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(hydrocodone bitartrate) Extended-release Tablets
ADDICTION, ABUSE, AND MISUSE; LIFE THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
VANTRELA 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 VANTRELA ER and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS AND PRECAUTIONS].
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of VANTRELA ER. Monitor for respiratory depression, especially during initiation of VANTRELA ER or following a dose increase. Instruct patients to swallow VANTRELA ER tablets whole; crushing, chewing or dissolving VANTRELA ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see WARNINGS AND PRECAUTIONS].
Accidental ingestion of even one dose of VANTRELA ER, especially by children, can result in a fatal overdose of hydrocodone [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of VANTRELA 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 VANTRELA ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone 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 hydrocodone plasma concentration. Monitor patients receiving VANTRELA ER and any CYP3A4 inhibitor or inducer [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].
- Reserve concomitant prescribing of VANTRELA ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
VANTRELA ER (hydrocodone bitartrate) extended-release tablets are an opioid agonist for oral use. The tablets contain hydrocodone bitartrate, an opioid agonist. Hydrocodone bitartrate is a white to slightly yellow-white crystalline powder. The chemical name is 4,5α-epoxy-3-methoxy- 17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). The structural formula for hydrocodone bitartrate is provided below:
C18H21NO3 • C4H6O6 • 2.5 H2O Molecular Mass: 494.50 g/mol
VANTRELA ER (hydrocodone bitartrate) extended-release tablets contain 15 mg, 30 mg, 45 mg, 60 mg, or 90 mg of hydrocodone bitartrate.
The 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg tablets contain the following inactive ingredients: lactose monohydrate, ethyl cellulose, hypromellose, glyceryl behenate, and magnesium stearate.
The 15 mg tablets also contain red ferric oxide.
The 30 mg tablets also contain yellow ferric oxide.
The 60 mg tablets also contain FD&C Blue #2 aluminum lake.
The 90 mg tablets also contain yellow ferric oxide and FD&C Blue #2 aluminum lake.
Last reviewed on RxList: 1/26/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Vantrela ER Information
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