Butorphanol Tartrate (butorphanol tartrate)

Opiate analgesics should be given at the lowest effective dosage and for the shortest duration of therapy consistent with the treatment goals of the patient. Dosage of butorphanol tartrate should be adjusted according to the severity of pain, physical status of the patient, and other drugs that the patient is receiving. If concomitant therapy with other CNS depressants is required, the lowest effective dosages and shortest possible duration of concomitant therapy should be used. (See Cautions: Precautions and Contraindications, Chronic Toxicity, and Drug Interactions.)

The usual adult dose of butorphanol tartrate is 2 mg IM or 1 mg IV. These doses may be repeated every 3-4 hours as necessary. The usual effective dosage, depending on the severity of the pain, ranges from 1-4 mg IM or 0.5-2 mg IV, repeated every 3-4 hours. There are insufficient clinical data to recommend IM doses greater than 4 mg.

After initial priming, the nasal solution spray pump delivers about 14-15 metered doses containing 1 mg of butorphanol tartrate per spray. If repriming of the pump is necessary because of intermittent use, the spray pump will deliver about 8-10 metered doses, depending on the extent of repriming. The usual initial intranasal butorphanol tartrate dose is 1 mg (1 spray in one nostril); if adequate analgesia is not achieved, an additional 1-mg dose may be given within 60-90 minutes. This initial dose sequence may be repeated in 3-4 hours if needed. For the management of severe pain, an initial dose of 2 mg (1 spray in each nostril) may be given to patients who can remain recumbent if drowsiness or dizziness occurs; however, these patients should not receive additional 2-mg doses at intervals shorter than 3-4 hours, since the incidence of adverse effects may be increased.

In the treatment of postepisiotomy and musculoskeletal pain, 4-16 mg of butorphanol tartrate has been given orally+ every 4-6 hours.

For acute pain not related to trauma or surgery, the prescribed quantity should be limited to the amount needed for the expected duration of pain severe enough to require opiate analgesia (generally 3 days or less and rarely more than 7 days).

For further information on the management of opiate analgesic therapy, see Dosage and Administration: Dosage, in the Opiate Agonists General Statement 28:08.08.

Patients with hepatic or renal impairment and geriatric patients should receive half of the recommended parenteral adult dose (i.e., 1 mg IM or 0.5 mg IV). If needed these doses may be repeated within usually not less than 6 hours. The usual initial dose of butorphanol tartrate nasal solution is 1 mg (1 spray in one nostril) in these patients; an additional 1-mg dose may be given within 90-120 minutes. This initial dose sequence may be repeated within usually not less than 6 hours.

Butorphanol tartrate is administered by IM or IV injection or by nasal inhalation using a spray pump. The nasal solution spray pump containing butorphanol tartrate should be assembled according to the manufacturer's instructions. Prior to initial use, the spray pump should be fully primed; priming of the pump should be repeated whenever the pump has not been used for 48 hours or longer. The patient instructions provided by the manufacturer should be consulted for use of the nasal solution spray pump. Since butorphanol nasal solution spray pump is an open delivery system that may increase environmental exposure of health-care personnel and visitors, the pump spray should be aimed away from such individuals.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Safe use of butorphanol during pregnancy (except during labor) has not been established. Reproduction studies in rats, mice, and rabbits using butorphanol dosages of approximately 2.5-5 times the usual human dosage, during organogenesis, have not revealed evidence of harm to the fetus. However, subcutaneous butorphanol doses of 1 mg/kg were associated with higher incidences of stillbirths in rats. In addition, increased postimplantation losses occurred in rabbits receiving oral butorphanol doses of 30 and 60 mg/kg. There are no adequate and controlled studies to date using butorphanol tartrate in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. When butorphanol is administered during labor and delivery, respiratory depression may occur in the neonate; the drug should be used with caution in women delivering premature infants. In one clinical study using 1-mg IV doses of butorphanol tartrate during labor, transient (10-90 minutes) sinusoidal fetal heart rate patterns were reported; however, no adverse neonatal outcomes occurred. Butorphanol should be used with caution in the presence of abnormal fetal heart rate pattern. Because of the absence of clinical experience with butorphanol nasal solution during labor and delivery, use of the nasal preparation is not recommended in such circumstances.

Butorphanol is distributed into human milk following parenteral administration of the drug in nursing women. The manufacturer states that the amount of the drug distributed into milk probably is clinically insignificant, estimated at 4 mcg/L of milk in a woman receiving 2 mg of butorphanol IM 4 times daily. Although there is no clinical experience with the use of butorphanol tartrate nasal solution in nursing women, it is assumed that the amount of the drug distributed into milk will be similar to that when administered parenterally.

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