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Applies to hydrocodone: oral capsule extended release, oral tablet extended release
Oral route (Capsule, Extended Release)
Prior to prescribing hydrocodone, assess each patient's risk for opioid addiction, abuse, and misuse, and regularly monitor all patients for opioid addiction behaviors or conditions. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Monitor for respiratory depression, which can be serious, life-threatening, or fatal, especially during initiation or following a dose increase. Instruct patients to swallow extended release forms whole to avoid potentially fatal overdose. Accidental ingestion of hydrocodone can result in a fatal overdose, especially in children. If prolonged opioid use is necessary during pregnancy, advise patient of potential risk of life-threatening neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available. Use with CYP3A4 inhibitors or inducers may change hydrocodone plasma levels resulting in prolonged adverse effects or potentially fatal respiratory depression; monitoring is recommended. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options, limit dosage and duration to the minimum required, and monitor for respiratory depression and sedation. Alcoholic beverages or medications containing alcohol should be avoided due to the potential for increased hydrocodone plasma levels and a potentially fatal overdose.
Oral route (Tablet, Extended Release)
Addiction, Abuse, and MisuseHydrocodone extended-release (ER) exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Hydrocodone ER, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone ER. Monitor for respiratory depression, especially during initiation of Hydrocodone ER or following a dose increase. Instruct patients to swallow hydrocodone bitartrate ER tablets whole; crushing, chewing, or dissolving hydrocodone bitartrate tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone bitartrate.Accidental IngestionAccidental ingestion of even one dose of Hydrocodone ER, especially by children, can result in a fatal overdose of Hydrocodone ER.Neonatal Opioid Withdrawal SyndromeProlonged use of Hydrocodone ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Cytochrome P450 3A4 InteractionThe concomitant use of Hydrocodone ER with all cytochrome P450 3A4 inhibitors may result in an increase in Hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in Hydrocodone plasma concentration. Monitor patients receiving Hydrocodone ER and any CYP3A4 inhibitor or inducer.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsReserve concomitant prescribing of Hydrocodone ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Along with its needed effects, hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking hydrocodone:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking hydrocodone:
Symptoms of overdose
Some side effects of hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to hydrocodone: compounding powder, oral capsule extended release, oral tablet extended release
The most commonly reported side effects included constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.
Common (1% to 10%): Upper respiratory tract infection, cough, bronchitis, nasopharyngitis, sinusitis, nasal congestion
Uncommon (0.1% to 1%): Dyspnea
Common (1 to 10%): Hot flush, hypertension, chest pain, peripheral edema
Rare (less than 0.1%): Hypotension, orthostatic hypotension, palpitations, presyncope, syncope
Frequency not reported: QTC interval prolongation
QT interval prolongation has been observed in healthy subjects following daily dosing with hydrocodone extended-release tablets. The difference in QT interval at steady state was found to be 6 milliseconds, 7 milliseconds, and 10 milliseconds at doses of 80 mg, 120 mg and 160 mg, daily, respectively.
Very common (10% or more): Constipation (up to 11%), nausea (up to 10%)
Common (1% to 10%): Dry mouth, vomiting, abdominal pain or discomfort, gastroesophageal reflux disease, diarrhea, dyspepsia
Rare (less than 0.1%): Dysphagia, esophageal obstruction, retching, chocking
Very rare (less than 0.01%): Difficulty swallowing tablet
In clinical trials with extended release tablets, 11 or 2476 subjects reported difficulty swallowing the tablets. These reports included esophageal obstruction, dysphagia, and choking. One case required medical intervention to remove the tablet.
Common (1% to 10%): Somnolence, fatigue, headache, tremor, dizziness, lethargy, migraine, paresthesia, sedation
Uncommon (0.1% to 1%): Abnormal thinking
Common (1% to 10%): Pain, pyrexia, fatigue, tinnitus, chills
Uncommon (0.1% to 1%): Asthenia, neonatal abstinence syndrome, drug withdrawal
Common (1 to 10%): Anxiety, depression, insomnia
Uncommon (0.1% to 1%): Agitation, altered mood, irritability, libido decreased
Common (1% to 10%): Dehydration, hypokalemia, increased blood cholesterol, decreased appetite
Uncommon (0.1% to 1%): Thirst
Common (1 to 10%): Increased gamma-glutamyltransferase
Common (1% to 10%): Back pain, muscle spasms , contusion, fall, foot fracture, joint injury or sprain, muscle strain, arthralgia, musculoskeletal pain, myalgia, neck pain, osteoarthritis, pain in extremity
Uncommon (0.1% to 1%): Muscle twitching
Uncommon (0.1% to 1%): Drug hypersensitivity
Uncommon (0.1% to 1%): Hypogonadism
Common (1% to 10%): Pruritus, skin laceration, hyperhidrosis, night sweats, rash
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Urinary retention