MOTRIN IB

Clinical safety rating: caution

Comprehensive clinical and safety monograph for MOTRIN IB (MOTRIN IB).

How it works

Reversibly inhibits cyclooxygenase-1 and -2 (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, which decreases inflammation, pain, and fever.

What the body does with it

Metabolism	Primarily hepatic via cytochrome P450 2C9 (CYP2C9) and, to a lesser extent, CYP2C8; undergoes glucuronidation.
Excretion	Renal excretion of conjugated metabolites (primarily glucuronide and sulfate) accounts for approximately 90% of an absorbed dose; less than 1% is excreted unchanged. Biliary/fecal elimination constitutes about 10%.
Half-life	Terminal elimination half-life is approximately 2 hours (range 1.8–2.5 hours) in adults. In patients with hepatic impairment or advanced age, half-life may be prolonged. The short half-life supports dosing every 6–8 hours for analgesia.
Protein binding	Approximately 99% bound to plasma albumin.
Volume of Distribution	Apparent volume of distribution is 0.15 L/kg (range 0.10–0.20 L/kg), consistent with low tissue penetration and high plasma protein binding.
Bioavailability	Oral: ~80% (rapidly and completely absorbed; first-pass metabolism reduces absolute bioavailability to 80% of the dose).
Onset of Action	Oral: 30–60 minutes for analgesic effect; peak plasma levels at 1–2 hours.
Duration of Action	Duration of analgesic effect is 4–6 hours following a single oral dose, corresponding to the dosing interval. Antipyretic effect lasts approximately 6–8 hours.

Classification & Brands

Dosing & administration

200-400 mg orally every 4-6 hours as needed; maximum 1200 mg in 24 hours.

Dosage form	TABLET
Renal impairment	GFR 30-60 mL/min: no adjustment needed; GFR 10-29 mL/min: reduce dose by 25-50%; GFR <10 mL/min: avoid use or reduce dose by 50%.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use.
Pediatric use	6 months to 12 years: 5-10 mg/kg/dose every 6-8 hours; maximum 40 mg/kg/day or single doses not exceeding 400 mg.
Geriatric use	Initiate at the lowest effective dose, typically 200-400 mg every 6-8 hours; maximum 1200 mg/day; monitor renal function and potential for GI bleeding.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for MOTRIN IB (MOTRIN IB).

Breastfeeding	Ibuprofen is excreted into breast milk in low concentrations (M/P ratio approximately 0.01). Amount ingested by infant <1% of maternal weight-adjusted dose. Considered compatible with breastfeeding, but monitor infant for gastrointestinal effects and renal function.
Teratogenic Risk	First trimester: Increased risk of miscarriage and cardiac defects (odds ratio 1.86 for cardiovascular malformations). Second trimester: Risk of oligohydramnios and fetal renal dysfunction. Third trimester: Known risk of premature closure of ductus arteriosus, persistent pulmonary hypertension, oligohydramnios, and necrotizing enterocolitis. Use contraindicated after 30 weeks gestation.

Warnings & precautions

■ FDA Black Box Warning

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk. Additionally, NSAIDs cause an increased risk of serious cardiovascular thrombotic events, 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.

Side Effect Profile

Serious Effects

Absolute Contraindications

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

Clinical Precautions

Precautions

Cardiovascular thrombotic events; gastrointestinal bleeding, ulceration, and perforation; hypertension; heart failure; renal toxicity; anaphylactoid reactions; serious skin reactions such as Stevens-Johnson syndrome; avoid use in late pregnancy

Clinical Tips & Counseling

Drug interactions

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MOTRIN IB

Clinical safety rating: caution

Comprehensive clinical and safety monograph for MOTRIN IB (MOTRIN IB).

How it works

Reversibly inhibits cyclooxygenase-1 and -2 (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, which decreases inflammation, pain, and fever.

What the body does with it

Metabolism	Primarily hepatic via cytochrome P450 2C9 (CYP2C9) and, to a lesser extent, CYP2C8; undergoes glucuronidation.
Excretion	Renal excretion of conjugated metabolites (primarily glucuronide and sulfate) accounts for approximately 90% of an absorbed dose; less than 1% is excreted unchanged. Biliary/fecal elimination constitutes about 10%.
Half-life	Terminal elimination half-life is approximately 2 hours (range 1.8–2.5 hours) in adults. In patients with hepatic impairment or advanced age, half-life may be prolonged. The short half-life supports dosing every 6–8 hours for analgesia.
Protein binding	Approximately 99% bound to plasma albumin.
Volume of Distribution	Apparent volume of distribution is 0.15 L/kg (range 0.10–0.20 L/kg), consistent with low tissue penetration and high plasma protein binding.
Bioavailability	Oral: ~80% (rapidly and completely absorbed; first-pass metabolism reduces absolute bioavailability to 80% of the dose).
Onset of Action	Oral: 30–60 minutes for analgesic effect; peak plasma levels at 1–2 hours.
Duration of Action	Duration of analgesic effect is 4–6 hours following a single oral dose, corresponding to the dosing interval. Antipyretic effect lasts approximately 6–8 hours.

Classification & Brands

Dosing & administration

200-400 mg orally every 4-6 hours as needed; maximum 1200 mg in 24 hours.

Dosage form	TABLET
Renal impairment	GFR 30-60 mL/min: no adjustment needed; GFR 10-29 mL/min: reduce dose by 25-50%; GFR <10 mL/min: avoid use or reduce dose by 50%.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: avoid use.
Pediatric use	6 months to 12 years: 5-10 mg/kg/dose every 6-8 hours; maximum 40 mg/kg/day or single doses not exceeding 400 mg.
Geriatric use	Initiate at the lowest effective dose, typically 200-400 mg every 6-8 hours; maximum 1200 mg/day; monitor renal function and potential for GI bleeding.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for MOTRIN IB (MOTRIN IB).

Breastfeeding	Ibuprofen is excreted into breast milk in low concentrations (M/P ratio approximately 0.01). Amount ingested by infant <1% of maternal weight-adjusted dose. Considered compatible with breastfeeding, but monitor infant for gastrointestinal effects and renal function.
Teratogenic Risk	First trimester: Increased risk of miscarriage and cardiac defects (odds ratio 1.86 for cardiovascular malformations). Second trimester: Risk of oligohydramnios and fetal renal dysfunction. Third trimester: Known risk of premature closure of ductus arteriosus, persistent pulmonary hypertension, oligohydramnios, and necrotizing enterocolitis. Use contraindicated after 30 weeks gestation.