Naltrexone Hydrochloride (nal-TREX-one hye-droe-KLOR-ide), Oxycodone Hydrochloride (ox-i-KOE-done hye-droe-KLOR-ide)

Treat severe pain. This medicine is an opioid pain reliever.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
• Swallow the extended-release capsule whole. Do not crush, break, or chew it.
• If you have trouble swallowing the capsule, you may open and sprinkle the medicine into one tablespoon of applesauce. Swallow the mixture right away. Do not save the mixture for later use. Rinse your mouth to make sure you have swallowed all of the mixture. Do not chew it. Do not give this medicine through a nasogastric or gastric tube (stomach tube).
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor in the past 14 days.
• Some medicines can affect how oxycodone/naltrexone works. Tell your doctor if you are using any of the following:
  • Carbamazepine, erythromycin, ketoconazole, mirtazapine, phenytoin, rifampin, ritonavir, tramadol, trazodone
  • Diuretic (water pill)
  • Medicine to treat depression, anxiety, or mental health problems (including SNRIs, SSRIs, TCAs)
  • Medicine to treat migraine headache
  • Phenothiazine medicine (including chlorpromazine, perphenazine, promethazine, prochlorperazine, thioridazine)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, breathing problems or lung disease (including asthma or COPD), low blood pressure, adrenal problems, gallbladder disease, or pancreas disease. Tell your doctor if you have a history of head injury, brain tumor, depression, mental health problems, seizures, or alcohol or drug use disorder.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Adrenal gland problems
  • Low blood pressure
  • Seizures
  • Serotonin syndrome, when used with certain medicines
• This medicine may make you dizzy, drowsy, or faint. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blue lips, fingernails, or skin
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, seizures
• Severe confusion, lightheadedness, dizziness, fainting
• Severe constipation, stomach pain
• Trouble breathing or slow breathing

If you notice these less serious side effects, talk with your doctor:

• Headache, drowsiness
• Mild constipation, diarrhea, nausea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088