Drugs Details

Drugs Info of Levo-Dromoran
Drugs Details
  • Drugs Type  : FDA
  • Date : 14th Feb 2015 04:34 am
  • Brand Name : Levo-Dromoran
  • Generic Name : levorphanol (Pronunciation: lee VOR fa nole)
Descriptions

Levo-Dromoran (levorphanol tartrate) is a potent opioid analgesic with empirical formula C17H23NO•C4H6O6•2H2O and molecular weight 443.5. Each mg of levorphanol tartrate is equivalent to 0.58 mg levorphanol base. Chemically levorphanol is levo-3-hydroxy-N-methylmorphinan. The USP nomenclature is 17-methylmorphinan 3-ol tartrate (1:1)(Salt) dihydrate. The material has 3 asymmetric carbon atoms. The chemical structure is:

 

 Levo-Dromoran (levorphanol tartrate) Structural Formula Illustration

Levorphanol tartrate is a white crystalline powder, soluble in water and ether but insoluble in chloroform.

Each 1-mL ampul contains 2 mg levorphanol tartrate, 1.8 mg methyl paraben preservative, 0.2 mg propyl paraben preservative, sodium hydroxide to adjust pH to approximately 4.3 and Water for Injection.

Each milliliter in the 10 mL vials contains 2 mg levorphanol tartrate, 4.5 mg phenol preservative, sodium hydroxide to adjust pH to approximately 4.3 and Water for Injection.

Each tablet contains 2 mg levorphanol tartrate, lactose, corn starch, stearic acid and talc.

What are the possible side effects of levorphanol (Levo-Dromoran)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • mood changes, confusion, unusual thoughts or behavior;
  • thoughts of suicide or hurting yourself;
  • feeling like you might pass out;
  • weak or shallow breathing;
  • cold, clammy skin;
  • blue lips or skin;
  • painful or difficult urination; or
  • slow heart rate, weak pulse, fainting, slow breathing...

Read All Potential Side Effects and See Pictures of Levo Dromoran »

What are the precautions when taking levorphanol (Levo Dromoran)?

Before taking levorphanol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat), low blood pressure, certain bowel diseases (e.g., paralytic ileus, toxic megacolon), breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, emphysema, low oxygen/high carbon dioxide in the blood), disease of the pancreas (e.g., pancreatitis), mental/mood disorders (e.g.,...

Read All Potential Precautions of Levo Dromoran »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Levo-Dromoran (levorphanol) is indicated for the management of moderate to severe pain or as a preoperative medication where an opioid analgesic is appropriate.

Dosage Administration

Intravenous

The usual recommended starting dose for IV administration is up to 1 mg, given in divided doses, by slow injection. This may be repeated in 3 to 6 hours as needed, provided the patient is assessed for signs of hypoventilation or excessive sedation. Dosage should be adjusted according to the severity of the pain; age, weight and physical status of the patient; the patient's underlying diseases; use of concomitant medications; and other factors (see Individualization Of Dosage, WARNINGS and PRECAUTIONS). Total daily doses of more than 4 to 8 mg IV in 24 hours are generally not recommended as starting doses in nonopioid tolerant patients; lower total daily doses may be appropriate.

Intramuscular or Subcutaneous

The usual recommended starting dose for IM or SC administration is 1 to 2 mg. This may be repeated in 6 to 8 hours as needed, provided the patient is assessed for signs of hypoventilation or excessive sedation. Dosage should be adjusted according to the severity of the pain; age, weight and physical status of the patient; the patient's underlying diseases; use of concomitant medications; and other factors (see Individualization Of Dosage, WARNINGS and PRECAUTIONS). Total daily doses of more than 3 to 8 mg IM in 24 hours are generally not recommended as starting doses in nonopioid tolerant patients; lower total daily doses may be appropriate.

Oral

The usual recommended starting dose for oral administration is 2 mg. This may be repeated in 6 to 8 hours as needed, provided the patient is assessed for signs of hypoventilation and excessive sedation. If necessary, the dose may be increased to up to 3 mg every 6 to 8 hours, after adequate evaluation of the patient's response. Higher doses may be appropriate in opioid tolerant patients. Dosage should be adjusted according to the severity of the pain; age, weight and physical status of the patient; the patient's underlying diseases; use of concomitant medications; and other factors (see Individualization Of Dosage, WARNINGS and PRECAUTIONS). Total oral daily doses of more than 6 to 12 mg in 24 hours are generally not recommended as starting doses in nonopioid tolerant patients; lower total daily doses may be appropriate.

Use in Chronic Pain

The dosage of Levo-Dromoran (levorphanol) in patients with cancer or with other conditions for which chronic opioid therapy is indicated must be individualized (see Individualization Of Dosage). Levo-Dromoran (levorphanol) is 4 to 8 times as potent as morphine and has a longer half-life. Because there is incomplete cross-tolerance among opioids, when converting a patient from morphine to Levo-Dromoran (levorphanol) , the total daily dose of oral Levo-Dromoran (levorphanol) should begin at approximately 1/15 to 1/12 of the total daily dose of oral morphine that such patients had previously required and then the dose should be adjusted to the patient's clinical response. If a patient is to be placed on fixed-schedule dosing (round-the-clock) with this drug, care should be taken to allow adequate time after each dose change (approximately 72 hours) for the patient to reach a new steady-state before a subsequent dose adjustment to avoid excessive sedation due to drug accumulation.

Use in The Perioperative Period

Levo-Dromoran (levorphanol) has been used for analgesic action during premedication and the postoperative period. Factors to be considered in determining the dosage include age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia used, the surgical procedure involved and the severity of pain (see Individualization Of Dosage, WARNINGS and PRECAUTIONS).

Premedication

The preoperative medication dose of Levo-Dromoran should be individualized (see Individualization Of Dosage, WARNINGS and PRECAUTIONS). The usual dose for healthy young adults is 1 to 2 mg intramuscularly or subcutaneously, administered 60 to 90 minutes before surgery. Older or debilitated patients usually require less drug. Two mg of Levo-Dromoran (levorphanol) is approximately equivalent to 10 to 15 mg of morphine or 100 mg of meperidine.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Pharmaceutical Incompatibilities of Levo-Dromoran

Levorphanol tartrate injection has been reported to be physically incompatible with solutions containing aminophylline, ammonium chloride, amobarbital sodium, chlorothiazide sodium, heparin sodium, methicillin sodium, nitrofurantoin sodium, novobiocin sodium, pentobarbital sodium, perphenazine, phenobarbital sodium, phenytoin sodium, secobarbital sodium, sodium bicarbonate, sodium iodide, sulfadiazine sodium, sulfisoxazole diethanolamine and thiopental sodium.

Safety and Handling

Levo-Dromoran (levorphanol) is packaged in sealed systems that have a low risk of accidental exposure to health care workers. Ordinary care should be taken to avoid aerosol generation while preparing a syringe for use. Significant absorption from accidental dermal exposure is unlikely, and spilled Levo-Dromoran (levorphanol) should be washed from the skin by rinsing with cool water. As with all controlled substances, abuse by health care personnel is possible and the drug should be handled accordingly.

How Supplied

Ampuls: 1 mL, 2 mg/mL levorphanol tartrate – boxes of 10 (NDC 0187-3072-10).

Multiple-Dose Vials: 10 mL, 2 mg/mL levorphanol tartrate – boxes of 1 (NDC 0187-3074-20).

Scored Oral Tablets: 2 mg round, white, flat beveled edge tablets in bottles of 100 (NDC 0187-3251-10); with LEVO engraved on one side and 3251 and full bisect scored on the other side.

Storage: Tablets should be stored at 25°C (77°F); excursions permitted to 15°C- 30°C (59°F - 86°F).

Dispense in tight containers as defined in USP/NF.

Parenteral dosage forms should be stored at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).

DEA Order Form Required.

Manufactured for: Valeant Pharmaceuticals International, Costa Mesa, CA 92626. Valeant Pharmaceuticals International, 3300 Hyland Ave., Costa Mesa, CA 92626 U.S.A. 714-545-0100. Rev. April 2004.

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

In approximately 1400 patients treated with Levo-Dromoran (levorphanol) in controlled clinical trials, the type and incidence of side effects were those expected of an opioid analgesic, and no unforeseen or unusual toxicity was reported.

Drugs of this type are expected to produce a cluster of typical opioid effects in addition to analgesia, consisting of nausea, vomiting, altered mood and mentation, pruritus, flushing, difficulties in urination, constipation and biliary spasm. The frequency and intensity of these effects appears to be dose related. Although listed as adverse events these are expected pharmacologic actions of these drugs and should be interpreted as such by the clinician.

The following adverse events have been reported with the use of Levo-Dromoran (levorphanol) :

Body as a Whole: abdominal pain, dry mouth, sweating

Cardiovascular System: cardiac arrest, shock, hypotension, arrhythmias including bradycardia and tachycardia, palpitations, extrasystoles

Digestive System: nausea, vomiting, dyspepsia, biliary tract spasm

Nervous System: coma, suicide attempt, convulsions, depression, dizziness, confusion, lethargy, abnormal dreams, abnormal thinking, nervousness, drug withdrawal, hypokinesia, dyskinesia, hyperkinesia, CNS stimulation, personality disorder, amnesia, insomnia

Respiratory System: apnea, cyanosis, hypoventilation

Skin & Appendages: pruritus, urticaria, rash, injection site reaction

Special Senses: abnormal vision, pupillary disorder, diplopia

Urogenital System: kidney failure, urinary retention, difficulty urinating

Drug Abuse And Dependence

Warning: May be Habit Forming

Levo-Dromoran (levorphanol) is a Schedule II Controlled Substance. All drugs of this class (mu-opioids of the morphine type) are habit forming and should be stored, prescribed, used and disposed of accordingly. Psychological/physical dependence and tolerance may develop upon repeated administration of Levo-Dromoran (levorphanol) .

Discontinuation of Levo-Dromoran (levorphanol) after chronic use has been reported to result in withdrawal syndromes, and some reports of overuse and self-reported addiction have been received. Neither withdrawal nor withdrawal symptoms are usually expected in postoperative patients who used the drug for less than a week or in patients who are gradually tapered off the drug after longer use.

Read the Levo Dromoran (levorphanol) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

Interactions with Other CNS Agents

Concurrent use of Levo-Dromoran (levorphanol) with all central nervous system depressants (eg, alcohol, sedatives, hypnotics, other opioids, general anesthetics, barbitu-rates, tricyclic antidepressants, phenothiazines, tranquilizers, skeletal muscle relaxants and antihistamines) may result in additive central nervous system depressant effects. Respiratory depression, hypotension, and profound sedation or coma may occur. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Although no interaction between MAO inhibitors and Levo-Dromoran (levorphanol) has been observed, it is not recommended for use with MAO inhibitors.

Most cases of serious or fatal adverse events involving Levo-Dromoran (levorphanol) reported to the manufacturer or the FDA have involved either the administration of large initial doses or too frequent doses of the drug to nonopioid tolerant patients, or the simultaneous administration of levorphanol with other drugs affecting respiration (see Individualization Of Dosage and WARNINGS).

The initial dose of levorphanol should be reduced by approximately 50% or more when it is given to patients along with another drug affecting respiration.

Interactions with Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist analgesics (eg, pentazocine, nalbuphine, butorphanol, dezocine and buprenorphine) should NOT be administered to a patient who has received or is receiving a course of therapy with a pure agonist opioid analgesic such as Levo-Dromoran (levorphanol) . In opioid-dependent patients, mixed agonist/antagonist analgesics may precipitate withdrawal symptoms.

Use in Ambulatory Patients

Levo-Dromoran (levorphanol) has been used in both inpatient and outpatient settings, but both physicians and patients must be aware of the risk of orthostatic hypotension, dizziness and syncope in ambulatory patients.

As with other opioids, the use of Levo-Dromoran (levorphanol) may impair mental and/or physical abilities required for the performance of potentially hazardous tasks or for the exercise of normal good judgement and patients and staff should be advised accordingly. Concurrent use of Levo-Dromoran (levorphanol) with central nervous system depressants (eg, alcohol, sedatives, hypnotics, other opioids, barbiturates, tricyclic antidepressants, phenothiazines, tranquilizers, skeletal muscle relaxants and antihistamines) may result in additive central nervous system depressant effects.

Read the Levo Dromoran Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Respiratory Depression

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.

Cardiovascular Effects

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.

Hypotensive Effect

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.

Biliary Surgery

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).

Precautions

General

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

Teratogenic Effects

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.

Nonteratogenic Effects

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.

Nursing Mothers

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.

Pediatric Use

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.

Geriatric Use

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.

OverDose

Most reports of overdosage known to the manufacturer and to the FDA involve three clinical situations. These are: 1. the use of larger than recommended doses or too frequent doses, 2. administration of the drug to children or small adults without any reduction in dosage, and 3. the use of the drug in ordinary dosage in patients compromised by concurrent illness.

As with all opioids, overdose can occur due to accidental or intentional misuse of this product, especially in infants and children who may gain access to the drug in the home. Based on its pharmacology, levorphanol overdosage would be expected to produce signs of respiratory depression, cardiovascular failure (especially in predisposed patients) and/or central nervous system depression.

Serious overdosage with Levo-Dromoran (levorphanol) is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, periodic breathing, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Treatment

The specific treatment of suspected levorphanol tartrate overdosage is immediate establishment of an adequate airway and ventilation, followed (if necessary) by intravenous naloxone. The respiratory and cardiac status of the patient should be continuously monitored and appropriate supportive measures instituted, such as oxygen, intravenous fluids and/or vasopressors, if required. Physicians are reminded that the duration of levorphanol action far exceeds the duration of action of naloxone, and repeated dosing with naloxone may be required. Naloxone should be administered cautiously to persons known or suspected to be physically dependent on Levo-Dromoran (levorphanol) . In such cases an abrupt and complete reversal of opioid effects may precipitate an acute abstinence syndrome. If necessary to administer naloxone to the physically dependent patient, the antagonist should be administered with extreme care and by titration with smaller than usual doses of the antagonist.

ContrainDications

Levo-Dromoran (levorphanol) is contraindicated in patients hypersensitive to levorphanol tartrate.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Pharmacodynamics

Levo-Dromoran (levorphanol) is a potent synthetic opioid similar to morphine in its actions. Like other mu-agonist opioids it is believed to act at receptors in the periventricular and periaqueductal gray matter in both the brain and spinal cord to alter the transmission and perception of pain. Onset of analgesia and peak analgesic effect following administration of levorphanol are similar to morphine when administered at equianalgesic doses.

Levorphanol produces a degree of respiratory depression similar to that produced by morphine at equianalgesic doses, and like many mu-opioid drugs, levorphanol produces euphoria or has a positive effect on mood in many individuals. Two mg of intramuscular levorphanol tartrate depresses respiration to a degree approximately equivalent to that produced by 10 to 15 mg of intramuscular morphine in man. The hemodynamic changes after intravenous administration of levorphanol have not been studied in man but are expected to clinically resemble those seen after morphine.

As with other opioids, the blood levels required for analgesia are determined by the opioid tolerance of the patient and are likely to rise with chronic use. The rate of development of tolerance is highly variable and is determined by the dose, dosing interval, age, use of concomitant drugs and physical status of the patient. While blood levels of opioid drugs may be helpful in assessing individual cases, dosage is usually adjusted by careful clinical observation of the patient.

Pharmacokinetics

The pharmacokinetics of levorphanol have been studied in a limited number of cancer patients following intravenous (IV), intramuscular (IM) and oral (PO) administration. Following IV administration, plasma concentrations of levorphanol decline in a triexponential manner with a terminal half-life of approximately 11 to 16 hours and a clearance of 0.78 to 1.1 L/kg/hr. Based on terminal half-life, steady-state plasma concentrations should be achieved by the third day of dosing. Levorphanol is rapidly distributed ( < 1 hr) and redistributed (1 to 2 hours) following IV administration and has a steady-state volume of distribution of 10 to 13 L/kg. In vitro studies of protein binding indicate that levorphanol is only 40% bound to plasma proteins.

No pharmacokinetic studies of the absorption of IM levorphanol are available, but clinical data suggests that absorption is rapid with onset of effects within 15 to 30 minutes of administration.

Levorphanol is well absorbed after PO administration with peak plasma concentrations occurring approximately 1 hour after dosing. The bioavailability of levorphanol tablets compared to IM or IV administration is not known.

Plasma concentrations of levorphanol following chronic administration in patients with cancer increased with the dose, but the analgesic effect was dependent on the degree of opioid tolerance of the patient. Expected steady-state plasma concentrations for a 6-hour dosing interval can reach 2 to 5 times those following a single dose, depending on the patient's individual clearance of the drug.

Very high plasma concentrations of levorphanol can be reached in patients on chronic therapy due to the long half-life of the drug. One study in 11 patients using the drug for control of cancer pain reported plasma concentrations from 5 to 10 ng/mL after a single 2-mg dose up to 50 to 100 ng/mL after repeated oral doses of 20 to 50 mg/day.

Animal studies suggest that levorphanol is extensively metabolized in the liver and is eliminated as the glucuronide metabolite. This renally excreted inactive glucuronide metabolite accumulates with chronic dosing in plasma at concentrations that reach fivefold that of the parent compound.

The effects of age, gender, hepatic and renal disease on the pharmacokinetics of levorphanol are not known. As with all drugs of this class, patients at the extremes of age are expected to be more susceptible to adverse effects because of a greater pharmacodynamic sensitivity and probable increased variability in pharmacokinetics due to age or disease.

Clinical Trials

Clinical trials have been reported in the medical literature that investigated the use of Levo-Dromoran (levorphanol) as a preoperative medication, as a postoperative analgesic and in the management of chronic pain due primarily to malignancy. In each of these clinical settings Levo-Dromoran (levorphanol) has been shown to be an effective analgesic of the mu-opioid type and similar to morphine, meperidine or fentanyl. A single 2 mg intramuscular dose of Levo-Dromoran (levorphanol) was studied as a routine preoperative medication in 100 patients as part of a blinded 1500 patient trial of a number of synthetic opioids and was found to provide sedation similar to that observed with 100 mg meperidine or 10 mg of methadone.

Levo-Dromoran (levorphanol) has been studied in chronic cancer patients. Dosages were individualized to each patient's level of opioid tolerance. In one study, starting doses of 2 mg twice a day often had to be advanced by 50% or more within a few weeks of starting therapy. A study of levorphanol indicates that the relative potency is approximately 4 to 8 times that of morphine, depending on the specific circumstances of use. In postoperative patients, intramuscular levorphanol was determined to be about 8 times as potent as intramuscular morphine, whereas in cancer patients with chronic pain, it was found to be only about 4 times as potent.

Individualization Of Dosage

Accepted medical practice dictates that the dose of any opioid analgesic be appropriate to the degree of pain to be relieved, the clinical setting, the physical condition of the patient, and the kind and dose of concurrent medication. This is especially important during recovery from anesthesia because of the residual CNS-depressant effects of anesthetic agents and the adverse effects of surgery on respiratory reserve. In consequence, the dose of Levo-Dromoran (levorphanol) should be reduced under circumstances likely to increase the patient's sensitivity to the adverse effects of opioids. As there is substantial redistribution involved in the kinetics of levorphanol, the duration of effect of a single dose may vary and physicians must judge the need for a repeat dose based on the clinical response of the patient. Clinicians are advised to remember that while the long terminal half-life of levorphanol may reduce the need for postoperative analgesics, the administration of an excessive dose preoperatively may cause a delay in the return of spontaneous respirations or prolonged hypoventilation in the postoperative period. In addition, accumulation of the drug following excessive dosage postoperatively may prolong or result in hypoventilation.

Levo-Dromoran (levorphanol) has a long half-life similar to methadone or other slowly excreted opioids, rather than quickly excreted agents such as morphine or meperidine. Slowly excreted drugs may have some advantages in the management of chronic pain. Unfortunately, the duration of pain relief after a single dose of a slowly excreted opioid cannot always be predicted from pharmacokinetic principles, and the inter-dose interval may have to be adjusted to suit the patient's individual pharmacodynamic response. Levo-Dromoran (levorphanol) is 4 to 8 times as potent as morphine and has a longer half-life. Because there is incomplete cross-tolerance among opioids, when converting a patient from morphine to Levo-Dromoran (levorphanol) , the total daily dose of oral Levo-Dromoran (levorphanol) should begin at approximately 1/15 to 1/12 of the total daily dose of oral morphine that such patients had previously required and then the dose should be adjusted to the patient's clinical response. If a patient is to be placed on fixed-schedule dosing (round-the-clock) with this drug, care should be taken to allow adequate time after each dose change (approximately 72 hours) for the patient to reach a new steadystate before a subsequent dose adjustment to avoid excessive sedation due to drug accumulation.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

If Levo-Dromoran (levorphanol) is administered to ambulatory patients, they should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle. They should also be warned that concurrent use of Levo-Dromoran (levorphanol) with central nervous system depressants (eg, alcohol, sedatives, hypnotics, other opioids, barbiturates, tricyclic antidepressants, phenothiazines, tranquilizers, skeletal muscle relaxants and antihistamines) may result in additive central nervous system depressant effects. Patients should be made aware of the risk of orthostatic hypotension, dizziness and syncope in ambulatory patients taking Levo-Dromoran (levorphanol) .

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

LEVORPHANOL - ORAL

 

(lee-VOR-fa-nole)

 

COMMON BRAND NAME(S): Levo-Dromoran

 

WARNING: Levorphanol has a high risk for abuse and severe, possibly fatal, breathing problems. The risk for harm is higher if you take the wrong dose/strength, or if you take it along with other drugs that might also affect breathing. Be sure you know how to take levorphanol and what other drugs you should avoid taking with it. The risk for breathing problems might also be higher when you start this medication and after a dose increase. Get immediate help if you notice unusual slow/shallow breathing.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally swallows this drug, get emergency medical help right away.

 

USES: This medication is used to treat moderate to severe pain. Levorphanol is a narcotic pain reliever. It acts on certain centers in the brain to give you pain relief.

 

HOW TO USE: Take this medication by mouth, usually every 6 to 8 hours as needed or as directed by your doctor. You may take this drug with or without food. If you have nausea, you may take this drug with food, although this may cause your body to absorb less of the drug and get less benefit from it. Consult your doctor or pharmacist about other ways to decrease nausea (e.g., antihistamines, lying down for 1-2 hours with as little head movement as possible).

The dosage is based on your medical condition, age, response to treatment, and other medications that you may be taking. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

You may take quick-acting narcotic pain medications for sudden (breakthrough) pain if so directed by your doctor. Also follow your doctor's or pharmacist's instructions for safely using non-narcotic pain relievers (e.g., naproxen, ibuprofen). If you have been using other long-acting narcotic pain medications or narcotic patches regularly, check with your doctor or pharmacist since they may need to be stopped before you start using this medication. If you are currently using a narcotic patch (e.g., fentanyl), the effects may continue after it is removed. Ask your doctor or pharmacist when it will be safe to start taking this medication (usually 18 hours after removing the patch).

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, sweating, shaking, body aches, stomach cramps, nausea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your pain persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, dry mouth, flushing, or vision problems may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, depression, abnormal thoughts), trouble urinating, fast/slow/irregular heartbeat, severe stomach/abdominal pain, change in the amount of urine.

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Levo Dromoran (levorphanol) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking levorphanol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat), low blood pressure, certain bowel diseases (e.g., paralytic ileus, toxic megacolon), breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, emphysema, low oxygen/high carbon dioxide in the blood), disease of the pancreas (e.g., pancreatitis), mental/mood disorders (e.g., toxic psychosis), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

Based on information from related drugs, this medication may pass into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other medications for pain (e.g., partial agonist/antagonist narcotic pain relievers such as pentazocine, butorphanol, nalbuphine), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), naltrexone, cimetidine.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and other narcotic pain relievers (such as codeine).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, weak muscles, extreme drowsiness leading to loss of consciousness.

 

NOTES: Do not share this medication with others. It is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Levo-Dromoran

Generic Name: levorphanol (Pronunciation: lee VOR fa nole)

  • What is levorphanol (Levo Dromoran)?
  • What are the possible side effects of levorphanol (Levo Dromoran)?
  • What is the most important information I should know about levorphanol (Levo Dromoran)?
  • What should I discuss with my healthcare provider before taking levorphanol (Levo Dromoran)?
  • How should I take levorphanol (Levo Dromoran)?
  • What happens if I miss a dose (Levo Dromoran)?
  • What happens if I overdose (Levo Dromoran)?
  • What should I avoid while taking levorphanol (Levo Dromoran)?
  • What other drugs will affect levorphanol (Levo Dromoran)?
  • Where can I get more information?

What is levorphanol (Levo Dromoran)?

Levorphanol is an opioid pain medication. An opioid is sometimes called a narcotic.

Levorphanol is used to treat moderate to severe pain.

Levorphanol may also be used for purposes not listed in this medication guide.

Levorphanol 2 mg-ROX

round, white, imprinted with 54 410

What are the possible side effects of levorphanol (Levo Dromoran)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • mood changes, confusion, unusual thoughts or behavior;
  • thoughts of suicide or hurting yourself;
  • feeling like you might pass out;
  • weak or shallow breathing;
  • cold, clammy skin;
  • blue lips or skin;
  • painful or difficult urination; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects are more likely to occur, such as:

  • dizziness, drowsiness;
  • nausea, vomiting, constipation, stomach pain;
  • dry mouth;
  • double vision;
  • itching, sweating; or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Levo Dromoran (levorphanol) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about levorphanol (Levo Dromoran)?

You should not use levorphanol if you are allergic to it.

Do not use levorphanol if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Levorphanol may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are using this medication. Dangerous side effects or death can occur when alcohol is combined with levorphanol. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take levorphanol in larger amounts, or for longer than recommended by your doctor. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how levorphanol will affect you.

Side Effects Centers
  • Levo Dromoran

Patient Detailed How Take

What should I discuss with my healthcare provider before taking levorphanol (Levo Dromoran)?

You should not use levorphanol if you are allergic to it.

Do not use levorphanol if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You should not use levorphanol unless you are already being treated with a similar opioid medicine and your body is tolerant to it. Opioid medicines include fentanyl (Actiq, Duragesic), hydromorphone (Dilaudid, Palladone), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph), oxycodone (Oxycontin), oxymorphone (Opana), and many others. Talk with your doctor if you are not sure you are opioid-tolerant.

To make sure you can safely take levorphanol, tell your doctor if you have any of these other conditions:

  • asthma, COPD, sleep apnea, or other breathing disorder;
  • liver or kidney disease;
  • heart disease;
  • low blood pressure;
  • a history of head injury or brain tumor;
  • a thyroid disorder;
  • gallbladder disease;
  • enlarged prostate or urination problems;
  • an adrenal gland tumor or disorder (such as Addison's disease);
  • mental illness;
  • a history of alcoholism or drug addiction; or
  • if you recently drank large amounts of alcohol.

Levorphanol may be habit forming and should be used only by the person for whom it was prescribed. Never share levorphanol with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether levorphanol will harm an unborn baby. Levorphanol may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using levorphanol.

It is not known whether levorphanol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using levorphanol.

Do not give this medication to anyone under 18 years old without medical advice.

Serious side effects may be more likely in older adults taking levorphanol.

How should I take levorphanol (Levo Dromoran)?

Take exactly as prescribed. Never take levorphanol in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Your doctor may occasionally change your dose to make sure you get the best results.

Take levorphanol with food or milk if it upsets your stomach.

Do not stop using levorphanol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using levorphanol.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Levorphanol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Side Effects Centers
  • Levo Dromoran

Patient Detailed Avoid Taking

What happens if I miss a dose (Levo Dromoran)?

Since levorphanol is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Levo Dromoran)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of levorphanol can be fatal.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking levorphanol (Levo Dromoran)?

Do not drink alcohol while you are using this medication. Dangerous side effects or death can occur when alcohol is combined with levorphanol. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how levorphanol will affect you.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What other drugs will affect levorphanol (Levo Dromoran)?

You should not take levorphanol with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Tell your doctor if you regularly use any of these medications, or medicine for seizures, depression, or anxiety.

Tell your doctor about all other medicines you use, especially:

  • pentazocine (Talwin);
  • nalbuphine (Nubain);
  • butorphanol (Stadol); or
  • buprenorphine (Buprenex, Butrans, Subutex).

There may be other drugs that can interact with levorphanol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about levorphanol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 5.01. Revision date: 7/12/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Levo Dromoran

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI