Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
ROXICET vs CO-GESIC
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Roxicet is a combination of oxycodone, a full mu-opioid receptor agonist, and acetaminophen, which inhibits cyclooxygenase (COX) enzymes, primarily in the central nervous system, to reduce pain perception and fever.
CO-GESIC (hydrocodone/acetaminophen) is a combination analgesic. Hydrocodone is an opioid agonist that binds to mu-opioid receptors in the CNS, inhibiting ascending pain pathways and altering pain perception. Acetaminophen inhibits cyclooxygenase (COX) enzymes in the CNS, reducing prostaglandin synthesis and elevating pain threshold.
Management of moderate to severe pain where an opioid analgesic is appropriate
FDA: Management of moderate to moderately severe pain where an opioid is appropriate.,Off-label: Not commonly used off-label; may be considered for refractory pain conditions.
1-2 tablets (oxycodone 5-10 mg/acetaminophen 325-650 mg) orally every 4-6 hours as needed for pain; maximum acetaminophen 4000 mg/day (3000 mg/day in high-risk patients).
1-2 tablets (hydrocodone 5 mg/acetaminophen 500 mg per tablet) orally every 4-6 hours as needed for pain, maximum 8 tablets per day.
Oxycodone: 3-5 hours (immediate-release); prolonged in hepatic/renal impairment. Acetaminophen: 2-3 hours.
Terminal elimination half-life is approximately 2–4 hours in adults with normal renal function; prolonged in renal impairment.
Oxycodone is primarily metabolized by CYP3A4 and to a lesser extent by CYP2D6; acetaminophen is metabolized via conjugation (glucuronidation and sulfation) and by CYP2E1 (minor, but produces toxic NAPQI).
Hydrocodone: primarily hepatic via CYP3A4-mediated N-demethylation to norhydrocodone (active) and O-demethylation via CYP2D6 to hydromorphone (active). Acetaminophen: hepatic via glucuronidation and sulfation; minor oxidation by CYP2E1 to NAPQI (toxic metabolite).
Primarily renal (90% as glucuronide conjugates, <10% unchanged). Biliary/fecal excretion is minor (<5%).
Primarily renal (60–70% as unchanged drug and metabolites); minor biliary/fecal excretion (<5%).
Oxycodone: 45-50% (primarily albumin). Acetaminophen: 10-25% (minimal).
<20%; primarily binds to albumin.
Oxycodone: 2.6 L/kg; large Vd indicates extensive tissue distribution.
1.2–1.9 L/kg; suggests extensive distribution into total body water.
Oral oxycodone: 60-87%; Acetaminophen: 75-85%.
Oral: 85–95%; rectal: 70–80%.
e GFR 30-60 m L/min: reduce dose to 50-75% of usual. e GFR 10-29 m L/min: reduce dose to 25-50% of usual. e GFR <10 m L/min: avoid use or use with extreme caution; reduce dose to 25% and extend dosing interval to every 8-12 hours.
GFR 30-59 m L/min: Administer every 6 hours; GFR 10-29 m L/min: Administer every 8 hours; GFR <10 m L/min: Administer every 12 hours; avoid use in severe renal impairment.
Child-Pugh Class A: no adjustment necessary. Child-Pugh Class B: reduce starting dose by 50% (e.g., oxycodone 2.5-5 mg) and monitor. Child-Pugh Class C: avoid use or use with extreme caution; reduce dose to 25% and extend interval.
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: Use not recommended due to hepatotoxicity risk.
Weight-based: oxycodone 0.05-0.15 mg/kg per dose, acetaminophen 10-15 mg/kg per dose, orally every 4-6 hours as needed; maximum acetaminophen 75 mg/kg/day (not to exceed 4000 mg/day) in children ≥12 years; for children <12 years, max acetaminophen 75 mg/kg/day (max 325 mg per dose in children <6 years).
Children ≥2 years: Hydrocodone 0.1-0.2 mg/kg/dose (max 5 mg/dose) plus acetaminophen 10-15 mg/kg/dose (max 500 mg/dose) orally every 4-6 hours as needed; maximum 5 doses per day.
Start with lowest available dose (oxycodone 2.5-5 mg); consider extended dosing interval (every 6-8 hours); monitor renal and hepatic function; avoid in patients with advanced liver disease or GFR <30 m L/min.
Start at lower end of dosing range (e.g., 1 tablet every 6 hours) due to increased sensitivity to opioids and renal clearance decline; monitor for respiratory depression and sedation.
Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; risks from concomitant use with benzodiazepines or other CNS depressants; hepatotoxicity associated with acetaminophen.
Risk of addiction, abuse, and misuse; serious, life-threatening or fatal respiratory depression from opioid use; accidental ingestion of acetaminophen can cause acute liver failure; neonatal opioid withdrawal syndrome with prolonged use during pregnancy; risks from concomitant use with benzodiazepines or other CNS depressants.
Respiratory depression; increased intracranial pressure; severe hypotension; hepatotoxicity (acetaminophen); opioid-induced hyperalgesia; adrenal insufficiency; severe hypotension; risks of use in patients with gastrointestinal obstruction; seizures; severe renal impairment.
Addiction, abuse, and misuse; respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; risk with concomitant use of CNS depressants; severe hypotension; seizures; serotonin syndrome; adrenal insufficiency; hepatotoxicity (acetaminophen overdose); hypersensitivity reactions; constipation; urinary retention; impaired mental/physical abilities.
Significant respiratory depression; acute or severe bronchial asthma; known hypersensitivity to oxycodone, acetaminophen, or any component; suspected or known gastrointestinal obstruction (e.g., paralytic ileus); severe hepatic impairment.
Hypersensitivity to hydrocodone, acetaminophen, or any component; significant respiratory depression; acute or severe bronchial asthma; known or suspected GI obstruction (e.g., paralytic ileus); use of MAO inhibitors (concurrent or within 14 days).
Avoid alcohol consumption as it increases the risk of hepatotoxicity from acetaminophen and enhances CNS depression from oxycodone. Grapefruit juice may potentiate oxycodone effects by inhibiting CYP3A4 metabolism; avoid concurrent use. High-fat meals may delay absorption of oxycodone but no specific food restrictions otherwise.
Avoid grapefruit and grapefruit juice as they may alter metabolism of hydrocodone. Take with food if gastrointestinal upset occurs. Avoid alcohol-containing foods or beverages. No other significant food interactions.
Pregnancy Category D (FDA). First trimester: Risk of neural tube defects and congenital anomalies with chronic use; no adequate studies. Second trimester: Continued risk of fetal dependence and withdrawal; growth restriction possible. Third trimester: High risk of neonatal opioid withdrawal syndrome (NOWS), respiratory depression, and preterm birth; avoid prolonged use.
First trimester: No adequate studies; risk cannot be ruled out. Second and third trimesters: Avoid prolonged use or high doses near term due to potential premature closure of ductus arteriosus and oligohydramnios.
Oxycodone is excreted into breast milk; M/P ratio ~3.4 (for oxycodone). Relative infant dose 1.7-6.8% of maternal weight-adjusted dose; may cause infant sedation, respiratory depression, and withdrawal. Use with caution, monitor infant for somnolence and feeding difficulties; avoid if mother is on high doses or has CYP2D6 ultra-rapid metabolizer status.
No data on M/P ratio; use with caution. Low molecular weight may be excreted into breast milk; monitor infant for sedation or respiratory depression.
Increased hepatic clearance and volume of distribution in pregnancy may require dose adjustments. No specific guidelines; consider using lowest effective dose and short-term therapy. Taper if discontinuing to prevent withdrawal. Avoid in labor due to neonatal respiratory depression; reserve for severe pain.
No specific dose adjustments required; however, due to increased renal clearance in pregnancy, shortened dosing intervals or higher doses may be needed for adequate analgesia. Monitor clinical response and adjust accordingly.
ROXICET contains oxycodone (an opioid agonist) and acetaminophen. Always assess pain severity and opioid tolerance before prescribing. Monitor for respiratory depression, especially in opioid-naive patients. The maximum daily acetaminophen dose is 4 g (consider hepatic impairment and alcohol use). Avoid concurrent use of other acetaminophen-containing products. Prescribe naloxone for patients at risk of overdose. Use with caution in elderly, renal impairment, and respiratory conditions.
Co-Gesic is a fixed-dose combination of hydrocodone and acetaminophen. Monitor for acetaminophen hepatotoxicity; maximum daily acetaminophen dose should not exceed 4 g. Hydrocodone is a Schedule II controlled substance with abuse potential. Use with caution in patients with respiratory compromise, COPD, or sleep apnea. Avoid concurrent use with other CNS depressants including alcohol. In opioid-tolerant patients, withdrawal may occur if discontinued abruptly.
Take exactly as prescribed; do not increase dose or frequency without consulting your doctor.,This medication can cause drowsiness or dizziness; avoid driving or operating machinery until you know how you react.,Do not consume alcohol or other central nervous system depressants (e.g., benzodiazepines) while taking this medication.,Risk of dependence; do not share this medication with others. Store securely out of reach of children and pets.,Dispose of unused medication via a drug take-back program or mix with unpalatable substances and seal in a plastic bag before discarding.,Contact your doctor if you experience signs of allergic reaction (rash, itching, swelling), severe constipation, nausea/vomiting, or difficulty breathing.,Avoid taking other acetaminophen-containing products; do not exceed 4,000 mg of acetaminophen per day.
Take exactly as prescribed; do not increase dose or frequency without consulting your doctor.,Avoid alcohol while taking this medication due to risk of liver damage and increased sedation.,Do not take other medications containing acetaminophen (Tylenol, many cold/flu products) to avoid exceeding the maximum daily dose (4 grams).,This medication may cause drowsiness or dizziness; do not drive or operate machinery until you know how it affects you.,Store securely out of reach of children and dispose of unused medication properly (take-back programs preferred).,Do not crush or chew extended-release formulations (if applicable).,Report signs of liver injury (yellowing skin/eyes, dark urine, abdominal pain) or respiratory depression (slow/shallow breathing) immediately.
No interactions on record
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about ROXICET vs CO-GESIC, answered by our medical review team.
ROXICET is a Opioid Analgesic Combination that works by Roxicet is a combination of oxycodone, a full mu-opioid receptor agonist, and acetaminophen, which inhibits cyclooxygenase (COX) enzymes, primarily in the central nervous system, to reduce pain perception and fever.. CO-GESIC is a Opioid Analgesic Combination that works by CO-GESIC (hydrocodone/acetaminophen) is a combination analgesic. Hydrocodone is an opioid agonist that binds to mu-opioid receptors in the CNS, inhibiting ascending pain pathways and altering pain perception. Acetaminophen inhibits cyclooxygenase (COX) enzymes in the CNS, reducing prostaglandin synthesis and elevating pain threshold.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between ROXICET and CO-GESIC depend on the specific clinical indication. These are both Opioid Analgesic Combination agents and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of ROXICET is: 1-2 tablets (oxycodone 5-10 mg/acetaminophen 325-650 mg) orally every 4-6 hours as needed for pain; maximum acetaminophen 4000 mg/day (3000 mg/day in high-risk patients).. The standard adult dose of CO-GESIC is: 1-2 tablets (hydrocodone 5 mg/acetaminophen 500 mg per tablet) orally every 4-6 hours as needed for pain, maximum 8 tablets per day.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between ROXICET and CO-GESIC in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. ROXICET is classified as Category C. Pregnancy Category D (FDA). First trimester: Risk of neural tube defects and congenital anomalies with chronic use; no adequate studies. Second trimester: Continued risk of fetal d. CO-GESIC is classified as Category C. First trimester: No adequate studies; risk cannot be ruled out. Second and third trimesters: Avoid prolonged use or high doses near term due to potential premature closure of ductu. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.