Acetaminophen and oxycodone

Name: Acetaminophen and oxycodone

How should I take acetaminophen and oxycodone?

Follow all directions on your prescription label. Oxycodone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Oxycodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away acetaminophen and oxycodone is against the law.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using the medicine.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover acetaminophen and oxycodone pills or liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills or liquid medicine down the toilet.

Never crush or break an acetaminophen and oxycodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Acetaminophen and oxycodone dosing information

Usual Adult Dose for Pain:

Immediate-release:
Oxycodone 2.5 mg/acetaminophen 300 or 325 mg: 1 to 2 tablets every 6 hours
Maximum dose: 12 tablets in 24 hours

Oxycodone 5 mg/acetaminophen 300 or 325 mg: 1 tablet orally every 6 hours as needed for pain
Maximum dose: 12 tablets in 24 hours

Oxycodone 7.5 mg/acetaminophen 300 or 325 mg: 1 tablet orally every 6 hours as needed for pain
Maximum dose: 8 tablets in 24 hours

Oxycodone 10 mg/acetaminophen 300 or 325 mg: 1 tablet orally every 6 hours as needed for pain
Maximum dose: 6 tablets in 24 hours

Oral Solution: Oxycodone 5 mg/acetaminophen 325 mg per 5 mL:
Usual dose: Oxycodone 5 mg/acetaminophen 325 mg (5 mL) orally every 6 hours as needed for pain
Maximum dose: Oxycodone 60 mg/acetaminophen 3900 mg (60 mL) in 24 hours
-Verify dose in mg and mL prior to administration

EXTENDED-RELEASE (ER) DOSING:
As First Opioid Analgesic: 2 tablets orally every 12 hours (each ER tablet contains oxycodone 7.5 mg/acetaminophen 325 mg)
-The second dose may be administered as early as 8 hours after initial dose if needed; however, subsequent doses should be administered every 12 hours

Comments:
-Doses should be individually titrated to provide adequate analgesia while minimizing adverse reactions.
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.
-Oxycodone/acetaminophen ER Tablets are not interchangeable with other oxycodone/acetaminophen products.

Use: For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Renal Dose Adjustments

Immediate-release:
-Use with caution; therapy should be initiated with a lower than usual dose; titrate carefully

Extended-release (ER):
Initial dose: Oxycodone 7.5 mg/Acetaminophen 325 mg ER: 1 tablet orally every 12 hours; adjust does as needed

Liver Dose Adjustments

Immediate-release:
-Use with caution; therapy should be initiated with a lower than usual dose; titrate carefully

Extended-release (ER):
Initial dose: Oxycodone 7.5 mg/Acetaminophen 325 mg ER: 1 tablet orally every 12 hours; adjust dose as needed

Other Comments

Administration advice:
-Take orally with or without food

Oral Solution:
-Verify dose in mg and mL prior to administration
-Measure dose with a calibrated measuring device

Extended-release tablets
-Swallow whole, 1 tablet at a time with sufficient water to ensure complete swallowing
-Do not break, chew, crush, cut, dissolve, or split tablets

Storage requirements:
-Protect from light and moisture

General:
-The total acetaminophen dose should not exceed 4 g in 24 hours; be sure to account for all acetaminophen use when calculating total daily dose.
-Because of the risks of addiction, abuse and misuse, the lowest dose for the shortest duration consistent with individual patient treatment goals should be used.
-Frequent communication between members of the healthcare team, patients, and their caregiver/family is important during periods of changing analgesic requirements; if the level of pain increases after dose stabilization, an attempt should be made to identify the source of increased pain before increasing the dose of pain medication.
-Oxycodone/acetaminophen formulations are not interchangeable because of differing pharmacokinetics; if patients switch from the immediate-release formulation to the extended-release tablet, monitor closely for signs of excessive sedation and respiratory depression.

Monitoring:
-Monitor for respiratory depression, especially during initiation and following any increase in dose; close monitoring will be necessary in patients at increased risk and/or those receiving concomitant medications that increase the risk of respiratory depression
-Monitor for signs of hypotension
-Monitor for signs of constipation
-Monitor for the development of behaviors indicative of addiction, abuse, or misuse

Patient advice:
-Advise patients to store this drug safely out of the sight and reach of children; accidental use by a child is a medical emergency and can result in death.
-Patients should understand that this drug, even when taken as recommended can result in addiction, abuse, and misuse; instruct patients not to share their drug with others and protect their drug from theft or misuse.
-Patients should understand the risks of life-threatening respiratory depression, and be informed as to when this risk is greatest; patients and caregivers should be instructed to get emergency help right away if too much drug is taken or if breathing problems occur.
-Patients should be instructed to check with their healthcare provider before taking any new medications, herbal supplements, and over the counter products; patients should not drink alcohol while taking this drug.
-Patients should seek medical advice for signs and symptoms of gastrointestinal events, allergic reactions, and bleeding events; this drug effects platelets and may cause them to bruise or bleed more easily; however, any prolonged, unusual or excessive bleed should be reported promptly.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary; this drug should not be used at 30 weeks gestation or later.
-Patients should be instructed in proper disposal.

Upsides

  • Effective for the management of moderate-to-moderately severe pain unresponsive to other treatment options.
  • The combination is more effective than either drug alone.
  • Available in tablet and oral solution forms, extended-release forms (Xartemis XR), as well as some cost-saving generic versions.

Tips

  • May be taken with or without food.
  • Take as directed by your doctor. Do not increase the dosage without his or her advice.
  • Call emergency services if you experience any breathing difficulties, wheezing, or facial swelling.
  • Tell your doctor if you think you have become addicted to this combination drug.
  • Short-term use is recommended. Do not exceed the prescribed dosage.
  • Tell your doctor if you have severe uncontrolled asthma, other breathing problems, or an intestinal blockage; you may not be able to use this medicine.
  • Call your doctor if you experience nausea or vomiting, stomach pain, itching, yellowing of your skin or eyes (jaundice), or dark (brown) urine, or light-colored stools.
  • Keep out of reach of children and pets because even one dose of this combination narcotic can be fatal.
  • Avoid alcohol as the combination of alcohol and acetaminophen/oxycodone can increase side effects such as sedation and respiratory depression.
  • Xartemis XR is not interchangeable with other acetaminophen/oxycodone products because of differences in the frequency of administration.
  • Swallow extended-release acetaminophen/oxycodone (Xartemis XR) whole.
  • Do not cut, crush, chew or attempt to dissolve Xartemis XR because rapid release and absorption of a potentially fatal dose of oxycodone may occur.
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