NUPRIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NUPRIN (NUPRIN).

How it works

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (Cox-1 and Cox-2) activity, reducing prostaglandin synthesis. This results in anti-inflammatory, analgesic, and antipyretic effects.

What the body does with it

Metabolism	Metabolized primarily in the liver via cytochrome P450 enzymes, mainly CYP2C9. Undergoes oxidation to hydroxylated and carboxylated metabolites, then conjugated with glucuronic acid.
Excretion	Renal elimination of conjugates and metabolites (90%) and biliary/fecal (10%). Unchanged drug excretion is negligible (<1%).
Half-life	Approximately 2 hours (range 1.5-3 hours) for the terminal elimination half-life in adults. Longer half-life in elderly and patients with renal impairment.
Protein binding	Highly protein-bound (>99%) primarily to albumin.
Volume of Distribution	0.1-0.2 L/kg, indicating limited distribution outside plasma due to high protein binding.
Bioavailability	Oral: 80-90% (presystemic metabolism minimal). Rectal: approximately 75%. Topical: minimal systemic absorption (<5%).
Onset of Action	Oral: 30-60 minutes for analgesic effect; peak effect at 1-2 hours. Rectal: similar to oral. Topical: local effect within 1-2 hours.
Duration of Action	4-6 hours for analgesic effect after single oral dose. Duration may be shorter with repeated dosing due to tolerance.

Classification & Brands

Action Class	NSAID's- Non-Selective COX 1&2 Inhibitors (propionic acid)
Brand Substitutes	Ibusoft 300mg Tablet, Sibet 300mg Tablet

Dosing & administration

200-400 mg orally every 4-6 hours as needed; maximum 1200 mg/day (OTC) or 3200 mg/day (prescription).

Dosage form	TABLET
Renal impairment	GFR 30-59 mL/min: use lowest effective dose, max 400 mg/day; GFR <30 mL/min: avoid use.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%, max 400 mg/day; Child-Pugh C: avoid use.
Pediatric use	6 months to 12 years: 5-10 mg/kg/dose orally every 6-8 hours; max 40 mg/kg/day. For fever or pain.
Geriatric use	Initiate at lowest effective dose (e.g., 200 mg every 6-8 hours), monitor renal function and GI bleeding risk; avoid long-term use.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for NUPRIN (NUPRIN).

Breastfeeding	Excreted in breast milk in low amounts (M/P ratio ~0.5-1.0). Generally considered compatible with breastfeeding; however, avoid in late pregnancy or high doses due to potential adverse effects in the infant.
Teratogenic Risk	First trimester: Avoid due to risk of cardiac defects and gastroschisis. Second trimester: Use with caution; risk of oligohydramnios and fetal renal dysfunction. Third trimester: Contraindicated due to risk of premature ductus arteriosus closure, pulmonary hypertension, and oligohydramnios.

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. The risk may be greater in patients with cardiovascular disease or risk factors. NSAIDs are contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to ibuprofen or any NSAID, history of asthma, urticaria, or allergic-type reaction after taking aspirin or other NSAIDs, perioperative pain in CABG surgery, active peptic ulcer disease or gastrointestinal bleeding, severe renal failure, third trimester of pregnancy.

Clinical Precautions

Precautions

Cardiovascular risk (thrombotic events, hypertension), gastrointestinal risk (bleeding, ulceration, perforation), renal impairment, fluid retention, hypersensitivity reactions (including anaphylaxis), severe skin reactions (e.g., Stevens-Johnson syndrome). Use with caution in patients with asthma, hepatic impairment, or bleeding disorders.

Clinical Tips & Counseling

Drug interactions

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NUPRIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NUPRIN (NUPRIN).

How it works

What the body does with it

Metabolism	Metabolized primarily in the liver via cytochrome P450 enzymes, mainly CYP2C9. Undergoes oxidation to hydroxylated and carboxylated metabolites, then conjugated with glucuronic acid.
Excretion	Renal elimination of conjugates and metabolites (90%) and biliary/fecal (10%). Unchanged drug excretion is negligible (<1%).
Half-life	Approximately 2 hours (range 1.5-3 hours) for the terminal elimination half-life in adults. Longer half-life in elderly and patients with renal impairment.
Protein binding	Highly protein-bound (>99%) primarily to albumin.
Volume of Distribution	0.1-0.2 L/kg, indicating limited distribution outside plasma due to high protein binding.
Bioavailability	Oral: 80-90% (presystemic metabolism minimal). Rectal: approximately 75%. Topical: minimal systemic absorption (<5%).
Onset of Action	Oral: 30-60 minutes for analgesic effect; peak effect at 1-2 hours. Rectal: similar to oral. Topical: local effect within 1-2 hours.
Duration of Action	4-6 hours for analgesic effect after single oral dose. Duration may be shorter with repeated dosing due to tolerance.

Classification & Brands

Action Class	NSAID's- Non-Selective COX 1&2 Inhibitors (propionic acid)
Brand Substitutes	Ibusoft 300mg Tablet, Sibet 300mg Tablet

Dosing & administration

200-400 mg orally every 4-6 hours as needed; maximum 1200 mg/day (OTC) or 3200 mg/day (prescription).

Dosage form	TABLET
Renal impairment	GFR 30-59 mL/min: use lowest effective dose, max 400 mg/day; GFR <30 mL/min: avoid use.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%, max 400 mg/day; Child-Pugh C: avoid use.
Pediatric use	6 months to 12 years: 5-10 mg/kg/dose orally every 6-8 hours; max 40 mg/kg/day. For fever or pain.
Geriatric use	Initiate at lowest effective dose (e.g., 200 mg every 6-8 hours), monitor renal function and GI bleeding risk; avoid long-term use.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for NUPRIN (NUPRIN).

Breastfeeding	Excreted in breast milk in low amounts (M/P ratio ~0.5-1.0). Generally considered compatible with breastfeeding; however, avoid in late pregnancy or high doses due to potential adverse effects in the infant.
Teratogenic Risk	First trimester: Avoid due to risk of cardiac defects and gastroschisis. Second trimester: Use with caution; risk of oligohydramnios and fetal renal dysfunction. Third trimester: Contraindicated due to risk of premature ductus arteriosus closure, pulmonary hypertension, and oligohydramnios.