Oxycodone & Naloxone

Oxycodone/naloxone is a prescription medication used to treat pain. It is a single product containing 2 medications: oxycodone and naloxone.

Oxycodone/naloxone belongs to a group of drugs called opioids (narcotic) analgesics. These work by changing the way the brain and nervous system respond to pain.

Naloxone belongs to a group or drugs called opiate antagonists. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood.

This medication comes in tablet form and is taken typically 2 times a day, every 12 hours.

Do not chew, divide, or break oxycodone/naloxone tablets. Swallow oxycodone/naloxone tablets whole.

Common side effects of oxycodone/naloxone include constipation, nausea, and vomiting.

Oxycodone/naloxone is a prescription medication used to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Oxycodone & Naloxone may be found in some form under the following brand names:

• Targiniq

Serious side effects have been reported with oxycodone/naloxone. See the “Oxycodone/Naloxone Precautions” section.

Common side effects of oxycodone/naloxone include the following:

• nausea
• vomiting
• constipation
• sleepiness
• tiredness
• headache
• dizziness
• abdominal pain
• anxiety
• sweating

This is not a complete list of oxycodone/naloxone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non­prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Central Nervous System (CNS) depressants such as sedatives, anxiolytics, hypnotics, neuroleptics, other opioids

• Medications that block the protein enzyme (CYP3A4) in the body such as:
  • macrolide antibiotics (clarithromycin, telithromycin)
  • HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir)
  • HCV protease inhibitors (boceprevir, telaprevir)
  • antifungals (ketoconazole, itraconazole, posaconazole, voriconazole)
  • conivaptan (Vaprisol)
  • delavirdine (Rescriptor)
• Medications that increase the protein enzyme CYP3A4 in the body such as:
  • carbamazepine (Tegretol, Equetro, Carbatrol)
  • phenobarbital
  • phenytoin (Dilantin)
  • rifampin (Rifadin)
  • St John's wort
  • nimodipine (Nimotop)

This is not a complete list of oxycodone/naloxone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with oxycodone/naloxone. 

Get emergency medical help if you have:

• trouble breathing
• shortness of breath
• fast heartbeat
• chest pain
• swelling of your face, tongue or throat
• extreme drowsiness, dizzy, feeling faint
• lightheadedness when changing positions

Do not take oxycodone/naloxone if:

• you are allergic to oxycodone, naloxone or to any of its ingredients
• have moderate to severe liver impairment
• have severe asthma, trouble breathing, or other lung problems
• have a bowel blockage or have narrowing of the stomach or intestines

Oxycodone/naloxone can put you at risk for, opioid addiction, abuse, misuse, overdose and death even if you take your dose exactly as prescribed.

Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Using products containing alcohol during treatment with oxycodone/naloxone may cause you to overdose cause you harm and can even result in death. 

Call your healthcare provider if the dose you are taking does not control your pain.

Do not stop taking oxycodone/naloxone without talking to your healthcare provider.

Oxycodone/naloxone can cause drowsiness. Do not drive or operate heavy machinery until you know how oxycodone/naloxone affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of oxycodone/naloxone there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking oxycodone/naloxone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to oxycodone, naloxone or any of its ingredients
• have hypersensitivity to other opioids
• have asthma, trouble breathing or other lung problems
• have a bowel blockage or have narrowing of the stomach or intestines
• have head injuries or seizures
• have liver, kidney or heart problems
• have problems urinating
• have pancreas or gall bladder problems
• abuse of street or prescription drugs
• have an alcohol addiction
• have mental health problems
• are pregnant or breastfeeding

Tell your baby's doctor right away if your baby experiences any of the following symptoms:

• irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Tell your doctor about all the medicines you take including prescription and non­prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D,   and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Oxycodone/naloxone falls into category C. Based on animal data, may cause harm to the unborn baby. No adequate and well-controlled studies were done in humans. Oxycodone/naloxone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Regular use of oxycodone/naloxone during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

The oxycodone component is likely to be present in breast milk and cause harm to your baby. It is unknown whether naloxone component is present in breast milk.  Women should not breastfeed while taking oxycodone/naloxone, due to the possibility of causing sedation or respiratory depression in the infant. In addition, if oxycodone/naloxone is no longer taken or breastfeeding has stopped, breast-fed infants can experience withdrawal signs. 

Take oxycodone/naloxone exactly as prescribed.

Oxycodone/naloxone comes in an extended release tablet form and is taken every 12 hours at the same time every day.

Do not chew, divide, or break the tablet. Swallow tablets whole.

Do not snort or inject oxycodone/naloxone tablets. 

It can be taken with or without food.

Do not discontinue oxycodone/naloxone without first discussing the need for a tapering regimen with the prescriber. 

Alcohol may intensify some of the side effects of this medication.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of oxycodone/naloxone at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• if you have been taking pain medications prior to oxycodone/naloxone
• what pain medications you were taking prior to oxycodone/naloxone
• kidney function
• liver function

Oxycodone/naloxone doses are also determined by how much pain medication you have recently been taking.

Doses are typically started at 10mg/5mg taken every 12 hours. The maximum daily dose recommended is 80mg/40mg (40mg/20mg every 12 hours).

If you take too much oxycodone/naloxone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

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

Store Targiniq and all medicines out of the reach of children.

Do not drink alcohol while taking Targiniq.

WARNING: ADDICTION, ABUSE, and MISUSE; LIFETHREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION See full prescribing information for complete boxed warning.  

TARGINIQ™ ER exposes users to risks of addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing and monitor regularly for development of these behaviors and conditions.

Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow TARGINIQ ER tablets whole to avoid exposure to a potentially fatal dose of oxycodone.

Accidental ingestion of TARGINIQ ER, especially in children, can result in a fatal overdose of oxycodone.

Prolonged use of TARGINIQ ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone from TARGINIQ ER.