VICOPRIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VICOPRIN (VICOPRIN).

How it works

VICOPRIN (hydrocodone/acetaminophen) combines a mu-opioid receptor agonist (hydrocodone) that inhibits ascending pain pathways and alters pain perception, with an analgesic and antipyretic (acetaminophen) that inhibits cyclooxygenase (COX) and central prostaglandin synthesis.

What the body does with it

Metabolism	Hydrocodone is primarily metabolized by CYP2D6 and CYP3A4 to hydromorphone and norhydrocodone; acetaminophen is metabolized primarily by conjugation (glucuronidation, sulfation) and CYP2E1 to NAPQI.
Excretion	Renal excretion of metabolites (hydrocodone: ~60% as conjugates; acetaminophen: ~85-90% as glucuronide and sulfate conjugates). Biliary/fecal elimination accounts for <5%.
Half-life	Hydrocodone: 3.8-6.0 hours in adults; acetaminophen: 2.0-4.0 hours. Clinically, Vicoprofen (hydrocodone/ibuprofen) has an effective half-life of ~4-6 hours for hydrocodone; ibuprofen half-life is 2-4 hours.
Protein binding	Hydrocodone: ~20-30% bound to albumin; ibuprofen: >99% bound primarily to albumin.
Volume of Distribution	Hydrocodone: Vd ~3-4 L/kg, indicating extensive tissue distribution; ibuprofen: Vd ~0.1-0.2 L/kg, limited to plasma and extracellular fluid.
Bioavailability	Oral: hydrocodone bioavailability ~70-80% (first-pass metabolism); ibuprofen bioavailability >80% (rapid and complete absorption).
Onset of Action	Oral: hydrocodone onset 15-30 minutes; ibuprofen onset 30-60 minutes. Peak analgesia occurs at 1-2 hours.
Duration of Action	Oral: 4-6 hours for analgesia from hydrocodone; ibuprofen duration 4-6 hours. Duration may be shorter with acute pain conditions.

Classification & Brands

Dosing & administration

1 to 2 tablets (each containing 7.5 mg hydrocodone bitartrate and 200 mg ibuprofen) orally every 4 to 6 hours as needed for pain; maximum 5 tablets per day.

Dosage form	TABLET
Renal impairment	CrCl 30-89 mL/min: No adjustment needed; CrCl < 30 mL/min: Avoid use due to accumulation of hydrocodone and NSAID nephrotoxicity.
Liver impairment	Child-Pugh A: No adjustment; Child-Pugh B: Use with caution, consider lower doses; Child-Pugh C: Avoid use.
Pediatric use	Not approved for pediatric use; safety and efficacy not established.
Geriatric use	Start at lower doses (e.g., 1 tablet every 6 hours) due to increased sensitivity and risk of renal impairment; monitor for CNS and respiratory depression.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VICOPRIN (VICOPRIN).

Breastfeeding	Hydrocodone and acetaminophen are excreted into breast milk. M/P ratio for hydrocodone is approximately 2.0-2.5. Monitor infant for excessive sedation, respiratory depression, and poor feeding. Avoid use in breastfeeding mothers with CYP2D6 ultra-rapid metabolizer phenotype due to risk of morphine accumulation.
Teratogenic Risk	Pregnancy Category C before 30 weeks; Category D from 30 weeks onward. First trimester: risk of neural tube defects and congenital heart defects associated with opioid use. Second trimester: potential growth restriction. Third trimester: risk of neonatal opioid withdrawal syndrome and respiratory depression at delivery.

Warnings & precautions

■ FDA Black Box Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion of acetaminophen may cause hepatotoxicity; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other CNS depressants.

Side Effect Profile

Serious Effects

Absolute Contraindications

Significant respiratory depression; acute or severe bronchial asthma; known or suspected gastrointestinal obstruction (e.g., paralytic ileus); hypersensitivity to hydrocodone, acetaminophen, or any component; concurrent use of MAOIs or within 14 days; severe hepatic impairment.

Clinical Precautions

Precautions

Risk of respiratory depression, especially in elderly or debilitated; hepatotoxicity from acetaminophen overdose; adrenal insufficiency; severe hypotension; seizures; opioid-induced hyperalgesia; serotonin syndrome; risks in patients with head injury, impaired consciousness, or pulmonary disease; use in pregnancy may cause neonatal withdrawal; avoid abrupt discontinuation.

Clinical Tips & Counseling

Drug interactions

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VICOPRIN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VICOPRIN (VICOPRIN).

How it works

What the body does with it

Metabolism	Hydrocodone is primarily metabolized by CYP2D6 and CYP3A4 to hydromorphone and norhydrocodone; acetaminophen is metabolized primarily by conjugation (glucuronidation, sulfation) and CYP2E1 to NAPQI.
Excretion	Renal excretion of metabolites (hydrocodone: ~60% as conjugates; acetaminophen: ~85-90% as glucuronide and sulfate conjugates). Biliary/fecal elimination accounts for <5%.
Half-life	Hydrocodone: 3.8-6.0 hours in adults; acetaminophen: 2.0-4.0 hours. Clinically, Vicoprofen (hydrocodone/ibuprofen) has an effective half-life of ~4-6 hours for hydrocodone; ibuprofen half-life is 2-4 hours.
Protein binding	Hydrocodone: ~20-30% bound to albumin; ibuprofen: >99% bound primarily to albumin.
Volume of Distribution	Hydrocodone: Vd ~3-4 L/kg, indicating extensive tissue distribution; ibuprofen: Vd ~0.1-0.2 L/kg, limited to plasma and extracellular fluid.
Bioavailability	Oral: hydrocodone bioavailability ~70-80% (first-pass metabolism); ibuprofen bioavailability >80% (rapid and complete absorption).
Onset of Action	Oral: hydrocodone onset 15-30 minutes; ibuprofen onset 30-60 minutes. Peak analgesia occurs at 1-2 hours.
Duration of Action	Oral: 4-6 hours for analgesia from hydrocodone; ibuprofen duration 4-6 hours. Duration may be shorter with acute pain conditions.

Classification & Brands

Dosing & administration

1 to 2 tablets (each containing 7.5 mg hydrocodone bitartrate and 200 mg ibuprofen) orally every 4 to 6 hours as needed for pain; maximum 5 tablets per day.

Dosage form	TABLET
Renal impairment	CrCl 30-89 mL/min: No adjustment needed; CrCl < 30 mL/min: Avoid use due to accumulation of hydrocodone and NSAID nephrotoxicity.
Liver impairment	Child-Pugh A: No adjustment; Child-Pugh B: Use with caution, consider lower doses; Child-Pugh C: Avoid use.
Pediatric use	Not approved for pediatric use; safety and efficacy not established.
Geriatric use	Start at lower doses (e.g., 1 tablet every 6 hours) due to increased sensitivity and risk of renal impairment; monitor for CNS and respiratory depression.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VICOPRIN (VICOPRIN).

Breastfeeding	Hydrocodone and acetaminophen are excreted into breast milk. M/P ratio for hydrocodone is approximately 2.0-2.5. Monitor infant for excessive sedation, respiratory depression, and poor feeding. Avoid use in breastfeeding mothers with CYP2D6 ultra-rapid metabolizer phenotype due to risk of morphine accumulation.
Teratogenic Risk	Pregnancy Category C before 30 weeks; Category D from 30 weeks onward. First trimester: risk of neural tube defects and congenital heart defects associated with opioid use. Second trimester: potential growth restriction. Third trimester: risk of neonatal opioid withdrawal syndrome and respiratory depression at delivery.