TYLOX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TYLOX (TYLOX).

How it works

Tylox combines oxycodone, a mu-opioid receptor agonist, with acetaminophen, which inhibits cyclooxygenase (COX) and modulates descending serotonergic pathways.

What the body does with it

Metabolism	Oxycodone is metabolized primarily via CYP3A4 and CYP2D6; acetaminophen is metabolized in the liver via conjugation (glucuronidation, sulfation) and CYP2E1 for a minor toxic metabolite (NAPQI).
Excretion	Renal: oxycodone ~19% unchanged; acetaminophen ~2-5% unchanged. Biliary: minimal. Fecal: <5% total. Total renal elimination: ~60-70% as metabolites of oxycodone (noroxycodone, oxymorphone) and acetaminophen conjugates.
Half-life	Oxycodone: 3.5-5.6 hours; acetaminophen: 2-3 hours. In hepatic impairment, oxycodone half-life prolonged up to 13 hours.
Protein binding	Oxycodone: 38-45% primarily to albumin; acetaminophen: 10-25%.
Volume of Distribution	Oxycodone: 2.6 L/kg (large, indicates extensive tissue distribution); acetaminophen: 0.9 L/kg.
Bioavailability	Oral: oxycodone 60-87% (first-pass metabolism); acetaminophen 63-89%.
Onset of Action	Oral: 15-30 minutes; peak analgesia: 60-90 minutes.
Duration of Action	3-6 hours (immediate-release); longer with controlled-release formulations (not applicable to Tylox).

Classification & Brands

Dosing & administration

1-2 capsules (oxycodone 5 mg/acetaminophen 325 mg) orally every 6 hours as needed for pain; maximum 12 capsules per day.

Dosage form	CAPSULE
Renal impairment	GFR 30-50 mL/min: administer 75% of usual dose every 6 hours; GFR 10-29 mL/min: 50% of usual dose every 6 hours; GFR <10 mL/min: 25-50% of usual dose every 12 hours.
Liver impairment	Child-Pugh A: reduce dose by 50% and consider extended interval; Child-Pugh B: 25-50% of usual dose every 8-12 hours; Child-Pugh C: contraindicated or use with extreme caution at 25% of dose every 12 hours.
Pediatric use	Children ≥11 years: 1 capsule (oxycodone 5 mg/acetaminophen 325 mg) orally every 6 hours as needed; maximum 4 doses per day. For children <11 years: weight-based dosing of oxycodone 0.05-0.15 mg/kg/dose (max 5 mg) and acetaminophen 10-15 mg/kg/dose (max 650 mg) every 4-6 hours; use appropriate separate formulations.
Geriatric use	Initiate at 50% of adult dose (e.g., 1 capsule every 8-12 hours) and titrate cautiously due to increased sensitivity and risk of adverse effects; monitor renal and hepatic function.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TYLOX (TYLOX).

Breastfeeding	Acetaminophen and oxycodone are excreted into breast milk. Oxycodone M/P ratio is approximately 3.6:1. At maternal therapeutic doses, infant exposure is low but may cause sedation or respiratory depression. Caution advised; monitor infant for signs of opioid toxicity. American Academy of Pediatrics considers oxycodone compatible with breastfeeding with caution.
Teratogenic Risk	Pregnancy Category C. First trimester: acetaminophen is generally considered safe; oxycodone has shown teratogenic effects in animal studies at high doses, but human data are limited. Second and third trimesters: chronic oxycodone use may lead to neonatal opioid withdrawal syndrome (NOWS). There is no evidence of major malformations with standard therapeutic doses.

Warnings & precautions

■ FDA Black Box Warning

Risk of addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; interactions with CNS depressants; and hepatotoxicity from acetaminophen overdose.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity, significant respiratory depression, acute or severe bronchial asthma, GI obstruction, known or suspected paralytic ileus, and severe hepatic impairment (acetaminophen component).

Clinical Precautions

Precautions

Risk of respiratory depression, opioid-induced hyperalgesia, hypotension, adrenal insufficiency, serotonin syndrome, severe hypotension, and hepatotoxicity; avoid abrupt discontinuation; use with caution in elderly, debilitated, or those with pulmonary disease.

Clinical Tips & Counseling

Drug interactions

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TYLOX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TYLOX (TYLOX).

How it works

Tylox combines oxycodone, a mu-opioid receptor agonist, with acetaminophen, which inhibits cyclooxygenase (COX) and modulates descending serotonergic pathways.

What the body does with it

Metabolism	Oxycodone is metabolized primarily via CYP3A4 and CYP2D6; acetaminophen is metabolized in the liver via conjugation (glucuronidation, sulfation) and CYP2E1 for a minor toxic metabolite (NAPQI).
Excretion	Renal: oxycodone ~19% unchanged; acetaminophen ~2-5% unchanged. Biliary: minimal. Fecal: <5% total. Total renal elimination: ~60-70% as metabolites of oxycodone (noroxycodone, oxymorphone) and acetaminophen conjugates.
Half-life	Oxycodone: 3.5-5.6 hours; acetaminophen: 2-3 hours. In hepatic impairment, oxycodone half-life prolonged up to 13 hours.
Protein binding	Oxycodone: 38-45% primarily to albumin; acetaminophen: 10-25%.
Volume of Distribution	Oxycodone: 2.6 L/kg (large, indicates extensive tissue distribution); acetaminophen: 0.9 L/kg.
Bioavailability	Oral: oxycodone 60-87% (first-pass metabolism); acetaminophen 63-89%.
Onset of Action	Oral: 15-30 minutes; peak analgesia: 60-90 minutes.
Duration of Action	3-6 hours (immediate-release); longer with controlled-release formulations (not applicable to Tylox).

Classification & Brands

Dosing & administration

1-2 capsules (oxycodone 5 mg/acetaminophen 325 mg) orally every 6 hours as needed for pain; maximum 12 capsules per day.

Dosage form	CAPSULE
Renal impairment	GFR 30-50 mL/min: administer 75% of usual dose every 6 hours; GFR 10-29 mL/min: 50% of usual dose every 6 hours; GFR <10 mL/min: 25-50% of usual dose every 12 hours.
Liver impairment	Child-Pugh A: reduce dose by 50% and consider extended interval; Child-Pugh B: 25-50% of usual dose every 8-12 hours; Child-Pugh C: contraindicated or use with extreme caution at 25% of dose every 12 hours.
Pediatric use	Children ≥11 years: 1 capsule (oxycodone 5 mg/acetaminophen 325 mg) orally every 6 hours as needed; maximum 4 doses per day. For children <11 years: weight-based dosing of oxycodone 0.05-0.15 mg/kg/dose (max 5 mg) and acetaminophen 10-15 mg/kg/dose (max 650 mg) every 4-6 hours; use appropriate separate formulations.
Geriatric use	Initiate at 50% of adult dose (e.g., 1 capsule every 8-12 hours) and titrate cautiously due to increased sensitivity and risk of adverse effects; monitor renal and hepatic function.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TYLOX (TYLOX).

Breastfeeding	Acetaminophen and oxycodone are excreted into breast milk. Oxycodone M/P ratio is approximately 3.6:1. At maternal therapeutic doses, infant exposure is low but may cause sedation or respiratory depression. Caution advised; monitor infant for signs of opioid toxicity. American Academy of Pediatrics considers oxycodone compatible with breastfeeding with caution.
Teratogenic Risk	Pregnancy Category C. First trimester: acetaminophen is generally considered safe; oxycodone has shown teratogenic effects in animal studies at high doses, but human data are limited. Second and third trimesters: chronic oxycodone use may lead to neonatal opioid withdrawal syndrome (NOWS). There is no evidence of major malformations with standard therapeutic doses.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity, significant respiratory depression, acute or severe bronchial asthma, GI obstruction, known or suspected paralytic ileus, and severe hepatic impairment (acetaminophen component).