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Hysingla ER is a long acting hydrocodone to treat pain severe enough to require around-the-clock, long term treatment. Hysingla ER is not approved for as-needed pain relief. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Hysingla ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Hysingla ER is a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone. This should be considered when prescribing or dispensing Hysingla ER in a situation where misuse, abuse, or diversion are a concern. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness.
DOSAGE AND ADMINISTRATION
Important Dosage and Administration Information
HYSINGLA ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Daily doses of HYSINGLA ER greater than or equal to 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
Adverse Reactions/Side Effects
Noted for hydrocodone only; see acetaminophen/ibuprofen monographs for specific information on individual components CNS: confusion, dizziness, sedation, euphoria, hallucinations, headache, unusual dreams.EENT: blurred vision, diplopia,miosis. Resp: respiratory depression. CV: hypotension, bradycardia. GI:constipation, dyspepsia, nausea, vomiting. GU: urinary retention. Derm: sweating. Misc: physical dependence, psychological dependence, tolerance.
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse
HYSINGLA ER contains hydrocodone, a Schedule II controlled substance. As an opioid, HYSINGLA ER exposes users to the risks of addiction, abuse, and misuse. Because extended-release products such as HYSINGLA ER deliver the opioid over an extended period of time, there is a greater risk for overdoseand death due to the larger amount of hydrocodone present.
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed HYSINGLA ER. Addiction can occur at recommended doses and if the drug is misused or abused.
How to use Hysingla ER
The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Properly stop the medication when so directed.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
Before you start using this medication, ask your doctor or pharmacist if you should stop or change how you use your other opioid medication(s). Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using hydrocodone safely with other drugs.
Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.
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