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In addition to requiring new labeling on these prescript"...
(hydrocodone bitartrate) Extended Release Capsules
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL
Addiction, Abuse, and Misuse
Zohydro 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 Zohydro 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 Zohydro ER. Monitor for respiratory depression, especially during initiation of Zohydro ER or following a dose increase. Instruct patients to swallow Zohydro ER capsules whole; crushing, chewing, or dissolving Zohydro ER capsules can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see WARNINGS AND PRECAUTIONS].
Accidental consumption of even one dose of Zohydro ER, especially by children, can result in a fatal overdose of hydrocodone [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged maternal use of Zohydro ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening and requires management according to protocols developed by neonatology experts [see WARNINGS AND PRECAUTIONS].
Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Zohydro ER. The co-ingestion of alcohol with Zohydro ER may result in increased plasma levels and a potentially fatal overdose of hydrocodone [see CLINICAL PHARMACOLOGY].
Hydrocodone bitartrate is an opioid agonist and occurs as fine, white crystals, or as a crystalline powder.
The chemical name is 4,5(alpha)-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5) or morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5 alpha)-, [R (R*, R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It has the following structural formula:
C18H21NO3• C4H6O6 2 ½ H2O
Zohydro ER (hydrocodone bitartrate) extended-release capsules are hard gelatin capsules for oral administration. Each Zohydro ER capsule contains either 10, 15, 20, 30, 40, or 50 mg of hydrocodone bitartrate USP and the following inactive ingredients: sugar spheres NF, hypromellose USP, ammonio methacrylate copolymer NF, silicon dioxide NF, and talc USP. The capsule shells collectively contain titanium dioxide, FD&C Blue #1, FD&C Red #40, FDA Yellow iron oxide, FD&C Red #3, FDA Black iron oxide, FDA Red iron oxide, and gelatin.
Last reviewed on RxList: 11/7/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Zohydro ER Information
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