OBREDON (Page 2 of 10)

2.2 Recommended Dosage

Adults and adolescents 18 years of age and older: 10 mL every 4 to 6 hours, not to exceed 6 doses (60 mL) in 24 hours.

2.3 Monitoring, Maintenance, and Discontinuation of Therapy

Prescribe OBREDON for the shortest duration that is consistent with individual patient treatment goals [ see Warnings and Precautions ( 5.1) ].

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [ see Warnings and Precautions ( 5.2) ].

Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [ see Warnings and Precautions ( 5.4) ]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with OBREDON, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [ see Warnings and Precautions ( 5.1) ].

Do not abruptly discontinue OBREDON in a physically-dependent patient [ see Drug Abuse and Dependence ( 9.3) ]. When a patient who has been taking OBREDON regularly and may be physically dependent no longer requires therapy with OBREDON, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.

3 DOSAGE FORMS AND STRENGTHS

Oral Solution: Each 5 mL contains hydrocodone bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg [see Description ( 11)] .

4 CONTRAINDICATIONS

OBREDON is contraindicated for:

  • All children younger than 6 years of age [see Warnings and Precautions ( 5.2, 5.3), Use in Specific Populations ( 8.4)]. All children younger than 6 years of age [see Warnings and Precautions ( 5.2, 5.3), Use in Specific Populations ( 8.4)].

OBREDON is also contraindicated in patients with:

  • Significant respiratory depression [see Warnings and Precautions ( 5.2)]. Significant respiratory depression [see Warnings and Precautions ( 5.2)].
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.4)]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.4)].
  • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.9)]. Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.9)].
  • Hypersensitivity to hydrocodone, guaifenesin, or any of the inactive ingredients in OBREDON [see Adverse Reactions ( 6)].

5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

OBREDON contains hydrocodone, a Schedule II controlled substance. As an opioid, OBREDON 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 OBREDON 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 OBREDON, prescribe OBREDON 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 OBREDON. 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 OBREDON. 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 OBREDON. 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 OBREDON, OBREDON close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), depending on the patient’s clinical status [ see Overdosage ( 10) ]. Carbon dioxide (CO 2 ) 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 OBREDON, the risk is greatest during the initiation of therapy, when OBREDON 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 OBREDON is essential [ see Dosage and Administration ( 2.1), Warnings and Precautions ( 5.5) ]. Monitor patients closely, especially within the first 24-72 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 children younger than 6 years of age has been associated with fatal respiratory depression when used as recommended. Accidental ingestion of even one dose of OBREDON, especially by children, can result in respiratory depression and death.

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