warnings
WARNINGS Respiratory Depression Levo-Dromoran, like morphine, may be expected to produce serious or potentially fatal respiratory depression if given in an excessive dose, too frequently, or if given in full dosage to compromised or vulnerable patients. This is because the doses required to produce analgesia in the general clinical population may cause serious respiratory depression in vulnerable patients. Safe usage of this potent opioid requires that the dose and dosage interval be individualized to each patient based on the severity of the pain, weight, age, diagnosis and physical status of the patient, and the kind and dose of concurrently administered medication. The initial dose of Levo-Dromoran should be reduced by 50% or more when the drug is given to patients with any condition affecting respiratory reserve or in conjunction with other drugs affecting the respiratory center. Subsequent doses should then be individually titrated according to the patient’s response. Respiratory depression produced by levorphanol tartrate can be reversed by naloxone, a specific antagonist (see OVERDOSAGE ). Preexisting Pulmonary Disease Because Levo-Dromoran causes respiratory depression, it should be administered with caution to patients with impaired respiratory reserve or respiratory depression from some other cause (eg, from other medication, uremia, severe infection, obstructive respiratory conditions, restrictive respiratory diseases, intrapulmonary shunting or chronic bronchial asthma). As with other strong opioids, use of Levo-Dromoran in acute or severe bronchial asthma is not recommended (see Respiratory Depression ). Head Injury and Increased Intracranial Pressure The respiratory depressant effects of Levo-Dromoran with carbon dioxide retention and secondary elevation of cerebral spinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or pre-existing increase in intracranial pressure. Opioids, including Levo-Dromoran, produce effects that may obscure neurological signs of further increase in pressure in patients with head injuries. In addition, Levo-Dromoran may affect level of consciousness that may complicate neurological evaluation. Cardiovascular Effects The use of Levo-Dromoran in acute myocardial infarction or in cardiac patients with myocardial dysfunction or coronary insufficiency should be limited because the effects of levorphanol on the work of the heart are unknown. Hypotensive Effect The administration of Levo-Dromoran may result in severe hypotension in the postoperative patient or in any individual whose ability to maintain blood pressure has been compromised by a depleted blood volume or by administration of drugs, such as phenothiazines or general anesthetics. Opioids may produce orthostatic hypotension in ambulatory patients. Use in Liver Disease Levo-Dromoran should be administered with caution to patients with extensive liver disease who may be vulnerable to excessive sedation due to increased pharmacodynamic sensitivity or impaired metabolism of the drug. Biliary Surgery Levo-Dromoran has been shown to cause moderate to marked rises in pressure in the common bile duct when given in analgesic doses. It is not recommended for use in biliary surgery. Use in Alcoholism or Drug Dependence Levo-Dromoran has an abuse potential as great as morphine, and the prescription of this drug must always balance the prospective benefits against the risk of abuse and dependence. The use of levorphanol in patients with a history of alcohol or other drug dependence, either active or in remission, has not been specifically studied (see DRUG ABUSE AND DEPENDENCE ).