Drugplain

Hysingla ER 60 mg/1

hydrocodone bitartrate · TABLET, EXTENDED RELEASE · Knoa Pharma LLC

No Recall HistoryCurrently in Shortage
Plain English

Hysingla ER is a tablet, extended release containing hydrocodone bitartrate at 60 mg/1, taken oral. Manufactured by Knoa Pharma LLC.

Key Facts

Brand Name
Hysingla ER
Generic Name
hydrocodone bitartrate
NDC Code (Product)
59011-274
Manufacturer
Knoa Pharma LLC
Strength
60 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
NDA206627
Marketing Start
01/15/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death11,932 reports
drug dependence10,345 reports
overdose9,653 reports
toxicity to various agents9,499 reports
pain7,309 reports
emotional distress6,714 reports
drug withdrawal syndrome5,571 reports
drug abuse1,760 reports
drug withdrawal syndrome neonatal1,289 reports
nausea1,057 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE HYSINGLA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including HYSINGLA ER, 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 not indicated as an as-needed (prn) analgesic. HYSINGLA ER is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including HYSINGLA ER, for use in patients for …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION HYSINGLA ER should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. ( 2.1 ) 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. ( 2.1 ) Patients considered opioid-tolerant are those taking, 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. ( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( 2.1 ). Reserve titration to higher doses of HYSINGLA ER for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5.1 ) Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, …

Contraindications

4 CONTRAINDICATIONS HYSINGLA ER is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13 , 5.14) ] Hypersensitivity to hydrocodone or any component of HYSINGLA ER. Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) Hypersensitivity to hydrocodone or to any other components of HYSINGLA ER ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with HYSINGLA ER. Table 3: Clinically Significant Drug Interactions with HYSINGLA ER Inhibitors of CYP3A4 Clinical Impact: The concomitant use of HYSINGLA ER and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of HYSINGLA ER and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of HYSINGLA ER is achieved [see Warnings and Precautions (5.6) ] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [see Clinical Pharmacology (12.3) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to hydrocodone. Intervention: If concomitant use is necessary, consider dosage reduction of HYSINGLA ER until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the HYSINGLA ER dosage until stable drug effects…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13 , 5.14) ] Seizures [see Warnings and Precautions (5.15) ] Withdrawal [see Warnings and Precautions (5.16) ] Most common treatment-emergent adverse events (incidence ≥ 5%) are constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Knoa Pharma LLC at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying…

Frequently Asked Questions

What is Hysingla ER used for?

Hysingla ER contains hydrocodone bitartrate. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is Hysingla ER a controlled substance?

Yes, Hysingla ER is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Hysingla ER?

The generic name for Hysingla ER is hydrocodone bitartrate. There are 12 other brand versions of hydrocodone bitartrate.

What is the NDC code for Hysingla ER 60 mg/1?

The NDC (National Drug Code) for Hysingla ER 60 mg/1 is 59011-274, listed by Knoa Pharma LLC.

Product NDC

59011-274

Package NDC

59011-274-60

Other Hydrocodone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)