"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"...
Provide the following information to patients receiving OXECTA or their caregivers:
- Advise patients that OXECTA is a narcotic pain reliever and must be taken only as directed.
- Advise patients to take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth. Advise patients that OXECTA tablets must be swallowed whole. Do not crush or dissolve. Do not use OXECTA for administration via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.
- Advise patients not to pre-soak, lick or otherwise wet the tablet prior to placing in the mouth.
- Advise patients to take OXECTA only as directed.
- Advise patients not to adjust the dose of OXECTA without consulting with a physician or other healthcare professional.
- Advise patients that OXECTA may cause drowsiness, dizziness, or lightheadedness and may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery). Advise patients started on OXECTA or patients whose dose has been adjusted to refrain from any potentially dangerous activity until it is established that they are not adversely affected.
- Instruct patients not to combine OXECTA with central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, and not to combine with alcohol because dangerous additive effects may occur, resulting in serious injury or death.
- Instruct women of childbearing potential who become or are planning to become pregnant to consult a physician prior to initiating or continuing therapy with OXECTA. Advise patients that safe use in pregnancy has not been established and that prolonged use of opioid analgesics, including OXECTA, during pregnancy may cause fetal-neonatal physical dependence, and neonatal withdrawal may occur.
- If patients have been receiving treatment with OXECTA for more than a few weeks and cessation of therapy is indicated, counsel them on the importance of safely tapering the dose and that abruptly discontinuing the medication could precipitate withdrawal symptoms. Provide a dose schedule to help patients gradually discontinue the medication.
- Advise patients that sharing this OXECTA can result in fatal overdose and death.
- Advise patients that OXECTA is a potential drug of abuse. They must protect it from theft. Patients should keep OXECTA in a locked cabinet, drawer, or medicine safe. It must never be given to anyone other than the individual for whom it was prescribed.
- Instruct patients to keep OXECTA in a secure place out of the reach of children. When OXECTA is no longer needed, the unused tablets should be destroyed by flushing them down the toilet.
- Advise patients taking OXECTA of the potential for severe constipation; appropriate laxatives and/or stool softeners as well as other appropriate treatments should be initiated from the onset of opioid therapy.
- Advise patients of the most common adverse reactions that may occur while taking OXECTA: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
- Advise patients to call 911 or the local Poison Control center and get emergency help immediately if they take more OXECTA than prescribed.
- Advise patients that if they miss a dose to take it as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regularly scheduled time. Do not take 2 doses at once unless instructed by their healthcare provider. If they are not sure about their dosing, call their healthcare provider.
Last reviewed on RxList: 1/29/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Oxecta Information
- Oxecta Drug Interactions Center: oxycodone oral
- Oxecta Side Effects Center
- Oxecta FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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