LORTAB

Clinical safety rating: caution

Comprehensive clinical and safety monograph for LORTAB (LORTAB).

How it works

Hydrocodone is a mu-opioid receptor agonist; acetaminophen inhibits cyclooxygenase (COX) and modulates pain pathways centrally.

What the body does with it

Metabolism	Hydrocodone: CYP3A4, CYP2D6; acetaminophen: hepatic conjugation (glucuronidation, sulfation) and CYP450 (minor).
Excretion	Renal: ~90% (unchanged: ~5% hydrocodone, ~60% hydromorphone and other conjugates; codeine-like metabolites). Biliary/fecal: minor (<10%).
Half-life	Hydrocodone: 3.3-4.4 hours in adults; prolonged in hepatic/renal impairment (up to 6-8 hours). Clinical context: requires 4-6 hour dosing intervals; steady-state in ~24 hours.
Protein binding	Hydrocodone: ~20-30% bound (primarily albumin).
Volume of Distribution	Hydrocodone: 3.3-4.7 L/kg; indicates extensive tissue distribution.
Bioavailability	Oral: ~90% (first-pass metabolism reduces to ~50% due to extensive hepatic extraction; absolute bioavailability not well defined, but high oral absorption).
Onset of Action	Oral: 10-20 minutes; peak effect at 30-60 minutes.
Duration of Action	4-6 hours (analgesic); may be extended with hepatic/renal impairment or in elderly.

Classification & Brands

Dosing & administration

1-2 tablets (each containing 5 mg hydrocodone/325 mg acetaminophen) orally every 4-6 hours as needed for pain. Maximum acetaminophen 3000 mg/day.

Dosage form	TABLET
Renal impairment	Hydrocodone: eGFR 30-59 mL/min: administer 50-75% of usual dose; eGFR 15-29 mL/min: 50% of usual dose; eGFR <15 mL/min: avoid or use with caution. Acetaminophen: no specific GFR-based adjustment; avoid in severe renal impairment due to metabolite accumulation.
Liver impairment	Hydrocodone: Child-Pugh Class A: no adjustment; Class B: reduce dose by 50% and monitor; Class C: avoid. Acetaminophen: reduce dose or avoid in significant liver disease; maximum 2000 mg/day in mild-moderate impairment.
Pediatric use	Not recommended for children <18 years due to risk of respiratory depression and acetaminophen toxicity. In specific circumstances, weight-based dosing for hydrocodone 0.1-0.2 mg/kg/dose every 4-6 hours, max 10 mg/dose; acetaminophen 10-15 mg/kg/dose, max 60 mg/kg/day, not to exceed 3000 mg/day.
Geriatric use	Start at the low end of dosing range (e.g., 1 tablet of 5 mg hydrocodone/325 mg acetaminophen every 6 hours). Monitor for respiratory depression, sedation, and constipation. Avoid acetaminophen >3000 mg/day due to hepatotoxicity risk.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for LORTAB (LORTAB).

Breastfeeding	Codeine is excreted into breast milk; M/P ratio approximately 2.5 for morphine (active metabolite); potential for infant CNS depression; use caution, especially in CYP2D6 ultra-rapid metabolizers.
Teratogenic Risk	FDA Category C in 1st and 2nd trimesters; increased risk of neural tube defects and congenital heart defects with codeine use; risk of respiratory depression and neonatal withdrawal syndrome in 3rd trimester with prolonged use.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Risk of addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; risk with CYP3A4 inhibitors or discontinuation; risk of medication errors.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity; respiratory depression; acute/severe asthma; GI obstruction; suspected surgical abdomen; severe hepatic impairment; concurrent use with MAOIs or within 14 days.

Clinical Precautions

Precautions

Addiction, abuse, misuse; respiratory depression; head injury; GI obstruction; hepatic toxicity; renal impairment; hypotension; adrenal insufficiency; seizures; serotonin syndrome; severe hypotension; risk with MAOIs; pregnancy; lactation.

Clinical Tips & Counseling

Drug interactions

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LORTAB

Clinical safety rating: caution

Comprehensive clinical and safety monograph for LORTAB (LORTAB).

How it works

Hydrocodone is a mu-opioid receptor agonist; acetaminophen inhibits cyclooxygenase (COX) and modulates pain pathways centrally.

What the body does with it

Metabolism	Hydrocodone: CYP3A4, CYP2D6; acetaminophen: hepatic conjugation (glucuronidation, sulfation) and CYP450 (minor).
Excretion	Renal: ~90% (unchanged: ~5% hydrocodone, ~60% hydromorphone and other conjugates; codeine-like metabolites). Biliary/fecal: minor (<10%).
Half-life	Hydrocodone: 3.3-4.4 hours in adults; prolonged in hepatic/renal impairment (up to 6-8 hours). Clinical context: requires 4-6 hour dosing intervals; steady-state in ~24 hours.
Protein binding	Hydrocodone: ~20-30% bound (primarily albumin).
Volume of Distribution	Hydrocodone: 3.3-4.7 L/kg; indicates extensive tissue distribution.
Bioavailability	Oral: ~90% (first-pass metabolism reduces to ~50% due to extensive hepatic extraction; absolute bioavailability not well defined, but high oral absorption).
Onset of Action	Oral: 10-20 minutes; peak effect at 30-60 minutes.
Duration of Action	4-6 hours (analgesic); may be extended with hepatic/renal impairment or in elderly.

Classification & Brands

Dosing & administration

1-2 tablets (each containing 5 mg hydrocodone/325 mg acetaminophen) orally every 4-6 hours as needed for pain. Maximum acetaminophen 3000 mg/day.

Dosage form	TABLET
Renal impairment	Hydrocodone: eGFR 30-59 mL/min: administer 50-75% of usual dose; eGFR 15-29 mL/min: 50% of usual dose; eGFR <15 mL/min: avoid or use with caution. Acetaminophen: no specific GFR-based adjustment; avoid in severe renal impairment due to metabolite accumulation.
Liver impairment	Hydrocodone: Child-Pugh Class A: no adjustment; Class B: reduce dose by 50% and monitor; Class C: avoid. Acetaminophen: reduce dose or avoid in significant liver disease; maximum 2000 mg/day in mild-moderate impairment.
Pediatric use	Not recommended for children <18 years due to risk of respiratory depression and acetaminophen toxicity. In specific circumstances, weight-based dosing for hydrocodone 0.1-0.2 mg/kg/dose every 4-6 hours, max 10 mg/dose; acetaminophen 10-15 mg/kg/dose, max 60 mg/kg/day, not to exceed 3000 mg/day.
Geriatric use	Start at the low end of dosing range (e.g., 1 tablet of 5 mg hydrocodone/325 mg acetaminophen every 6 hours). Monitor for respiratory depression, sedation, and constipation. Avoid acetaminophen >3000 mg/day due to hepatotoxicity risk.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for LORTAB (LORTAB).

Breastfeeding	Codeine is excreted into breast milk; M/P ratio approximately 2.5 for morphine (active metabolite); potential for infant CNS depression; use caution, especially in CYP2D6 ultra-rapid metabolizers.
Teratogenic Risk	FDA Category C in 1st and 2nd trimesters; increased risk of neural tube defects and congenital heart defects with codeine use; risk of respiratory depression and neonatal withdrawal syndrome in 3rd trimester with prolonged use.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity; respiratory depression; acute/severe asthma; GI obstruction; suspected surgical abdomen; severe hepatic impairment; concurrent use with MAOIs or within 14 days.