Drug Safety-related Labeling Changes (SrLC)

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OBREDON (NDA-205474)

(GUAIFENESIN; HYDROCODONE BITARTRATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/28/2018 (SUPPL-5)

Approved Drug Label (PDF)

Boxed Warning

(extensive additions, please refer to label)

4 Contraindications

(additions underlined)

OBREDON is contraindicated for:

  • All children younger than 6 years of age.

OBREDON is also contraindicated in patients with:

  • Significant respiratory depression.

  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.

  • Known or suspected gastrointestinal obstruction, including paralytic ileus.

  • Hypersensitivity to hydrocodone, guaifenesin, or any of the inactive ingredients in OBREDON

5 Warnings and Precautions

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

(additions underlined)

Avoid the use of OBREDON 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), OBREDON 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.

5.5 Risk of Accidental Overdose and Death due to Medication Errors

(additions underlined)

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.

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.

5.8 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants

(additions underlined)

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.

(The following new subsections added, please refer to label for more information)

5.1 Addiction, Abuse, and Misuse

5.2 Life-Threatening Respiratory Depression

5.3 Risks with Use in Pediatric Populations

5.4 Risks with Use in Other At-Risk Populations

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

5.9 Risks of Use in Patients with Gastrointestinal Conditions

5.11 Increased Risk of Seizures in Patients with Seizure Disorders

5.12 Severe Hypotension

5.13 Neonatal Opioid Withdrawal Syndrome

5.14 Adrenal Insufficiency

5.15 Drug/Laboratory Test Interactions

6 Adverse Reactions

(extensive additions, please refer to label)

7 Drug Interactions

7.4 Benzodiazepines, and Other CNS Depressants

(additions underlined)

Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.  Avoid the use of OBREDON in patients who are taking benzodiazepines or other CNS depressants, and instruct patients to avoid consumption of alcohol while on OBREDON.

7.6 Monoamine Oxidase Inhibitors (MAOIs)

(additions underlined)

Avoid the use of OBREDON in patients who are taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days.  The use of MAOIs or tricyclic antidepressants with hydrocodone, one of the active ingredients in OBREDON, may increase the effect of either the antidepressant or hydrocodone. MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). 

7.9 Anticholinergic Drugs

(additions underlined)

The concomitant use of anticholinergic drugs with OBREDON may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of urinary retention or reduced gastric motility when OBREDON is used concomitantly with anticholinergic drugs.

(The following new subsections added, please refer to label for more information)

7.1 Alcohol

7.2 Inhibitors of CYP3A4 and CYP2D6

7.3 CYP3A4 Inducers

7.5 Serotonergic Drugs

7.7 Muscle Relaxants

7.8 Diuretics

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion, please refer to label)

8.2 Lactation

(PLLR conversion, please refer to label)

8.3 Females and Males of Reproductive Potential

(PLLR conversion)

Infertility

Chronic use of opioids, such as hydrocodone, a component of OBREDON, may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible.

8.4 Pediatric Use

(additions underlined)

OBREDON is not indicated for use in patients younger than 18 years of age because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of hydrocodone in these patients .

Life-threatening respiratory depression and death have occurred in children who received hydrocodone. Because of the risk of life-threatening respiratory depression and death, OBREDON is contraindicated in children less than 6 years of age.

8.5 Geriatric Use

(additions underlined)

Clinical studies have not been conducted with OBREDON in geriatric populations.

Use caution when considering the use of OBREDON in patients 65 years of age or older.  Elderly patients may have increased sensitivity to hydrocodone; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy.

Respiratory depression is the chief risk for elderly patients treated with opioids, including OBREDON. Respiratory depression has occurred after large initial doses of opioids were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.

Hydrocodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, monitor these patients closely for respiratory depression, sedation, and hypotension.

8.6 Renal Impairment

(additions underlined)

The pharmacokinetics of OBREDON has not been characterized in patients with renal impairment. Patients with renal impairment may have higher plasma concentrations than those with normal function. OBREDON should be used with caution in patients with severe impairment of renal function, and patients should be monitored closely for respiratory depression, sedation, and hypotension. 

8.7 Hepatic Impairment

(additions underlined)

The pharmacokinetics of OBREDON has not been characterized in patients with hepatic impairment. Patients with severe hepatic impairment may have higher plasma concentrations than those with normal hepatic function. Therefore, OBREDON should be used with caution in patients with severe impairment of hepatic function, and patients should be monitored closely for respiratory depression, sedation, and hypotension.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

(extensive additions, please refer to label)

PATIENT COUNSELING INFORMATION

(extensive additions, please refer to label)

01/13/2017 (SUPPL-3)

Approved Drug Label (PDF)

Boxed Warning

(New section added)

RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use of opioids with benzodiazepinies or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opiod cough medications in patients taking benzodiazepines, other CNs depressants, or alcohol.

5 Warnings and Precautions

5.1 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants

(New subsection added)

Concomitant use of opioids, including OBREDON 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.

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 Oral Solution is used with benzodiazepines, alcohol, or other CNS depressants.

7 Drug Interactions

7.1 Benzodiazepines, Opioids, Antihistamines, Antipsychotics, Anti-anxiety Agents, or Other CNS Depressants (Including Alcohol)

(additions underlined)

The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS

depressants concomitantly with OBREDON Oral Solution may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

Interactions with Benzodiazepines and Other Central Nervous System Depressants

Advise patients and caregivers that potentially fatal additive effects may occur if OBREDON Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol.

Because of this risk, patients should avoid concomitant use of OBREDON Oral Solution with benzodiazepines or other CNS depressants, including alcohol.

MEDICATION GUIDE

(New section added, please refer to label)

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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