FDA label 5b21dbc4-23fe-1d3b-e053-2a91aa0adfef

WARNING: 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 [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )] . Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol. WARNING: 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 [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )] . Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

5 WARNINGS AND PRECAUTIONS Dose-related respiratory depression: Use with caution. ( 5.2 ) Drug Dependence: Prescribe with caution that is appropriate to the use of other opioids. ( 5.3 ) Head injury and increased intracranial pressure: Avoid in patients with head injury, intracranial lesions or increased intracranial pressure. ( 5.4 ) Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery. ( 5.5 ) Acute abdominal conditions: Use with caution in patients with acute abdominal conditions. ( 5.6 ) Coexisting conditions: Use with caution in patients with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy, or urethral stricture, or asthma. ( 5.11 ) 5.1 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants 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 [see DRUG INTERACTIONS ( 7.1 )] . 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 [see PATIENT COUNSELING INFORMATION ( 17 )] . 5.2 Respiratory Depression Hydrocodone bitartrate, one of the active ingredients in OBREDON Oral Solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of hydrocodone bitartrate in adults has been associated with fatal respiratory depression, and the use of hydrocodone bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administering OBREDON Oral Solution because of the potential for respiratory depression. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated [see OVERDOSAGE ( 10 )]. 5.3 Drug Dependence Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of OBREDON Oral Solution. Prescribe and administer OBREDON Oral Solution with the same degree of caution appropriate to the use of other opioid drugs [see DRUG ABUSE AND DEPENDENCE ( 9.2 ), ( 9.3 )]. 5.4 Head Injury and Increased Intracranial Pressure The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of OBREDON Oral Solution should be avoided in these patients. 5.5 Activities Requiring Mental Alertness Hydrocodone bitartrate, one of the active ingredients in OBREDON Oral Solution, 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 Oral Solution. Concurrent use of OBREDON Oral Solution with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur. 5.6 Acute Abdominal Conditions OBREDON Oral Solution should be used with caution in patients with acute abdominal conditions since the administration of hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus [see DRUG INTERACTIONS ( 7.3 )]. 5.7 Co-administration with Anticholinergics The concurrent use of anticholinergics with hydrocodone may produce paralytic ileus. Exercise caution when using OBREDON Oral Solution in patients taking anticholinergic medications [see DRUG INTERACTIONS ( 7.3 )]. 5.8 Co-administration with MAOIs or Tricyclic Antidepressants OBREDON Oral Solution should not be used in patients receiving MAOI therapy or within 14 days of stopping such therapy. The use of MAOIs or tricyclic antidepressants with hydrocodone bitartrate may increase the effect of either the antidepressant or hydrocodone [see CONTRAINDICATIONS ( 4 ) and DRUG INTERACTIONS ( 7.2 )]. 5.9 Persistent Cough OBREDON Oral Solution should not be used in patients with a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus). 5.10 Dosing Patients should be advised to measure OBREDON Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions [see OVERDOSAGE ( 10 )]. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose. 5.11 Coexisting Conditions OBREDON Oral Solution should be used with caution in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, and asthma. 5.12 Renal Impairment OBREDON Oral Solution should be used with caution in patients with severe renal impairment. [see Renal Impairment ( 8.6 )] 5.13 Hepatic Impairment OBREDON Oral Solution should be used with caution in patients with severe hepatic impairment [see Hepatic Impairment ( 8.7 )].

6 ADVERSE REACTIONS Use of hydrocodone bitartrate is associated with the following: Respiratory depression [see WARNINGS AND PRECAUTIONS ( 5.2 ) and OVERDOSAGE ( 10 )] Drug dependence [see WARNINGS AND PRECAUTIONS ( 5.3 ) and DRUG ABUSE AND DEPENDENCE ( 9.3 )] Increased intracranial pressure [see WARNINGS AND PRECAUTIONS ( 5.4 )] Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS ( 5.5 )] Paralytic ileus [see WARNINGS AND PRECAUTIONS ( 5.6 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common adverse reactions experienced by subjects taking a single dose of OBREDON Oral Solution in the clinical setting include the following: Central Nervous System: headache, dizziness, sedation (somnolence); Gastrointestinal System: nausea, diarrhea; Cardiovascular System: decreased blood pressure; Vascular System: hot flush. The most common adverse reactions of OBREDON Oral Solution include: Dizziness, headache, sedation, nausea, and decreased blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ABER Pharmaceuticals, LLC. at tel: 1-855-461-5102; www.obredon.com or FDA at 1-800-FDA-1088; www.fda.gov/medwatch .