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Oxycodone (60 MG)

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Oxycodone is an opioid pain medication. Oxycodone is used to treat moderate to severe pain.

The extended-release form of this medicine is for around-the-clock treatment of pain. This form of oxycodone is not for use on an as-needed basis for pain.

Oxycodone may also be used for purposes not listed in this medication guide.

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Description

How should I use 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 take oxycodone in larger amounts, or for longer than prescribed. 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.

Some medicines can interact with oxycodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure oxycodone is safe for you, tell your doctor if you have:

any type of breathing problem or lung disease;
a history of head injury, brain tumor, or seizures;
a history of drug abuse, alcohol addiction, or mental illness;
urination problems;
liver or kidney disease;
Addison’s disease or other adrenal gland disorder;
problems with your gallbladder, pancreas, or thyroid; or
if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).
If you use oxycodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Oxycodone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using oxycodone.

Take oxycodone with food.

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

If your doctor has told you to take two or more oxycodone tablets per dose, take the tablets one at a time. Drink plenty of water to make swallowing easier and to prevent choking.

Measure liquid medicine with the dosing syringe provided, or 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 stop using oxycodone suddenly after long-term use. Ask your doctor how to safely stop using this medicine.

Store at room temperature, away from heat, moisture, and light.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor.

Do not keep leftover 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.

What happens if I miss a dose?
Since oxycodone 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.

What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using oxycodone?
Do not drink alcohol. Dangerous side effects or death could occur.

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how oxycodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Grapefruit and grapefruit juice may interact with oxycodone and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Oxycodone dosing information
Usual Adult Dose for Pain:

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Oral solution: To avoid dosing errors include total dose in mg and mL when prescribing and dispensing oral solution.

Immediate-release:
Initial dose in opioid-naive patients: 5 to 15 mg orally every 4 to 6 hours
-Titrate according to patient’s pain response and tolerability

Comments:
-Selection of initial dose should take into account degree of opioid tolerance, patient’s general condition, medical status, concurrent medications, type and severity of pain, and risk factors for abuse, addiction, or diversion.
-Use of the 100 mg per 5 mL (20 mg/mL) oral solution should be restricted to opioid-tolerant patients only; it may be used in patients who have been titrated to a stable analgesic regimen and who could benefit from a smaller volume of solution.
-It is important to account for inter-patient variability in the potency of opioid drugs and their formulations when converting patients to this drug from other opioids or when switching from controlled-release products; it is best to underestimate a patients oral oxycodone requirement and provide rescue medication than to overestimate and manage an overdose; the manufacturer’s product information and/or local protocol may be consulted for guidance.

Use: For the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic.

Usual Adult Dose for Chronic Pain:

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Extended-release:
Initial dose for opioid-naive and opioid non-tolerant patients:
-Extended-release oxycodone hydrochloride tablets: 10 mg orally every 12 hours
-Extended-release oxycodone (base) capsules: 9 mg orally every 12 hours with food
-Adjust dose every 1 to 2 days as needed to obtain an appropriate balance between pain management and opioid-related adverse reactions
Maintenance dose: Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
Maximum dose: Extended-release oxycodone (base) capsules: 288 mg per day as the safety of the excipients has not been established

Immediate-release:
To avoid dosing errors include total dose in mg and mL when prescribing and dispensing oral solution
-Initial dose in opioid-naive patients: 5 to 15 mg orally every 4 to 6 hours
-Adjust dose as needed to obtain an appropriate balance between pain management and opioid-related adverse reactions.
Maintenance dose: For control of severe chronic pain, the lowest dosage level that will achieve adequate analgesia should be administered on a regularly scheduled basis every 4 to 6 hours.

Comments:
-Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression with first dose; selection of initial dose should take into account degree of opioid tolerance, patient’s general condition, medical status, concurrent medications, type and severity of pain, and risk factors for abuse, addiction, or diversion.
-Use of oxycodone hydrochloride 60 and 80 mg extended release tablets, single doses greater than 40 mg (oxycodone hydrochloride) or 36 mg (oxycodone base), or a total daily dose greater than 80 mg (oxycodone hydrochloride) or 72 mg (oxycodone base), and use of the 100 mg per 5 mL (20 mg/mL) oral solution should be restricted to opioid-tolerant patients.
-Opioid tolerant patients are those who have received for 1 week or longer: oral morphine 60 mg/day; transdermal fentanyl 25 mcg/hr; oral oxycodone 30 mg/day; oral hydromorphone 8 mg/day; oral oxymorphone 25 mg/day or an equianalgesic dose of another opioid.
-Extended-release products are reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; these products are not intended to be used as as-needed (prn) analgesics.

DOSE CONVERSIONS: Dose conversions should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response; the manufacturer’s product information and/or local protocol may be consulted for guidance.
-Discontinue all other around the clock opioid drugs when initiating therapy with extended-release oxycodone.

EQUIVALENCE OF OXYCODONE HYDROCHLORIDE TO OXYCODONE BASE:
-Oxycodone hydrochloride 10 mg = Oxycodone base 9 mg
-Oxycodone hydrochloride 15 mg = Oxycodone base 13.5 mg
-Oxycodone hydrochloride 20 mg = Oxycodone base 18 mg
-Oxycodone hydrochloride 30 mg = Oxycodone base 27 mg
-Oxycodone hydrochloride 40 mg = Oxycodone base 36 mg

Oxycodone Hydrochloride Extended-Release (ER) TABLETS:
-The 60 and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are reserved for opioid tolerant individuals.
CONVERSION FROM OTHER ORAL OXYCODONE FORMULATIONS:
-Administer one-half the patient’s total daily oxycodone hydrochloride dose as extended-release oxycodone hydrochloride every 12 hours.
CONVERSION FROM OTHER ORAL OPIOIDS:
-Initial dose: 10 mg orally every 12 hours
-It is best to underestimate a patient’s 24-hour requirement and provide rescue medication as the dose is titrated.
-Published potency tables can be used to estimate a patient’s 24-hour oral oxycodone requirement; however, there is substantial inter-patient variability.
CONVERSION FROM TRANSDERMAL FENTANYL: Remove transdermal fentanyl patch and 18 hours later initiate oxycodone extended-release tablets at 10 mg every 12 hours for each 25 mcg/hr fentanyl transdermal patch; monitor closely as there is limited documented experience with this conversion.
CONVERSION FROM METHADONE:
-When converting from methadone, close monitoring is of particular importance due to methadone’s long half-life.

Oxycodone Extended-Release (ER) CAPSULES:
-Single doses greater than 36 mg, or a total daily dose greater than 72 mg are reserved for opioid tolerant individuals.
CONVERSION FROM OTHER ORAL OXYCODONE FORMULATIONS:
-Use the same total daily dose of oxycodone and administer one-half the patient’s total daily oxycodone dose as extended-release oxycodone every 12 hours.
-Because Xtampza ER(R) is not bioequivalent to other oxycodone extended-release products, monitor for possible dose adjustment.
CONVERSION FROM OTHER ORAL OPIOIDS:
-Initial dose: 9 mg orally every 12 hours with food
-It is best to underestimate a patient’s 24-hour requirement and provide rescue medication as the dose is titrated.
-Published potency tables can be used to estimate a patient’s 24-hour oral oxycodone requirement; however, there is substantial inter-patient variability.
CONVERSION FROM TRANSDERMAL FENTANYL: Remove the transdermal fentanyl patch and 18 hours later initiate oxycodone extended-release capsules at 9 mg every 12 hours for each 25 mcg/hr fentanyl transdermal patch; monitor closely as there is limited documented experience with this conversion.
CONVERSION FROM METHADONE:
-When converting from methadone, close monitoring is of particular importance due to methadone’s long half-life.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Usual Geriatric Dose for Chronic Pain:

Dosing for geriatric patients should be conservative, generally starting at the lower end of the dosing range.

Extended-release: For geriatric patients who are debilitated and not opioid tolerant: Initial doses should be one-third to one-half the recommended starting doses; titrate carefully

Usual Pediatric Dose for Chronic Pain:

Extended-release tablets only
-Prior to initiating therapy with this drug, patients must be receiving and tolerating opioids for at least 5 consecutive days, and for the 2 days immediately preceding initiation, patients must be taking a minimum of 20 mg of oxycodone per day or its equivalent.
-Discontinue all around-the-clock opioid drugs when initiating oxycodone extended-release tablets

Age: 11 years and older:
-Usual dose: One-half of calculated total oxycodone daily dose orally every 12 hours

TO CALCULATE DOSAGE: Multiply total daily dose of prior opioid by the appropriate conversion factor (CF) provided below; divide by 2 to get the every 12-hour oxycodone extended-release dose; if rounding is necessary, always round down to the nearest tablet strength available
–For prior opioid use of OXYCODONE: Oral CF is 1
–For prior opioid use of HYDROCODONE: Oral CF is 0.9
–For prior opioid use of HYDROMORPHONE: Oral CF is 4; Parenteral CF is 20*
–For prior opioid use of MORPHINE: Oral CF is 0.5; Parenteral CF is 3*
–For prior opioid use of TRAMADOL: Oral CF is 0.17; Parenteral CF is 0.2*
*For patients receiving high-dose parenteral opioids, a more conservative CF is warranted (e.g., for high-dose parenteral morphine, use a CF of 1.5 instead of a CF of 3)
-The CFs listed above are to convert from prior opioid use to oxycodone extended-release tablets and not to convert from oxycodone extended-release tablets to another opioid as doing so will result in an over-estimation of the new opioid dose and possibly a fatal overdose.

CONVERSION FROM TRANSDERMAL FENTANYL: Remove patch 18 hours prior to starting oxycodone extended-release.
-Substitute 10 mg oxycodone extended-release every 12 hours for each 25 mcg per hour fentanyl transdermal patch

Titration and Maintenance:
-Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; dose adjustments can be made every 1 to 2 days; when a dose increase is clinically indicated, it is suggested that the total daily oxycodone dose not be increased by more than 25% at a time.
-Patients who experience breakthrough pain may require rescue medication or a dose increase; if the pain level increases after dose stabilization; attempt to identify the source of increased pain before increasing the dose.

Comments:
-Dose conversions should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response; it is preferable to underestimate a patient’s 24-hour oral oxycodone requirement and provide rescue medication than to overestimate and manage an adverse reaction.
-Extended-release oxycodone products are reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; these products are not intended to be used as as-needed (prn) analgesics.
-When selecting the initial dose, take into account the patient’s degree of opioid tolerance, patient’s general condition and medical status, concurrent medications, type and severity of the pain, and risk factors for abuse, addiction, or diversion.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment in opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent and for which alternative treatment options are inadequate.

What other drugs will affect oxycodone?

Some drugs can raise or lower your blood levels of oxycodone, which may cause side effects or make oxycodone less effective. Tell your doctor if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.

This medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • drugs that make you sleepy or slow your breathing–a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or
  • drugs that affect serotonin levels in your body–medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.
  • This list is not complete. Other drugs may interact with oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide
Oxycodone (60 MG)
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