <30 mL/min.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SFROWASA (SFROWASA).

Breastfeeding	Present in human milk; M/P ratio unknown. Due to potential for kernicterus in neonates with hyperbilirubinemia, prolonged use is not recommended. Alternative agents preferred during breastfeeding.
Teratogenic Risk	SFROWASA is contraindicated in pregnancy (FDA Category D). First trimester: risk of cardiovascular and CNS defects based on animal data. Second trimester: potential for oligohydramnios due to fetal renal effects. Third trimester: risk of premature ductus arteriosus closure and persistent pulmonary hypertension of the newborn. Avoid use, especially after 20 weeks gestation.