Troxyca ER

Generic name:naltrexone hydrochloride and oxycodone hydrochloride
Drug class:Narcotic analgesic combinations
Approval date: August 19, 2016
Company: Pfizer Inc.

Medically reviewed by Drugs.com. Last updated on Jul 30, 2021.

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.

Warnings

• 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 applesau...