TYLOX-325

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TYLOX-325 (TYLOX-325).

How it works

Acetaminophen and oxycodone combination. Acetaminophen inhibits cyclooxygenase (COX) enzymes, primarily in the CNS, reducing prostaglandin synthesis. Oxycodone is a mu-opioid receptor agonist, activating descending pain pathways and altering pain perception.

What the body does with it

Metabolism	Acetaminophen is primarily metabolized via conjugation (glucuronidation and sulfation) and via CYP2E1 (minor pathway forming toxic NAPQI). Oxycodone is metabolized via CYP3A4 (to noroxycodone) and CYP2D6 (to oxymorphone).
Excretion	Renal: acetaminophen metabolites (60-70% as glucuronide conjugate, 20-30% as sulfate conjugate, 5-10% as cysteine conjugate, 5% unchanged). Oxycodone: renal (primarily metabolites, <10% unchanged); biliary/fecal: minor (oxycodone metabolites).
Half-life	Acetaminophen: 2-3 hours (prolonged in hepatic impairment). Oxycodone: 3-5 hours (extended-release preparation); terminal half-life 4.5-5.5 hours. Clinical context: repeated dosing may lead to accumulation; half-life prolongation in elderly, renal or hepatic disease.
Protein binding	Acetaminophen: 10-25% (albumin). Oxycodone: 45% (primarily albumin).
Volume of Distribution	Acetaminophen: 0.9-1.0 L/kg; extensive distribution. Oxycodone: 2.6-3.6 L/kg; high tissue penetration including CNS.
Bioavailability	Acetaminophen: oral 85-90%. Oxycodone: oral 60-87% (variable first-pass metabolism).
Onset of Action	Oral: 10-15 minutes for analgesic effect (oxycodone); antipyretic/analgesic for acetaminophen: 30-60 minutes.
Duration of Action	Oral: analgesia 4-6 hours (immediate-release); antipyresis 4-6 hours. Clinical notes: concurrent use with other CNS depressants may prolong effects.

Classification & Brands

Dosing & administration

1-2 capsules (oxycodone 5-10 mg / acetaminophen 325-650 mg) orally every 4-6 hours as needed for pain; maximum 12 capsules per day.

Dosage form	CAPSULE
Renal impairment	eGFR 30-60 mL/min: administer at reduced frequency (e.g., every 8-12 hours); eGFR <30 mL/min: avoid use or use with extreme caution (reduce dose by 50% and monitor); hemodialysis: not recommended due to acetaminophen accumulation.
Liver impairment	Child-Pugh A (mild): no adjustment necessary; Child-Pugh B (moderate): reduce oxycodone dose by 50% and limit acetaminophen to ≤2000 mg/day; Child-Pugh C (severe): contraindicated.
Pediatric use	Not approved for children <18 years; weight-based dosing: oxycodone 0.05-0.15 mg/kg/dose (max 5 mg) and acetaminophen 10-15 mg/kg/dose (max 650 mg) orally every 4-6 hours as needed; total daily acetaminophen ≤75 mg/kg/day.
Geriatric use	Initiate at lowest dose (e.g., 1 capsule every 6 hours); titrate cautiously; avoid in patients with renal impairment or hepatic dysfunction; monitor for opioid-induced constipation, respiratory depression, and acetaminophen hepatotoxicity; consider alternative non-opioid analgesics if feasible.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TYLOX-325 (TYLOX-325).

Breastfeeding	Oxycodone is excreted in breast milk; M/P ratio approximately 3.4:1. American Academy of Pediatrics recommends cautious use; monitor infant for drowsiness, respiratory depression. Acetaminophen is compatible with breastfeeding. Overall, risk to infant is low with short-term maternal use.
Teratogenic Risk	Pregnancy Category C. Oxycodone crosses placenta. First trimester: risk of neural tube defects not established; avoid unless benefit outweighs risk. Second/third trimester: chronic use may cause neonatal opioid withdrawal syndrome (NOWS). Third trimester: high doses near term may cause neonatal respiratory depression.

Warnings & precautions

■ FDA Black Box Warning

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

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to acetaminophen or oxycodone, significant respiratory depression, acute or severe bronchial asthma, known or suspected gastrointestinal obstruction, paralytic ileus.

Clinical Precautions

Precautions

Respiratory depression, opioid-induced hyperalgesia, adrenal insufficiency, severe hypotension, seizures, serotonin syndrome, hepatotoxicity, risk of overdose with acetaminophen, risks of use in patients with head injury or increased intracranial pressure.

Clinical Tips & Counseling

Drug interactions

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TYLOX-325

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TYLOX-325 (TYLOX-325).

How it works

What the body does with it

Metabolism	Acetaminophen is primarily metabolized via conjugation (glucuronidation and sulfation) and via CYP2E1 (minor pathway forming toxic NAPQI). Oxycodone is metabolized via CYP3A4 (to noroxycodone) and CYP2D6 (to oxymorphone).
Excretion	Renal: acetaminophen metabolites (60-70% as glucuronide conjugate, 20-30% as sulfate conjugate, 5-10% as cysteine conjugate, 5% unchanged). Oxycodone: renal (primarily metabolites, <10% unchanged); biliary/fecal: minor (oxycodone metabolites).
Half-life	Acetaminophen: 2-3 hours (prolonged in hepatic impairment). Oxycodone: 3-5 hours (extended-release preparation); terminal half-life 4.5-5.5 hours. Clinical context: repeated dosing may lead to accumulation; half-life prolongation in elderly, renal or hepatic disease.
Protein binding	Acetaminophen: 10-25% (albumin). Oxycodone: 45% (primarily albumin).
Volume of Distribution	Acetaminophen: 0.9-1.0 L/kg; extensive distribution. Oxycodone: 2.6-3.6 L/kg; high tissue penetration including CNS.
Bioavailability	Acetaminophen: oral 85-90%. Oxycodone: oral 60-87% (variable first-pass metabolism).
Onset of Action	Oral: 10-15 minutes for analgesic effect (oxycodone); antipyretic/analgesic for acetaminophen: 30-60 minutes.
Duration of Action	Oral: analgesia 4-6 hours (immediate-release); antipyresis 4-6 hours. Clinical notes: concurrent use with other CNS depressants may prolong effects.

Classification & Brands

Dosing & administration

1-2 capsules (oxycodone 5-10 mg / acetaminophen 325-650 mg) orally every 4-6 hours as needed for pain; maximum 12 capsules per day.

Dosage form	CAPSULE
Renal impairment	eGFR 30-60 mL/min: administer at reduced frequency (e.g., every 8-12 hours); eGFR <30 mL/min: avoid use or use with extreme caution (reduce dose by 50% and monitor); hemodialysis: not recommended due to acetaminophen accumulation.
Liver impairment	Child-Pugh A (mild): no adjustment necessary; Child-Pugh B (moderate): reduce oxycodone dose by 50% and limit acetaminophen to ≤2000 mg/day; Child-Pugh C (severe): contraindicated.
Pediatric use	Not approved for children <18 years; weight-based dosing: oxycodone 0.05-0.15 mg/kg/dose (max 5 mg) and acetaminophen 10-15 mg/kg/dose (max 650 mg) orally every 4-6 hours as needed; total daily acetaminophen ≤75 mg/kg/day.
Geriatric use	Initiate at lowest dose (e.g., 1 capsule every 6 hours); titrate cautiously; avoid in patients with renal impairment or hepatic dysfunction; monitor for opioid-induced constipation, respiratory depression, and acetaminophen hepatotoxicity; consider alternative non-opioid analgesics if feasible.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TYLOX-325 (TYLOX-325).

Breastfeeding	Oxycodone is excreted in breast milk; M/P ratio approximately 3.4:1. American Academy of Pediatrics recommends cautious use; monitor infant for drowsiness, respiratory depression. Acetaminophen is compatible with breastfeeding. Overall, risk to infant is low with short-term maternal use.
Teratogenic Risk	Pregnancy Category C. Oxycodone crosses placenta. First trimester: risk of neural tube defects not established; avoid unless benefit outweighs risk. Second/third trimester: chronic use may cause neonatal opioid withdrawal syndrome (NOWS). Third trimester: high doses near term may cause neonatal respiratory depression.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to acetaminophen or oxycodone, significant respiratory depression, acute or severe bronchial asthma, known or suspected gastrointestinal obstruction, paralytic ileus.