warnings
WARNINGS Abuse and Dependence: Hydrocodone can produce drug dependence of the morphine type and therefore has the potential for being abused. Psychic and physical dependence as well as tolerance may develop upon repeated administration of this drug and it should be prescribed and administered with the same degree of caution as other narcotic drugs (see DRUG ABUSE AND DEPENDENCE ). Respiratory Depression : At high doses or in opioid-sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory centers. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Head Injury and Increased Intracranial Pressure : The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, 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 opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Gastrointestinal (GI) Effects-Risk of GI Ulceration, Bleeding and Perforation : Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs). Minor upper GI problems, such as dypsepsia, are common and may also occur at any time during NSAID therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding even in the absence of previous GI tract symptoms. Patients should be informed about the signs and/or symptoms of serious GI toxicity and what steps to take if they occur. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only one in five patients, who develop a serious upper GI adverse event of NSAID therapy, is symptomatic. Even short term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high risk patients, alternate therapies that do not involve NSAIDs have been considered. Studies have shown that patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold risk for developing a GI bleed than patients with neither of these risk factors. In addition to a past history of ulcer disease, pharmaco-epidemiological studies have identified several other co-therapies or co-morbid conditions that may increase the risk for GI bleeding such as: treatment with oral corticosteroids, treatment with anticoagulants, longer duration of NSAID therapy, smoking, alcoholism, older age, and poor general health status. Anaphylactoid Reactions : Anaphylactoid reactions may occur in patients without known prior exposure to hydrocodone bitartrate and ibuprofen. Hydrocodone bitartrate and ibuprofen should not be given to patients with the aspirin triad. The triad typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Fatal reactions to NSAIDs have been reported in such patients (see CONTRAINDICATIONS and PRECAUTIONS-Pre-existing Asthma ). Emergency help should be sought when anaphylactoid reaction occurs. Advanced Renal Disease : In cases with advanced kidney disease, treatment with hydrocodone bitartrate and ibuprofen are not recommended. If NSAID therapy, however, must be initiated, close monitoring of the patient’s kidney function is advisable (see PRECAUTIONS-Renal Effects ). Pregnancy : As with other NSAID-containing products, hydrocodone bitartrate and ibuprofen should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.