VICOPROFEN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VICOPROFEN (VICOPROFEN).

How it works

Hydrocodone is a mu-opioid receptor agonist that activates G-protein coupled opioid receptors, leading to analgesia; ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis.

What the body does with it

Metabolism	Hydrocodone is metabolized via CYP3A4 and CYP2D6; ibuprofen is primarily metabolized by CYP2C9.
Excretion	Hydrocodone: primarily renal (26% as unchanged drug and metabolites, including norhydrocodone, hydromorphone, and conjugates); less than 5% fecal. Ibuprofen: renal (50-60% as unchanged drug and metabolites, mainly conjugated with glucuronic acid; <10% unchanged); biliary/fecal (minor).
Half-life	Hydrocodone: 3.8-4.5 hours (immediate-release); clinical context: analgesic duration correlates with half-life, but may be prolonged in renal/hepatic impairment. Ibuprofen: 2-4 hours (immediate-release); clinical context: anti-inflammatory effect may outlast plasma half-life due to tissue distribution.
Protein binding	Hydrocodone: approximately 20-30% bound to plasma proteins (albumin). Ibuprofen: >99% bound to albumin.
Volume of Distribution	Hydrocodone: 3.3 L/kg (large Vd indicates extensive tissue distribution). Ibuprofen: 0.1-0.3 L/kg (low Vd reflects high protein binding and limited extravascular distribution).
Bioavailability	Oral: hydrocodone bioavailability 60-80% (due to first-pass metabolism); ibuprofen bioavailability 80-100% (rapid absorption).
Onset of Action	Oral: hydrocodone component analgesic onset within 20-30 minutes; ibuprofen component analgesic/anti-inflammatory onset within 30-60 minutes.
Duration of Action	Hydrocodone: analgesic effect lasts 4-6 hours. Ibuprofen: analgesic/anti-inflammatory effect lasts 4-6 hours. Clinical note: combination product VICOPROFEN is dosed every 4-6 hours as needed; hepatic or renal impairment may prolong effects.

Classification & Brands

Dosing & administration

1 tablet (hydrocodone 5 mg / ibuprofen 200 mg) orally every 4 to 6 hours as needed for pain; maximum 5 tablets per day.

Dosage form	TABLET
Renal impairment	Avoid use if CrCl <30 mL/min; for CrCl 30-59 mL/min, reduce dose frequency and avoid prolonged use due to ibuprofen component.
Liver impairment	Contraindicated in severe hepatic impairment (Child-Pugh class C); for moderate impairment (Child-Pugh class B), use with caution and consider dose reduction.
Pediatric use	Not recommended for use in pediatric patients (safety and efficacy not established).
Geriatric use	Use lowest effective dose for shortest duration; increased risk of GI bleeding and renal impairment; monitor renal function and avoid prolonged use.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VICOPROFEN (VICOPROFEN).

Breastfeeding	Excreted in breast milk in low amounts. M/P ratio for hydrocodone is approximately 2.5 for total opioids; ibuprofen M/P ratio is <1. Use with caution; monitor infant for sedation, respiratory depression, and poor feeding.
Teratogenic Risk	First trimester: NSAIDs associated with increased risk of miscarriage and cardiac defects. Second trimester: Potential for oligohydramnios and fetal renal dysfunction. Third trimester: Risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment.

Warnings & precautions

■ FDA Black Box Warning

Risk of addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion (especially in children) can be fatal; neonatal opioid withdrawal syndrome with prolonged use during pregnancy; risks from concomitant use with benzodiazepines or other CNS depressants (additive effects); hepatotoxicity from ibuprofen (NSAID).

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to hydrocodone, ibuprofen, or any component of the product; significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; in the setting of coronary artery bypass graft (CABG) surgery.

Clinical Precautions

Precautions

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; risks with benzodiazepines or other CNS depressants; hepatotoxicity; cardiovascular thrombotic events; gastrointestinal bleeding; renal toxicity; hypertension; anaphylactoid reactions; serious skin reactions; use in patients with renal or hepatic impairment; pregnancy; lactation.

Clinical Tips & Counseling

Drug interactions

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VICOPROFEN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VICOPROFEN (VICOPROFEN).

How it works

What the body does with it

Metabolism	Hydrocodone is metabolized via CYP3A4 and CYP2D6; ibuprofen is primarily metabolized by CYP2C9.
Excretion	Hydrocodone: primarily renal (26% as unchanged drug and metabolites, including norhydrocodone, hydromorphone, and conjugates); less than 5% fecal. Ibuprofen: renal (50-60% as unchanged drug and metabolites, mainly conjugated with glucuronic acid; <10% unchanged); biliary/fecal (minor).
Half-life	Hydrocodone: 3.8-4.5 hours (immediate-release); clinical context: analgesic duration correlates with half-life, but may be prolonged in renal/hepatic impairment. Ibuprofen: 2-4 hours (immediate-release); clinical context: anti-inflammatory effect may outlast plasma half-life due to tissue distribution.
Protein binding	Hydrocodone: approximately 20-30% bound to plasma proteins (albumin). Ibuprofen: >99% bound to albumin.
Volume of Distribution	Hydrocodone: 3.3 L/kg (large Vd indicates extensive tissue distribution). Ibuprofen: 0.1-0.3 L/kg (low Vd reflects high protein binding and limited extravascular distribution).
Bioavailability	Oral: hydrocodone bioavailability 60-80% (due to first-pass metabolism); ibuprofen bioavailability 80-100% (rapid absorption).
Onset of Action	Oral: hydrocodone component analgesic onset within 20-30 minutes; ibuprofen component analgesic/anti-inflammatory onset within 30-60 minutes.
Duration of Action	Hydrocodone: analgesic effect lasts 4-6 hours. Ibuprofen: analgesic/anti-inflammatory effect lasts 4-6 hours. Clinical note: combination product VICOPROFEN is dosed every 4-6 hours as needed; hepatic or renal impairment may prolong effects.

Classification & Brands

Dosing & administration

1 tablet (hydrocodone 5 mg / ibuprofen 200 mg) orally every 4 to 6 hours as needed for pain; maximum 5 tablets per day.

Dosage form	TABLET
Renal impairment	Avoid use if CrCl <30 mL/min; for CrCl 30-59 mL/min, reduce dose frequency and avoid prolonged use due to ibuprofen component.
Liver impairment	Contraindicated in severe hepatic impairment (Child-Pugh class C); for moderate impairment (Child-Pugh class B), use with caution and consider dose reduction.
Pediatric use	Not recommended for use in pediatric patients (safety and efficacy not established).
Geriatric use	Use lowest effective dose for shortest duration; increased risk of GI bleeding and renal impairment; monitor renal function and avoid prolonged use.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VICOPROFEN (VICOPROFEN).

Breastfeeding	Excreted in breast milk in low amounts. M/P ratio for hydrocodone is approximately 2.5 for total opioids; ibuprofen M/P ratio is <1. Use with caution; monitor infant for sedation, respiratory depression, and poor feeding.
Teratogenic Risk	First trimester: NSAIDs associated with increased risk of miscarriage and cardiac defects. Second trimester: Potential for oligohydramnios and fetal renal dysfunction. Third trimester: Risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment.