Treatment for: Severe Pain

FDA Approves Troxyca ER

The U.S. Food and Drug Administration (FDA) has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride), an extended-release opioid agonist and opioid antagonist abuse-deterrent formulation 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.

Troxyca ER Medication Guide

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

• Get emergency help right away if you take too much (overdose). Serious or life-threatening breathing problems that can lead to death may occur when you first start treatment, when your dose is changed, or if you take too much (overdose).
• Never give your Troxyca ER to anyone else. They could die from taking it. Store the capsules away from children and in a safe place to prevent stealing or abuse. Selling this medicine, or giving it away is against the law.

Do not take this medicine if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

Before you start treatment, tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• liver, kidney, thyroid problems
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, or mental health problems

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Breastfeeding is not recommended during treatment. It may cause harm to your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking this medicine with certain other medicines can cause serious side effects that could lead to death.

When taking Troxyca ER:

• Do not change your dose. Take this medicine exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose within 12 hours. If you miss a dose, take your next dose at your usual time.
• Swallow the capsules whole. Do not cut, break, chew, crush, dissolve, snort, or inject Troxyca ER because this may cause you to overdose and die.
• Do not give Troxyca ER through a nasogastric tube or gastric tube (stomach tube).
• If you cannot swallow the capsules whole, the contents of the capsule can be sprinkled on a tablespoonful of applesauce. Swallow all the applesauce and capsule contents right away. Rinse your mouth after you have taken the applesauce to make sure you have swallowed all the capsule contents. Flush the empty capsule down the toilet right away.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop treatment without talking to your healthcare provider.
• After you stop taking Troxyca ER, flush any unused capsules down the toilet.

While ta king Troxyca ER DO NOT:

• Drive or operate heavy machinery until you know how Troxyca ER affects you. This medicine can make you sleepy, dizzy, or lightheaded.
• Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment may cause you to overdose and die.

Possible side effects include:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain.

Call your healthcare provider if you have any of these symptoms and they are severe.

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, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.