hydrocodone

Noted for hydrocodone only; see acetaminophen/ibuprofen monographs for specific information on individual components

Contraindicated in:

Hypersensitivity to hydrocodone (cross-sensitivity may exist to other opioids);
Significant respiratory depression;
Paralytic ileus;
Acute or severe bronchial asthma or hypercarbia;
Congenital long QT syndrome (Hysingla only);
Products containing alcohol, aspartame, saccharin, sugar, or tartrazine (FDC yellow dye #5) should be avoided in patients who have hypersensitivity or intolerance to these compounds;
Lactation: Lactation.

Use Cautiously in:

Personal or family history of substance use disorder or mental illness;
Head trauma;
↑intracranial pressure;
Severe renal, hepatic, or pulmonary disease;
Difficulty swallowing;
Undiagnosed abdominal pain;
Prostatic hyperplasia;
OB: Avoid chronic use during pregnancy. Has been used during labor but may cause respiratory depression in the newborn;
Geri: Older adults are more prone to CNS depression and constipation (initial dose ↓ required).

Adv. Reactions/Side Effects ⬆ ⬇

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

GU: urinary retention

Neuro: confusion, dizziness, sedation, euphoria, hallucinations, headache, unusual dreams

Resp: RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)

Misc: allodynia, opioid-induced hyperalgesia, physical dependence, psychological dependence, tolerance

Interactions ⬆ ⬇

Drug-drug:

Use with extreme caution in patients receivingMAO inhibitors; may produce severe, unpredictable reactions—do not use within 14 days of each other.
CYP3A4 inhibitors, including ritonavir, ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, nefazodone, diltiazem, verapamil, nelfinavir, and fosamprenavir, may ↑ levels and risk of opioid toxicity; careful monitoring during initiation, dose changes, or discontinuation of the inhibitor is recommended.
CYP3A4 inducers, including barbiturates, carbamazepine, efavirenz, corticosteroids, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, or rifampin, may ↓ levels and analgesia; if inducers are discontinued or dosage ↓, patients should be monitored for signs of opioid toxicity and necessary dose adjustments should be made.
Use with benzodiazepines or other CNS depressants, including other opioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
Mixed agonist/antagonist analgesics, including nalbuphine or butorphanol, and partial agonist analgesics, including buprenorphine, may ↓ analgesic effects and/or precipitate opioid withdrawal in physically dependent patients.
Anticholinergic drugs may ↑ risk of urinary retention and constipation.
Drugs that affect serotonergic neurotransmitter systems, including tricyclic antidepressants, SSRIs, SNRIs, MAO inhibitors, TCAs, tramadol, trazodone, mirtazapine, 5-HT3 receptor antagonists, linezolid, methylene blue, and triptans, ↑ risk of serotonin syndrome.

Drug-Natural Products:

Concomitant use of kava-kava, valerian, skullcap, chamomile, or hops can ↑ CNS depression.

Availability ⬆ ⬇

Hydrocodone

(Generic available)

Extended-release capsules: 10 mg; 15 mg; 20 mg; 30 mg; 40 mg; 50 mg
Extended-release tablets (Hysingla ER) (abuse deterrent): 20 mg; 30 mg; 40 mg; 60 mg; 80 mg; 100 mg; 120 mg
In combination with: chlorpheniramine,

Hydrocodone/Acetaminophen

(Generic available)

Tablets: 5 mg hydrocodone/325 mg acetaminophen; 7.5 mg hydrocodone/325 mg acetaminophen; 10 mg hydrocodone/325 mg acetaminophen
Elixir/oral solution: 7.5 mg hydrocodone plus 325 mg acetaminophen/15 mL; 10 mg hydrocodone plus 325 mg acetaminophen/15 mL

Hydrocodone/Ibuprofen

(Generic available)

Tablets: 5 mg hydrocodone/200 mg ibuprofen; 7.5 mg hydrocodone/200 mg ibuprofen; 10 mg hydrocodone/200 mg ibuprofen

Route/Dosage ⬆ ⬇

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.

Renal Impairment

PO (Adults ): CCr <45 mL/min: Extended-release tablets: ↓ initial dose by 50%.

Hepatic Impairment

PO (Adults ): Extended-release tablets:↓ initial dose by 50%.

US Brand Names ⬆ ⬇

HYDROcodone: Hysingla ER, ~~Zohydro ER,~~

HYDROcodone/Acetaminophen: ~~Anexsia,~~ ~~Norco,~~ ~~Vicodin,~~

HYDROcodone/Ibuprofen: ~~Reprexain~~

Action ⬆ ⬇

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.

Therapeutic effects:

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

Classifications ⬆ ⬇

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

Pharmacologic Classification: opioid agonists nonopioid analgesic combinations

Pharmacokinetics ⬆ ⬇

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.

Contr. Subst. Schedule ⬆ ⬇

Time/Action Profile ⬆ ⬇

(analgesic effect)

ROUTE	ONSET	PEAK	DURATION
PO	10–30 min	30–60 min	4–6 hr
PO-ER	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

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 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 is available at www.fda.gov/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 ↓ fertility in females and males.

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆