This site is intended for healthcare professionals

ADD THIS DRUG TO MY LIST

Select the drug indication to add to your list

HYSINGLA ER
Narcotic analgesics
Compare To Related Drugs
View/Edit/Compare Drugs In My List

Only 4 drugs may be compared at once

Drug Name:

HYSINGLA ER CII

Generic Name and Formulations:
Hydrocodone bitartrate 20mg, 30mg, 40mg, 60mg, 80mg, 100mg, 120mg; ext-rel tabs.

Company:
Purdue Pharma L.P.

Therapeutic Use:

Indications for HYSINGLA ER:

Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations Of use:

Reserve for use in patients for whom alternative treatments (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or inadequate to manage pain. Not indicated as an as-needed (prn) analgesic.

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 by 25–50% every 2–4 days.

Children:

Not established.

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.

Warnings/Precautions:

Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Adrenal insufficiency. 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.

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. 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, 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 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.

Pharmacological Class:

Opioid agonist.

Adverse Reactions:

Constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, somnolence; respiratory depression, severe hypotension, syncope.

REMS:

YES

How Supplied:

ER tabs—60

Join MIMS Learning now to manage all your CPD and notes in one place!

By registering you agree with our Terms and Conditions and Privacy Policy.


Already a MIMS Learning member?

Sign In Now »
Red flag CPD modules
0.50 Credits
Red flags

Groin swelling - red flag symptomsExternal web site

This red flags article explains signs and symptoms of potentially serious pathology in patients presenting...

0.50 Credits
Red flags

Erectile dysfunction - red flag symptomsExternal web site

This article by Dr Tillmann Jacobi covers the possible red flag symptoms to consider when a patient...

0.50 Credits
Red flags

Headache - red flag symptomsExternal web site

Dr Suneeta Kochhar provides an overview of red flag symptoms in patients presenting with headaches...

Font Awesome Icons
View more
Clinical review CPD modules
1.50 Credits
Clinical Review

Basal cell carcinoma: clinical reviewExternal web site

In this article, Dr David Brass and Dr Neil Rajan discuss the risk factors for BCC, making the diagnosis...

1.50 Credits
Clinical Review

Cardiomyopathy: clinical reviewExternal web site

This article by Dr Rajiv Sankaranarayanan covers the diagnosis and management of cardiomyopathy. Key...

1.50 Credits
Clinical Review

Parkinson's disease: clinical reviewExternal web site

Dr Benjamin Simpson provides an in-depth overview of Parkinson’s disease, including information on risk...

Font Awesome Icons
View more

is free, fast, and customized just for you!

Already a member?

Sign In Now »