FDA label bd7d3e87-d87b-456e-b23f-5ee3b45ad366

WARNINGS 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 tablets 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 tablets 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 tablets produce 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets may produce doserelated respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE ). Use of hydrocodone bitartrate and homatropine methylbromide tablets in children less than 6 years of age has been associated with fatal respiratory depression. Overdose with hyodrocodone bitartrate and homatropine methylbromide tablets 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.