VICODIN HP

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VICODIN HP (VICODIN HP).

How it works

Hydrocodone is a mu-opioid receptor agonist that inhibits ascending pain pathways; acetaminophen inhibits cyclooxygenase and has antipyretic effects.

What the body does with it

Metabolism	Hydrocodone: CYP3A4 and CYP2D6; Acetaminophen: primarily glucuronidation (UGT1A1, UGT1A6, UGT1A9) and sulfation.
Excretion	Primarily renal: hydrocodone is eliminated as conjugated metabolites (glucuronides) ~80%; unchanged drug ~5%. Biliary/fecal: minor, <10%.
Half-life	Hydrocodone: 3.8-5.5 hours (mean 4.5 h). Acetaminophen: 2-3 hours. Clinical context: dosing interval every 4-6 hours for acute pain.
Protein binding	Hydrocodone: ~36% bound (primarily albumin). Acetaminophen: ~10-25% bound.
Volume of Distribution	Hydrocodone: Vd ~3-5 L/kg (extensive tissue distribution). Acetaminophen: Vd ~1 L/kg.
Bioavailability	Oral: hydrocodone ~60-70% (extensive first-pass metabolism); acetaminophen ~85-95%.
Onset of Action	Oral: 30-60 minutes for analgesia.
Duration of Action	Oral: 4-6 hours (analgesic effect; may be shorter with single doses, longer with repeated dosing).

Classification & Brands

Dosing & administration

One tablet (hydrocodone bitartrate 10 mg/acetaminophen 660 mg) orally every 4-6 hours as needed for pain; maximum 6 tablets per day.

Dosage form	TABLET
Renal impairment	GFR 30-50 mL/min: administer every 6 hours; GFR 10-29 mL/min: administer every 8-12 hours; GFR <10 mL/min: avoid use or consider extended interval dosing.
Liver impairment	Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce dose by 50% or extend interval; Child-Pugh Class C: avoid use due to risk of toxicity.
Pediatric use	Not approved for pediatric use; hydrocodone is contraindicated in children <6 years and not recommended in those <18 years due to risk of respiratory depression.
Geriatric use	Initiate at the lowest effective dose, typically one tablet every 6 hours; monitor for respiratory depression, constipation, and falls; avoid in patients with severe COPD or sleep apnea.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VICODIN HP (VICODIN HP).

Breastfeeding	Hydrocodone is excreted in breast milk (M/P ratio ~2:1). Relative infant dose is 2-4% of maternal weight-adjusted dose. Risk of infant sedation and respiratory depression; caution if mother is CYP2D6 ultra-rapid metabolizer. Short-term use (<72 hours) preferred; monitor for drowsiness, poor feeding.
Teratogenic Risk	First trimester: Increased risk of oral clefts (2-3x) and neural tube defects. Second and third trimesters: Risk of miscarriage, preterm birth, intrauterine growth restriction, and neonatal opioid withdrawal syndrome (NOWS) with chronic use. Avoid in late pregnancy due to risk of respiratory depression.

Warnings & precautions

■ FDA Black Box Warning

Risk of opioid addiction, abuse, misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome with prolonged use during pregnancy; accidental ingestion of acetaminophen; 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; hypersensitivity to hydrocodone or acetaminophen; use with MAOIs or within 14 days of such therapy.

Clinical Precautions

Precautions

Addiction, abuse, misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; hepatotoxicity due to acetaminophen; interactions with CNS depressants; severe hypotension; adrenal insufficiency; and seizure risk.

Clinical Tips & Counseling

Drug interactions

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VICODIN HP

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VICODIN HP (VICODIN HP).

How it works

Hydrocodone is a mu-opioid receptor agonist that inhibits ascending pain pathways; acetaminophen inhibits cyclooxygenase and has antipyretic effects.

What the body does with it

Metabolism	Hydrocodone: CYP3A4 and CYP2D6; Acetaminophen: primarily glucuronidation (UGT1A1, UGT1A6, UGT1A9) and sulfation.
Excretion	Primarily renal: hydrocodone is eliminated as conjugated metabolites (glucuronides) ~80%; unchanged drug ~5%. Biliary/fecal: minor, <10%.
Half-life	Hydrocodone: 3.8-5.5 hours (mean 4.5 h). Acetaminophen: 2-3 hours. Clinical context: dosing interval every 4-6 hours for acute pain.
Protein binding	Hydrocodone: ~36% bound (primarily albumin). Acetaminophen: ~10-25% bound.
Volume of Distribution	Hydrocodone: Vd ~3-5 L/kg (extensive tissue distribution). Acetaminophen: Vd ~1 L/kg.
Bioavailability	Oral: hydrocodone ~60-70% (extensive first-pass metabolism); acetaminophen ~85-95%.
Onset of Action	Oral: 30-60 minutes for analgesia.
Duration of Action	Oral: 4-6 hours (analgesic effect; may be shorter with single doses, longer with repeated dosing).

Classification & Brands

Dosing & administration

One tablet (hydrocodone bitartrate 10 mg/acetaminophen 660 mg) orally every 4-6 hours as needed for pain; maximum 6 tablets per day.

Dosage form	TABLET
Renal impairment	GFR 30-50 mL/min: administer every 6 hours; GFR 10-29 mL/min: administer every 8-12 hours; GFR <10 mL/min: avoid use or consider extended interval dosing.
Liver impairment	Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce dose by 50% or extend interval; Child-Pugh Class C: avoid use due to risk of toxicity.
Pediatric use	Not approved for pediatric use; hydrocodone is contraindicated in children <6 years and not recommended in those <18 years due to risk of respiratory depression.
Geriatric use	Initiate at the lowest effective dose, typically one tablet every 6 hours; monitor for respiratory depression, constipation, and falls; avoid in patients with severe COPD or sleep apnea.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for VICODIN HP (VICODIN HP).

Breastfeeding	Hydrocodone is excreted in breast milk (M/P ratio ~2:1). Relative infant dose is 2-4% of maternal weight-adjusted dose. Risk of infant sedation and respiratory depression; caution if mother is CYP2D6 ultra-rapid metabolizer. Short-term use (<72 hours) preferred; monitor for drowsiness, poor feeding.
Teratogenic Risk	First trimester: Increased risk of oral clefts (2-3x) and neural tube defects. Second and third trimesters: Risk of miscarriage, preterm birth, intrauterine growth restriction, and neonatal opioid withdrawal syndrome (NOWS) with chronic use. Avoid in late pregnancy due to risk of respiratory depression.