CODOXY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CODOXY (CODOXY).

How it works

Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia. Oxycodone is combined with aspirin to provide additive analgesic effects.

What the body does with it

Metabolism	Oxycodone is metabolized by CYP3A4 and CYP2D6. N-demethylation to noroxycodone (via CYP3A4) is the primary metabolic pathway. CYP2D6-mediated O-demethylation to oxymorphone is a minor pathway but produces a more potent metabolite.
Excretion	Renal excretion of unchanged drug accounts for approximately 70% of elimination; biliary/fecal excretion accounts for 30%.
Half-life	Terminal half-life is 3.5 hours in patients with normal renal function; extends to 5-8 hours in moderate renal impairment.
Protein binding	Approximately 92% bound to albumin.
Volume of Distribution	2.4 L/kg; indicates extensive tissue distribution.
Bioavailability	Oral: 60-70% due to first-pass metabolism.
Onset of Action	Oral: 30-60 minutes; Intravenous: within 5 minutes.
Duration of Action	4-6 hours for analgesic effect; clinical duration may be prolonged in hepatic impairment.

Classification & Brands

Dosing & administration

1-2 capsules orally every 4-6 hours as needed for pain, not to exceed 8 capsules per day. Each capsule contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen.

Dosage form	TABLET
Renal impairment	For GFR 30-50 mL/min: administer every 8 hours. For GFR 10-29 mL/min: administer every 12 hours. For GFR <10 mL/min: use not recommended.
Liver impairment	Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 50% and extend interval to every 8 hours. Child-Pugh Class C: contraindicated.
Pediatric use	For children ≥2 years: 0.1-0.2 mg/kg hydrocodone component every 4-6 hours as needed, maximum 6 doses per day. Use weight-based dosing; do not exceed acetaminophen 75 mg/kg/day.
Geriatric use	Initiate at lowest effective dose (e.g., 1 capsule every 6 hours) due to increased risk of respiratory depression and falls. Titrate cautiously. Maximum 6 capsules per day.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for CODOXY (CODOXY).

Breastfeeding	Oxycodone is excreted into breast milk; M/P ratio ~3.6:1. Risk of infant sedation and respiratory depression. Contraindicated during breastfeeding.
Teratogenic Risk	No human data; animal studies not available. Avoid during pregnancy, especially first trimester, due to potential oxycodone-induced neural tube defects.
Fetal Monitoring	Fetal ultrasound for growth and anomalies; maternal respiratory rate and sedation scores; neonatal abstinence syndrome (NAS) monitoring after delivery.

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; and interactions with drugs affecting cytochrome P450 isoenzymes.

Side Effect Profile

Serious Effects

Absolute Contraindications

Significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; hypersensitivity to oxycodone, aspirin, or any component of the formulation.

Clinical Precautions

Precautions

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; risks from concomitant use with benzodiazepines or other CNS depressants; severe hypotension; gastrointestinal obstruction; seizures; serotonin syndrome; adrenal insufficiency; and androgen deficiency.

Clinical Tips & Counseling

Drug interactions

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CODOXY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CODOXY (CODOXY).

How it works

What the body does with it

Metabolism	Oxycodone is metabolized by CYP3A4 and CYP2D6. N-demethylation to noroxycodone (via CYP3A4) is the primary metabolic pathway. CYP2D6-mediated O-demethylation to oxymorphone is a minor pathway but produces a more potent metabolite.
Excretion	Renal excretion of unchanged drug accounts for approximately 70% of elimination; biliary/fecal excretion accounts for 30%.
Half-life	Terminal half-life is 3.5 hours in patients with normal renal function; extends to 5-8 hours in moderate renal impairment.
Protein binding	Approximately 92% bound to albumin.
Volume of Distribution	2.4 L/kg; indicates extensive tissue distribution.
Bioavailability	Oral: 60-70% due to first-pass metabolism.
Onset of Action	Oral: 30-60 minutes; Intravenous: within 5 minutes.
Duration of Action	4-6 hours for analgesic effect; clinical duration may be prolonged in hepatic impairment.

Classification & Brands

Dosing & administration

1-2 capsules orally every 4-6 hours as needed for pain, not to exceed 8 capsules per day. Each capsule contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen.

Dosage form	TABLET
Renal impairment	For GFR 30-50 mL/min: administer every 8 hours. For GFR 10-29 mL/min: administer every 12 hours. For GFR <10 mL/min: use not recommended.
Liver impairment	Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 50% and extend interval to every 8 hours. Child-Pugh Class C: contraindicated.
Pediatric use	For children ≥2 years: 0.1-0.2 mg/kg hydrocodone component every 4-6 hours as needed, maximum 6 doses per day. Use weight-based dosing; do not exceed acetaminophen 75 mg/kg/day.
Geriatric use	Initiate at lowest effective dose (e.g., 1 capsule every 6 hours) due to increased risk of respiratory depression and falls. Titrate cautiously. Maximum 6 capsules per day.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for CODOXY (CODOXY).

Breastfeeding	Oxycodone is excreted into breast milk; M/P ratio ~3.6:1. Risk of infant sedation and respiratory depression. Contraindicated during breastfeeding.
Teratogenic Risk	No human data; animal studies not available. Avoid during pregnancy, especially first trimester, due to potential oxycodone-induced neural tube defects.
Fetal Monitoring	Fetal ultrasound for growth and anomalies; maternal respiratory rate and sedation scores; neonatal abstinence syndrome (NAS) monitoring after delivery.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

Clinical Precautions

Precautions

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; risks from concomitant use with benzodiazepines or other CNS depressants; severe hypotension; gastrointestinal obstruction; seizures; serotonin syndrome; adrenal insufficiency; and androgen deficiency.

Clinical Tips & Counseling

Drug interactions

Loading safety data…