FDA label 201c4ed5-ef15-46d5-bfe3-03e9183dd9f8

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, PRECAUTIONS - Drug Interactions ). Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

WARNINGS Risks from Concomitant Use with Benzodiazepines or other CNS Depressants Concomitant use of opioids, including Hydrocodone Bitartrate and Homatropine Methylbromide 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 PRECAUTIONS - Drug Interactions ). 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 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is used with benzodiazepines, alcohol, or other CNS depressants (see PRECAUTIONS - Information for Patients ) . 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 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs (see DRUG ABUSE AND DEPENDENCE ). Respiratory Depression The use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution is not recommended for use in children less than 6 years of age because of the risk of fatal respiratory depression (see ADVERSE REACTIONS – Respiratory Depression ). Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution produces dose-related respiratory depression by directly acting on brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated. Head Injury and Increased Intracranial Pressure The respiratory depression properties 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. Acute Abdominal Conditions The administration of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Pediatric Use In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of opioid cough suppressants in a dose-dependent manner. Caution should be exercised when administering Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution to pediatric patients 6 years of age and older because of the potential for fatal respiratory depression. Overdose or concomitant administration of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered especially in the pediatric population with respiratory embarrassment (e.g., croup) (see PRECAUTIONS ).

ADVERSE REACTIONS Central Nervous System Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes. Gastrointestinal System Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution may produce constipation. Genitourinary System Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates. Respiratory Depression Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE ). Use of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with hydrocodone bitartrate and homatropine methylbromide in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression. Postmarketing events seen in children under 6 years of age include accidental overdose, bronchopneumonia, coma, cyanosis, death, death neonatal, dyspnea, pulmonary edema, respiratory arrest, and respiratory depression. Postmarketing events seen in patients older than 6 years of age include accidental overdose, cardio-respiratory arrest, death due to drug toxicity, non-accidental overdose, and overdose. Dermatological Skin rash, pruritus. To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.