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Levo Dromoran

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Levo Dromoran

Indications
Dosage
How Supplied

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 AND 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.

Last reviewed on RxList: 6/3/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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