OBREDON (Page 3 of 10)

5.3 Risks with Use in Pediatric Populations

Children are particularly sensitive to the respiratory depressant effects of hydrocodone [see Warnings and Precautions ( 5.2)]. Because of the risk of life-threatening respiratory depression and death, OBREDON is contraindicated in children less than 6 years of age [ see Contraindications ( 4) ].

Use of OBREDON in children also exposes them to the risks of addiction, abuse, and misuse [ see Drug Abuse and Dependence ( 9) ], which can lead to overdose and death [ see Warnings and Precautions ( 5.1), Overdosage ( 10) ]. Because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of hydrocodone in pediatric patients, OBREDON is not indicated for use in patients younger than 18 years of age [ see Indications ( 1), Use in Specific Populations (8.4) ].

5.4 Risks with Use in Other At-Risk Populations

Unresponsive CoughThe dosage of OBREDON 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 DiseaseThe use of OBREDON 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 OBREDON, 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.

OBREDON 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 OBREDON [ 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 OBREDON in patients with compromised respiratory function, patients at risk of respiratory failure, and in elderly, cachectic, or debilitated patients. If OBREDON is prescribed, monitor such patients closely, particularly when initiating OBREDON and when OBREDON 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 OBREDON 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 OBREDON. Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [ ]. 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. Advise patients to always use an accurate milliliter measuring device when measuring and administering OBREDON. 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 OBREDON, 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 OBREDON. Avoid concurrent use of OBREDON 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 OBREDON 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 OBREDON is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in OBREDON-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions.

Concomitant use of OBREDON with CYP3A4 inducers or discontinuation of an 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 OBREDON in patients who are taking a CYP3A4 inhibitor or inducer. If concomitant use of OBREDON 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 OBREDON, 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 [ ]. Concomitant use of opioids, including OBREDON, 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.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 OBREDON is used with benzodiazepines, alcohol, or other CNS depressants [ ]. Advise both patients and caregivers about the risks of respiratory depression and sedation if OBREDON 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 OBREDON therapy. The co-ingestion of alcohol with OBREDON may result in increased plasma levels and a potentially fatal overdose of hydrocodone [ see Drug Interactions ( 7.1) ].​

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