Targiniq

Targiniq ER is a prescription medication used to treat severe pain. It is a single product containing 2 medications: oxycodone and naloxone.

Targiniq ER 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 Targiniq ER tablets. Swallow Targiniq ER tablets whole.

Common side effects of Targiniq ER include constipation, nausea, and vomiting.

Targiniq ER 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.

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 Targiniq
• what pain medications you were taking prior to Targiniq
• kidney function
• liver function

Targiniq ER 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).

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.

Serious side effects have been reported with Targiniq ER. 

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 Targiniq ER 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

Targiniq ER 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 Targiniq ER 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 Targiniq ER without talking to your healthcare provider.

Targiniq ER can cause drowsiness. Do not drive or operate heavy machinery until you know how Targiniq ER affects you.

Serious side effects have been reported with Targiniq ER. See the “Targiniq ER Precautions” section.

Common side effects of Targiniq ER include the following:

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

This is not a complete list of Targiniq ER 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 Targiniq ER drug interactions. Ask your doctor or pharmacist for more information.

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.

Targiniq ER 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. Targiniq ER should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Regular use of Targiniq ER 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 of Targiniq ER 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 Targiniq ER, due to the possibility of causing sedation or respiratory depression in the infant. In addition, if Targiniq ER is no longer taken or breastfeeding has stopped, breast-fed infants can experience withdrawal signs.