OBREDON: Package Insert and Label Information
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.
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) ].
- 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.
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) ].
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)].
OBREDON is also contraindicated in patients with:
- 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)].
- 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.
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) ].
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.