"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
(oxycodone hydrochloride and naloxone hydrochloride) Extended Release Tablets
ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION
Addiction, Abuse, and Misuse
TARGINIQ™ ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing TARGINIQ ER and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS AND PRECAUTIONS].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of TARGINIQ ER. Monitor for respiratory depression, especially during initiation of TARGINIQ ER or following a dose increase. Instruct patients to swallow TARGINIQ ER tablets whole; crushing, chewing, or dissolving TARGINIQ ER tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone [see WARNINGS AND PRECAUTIONS].
Accidental ingestion of even one dose of TARGINIQ ER, especially by children, can result in a fatal overdose of oxycodone [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of TARGINIQ ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 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 [see WARNINGS AND PRECAUTIONS].
Cytochrome P450 3A4 Interaction
The concomitant use of TARGINIQ ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving TARGINIQ ER and any CYP3A4 inhibitor or inducer [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
TARGINIQ ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) is a combination product containing an opioid agonist, oxycodone, and an opioid antagonist, naloxone. TARGINIQ ER is supplied as 10 mg/5 mg, 20 mg/10 mg, and 40 mg/20 mg tablets for oral administration. The tablet strengths, a 2:1 ratio in each, describe the amount of oxycodone and naloxone per tablet as the hydrochloride salts, respectively. The structural formula for oxycodone hydrochloride is as follows:
C18H21NO4 •HCl MW 351.83
The chemical name is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.
Oxycodone is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL). It is slightly soluble in alcohol (octanol water partition coefficient 0.7).
The structural formula for naloxone hydrochloride is as follows:
C19H21NO4 •HCl MW 363.84
The chemical name is (-)-17-Allyl-4,5α -epoxy-3,14-dihydroxy-morphinan-6-one hydrochloride.
Naloxone hydrochloride occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform.
The 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg extended-release tablets contain the following inactive ingredients: lactose monohydrate, stearyl alcohol, ethyl cellulose, povidone, talc, magnesium stearate, polyvinyl alcohol partially hydrolyzed, titanium dioxide, and Macrogol. The 20 mg/10 mg extended-release tablets also contain: Iron oxide red. The 40 mg/20 mg extended-release tablets also contain: Iron oxide yellow.
The film-coated extended-release tablets are color coded to distinguish different strengths as follows:
The 10 mg/5 mg extended-release tablets are white.
The 20 mg/10 mg extended-release tablets are pink.
The 40 mg/20 mg extended-release tablets are yellow.
Last reviewed on RxList: 8/4/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Targiniq ER Information
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