"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
Levo-Dromoran (levorphanol) , 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 (levorphanol) 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 (levorphanol) 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 (levorphanol) 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 (levorphanol) 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 (levorphanol) , produce effects that may obscure neurological signs of further increase in pressure in patients with head injuries. In addition, Levo-Dromoran (levorphanol) may affect level of consciousness that may complicate neurological evaluation.
The use of Levo-Dromoran (levorphanol) 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.
The administration of Levo-Dromoran (levorphanol) 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 (levorphanol) 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.
Levo-Dromoran (levorphanol) 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 (levorphanol) 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).
As with other opioids, the administration of Levo-Dromoran (levorphanol) may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Levo-Dromoran (levorphanol) should be administered with caution and the initial dose should be reduced in patients who are elderly or debilitated and in those patients with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, toxic psychosis, prostatic hypertrophy or urethral stricture, acute alcoholism, or delirium tremens.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No information about the effects of Levo-Dromoran (levorphanol) on carcinogenesis, mutagenesis, or fertility is available.
Pregnancy Category C. Levo-Dromoran (levorphanol) has been shown to be teratogenic in mice when given at a single oral dose of 25 mg/kg. The tested dose caused a near 50% mortality of the mouse embryos. There are no adequate and well-controlled studies in pregnant women. Levo-Dromoran (levorphanol) should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Babies born to mothers who have been taking opioids regularly prior to delivery may be physically dependent.
A study in rabbits has demonstrated that at doses of 1.5 to 20 mg/kg, Levo-Dromoran (levorphanol) administered intravenously crosses the placental barrier and depresses fetal respiration.
Labor and Delivery
The use of Levo-Dromoran (levorphanol) in labor and delivery in humans has not been studied. However, as with other opioids, administration of Levo-Dromoran (levorphanol) to the mother during labor and delivery may result in respiratory depression in the newborn. Therefore, its use during labor and delivery is not recommended.
Studies of levorphanol concentrations in breast milk have not been performed. However, morphine, which is structurally similar to levorphanol, is excreted in human milk. Because of the potential for serious adverse reactions from Levo-Dromoran (levorphanol) in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Levo-Dromoran (levorphanol) is not recommended in children under the age of 18 years as the safety and efficacy of the drug in this population has not been established.
The initial dose of Levo-Dromoran (levorphanol) should be reduced by 50% or more in the infirm elderly patient, even though there have been no reports of unexpected adverse events in older populations. All drugs of this class may be associated with a profound or prolonged effect in elderly patients for both pharmacokinetic and pharmacodynamic reasons and caution is indicated.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/3/2009
Additional Levo Dromoran Information
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