Names and pronunciation
Combunox
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Drug reference
Combunox
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Func. class.: Opiate analgesic
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Chem. class.: Semisynthetic derivative Controlled Substance Schedule II
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Do not confuse: oxyCODONE/HYDROcodone
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ACTION: Inhibits ascending pain pathways in CNS, increases pain thresh- old, alters pain perception
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USES: Moderate to severe pain
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Unlabeled uses: Postherpetic neuralgic (cont rel)
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CONTRAINDICATIONS: Hyper- sensitivity, addiction (opiate), asthma, ileus
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Black Box Warning: Respiratory depres- sion Precautions: Pregnancy, breastfeeding, child <18 yr, addictive personality, increased intracranial pressure, MI (acute), severe heart disease, renal/ hepatic disease, bowel impaction Black Box Warning: Opioid-naïve pa- tients, substance abuse, accidental ex- posure, potential for overdose/poisoning, status asthmaticus Black Box Warning: Increase: effects with other CNS depressants—alcohol, opioids, sedative/hypnotics, antipsychot- ics, skeletal muscle relaxants Increase: oxyCODONE level—CYP3A4 inhibitors Increase: toxicity—cimetidine, MAOIs Drug/Herb Increase: sedative effect—kava, St. John’s wort, valerian Drug/Lab Test Increase: amylase, lipase Black Box Warning: Respiratory dys- function: respiratory depression, char- acter, rate, rhythm; notify prescriber if respirations are <10/min; monitor B/P, pulse baseline and periodically • Bowel status: constipation; stimulant laxative may be needed with fluids, fiber Black Box Warning: Substance abuse: assess for substance abuse in patient/ family/friends before prescribing; moni- tor for abuse, may crush, chew, snort, or inject ext rel product; may be fatal Black Box Warning: Accidental ex- posure: dispose of properly away from pets, children Black Box Warning: Pregnancy/breast- feeding: use only if benefits outweigh fetal risk; neonatal opioid withdrawal syndrome may occur with extended use; avoid breastfeeding, excreted in breast milk • Beers: avoid in older adults; ataxia, impaired psychomotor function may oc- cur • Assistance with ambulation • Safety measures: night-light, call bell within easy reach
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SIDE EFFECTS CNS: Drowsiness, dizziness, confusion, headache, sedation, euphoria, fatigue, abnormal dreams/thoughts, hallucinations CV: Palpitations, bradycardia, change in B/P EENT: Tinnitus, blurred vision, miosis, diplopia GI: Nausea, vomiting, anorexia, con- stipation, cramps, gastritis, dyspepsia, biliary spasms GU: Increased urinary output, dysuria, urinary retention INTEG: Rash, urticaria, bruising, flush- ing, diaphoresis, pruritus RESP: Respiratory depression
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INTERACTIONS
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TREATMENT OF OVERDOSE: Naloxone (Narcan) 0.2-0.8 mg IV, O2, IV fluids, vasopressors, caution with patients physically dependent on opioids See Appendix B O See Appendix B HIGH ALERT
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DOSAGE AND ROUTES OxyCODONE Severe Pain • Adult: PO 10-30 mg q4hr (5-15 mg q4-6hr for opiate-naïve patients). Con- centrated sol is extremely concentrated; do not use interchangeably; CONT REL 10 mg q12hr for opiate-naïve patients • Child >5 yr/adolescent: PO (unla- beled) 0.2 mg/kg given 30 min pre procedural OxyCODONE/acetaminophen O moderate-moderately severe pain • Adult: PO IR 2.5-10 mg oxyCODONE and 325 mg acetaminophen q6hr, max 60 mg oxyCODONE or 4 g acetamino- phen per day Acute pain • Adult: PO ext rel 2 tabs q12hr, max acetaminophen 4 g OxyCODONE/aspirin moderate to moderately severe pain • Adult: PO 1 tab q6hr as needed, max 12 tabs/24 hr OxyCODONE/ibuprofen moderate to severe pain • Adult: PO 1 tab q6hr, max 4 tabs/24 hr, max 7 days
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Available forms: OxyCODONE: cont rel tabs (OxyCONTIN) 10, 15, 20, 30, 40, 80, 160 mg; immediate rel tabs 5, 7.5, 10, 15, 20, 30 mg; immediate rel caps 5 mg; oral sol 5 mg/5 mL, 20 mg/mL; oxyCODONE with acetaminophen: 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, 7.5 mg/300 mg, 10 mg/325 mg, oral sol 5 mg/325 mg/5 mL; ext rel caps 9, 13.5, 18, 27, 36 mg; oxyCODONE with aspirin: 4.835 mg/325 mg; oxyCO- DONE with ibuprofen: 5 mg/400 mg
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Administer: • Clarify all orders; fatalities have oc- curred • Regular administration is more effective than PRN; give before pain becomes severe • Discontinue gradually after long-term use • Store in light-resistant area at room temperature • OxyCODONE should be titrated from the initial recommended dosage to the dosage required to relieve pain • There is no maximum dosage of oxy- CODONE; however, careful titration is required until tolerance develops to some of the side effects (drowsiness, re- spiratory depression) Oral solid formulations Immediate-release tablets route • May be administered with food or milk to minimize GI irritation Extended-release caps route • Xtampza ER brand capsules: take with food and the same amount of food • Capsule contents may be sprinkled onto soft foods (applesauce, pudding, yogurt, ice cream, or jam) or into a cup and then given directly into the mouth; swallow immediately and rinse mouth • Capsule contents may be given through an NG or gastrostomy tube. Flush tube with water. Open a capsule and pour the con- tents directly into the tube. Do not premix capsule contents with the liquid that will be used to flush the tube. Draw up 15 mL of water into a syringe, insert the syringe into the tube, and flush the contents through the tube. Repeat flushing twice using 10 mL of water with each flush. Extended-release 36-mg capsules are for use ONLY in opioid- tolerant patients • Monitor patients closely for respiratory depression, particularly within the first 24-72 hr after initiation or dose escalation Controlled-release tablets route (OxyCONTIN): • Administer whole; do not crush, chew, or break in half; taking chewed, broken, or crushed controlled-release tablets could lead to the rapid release and absorption of a potentially toxic dose of oxyCODONE • OxyCONTIN brand tablets: do not pre- soak, lick, or otherwise wet tablet before administering dose; administer 1 tablet at a time; allow patient to swallow each tab- let separately with sufficient liquid • OxyCODONE controlled-release (Oxy- CONTIN) 60-mg and 80-mg tablets are for use only in opioid-tolerant patients • May be administered without food Oral liquid formulations Oral concentrate solution route • Is a highly concentrated sol (20 mg oxyCODONE/mL), and care should be taken in dispensing and administering this medication; the sol may be added to 30 mL of a liquid or semisolid food; if the medication is placed in liquid or food, consume immediately; do not store di- luted oxyCODONE for future use
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Assess: • Pain: intensity, location, type, character- istics; need for pain medication by pain/ sedation scoring; physical dependence • I&O ratio; check for decreasing out- put; may indicate urinary retention • CNS changes: dizziness, drowsiness, hallucinations, euphoria, LOC, pupil re- action • Allergic reactions: rash, urticaria
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Evaluate: • Therapeutic response: decrease in pain without dependence
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report any symptoms of CNS changes, allergic reactions • That physical dependency may result from extended use • That withdrawal symptoms may occur after long-term use: nausea, vomiting, cramps, fever, faintness, anorexia • To avoid CNS depressants, alcohol • To avoid driving, operating machinery if drowsiness occurs
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PHARMACOKINETICS PO: Onset 15-30 min, peak 1 hr, dura- tion reg rel 2-6 hr, cont rel 12 hr, metabolized by liver, excreted in urine, crosses placenta, excreted in breast milk, half-life 3-5 hr, protein binding 45%
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• Adult: PO 10-30 mg q4hr (5-15 mg q4-6hr for opiate-naïve patients). Con- centrated sol is extremely concentrated; do not use interchangeably; CONT REL 10 mg q12hr for opiate-naïve patients
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• Child >5 yr/adolescent: PO (unla- beled) 0.2 mg/kg given 30 min pre procedural OxyCODONE/acetaminophen O moderate-moderately severe pain
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• Adult: PO IR 2.5-10 mg oxyCODONE and 325 mg acetaminophen q6hr, max 60 mg oxyCODONE or 4 g acetamino- phen per day Acute pain
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• Adult: PO ext rel 2 tabs q12hr, max acetaminophen 4 g OxyCODONE/aspirin moderate to moderately severe pain
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• Adult: PO 1 tab q6hr as needed, max 12 tabs/24 hr OxyCODONE/ibuprofen moderate to severe pain
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• Adult: PO 1 tab q6hr, max 4 tabs/24 hr, max 7 days
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