- This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.
- Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.
WARNINGS AND PRECAUTIONS
- There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.
- At high doses or in sensitive patients, hydrocodone may produce dose-related life threatening respiratory depression.
- The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
- The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
- Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule II controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.
- Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when hydrocodone bitartrate and acetaminophen tablets are used postoperatively and in patients with pulmonary disease.
- Hydrocodone and the major metabolites of acetaminophen are known to be substantially excreted by the kidney. Thus the risk of toxic reactions may be greater in patients with impaired renal function due to accumulation of the parent compound and/or metabolites in the plasma.
- Serious adverse reactions may include respiratory depression.
- The most common adverse reactions include: lightheadedness, dizziness, sedation, constipation, nausea and vomiting.
USE IN SPECIFIC POPULATIONS
- As with any narcotic analgesic agent, hydrocodone bitartrate and acetaminophen tablets should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture.
- Safety and effectiveness in the pediatric population have not been established.
- Administration of opioids shortly before delivery may result in some degree of respiratory depression in the newborn. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent.