naloxone and oxycodone

Generic name: naloxone and oxycodone [ nal-OX-one-and-OX-i-KOE-done ]
Brand name: Targiniq ER
Drug class: Narcotic analgesic combinations

What is naloxone and oxycodone?

Naloxone blocks certain effects of opioid medication, including feelings of well-being that can lead to opioid abuse.

Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic.

Naloxone and oxycodone is a combination medicine used for around-the-clock treatment of severe pain that is not controlled by other medicines. Naloxone is included in this medicine to prevent the misuse of the narcotic ingredient.

This medicine is not for use on an as-needed basis for pain that is not around-the-clock.

Naloxone and oxycodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about naloxone and oxycodone?

You should not use this medicine if you have severe asthma or breathing problems, severe liver disease, or a blockage in your stomach or intestines.

This medicine can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the pill whole to avoid a potentially fatal dose. Never share naloxone and oxycodone medicine with another person.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Oxycodone may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Some medicines can interact with naloxone and oxycodone, and cause dangerous side effects or death. Tell your doctor about all your current medicines and any you start or stop using.

Do not drink alcohol. Dangerous side effects or death could occur.

What should I discuss with my healthcare provider before taking naloxone and oxycodone?

You should not use this medicine if you are allergic to naloxone or oxycodone, or if you have:

• severe asthma or breathing problems;

• severe liver disease; or

• a blockage in your stomach or intestines.

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 naloxone and 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;

• heart disease;

• 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).

It is not known whether this medicine will harm an unborn baby. 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. Tell your doctor if you are pregnant or plan to become pregnant.

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

How should I take naloxone 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 take naloxone and 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. 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 naloxone and oxycodone is against the law.

Do not crush, chew, or break a naloxone and oxycodone extended-release tablet. Swallow it whole to avoid exposure to a potentially fatal dose.

Naloxone and oxycodone is usually taken every 12 hours. Take the medicine at the same time each day.

Do not stop using naloxone and oxycodone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using naloxone and oxycodone.

Never crush or break a naloxone and oxycodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of oxycodone and similar prescription drugs.

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

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 naloxone and oxycodone pills. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills down the toilet.

What happens if I miss a dose?

Since naloxone and 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. A naloxone and oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness, weak or limp muscles, cold and clammy skin, pinpoint pupils, loss of consciousness, weak pulse, or slowed breathing (breathing may stop).

What should I avoid while taking naloxone and oxycodone?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with naloxone and oxycodone.

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

Naloxone and oxycodone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• shallow breathing, slow heartbeat, cold, clammy skin;

• seizure (convulsions);

• confusion, severe drowsiness;

• a light-headed feeling, like you might pass out;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex; or

• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Naloxone and oxycodone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common side effects may include:

• drowsiness, headache, dizziness;

• stomach pain, nausea, constipation;

• anxiety; or

• sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Naloxone and oxycodone dosing information

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. Discontinue all other around the clock opioid drugs when initiating therapy with extended-release oxycodone/naltrexone

All doses expressed as oxycodone/naloxone

Use of a single dose greater than 40 mg/20 mg or a total daily dose greater than 80 mg/40 mg is reserved for patients who are opioid tolerant.

OPIOID-NAIVE and OPIOID NON-TOLERANT patients:
Initial dose: 10 mg/5 mg orally every 12 hours

Comments:
-Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression with first dose.

DOSE CONVERSIONS
From Other Oral Oxycodone Formulations:
-Initial dose: One-half of total daily oral oxycodone dose as oxycodone/naloxone orally every 12 hours
From Other Opioids:
-Dose conversions should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response; see dose adjustment section

MAINTENANCE DOSE:
-Adjust by 10 mg/5 mg every 12 hours every 1 to 2 days as needed based on efficacy, safety, and tolerability; individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; close observation and frequent titration are warranted until pain management is stable; once stable, periodically reassess for continued need
Maximum Dose: 40 mg/20 mg every 12 hours

Comments:
-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, oral hydrocodone 60 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.
-Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following all dose increases.

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.

What other drugs will affect naloxone and oxycodone?

Sometimes it is not safe to use certain medications at the same time. Some drugs can raise or lower your blood levels of oxycodone, which may cause side effects or make oxycodone less effective. Oxycodone can also affect blood levels of certain other drugs, making them less effective or increasing side effects.

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

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• 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 naloxone and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Date modified: September 05, 2017
Last reviewed: October 14, 2016

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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