Troxyca ER

Troxyca ER is a prescription medication used to manage severe pain. It is formulated to deter abuse. 

Troxyca ER is a single product containing 2 medications: oxycodone and naltrexone.

Oxycodone belongs to a group of drugs called opioids. Opioids block the pain signal from reaching the brain, which helps to reduce the perception of pain. Naltrexone belongs to a group of drugs called opiate antagonists. It works by blocking the effects of opioid medications.

This medication comes in capsule form and is to be taken by mouth. The dosing is selected by a prescriber trained in pain management and depends on the severity of pain, response, prior pain management therapies, and risk factors for addiction, abuse, and misuse. The lowest effective dose should be given for the shortest possible duration. 

Swallow capsule whole; do not crush, chew, or dissolve the pellets in capsule.

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

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

Troxyca ER is a combination opioid agonist/opioid antagonist product indicated 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. The opioid antagonist component is present to deter abuse. 

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:

• severity of pain
• response to the medication
• prior pain management therapies
• risk factors for addiction, abuse, and misuse
• other medical conditions
• other medications used

The dosing is selected by a prescriber trained in pain management. For those who have never used opioids for pain management, the recommended initial dose is 10mg of oxycodone with 1.2mg naltrexone every 12 hours. There is no official maximum dose, but the lowest effective dose should be given for the shortest possible duration. 

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION

• Troxyca ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing, and monitor regularly for 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 Troxyca ER capsules whole to avoid exposure to a potentially fatal dose of oxycodone.

• Accidental ingestion of Troxyca ER, especially by children, can result in fatal overdose of oxycodone.

• Prolonged use of Troxyca ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

• Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in fatal overdose of oxycodone from Troxyca ER.

Serious side effects have been reported with Troxyca ER including the following: 

Addiction, Abuse, and Misuse. Use Troxyca ER exactly how prescribed for the purpose of managing severe pain. Inappropriate use of Troxyca ER can lead to overdose and death. Contact emergency services immediately if you experience any symptoms of overdose such as:

• difficulty breathing 
• shallow, infrequent breaths
• excess sedation
• loss of consiousness
• pin-point pupils
• blue skin

Life-threatening breathing problems (respiratory depression). Contact your healthcare provider right away if you experience any breathing difficulties. 

Neonatal opioid withdrawal syndrome. Use of Troxyca ER during pregnancy can lead to a life-threatening withdrawal syndrome once the baby is born. Do not use Troxyca if you are pregnant or plan to become pregnant. 

Severely low blood pressure (hypotension). Contact your healthcare provider if you experience any signs of hypotension such as:

• dizziness
• dizziness upon standing
• blurred vision
• lightheadedness
• nausea
• cold, clammy, pale skin

Serotonin syndrome. Contact your healthcare provider if you experience any signs of serotonin syndrome such as:

• agitation or restlessness
• confusion
• rapid heart rate and high blood pressure
• dilated pupils
• muscle twitches
• heavy sweating
• diarrhea

Risks due to interactions with other medications. Interactions with medications can increase the risk of serious, life-threatening side effects. See "Troxyca ER Drug Interactions" for more information. 

Adrenal insufficiency. Contact your healthcare provider if you experience any signs of adrenal insufficiency such as:

• nausea/vomiting
• anorexia
• fatigue
• weakness
• dizziness
• low blood pressure

Increased risk of seizures in those with seizure disorder. Contact your healthcare provider if you have a seizure disorder and experience an increase in seizures.

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

Common side effects of Troxyca ER include the following: 

• nausea
• constipation
• vomiting
• headache
• drowsiness/tiredness
• dizziness
• abdominal pain

This is not a complete list of Troxyca 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. 

Central nervous system depressants: could increase risk of breathing problems, coma, and death; includes the following:

• benzodiazepines such as alprazolam (Xanax), clonazepam (Klonopin), and diazepam (Valium) 
• sleep medications such as zolpidem (Ambien)
• muscle relaxants such as carisoprodol and cyclobenzaprine
• alcohol

Serotonergic medications: medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone, paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)

Monoamine oxidase inhibitors: a class of antidepressants that includes medications such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)

Mixed Agonist/Antagonist and Partial Agonist Opioids: Avoid use with Troxyca ER because they may reduce effect of Troxyca ER or lead to withdrawal symptoms. 

CYP3A4 inhibitors: medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone.

Tell your healthcare provider if you are pregnant or plan to become pregnant. 

Prolonged use of Troxyca ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. 

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. 

Troxyca ER use is not recommended if you are breastfeeding because it may harm your baby.