OBREDON

OBREDON- hydrocodone bitartrate and guaifenesin solution
Sovereign Pharmaceuticals, LLC

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME

Addiction, Abuse, and Misuse
OBREDON exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. 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 addition or abuse, and refill only after reevaluation of the need for continued treatment. [ see Warnings and Precautions ( 5.1) ]

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of OBREDON. Monitor for respiratory depression, especially during initiation of OBREDON therapy or when used in patients at higher risk [ see Warnings and Precautions ( 5.2) ].

Accidental Ingestion
Accidental ingestion of even one dose of OBREDON, especially by children, can result in a fatal overdose of hydrocodone [ see Warnings and Precautions ( 5.2) ].

Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering OBREDON. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering OBREDON [ see Dosage and Administration ( 2.1), Warnings and Precautions ( 5.5) ].

Cytochrome P450 3A4 Interaction
The concomitant use of OBREDON with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of OBREDON in patients taking a CYP3A4 inhibitor or inducer [ see Warnings and Precautions ( 5.7), Drug Interactions ( 7.2, 7.3) ].

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of OBREDON in patients taking benzodiazepines, other CNS depressants, or alcohol. [ see Warning and Precautions ( 5.8), Drug Interactions ( 7.4) ]

Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking OBREDON. The co-ingestion of alcohol with OBREDON may result in increased plasma levels and a potentially fatal overdose of hydrocodone [ see Warnings and Precautions ( 5.8), Drug Interactions ( 7.1) ].

Neonatal Opioid Withdrawal Syndrome
OBREDON is not recommended for use in pregnant women [ see Use in Specific Populations ( 8.1) ]. Prolonged use of OBREDON during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If OBREDON is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [ see Warnings and Precautions ( 5.13) ]

1 INDICATIONS AND USAGE

OBREDON is indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older.OBREDON is indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older.

Important Limitations of Use

  • Not indicated for pediatric patients under 18 years of age [ see Use in Specific Populations ( 8.4) ].
  • Contraindicated in pediatric patients less than 6 years of age [ see Contraindications ( 4) ]. Contraindicated in pediatric patients less than 6 years of age [ see Contraindications ( 4) ].
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions ( 5.1) ], 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. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions ( 5.1) ], 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Administer OBREDON by the oral route only.Administer OBREDON by the oral route only.

Always use an accurate milliliter measuring device when administering OBREDON to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [ ]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use. Always use an accurate milliliter measuring device when administering OBREDON to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage [ see Warnings and Precautions ( 5.5) ]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use.

Advise patients not to increase the dose or dosing frequency of OBREDON because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions ( 5.2), Overdosage ( 10) ]. The dosage of OBREDON should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [ see Dosage and Administration ( 2.3), Warnings and Precautions ( 5.4) ].

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