• Assess BP, pulse, and respirations before and periodically during administration. If respiratory rate is <10/min, assess level of sedation. Physical stimulation may be sufficient to prevent significant hypoventilation. Dose may need to be decreased by 25–50%. Initial drowsiness will diminish with continued use. Monitor for respiratory depression, especially during initiation or following dose increase; serious, life-threatening, or fatal respiratory depression may occur. May cause sleep-related breathing disorders (central sleep apnea [CSA], sleep-related hypoxemia).
  • Assess bowel function routinely. Prevention of constipation should be instituted with increased intake of fluids and bulk, and laxatives to minimize constipating effects. Stimulant laxatives should be administered routinely if opioid use exceeds 2–3 days, unless contraindicated. Consider drugs for opioid-induced constipation.
• Pain: Assess type, location, and intensity of pain prior to and 1 hr (peak) following administration. When titrating opioid doses, increases of 25–50% should be administered until there is either a 50% reduction in the patient’s pain rating on a numerical or visual analogue scale or the patient reports satisfactory pain relief. A repeat dose can be safely administered at the time of the peak if previous dose is ineffective and side effects are minimal.
  • Patients taking extended-release hydrocodone may require additional short-acting or rapid-onset opioid doses for breakthrough pain. Doses of short-acting opioids should be equivalent to 10–20% of 24 hr total and given every 2 hr as needed.
  • An equianalgesic chart (see Appendix K) should be used when changing routes or when changing from one opioid to another.
  • Prolonged use may lead to physical and psychological dependence and tolerance. This should not prevent patient from receiving adequate analgesia. Patients who receive opioids for pain rarely develop psychological dependence. If progressively higher doses are required, consider conversion to a stronger opioid. Prolonged use of opioids should be reserved for patients whose pain remains severe enough to require them and alternative treatment options continue to be inadequate. Many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
  • Assess risk for opioid addiction, abuse, or misuse prior to administration. Abuse or misuse of extended-release preparations by crushing, chewing, snorting, or injecting dissolved product will result in uncontrolled delivery of hydrocodone and can result in overdose and death. Hysingla ER is an abuse deterrent formulation that is difficult to crush and, if crushed, results in a gel.
• Cough: Assess cough and lung sounds during antitussive use.

• May cause ↑ plasma amylase and lipase concentrations.

• If an opioid antagonist is required to reverse respiratory depression or coma, naloxone is the antidote. Dilute the 0.4-mg ampule of naloxone in 10 mL of 0.9% NaCl and administer 0.5 mL (0.02 mg) by IV push every 2 min. For children and patients weighing <40 kg, dilute 0.1 mg of naloxone in 10 mL of 0.9% NaCl for a concentration of 10 mcg/mL and administer 0.5 mcg/kg every 2 min. Titrate dose to avoid withdrawal, seizures, and severe pain.

• Do not confuse hydrocodone with oxycodone.
• Explain therapeutic value of medication prior to administration to enhance the analgesic effect.
  • Regularly administered doses may be more effective than prn administration. Analgesic is more effective if given before pain becomes severe.
  • Combination with nonopioid analgesics may have additive analgesic effects and permit lower doses. Maximum doses of nonopioid agents limit the titration of hydrocodone doses.
  • Medication should be discontinued gradually after long-term use to prevent withdrawal symptoms. For patients on long-acting agents who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2–4 wk. May be necessary to provide patient with a lower dose strength for a successful taper. Monitor frequently to manage pain and withdrawal symptoms (restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate). If withdrawal symptoms occur, pause the taper for a period of time or raise the dose of opioid analgesic to the previous dose, and then proceed with a slower taper. Also, monitor patients for changes in mood, emergence of suicidal thoughts, or use of other substances. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic.
• REMS: FDA strongly encourages health care professionals to complete a REMS-compliant education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain, available at OpioidAnalgesicREMSBlueprint. Information on programs can be found at 1-800-503-0784 or .
• Discuss availability of naloxone for emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing therapy, especially if patient has household members (including children) or other close contacts at risk for accidental exposure or overdose. Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. However, the presence of risk factors for overdose should not prevent the proper management of pain in any patient.
• PO: May be administered with food or milk to minimize GI irritation.
  • DNC: Swallow extended-release capsules whole; do not open, crush, dissolve, or chew.

• REMS: Advise patient to take medication as directed and not to take more than the recommended amount. Severe and permanent liver damage may result from prolonged use or high doses of acetaminophen. Renal damage may occur with prolonged use of acetaminophen or ibuprofen. Doses of nonopioid agents should not exceed the maximum recommended daily dose. Do not stop taking without discussing with health care professional; may cause withdrawal symptoms if discontinued abruptly after prolonged use. Do not increase doses without discussing with health care professional, may lead to overdose. Discuss safe use, risks, and proper storage and disposal of opioid analgesics with patients and caregivers with each Rx. The Patient Counseling Guide (PCG) is available at OpioidAnalgesicREMSPCG.
• Instruct patient on how and when to ask for and take pain medication.
• Advise patient that hydrocodone is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store out of sight and reach of children, and in a location not accessible by others.
• Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose. Inform patients and caregivers about various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (by prescription, directly from a pharmacist, or as part of a community-based program).
• May cause drowsiness or dizziness. Advise patient to call for assistance when ambulating or smoking. Caution patient to avoid driving or other activities requiring alertness until response to the medication is known.
• Advise patient to notify health care professional if pain control is not adequate or if severe or persistent side effects occur.
• Advise patient to change positions slowly to minimize orthostatic hypotension.
• Caution patient to avoid concurrent use of alcohol or other CNS depressants with this medication, may lead to overdose.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Emphasize the importance of aggressive prevention of constipation with the use of hydrocodone.
• Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
• Advise patient that good oral hygiene, frequent mouth rinses, and sugarless gum or candy may decrease dry mouth.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor neonate for signs and symptoms of withdrawal symptoms (irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight); usually occur the first days after birth. Monitor infants exposed to hydrocodone through breast milk for excess sedation and respiratory depression. Chronic use may reduce fertility in females and males.

• Decrease in severity of pain without a significant alteration in level of consciousness or respiratory status.
• Suppression of nonproductive cough.

Hysingla ER, Zohydro ER

hydrocodone/acetaminophen: Anexsia

hydrocodone/ibuprofen: Reprexain

Schedule II (C-II)