Hydromet (Page 3 of 10)

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 hydrocodone bitartrate and homatropine methylbromide oral solution 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 hydrocodone bitartrate and homatropine methylbromide 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.

5.6 Activities Requiring Mental Alertness: Risks of Driving and Operating Machinery

Hydrocodone, one of the active ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of hydrocodone bitartrate and homatropine methylbromide oral solution. Avoid concurrent use of hydrocodone bitartrate and homatropine methylbromide oral solution with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur [see Warnings and Precautions (5.8)].

5.7 Risks from Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers

Concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of hydrocodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression [see Warnings and Precautions (5.2)] , particularly when an inhibitor is added after a stable dose of hydrocodone bitartrate and homatropine methylbromide oral solution is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in hydrocodone bitartrate and homatropine methylbromide oral solution-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions.

Concomitant use of hydrocodone bitartrate and homatropine methylbromide with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease hydrocodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to hydrocodone.

Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients who are taking a CYP3A4 inhibitor or inducer. If concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution with a CYP3A4 inhibitor or inducer is necessary, monitor patients for signs and symptoms that may reflect opioid toxicity and opioid withdrawal [see Drug Interactions (7.2, 7.3)].

5.8 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants

Concomitant use of opioids, including hydrocodone bitartrate and homatropine methylbromide oral solution, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [see Drug Interactions (7.1, 7.4)].

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.

Advise both patients and caregivers about the risks of respiratory depression and sedation if hydrocodone bitartrate and homatropine methylbromide oral solution is used with benzodiazepines, alcohol, or other CNS depressants [see Patient Counseling Information (17)].

Patients must not consume alcoholic beverages, or prescription or non-prescription products containing alcohol, while on hydrocodone bitartrate and homatropine methylbromide oral solution therapy. The co-ingestion of alcohol with hydrocodone bitartrate and homatropine methylbromide oral solution may result in increased plasma levels and a potentially fatal overdose of hydrocodone [see Drug Interactions (7.1)].

5.9 Risks of Use in Patients with Gastrointestinal Conditions

Hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Contraindications (4)]. The use of hydrocodone in hydrocodone bitartrate and homatropine methylbromide oral solution may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

The concurrent use of anticholinergics with hydrocodone bitartrate and homatropine methylbromide oral solution may produce paralytic ileus [see Drug Interactions (7.9)].

The hydrocodone in hydrocodone bitartrate and homatropine methylbromide oral solution may result in constipation or obstructive bowel disease, especially in patients with underlying intestinal motility disorders. Use with caution in patients with underlying intestinal motility disorders.

The hydrocodone in hydrocodone bitartrate and homatropine methylbromide oral solution may cause spasm of the sphincter of Oddi, resulting in an increase in biliary tract pressure. Opioids may cause increases in serum amylase [see Warnings and Precautions (5.15)]. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms.

5.10 Risks of Use in Patients with Head Injury, Impaired Consciousness, Increased Intracranial Pressure, or Brain Tumors

Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients with head injury, intracranial lesions, or a pre-existing increase in intracranial pressure. In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), hydrocodone bitartrate and homatropine methylbromide oral solution may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries.

5.11 Increased Risk of Seizures in Patients with Seizure Disorders

The hydrocodone in hydrocodone bitartrate and homatropine methylbromide oral solution may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during hydrocodone bitartrate and homatropine methylbromide oral solution therapy.

5.12 Severe Hypotension

Hydrocodone bitartrate and homatropine methylbromide oral solution may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see Drug Interactions (7.4)]. Monitor these patients for signs of hypotension after initiating hydrocodone bitartrate and homatropine methylbromide oral solution.

In patients with circulatory shock, hydrocodone bitartrate and homatropine methylbromide oral solution may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients with circulatory shock.

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