FDA Approves Troxyca ER

FDA Approved Troxyca ER oxycodone/naltrexone hydrochloride medication from Pfizer Inc. with abuse-deterrent properties for the management of pain!

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) have approved Troxyca ER (oxycodone/naltrexone hydrochloride) in the form of extended-release capsules for oral use to manage severe pain. The medication is safe enough to use daily, around-the-clock, and for long-term opioid treatment and several health conditions with inadequate alternative treatments.

Troxyca ER has some properties to reduce abuse when taken through oral and intranasal routes. However, abuse of Troxyca ER is still possible as it contains an extended-release oxycodone, an opioid agonist, surrounded with naltrexone, an opioid receptor antagonist.

According to Rory O’Connor, MD, Chief Medical Officer, Internal Medicine, Pfizer Inc. “Public health authorities and regulators have encouraged the development of treatments that are more difficult to abuse, yet offer pain relief to appropriate patients when used as indicated. And the development of this medication with abuse-deterrent properties is another example of our ongoing commitment to advancing science and the treatment of patients with pain conditions.”

The Troxyca ER consists of an ER oxycodone “pellet” that surrounds a naltrexone core. The naltrexone can offset the effects of oxycodone, if it is crushed. And the naltrexone remains sequestered and patients get oxycodone in an extended-release manner, if taken directly,

Troxya ER is recommended for patients suffering from various medical issues including respiratory depression, gastrointestinal obstruction, and severe bronchial asthma in certain situations. The most commonly reported medical problems also include constipation, nausea, and vomiting.

IMPORTANT SAFETY INFORMATION

Regular use of Troxyca ER can lead to the risks of opioid addiction, abuse, and misuse, and can result to drug overdose and death.

Life-threatening Respiratory Depression:

  • Use of Troxyca ER may lead to serious, life-threatening, or fatal respiratory depression.
  • Patients are instructed to swallow Troxyca ER capsules whole, swallow immediately without chewing or swallow immediately without chewing
  • Crushing, chewing, or dissolving Troxyca ER can cause its rapid release and absorption of a potentially fatal dose of oxycodone.
  • Monitor for respiratory depression, especially during initiation of Troxyca ER or following a dose increase.

Accidental Ingestion:

Accidental ingestion of Troxyca ER (even one dose), especially by children, can lead to respiratory depression and death due to oxycodone drug overdose.

Neonatal Opioid Withdrawal Syndrome:

Prolonged use of Troxyca ER capsules during pregnancy can increase the risk of neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated properly. The patients should be advised about the risk of neonatal opioid withdrawal syndrome, if opioid use is required for a prolonged time.

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