Hycodan (Page 2 of 8)

4 CONTRAINDICATIONS

HYCODAN is contraindicated for:

5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

  • HYCODAN contains hydrocodone, a Schedule II controlled substance. As an opioid, HYCODAN exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)], which can lead to overdose and death [see Overdosage (10)].
  • Reserve HYCODAN for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
  • Assess each patient’s risk prior to prescribing HYCODAN, prescribe HYCODAN for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment.
  • Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed HYCODAN. Addiction can occur at recommended dosages and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).
  • Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing HYCODAN. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17)]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2 Life-Threatening Respiratory Depression

  • Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including hydrocodone, one of the active ingredients in HYCODAN. Hydrocodone produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls respiratory rhythm and may produce irregular and periodic breathing. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression includes discontinuation of HYCODAN, close observation, supportive measures, and use of opioid antagonists (e.g., naloxone), depending on the patient’s clinical status [see Overdosage (10)]. Carbon dioxide (CO2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
  • While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of HYCODAN, the risk is greatest during the initiation of therapy, when HYCODAN is used concomitantly with other drugs that may cause respiratory depression [see Warnings and Precautions (5.8)] , in patients with chronic pulmonary disease or decreased respiratory reserve, and in patients with altered pharmacokinetics or altered clearance (e.g., elderly, cachectic, or debilitated patients) [see Warnings and Precautions (5.4)].
  • To reduce the risk of respiratory depression, proper dosing of HYCODAN is essential [see Dosage and Administration (2.1), Warnings and Precautions (5.5)]. Monitor patients closely, especially within the first 24 to 72 hours of initiating therapy or when used in patients at higher risk.
  • Overdose of hydrocodone in adults has been associated with fatal respiratory depression, and the use of hydrocodone in pediatric patients younger than 6 years of age has been associated with fatal respiratory depression when used as recommended. Accidental ingestion of even one dose of HYCODAN, especially by children, can result in respiratory depression and death.

5.3 Risks with Use in Pediatric Populations

5.4 Risks with Use in Other At-Risk Populations

Unresponsive Cough

The dosage of HYCODAN should not be increased if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Dosage and Administration (2.3)].

Asthma and Other Pulmonary Disease

  • The use of HYCODAN in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [see Contraindications (4)].
  • Opioid analgesics and antitussives, including hydrocodone, one of the active ingredients in HYCODAN, should not be used in patients with acute febrile illness associated with productive cough or in patients with chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient’s respiratory function.
  • HYCODAN-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of HYCODAN [see Warnings and Precautions (5.2)].

Elderly, Cachectic, or Debilitated Patients

  • Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions (5.2)].
  • Because of the risk of respiratory depression, avoid the use of opioid antitussives, including HYCODAN in patients with compromised respiratory function, patients at risk of respiratory failure, and in elderly, cachectic, or debilitated patients. If HYCODAN is prescribed, monitor such patients closely, particularly when initiating HYCODAN and when HYCODAN is given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.8)].

5.5 Risk of Accidental Overdose and Death due to Medication Errors

  • Dosing errors can result in accidental overdose and death. To reduce the risk of overdose and respiratory depression, ensure that the dose of HYCODAN is communicated clearly and dispensed accurately [see Dosage and Administration (2.1)].
  • Advise patients to always use an accurate milliliter measuring device when measuring and administering HYCODAN oral solution. Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [see Overdosage (10)]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate calibrated measuring device and can provide instructions for measuring the correct dose.

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