• PO (Adults): Analgesic (in combo products): 2.5–10 mg every 3–6 hr as needed; if using combination products, acetaminophen dose should not exceed 4 g/day and should not exceed 5 tablets/day of ibuprofen-containing products; Antitussive: 5 mg every 4–6 hr as needed; Extended-release capsules: 10 mg every 12 hr; may ↑ as needed in increments of 10 mg every 12 hr every 3–7 days; Extended-release tablets: 20 mg once daily; may ↑ as needed in increments of 10–20 mg/day every 3–5 days.

Hysingla ER, Zohydro ER

hydrocodone/acetaminophen: Anexsia

hydrocodone/ibuprofen: Reprexain

• Bind to opiate receptors in the CNS. Alter the perception of and response to painful stimuli while producing generalized CNS depression.
  • Suppress the cough reflex via a direct central action.

• Decrease in severity of moderate pain.
• Suppression of the cough reflex.

Therapeutic Classification: allergy, cold and cough remedies (antitussive), opioid analgesics

Pharmacologic Classification: opioid agonists nonopioid analgesic combinations

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Mostly metabolized by the liver; eliminated in the urine (50–60% as metabolites, 10% as unchanged drug).

Half-life: 2.2 hr; Extended-release: 8 hr.

Schedule II (C-II)

(analgesic effect)

• 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.

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