HYSINGLA ER Dosage & Rx Info | Uses, Side Effects

Hysingla Er Generic Name & Formulations

Legal Class

CII

General Description

Hydrocodone bitartrate 20mg, 30mg, 40mg, 60mg, 80mg, 100mg, 120mg; ext-rel tabs.

Pharmacological Class

Opioid agonist.

How Supplied

ER tabs—60

Manufacturer

Purdue Pharma L.P.

Generic Availability

Mechanism of Action

Hydrocodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Although the precise mechanism of the analgesic action is unknown, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Hysingla Er Indications

Indications

Management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.

Limitations of Use

Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration); increased risks of overdose and death with extended-release/long-acting opioid formulations, reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or inadequate to provide sufficient management of pain. Not indicated as an as-needed (prn) analgesic.

Hysingla Er Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Swallow whole. Individualize. Opioid-naïve or opioid non-tolerant: initially 20mg every 24hrs. May increase dose in increments of 10–20mg every 3–5 days as needed. ≥80mg: for use in opioid-tolerant patients only. Conversion from other opioids: see full labeling. Severe hepatic impairment, moderate to severe renal impairment, or ESRD: initiate with ½ the initial dose. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.

Children

Not established.

Hysingla Er Contraindications

Contraindications

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Hysingla Er Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Hysingla ER: Addiction, abuse, and misuse; Life-threatening respiratory depression; Accidental ingestion; Risks from concomitant use with benzodiazepines or other CNS depressant; Neonatal opioid withdrawal syndrome; Opioid analgesic risk evaluation and mitigation strategy (REMS); Cytochrome P450 3A4 interaction.

Hysingla Er Warnings/Precautions

Warnings/Precautions

Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression esp. during initiation or following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Risk of QT prolongation; consider dose reduction or use alternatives if develops; avoid in congenital long QT syndrome. Difficulty swallowing or at risk for underlying GI disorders (eg, esophageal or colon cancer): consider other analgesics. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

REMS

YES

Hysingla Er Pharmacokinetics

Absorption

Median time to peak concentration: 14–16 hours (for different dose strengths); peak plasma levels may occur in the range of 6–30 hours (after administration).

Distribution

Apparent volume of distribution: 402 L. Plasma protein bound: 36%.

Metabolism

Complex pattern of metabolism, including CYP3A4 mediated N-demethylation (primary), CYP2B6, CYP2C19, O-demethylation, and 6-keto reduction to the corresponding 6-α-and 6-β-hydroxy metabolites.

Elimination

Renal. Half-life: 7–9 hours.

Hysingla Er Interactions

Interactions

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor closely; consider prescribing naloxone if concomitant use is warranted. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT₃ antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. Concomitant strong laxatives (eg, lactulose); monitor.

Hysingla Er Adverse Reactions

Adverse Reactions

Constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, somnolence; respiratory depression, orthostatic hypotension, syncope, OIH and allodynia.

Hysingla Er Clinical Trials

See Literature

Hysingla Er Note

Not Applicable

Hysingla Er Patient Counseling