Therapeutic Classification: allergy, cold and cough remedies (antitussive), opioid analgesics
Pharmacologic Classification: opioid agonists nonopioid analgesic combinations
High Alert
Extended-release product
Combination products
Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Half-Life: 2.2 hr; Extended-release: 8 hr.
Noted for hydrocodone only; see acetaminophen/ibuprofen monographs for specific information on individual components
Contraindicated in:
Use Cautiously in:
Noted for hydrocodone only; see acetaminophen/ibuprofen monographs for specific information on individual components
CV: hypotension, bradycardia, QT interval prolongation (Hysingla only)
Derm: sweating
EENT: blurred vision, diplopia, miosis
Endo: adrenal insufficiency
GI: constipation, dyspepsia, nausea, choking, dysphagia, esophageal obstruction, vomiting
Neuro: confusion, dizziness, sedation, euphoria, hallucinations, headache, unusual dreams
Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)
Misc: physical dependence, psychological dependence, tolerance
Drug-drug:
Drug-Natural Products:
Renal Impairment
Hepatic Impairment
Hydrocodone
Hydrocodone/Acetaminophen
Hydrocodone/Ibuprofen
Lab Test Considerations:
Toxicity and Overdose:
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 www.fda.gov/OpioidAnalgesicREMSBlueprint. Information on programs can be found at 1-800-503-0784 or www.opioidanalgesicrems.com.
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 www.fda.gov/OpioidAnalgesicREMSPCG.
HYDROcodone: Hysingla ER, Zohydro ER,
HYDROcodone/Acetaminophen: Anexsia, Norco, Vicodin,
HYDROcodone/Ibuprofen: Reprexain