Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Hydrocodone

Brand Name: Zohydro ER, Hysingla ER, Vantrela ER

Generic Name: hydrocodone

Drug Class: Opioid Analgesics

What Is Hydrocodone and How Does It Work?

Hydrocodone is a prescription narcotic indicated for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

Hydrocodone is available under the following different brand names: Zohydro ER, Hysingla ER, and Vantrela ER.

Dosages of Hydrocodone

Adult dosage only. Safety and efficacy not established for pediatric use.

Capsule, extended release (Zohydro ER): Schedule II

Abuse-deterrent product (BeadTek technology)

  • 10 mg
  • 15 mg
  • 20 mg
  • 30 mg
  • 40 mg
  • 50 mg

Tablet, extended release (Hysingla ER): Schedule II

Abuse-deterrent product (RESISTEC)

  • 20 mg
  • 30 mg
  • 40 mg
  • 60 mg
  • 80 mg
  • 100 mg
  • 120 mg

Tablet, extended release (Vantrela ER): Schedule II

Abuse-deterrent product

  • 15 mg
  • 30 mg
  • 45 mg
  • 60 mg
  • 90 mg

Dosage Considerations -- Should Be Given As Follows:

Chronic Pain

  • Indicated for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate

Initial dosing

  • Should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain
  • Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy

Opioid naïve or first opioid analgesic

  • Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression

Zohydro ER

  • 10 mg orally every 12 hours initially
  • A single dose of Zohydro ER greater than 40 mg, Zohydro ER 50 mg capsules, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established

Hysingla ER

  • Administer once daily as 20 mg orally every 24 hours initially
  • Daily doses of Hysingla ER greater than or equal to 80 mg/day are only for use in opioid tolerant patients

Opioid tolerant

See prescribing information for conversion table from existing opioid analgesic to hydrocodone extended-release.

Opioid tolerance definition

Defined as patients who are receiving the following opioids (or an equianalgesic dose of another opioid) for 1 week or longer.

Dose adjustment, maintenance, and discontinuation

  • Zohydro ER: Increase by increments of 10 mg every 12 hours every 3-7 days as needed to achieve adequate analgesia
  • Hysingla ER: Increase by increments of 10-20 mg/day every 3-5 days as needed to achieve adequate analgesia
  • Vantrela ER: May increase to the next higher dose every 3-7 days as needed to achieve adequate analgesia
  • Assess pain frequently for toxicity, breakthrough pain, or need for short-acting rescue analgesia
  • Discontinue by a gradual downward titration every 2-4 days; do not withdraw abruptly

Dosage Modifications

Liver impairment

Mild-to-moderate (Vantrela ER): Initiate therapy with one-half of the recommended initial dose and adjust the dose carefully; use alternative analgesia for patients requiring less than 15 mg. Severe: Initiate with lowest dose, 10 mg (Zohydro ER) or 50% of initial dose (Hysingla ER) and monitor closely for signs of respiratory depression and excessive sedation.

Kidney impairment

Patients with kidney impairment may have higher plasma concentrations than those with normal function. Moderate-to-severe and end stage renal disease: Initiate therapy with a low initial dose (Zohydro ER) or 50% of initial dose (Hysingla ER, Vantrela ER) and monitor closely for respiratory depression and sedation.

Dosing Considerations

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve use for patients for whom alternative treatment options (for example non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Not indicated for acute pain or as an as-needed analgesic.

What Are Side Effects Associated with Using Hydrocodone ?

Side effects of hydrocodone include:

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What Other Drugs Interact with Hydrocodone?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of Hydrocodone include:

  • alvimopan
  • indinavir

Hydrocodone has serious interactions with at least 78 different drugs.

Hydrocodone has moderate interactions with at least 208 different drugs.

Hydrocodone has minor interactions with at least 23 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

What Are Warnings and Precautions for Hydrocodone?

Warnings

Addiction, abuse, and misuse

  • Long acting hydrocodone exposes patients and other users to the risk of opioid addiction, abuse, and misuse, which can lead to overdose and death
  • Assess each patient's risk prior to prescribing, and monitor all patients regularly for the development of these behaviors or conditions

Life-threatening respiratory depression

  • Serious, life-threating, or fatal respiratory depression may occur
  • Monitor for respiratory depression, especially during initiation or following a dose increase
  • Instruct patients to swallow capsules/tablets whole; crushing, chewing or dissolving the extended-release dosage forms can cause rapid release and absorption of a potentially fatal dose of hydrocodone

Accidental exposure

  • Accidental consumption of even 1 dose of hydrocodone, especially by children, can result in a fatal overdose of hydrocodone

Neonatal opioid withdrawal syndrome

  • For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome
  • Prolonged maternal use during pregnancy can result in in neonatal opioid withdrawal syndrome, which may be life-threatening and requires management according to protocols developed by neonatology experts

Interaction with central nervous system depressants:

  • Simultaneous use of opioids with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma and death
  • Reserve simultaneous prescribing for use in patients for whom alternative treatment options are inadequate
  • Limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation
  • Co-ingestion of Zohydro ER with alcohol may increase hydrocodone plasma levels and result in a potentially fatal overdose (alters release of drug from capsule)

Interaction with CYP3A4 inhibitors

  • Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose from hydrocodone from hydrocodone ER

This medication contains hydrocodone. Do not take Zohydro ER, Hysingla ER, or Vantrela ER if you are allergic to hydrocodone or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Effects of Drug Abuse

  • Long acting hydrocodone exposes patients and other users to the risk of opioid addiction, abuse, and misuse, which can lead to overdose and death
  • Hydrocodone is an opioid agonist and a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone

Short-Term Effects

  • Caution must be used with potentially hazardous activities
  • Hydrocodone is an opioid agonist and a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone
  • See also "What Are Side Effects Associated with Using Hydrocodone?”

Long-Term Effects

  • Hydrocodone is an opioid agonist and a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone
  • See also "What Are Side Effects Associated with Using Hydrocodone?”

Cautions

  • Do not prescribe for acute pain or as needed (prn) pain relief; only for severe chronic pain requiring continuous, around-the-clock opioid analgesia
  • Hydrocodone is an opioid agonist and a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone
  • Co-administration with other central nervous system depressants may cause profound sedation, respiratory depression, and death; if co-administration is required, consider dose reduction of 1 or both drugs
  • Monitor carefully in elderly, cachectic, debilitated patients, and those with chronic pulmonary disease because of increased risk for life-threatening respiratory depression
  • Monitor patients with head injury or increased ICP for sedation and respiratory depression; avoid use in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention
  • May cause severe low blood pressure, including feeling dizzy or lightheaded when standing and fainting; added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone
  • Prolonged gastric obstruction may occur
  • Co-administration with CYP3A4 inhibitors may increase hydrocodone systemic exposure and result in toxicity; if co-administration with CYP3A4 necessary, monitor patients closely who are currently taking, or discontinuing, CYP3A4 inhibitors or inducers; evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved
  • Caution must be used with potentially hazardous activities
  • Avoid use of mixed agonist/antagonist analgesics (such as pentazocine, nalbuphine, or butorphanol) when taking full opioid agonist analgesics
  • Hydrocodone ER may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings; monitor patients with a history of seizure disorders for worsened seizure control during hydrocodone ER therapy

Pregnancy and Lactation with Hydrocodone

  • Use hydrocodone with caution in pregnancy if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done
  • Fetuses of rabbits administered oral doses of 75 mg/kg/day hydrocodone bitartrate (15 times an adult human dose of 100 mg/day on a mg/m² basis) during the period of organogenesis exhibited an increased number of malformations consisting of umbilical hernia, and irregularly shaped bones (ulna, femur, tibia and/or fibula)
  • Lactation: Low concentrations of hydrocodone and hydromorphone in breast milk of nursing mothers using hydrocodone for postpartum pain control have been reported in published literature
  • Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue hydrocodone, taking into account the importance of the drug to the mother
Reviewed on 4/14/2017


SOURCE:
Medscape. Hydrocodone.
https://reference.medscape.com/drug/zohydro-er-hysingla-er-hydrocodone-343312

Health Solutions From Our Sponsors