FDA label 6a39ae02-7e9c-40dc-bfb3-8962d9d9742f

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, CNS depressants, or alcohol.

5 WARNINGS AND PRECAUTIONS Risks from Concomitant Use with Benzodiazepines or other CNS Depressants: Use with caution ( 5.1 ) 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, intra-cranial lesions, or increased intracranial pressure ( 5.4 ) Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery ( 5.5 ) Avoid concurrent use of alcohol or other central nervous system depressants ( 5.5 ) Acute abdominal conditions: Use with caution in patients with acute abdominal conditions ( 5.6 ) Coexisting Conditions: Use with caution in patients with thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, or asthma ( 5.10 ) 5.1 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants Concomitant use of opioids, including VITUZ, 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 VITUZ is used with benzodiazepines, alcohol, or other CNS depressants [see Patient Counseling Information (17.3) ] . 5.2 Respiratory Depression Hydrocodone bitartrate, one of the active ingredients of VITUZ 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 administrating VITUZ Oral Solution because of the potential for respiratory depression. If respiratory depression occurs, discontinue VITUZ Oral Solution and use naloxone hydrochloride when indicated to antagonize the effect and other supportive measures as necessary [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 VITUZ Oral Solution. Prescribe and administer VITUZ 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 VITUZ Oral Solution should be avoided in these patients. 5.5 Activities Requiring Mental Alertness Hydrocodone bitartrate and chlorpheniramine maleate, the active ingredients in VITUZ 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 VITUZ Oral Solution. Concurrent use of VITUZ 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 VITUZ 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 VITUZ Oral Solution in patients taking anticholinergic medications [see Drug Interactions (7.3) ] . 5.8 Co-administration with MAOIs or Tricyclic Antidepressants VITUZ 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, one of the active ingredients in VITUZ Oral Solution, may increase the effect of either the antidepressant or hydrocodone [ see Contraindications (4) and Drug Interactions (7.2) ]. 5.9 Dosing Patients should be advised to measure VITUZ 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. 5.10 Coexisting Conditions VITUZ Oral Solution should be used with caution in patients with thyroid disease, Addison's disease, prostatic hypertrophy, urethral stricture, or asthma. 5.11 Renal Impairment VITUZ Oral Solution should be used with caution in patients with severe renal impairment [see Use in Specific Populations (8.6) ] . 5.12 Hepatic Impairment VITUZ Oral Solution should be used with caution in patients with severe hepatic impairment [see Use in Specific Populations (8.7) ] .

6 ADVERSE REACTIONS Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following: Respiratory depression [see Warnings and Precautions (5.2) and Overdosage (10) ] Drug dependence [see Warnings and Precautions (5.3) ] Increased intracranial pressure [see Warnings and Precautions (5.4) and Overdosage (10) ] Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.5) ] Paralytic ileus [see Warnings and Precautions (5.6) ] Use of chlorpheniramine, an antihistamine, may result in: Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.5) ] The following adverse reactions have been identified either during clinical trials of hydrocodone bitartrate and/or chlorpheniramine maleate or during their use post-approval. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions of VITUZ Oral Solution include: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, nausea, psychic dependence, mood changes; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, irritability, tremor. Other adverse reactions include: Respiratory: Dryness of the pharynx and respiratory passages, occasional tightness of the chest, laryngismus, wheezing, or troubled breathing. Gastrointestinal System: Nausea and vomiting (more frequent in ambulatory than in recumbent patients), constipation, abdominal distension, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, and/or loss of appetite. Genitourinary System: Ureteral spasm, spasm of vesicle sphincters, urinary retention, dysuria, urinary frequency, urinary hesitancy. Dermatological System: Skin rash, pruritus, erythema, urticaria, excessive perspiration. Most common adverse reactions were sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, nausea, psychic dependence, mood changes; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, irritability, tremor ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hawthorn Pharmaceuticals, Inc. at 1-800-793-2145 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.