, non-opioid analgesics). Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
See 7 WARNINGS AND PRECAUTIONS, Addiction, Abuse and Misuse. BUTORPHANOL Nasal Spray (butorphanol tartrate) Page 7 of 58 Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with BUTORPHANOL Nasal Spray and adjust the dosage accordingly.
See 7 WARNINGS AND PRECAUTIONS, Respiratory, Respiratory Depression. For acute pain, it is recommended that BUTORPHANOL Nasal Spray be used for a maximum of 3 days at the lowest dose that provides adequate pain relief. All doses of opioids carry an inherent risk of fatal or non-fatal adverse events.
This risk is increased with higher doses. If BUTORPHANOL Nasal Spray is used for more than 3 days for the management of chronic non-cancer, non-palliative pain, it is recommended that a daily maximum of 16 sprays corresponding to 16 mg of BUTORPHANOL Nasal Spray (80 morphine milligram equivalent) not be exceeded.
Each patient should be assessed for their risk prior to prescribing BUTORPHANOL Nasal Spray, as the likelihood of experiencing serious adverse events can depend upon the type of opioid, duration of treatment, level of pain as well as the patient’s own level of tolerance.
In addition, the level of pain should be assessed routinely to confirm the most appropriate dose and the need for further use of BUTORPHANOL Nasal Spray. 2 Recommended Dose and Dosage Adjustment, Adjustment or Reduction of DosageAdjustment or Reduction of Dosage.
BUTORPHANOL Nasal Spray (butorphanol tartrate nasal spray) should be used with caution within 12 hours pre-operatively and within the first 12-24 hours post-operatively. See 7 WARNINGS AND PRECAUTIONS, Peri-Operative ConsiderationsPeri-Operative Considerations.
Geriatrics (> 65 years of age):
Respiratory depression has occurred in the elderly following administration of large initial doses of opioids to patients who were not opioid-tolerant or when opioids were co-administered with other agents that can depress respiration.
BUTORPHANOL Nasal Spray should be initiated at a low dose and slowly titrated to effect. 3 Pharmacokinetics, Special Populations and Conditions, Geriatrics.
Use with Non-Opioid Medications:
If a non-opioid analgesic is being provided, it may be continued. If the non-opioid is discontinued, consideration should be given to increasing the opioid dose to compensate for the non-opioid analgesic. BUTORPHANOL Nasal Spray can be safely used concomitantly with usual doses of other non-opioid analgesics.
Dose Titration:
Dose titration is the key to success with opioid analgesic therapy. Proper optimization of doses scaled to the relief of the individual's pain should aim at administration of the lowest dose which will achieve the overall treatment goal of satisfactory pain relief with acceptable side effects.
Dosage adjustments should be based on the patient's clinical response. 2 Recommended Dose and Dosage Adjustment BUTORPHANOL Nasal Spray (butorphanol tartrate) has an onset of effect within 15 to 30 minutes, and requires individualization of dosage based on clinical response.
BUTORPHANOL Nasal Spray (butorphanol tartrate) Page 8 of 58 Adults:
The usual recommended dose for initial nasal administration is one (1) spray in one (1) nostril (1 mg). Adherence to this dose may reduce the likelihood of drowsiness, dizziness, and nausea and vomiting. If adequate pain relief is not achieved within 60 to 90 minutes, an additional 1 mg dose may be given.
The initial dose sequence of BUTORPHANOL Nasal Spray may be repeated in 3 to 4 hours as needed. Due to limited clinical experience with higher doses, total daily doses of more than 16 mg are not recommended. Depending on the severity of the pain, an initial dose of 2 mg (1 spray in each nostril) may be used in patients who will be able to remain recumbent in the event drowsiness or dizziness occur.
In such patients, additional doses should not be given for 3 to 4 hours. 5 - 300 5 (rectal) - 1-3 3-4 - Heroin 5-8 10-15 3-4 Weak Opioid Agonists: Codeine Propoxyphene 120 50 200 100 3-4 2-4 Mixed Agonist-Antagonists7: Pentazocine6 Nalbuphine Butorphanol 60 10 2 180 - - 3-4 3-6 3-4 Footnotes: 1References: BUTORPHANOL Nasal Spray (butorphanol tartrate) Page 9 of 58 Expert Advisory Committee on the Management of Severe Chronic Pain in Cancer Patients, Health and Welfare Canada.
Cancer pain:
A monograph on the management of cancer pain. Ministry of Supplies and Services Canada, 1987. Cat. No. H42-2/5-1984E. Foley KM. The treatment of cancer pain. N Engl J Med 1985;313(2):84-95. Aronoff GM, Evans WO.
Pharmacological management of chronic pain:
A review. In: Aronoff GM, editor. Evaluation and treatment of chronic pain. 2nd ed.
Baltimore (MD):
Williams and Wilkins; 1992. p. 359-68. Cherny NI, Portenoy RK. Practical issues in the management of cancer pain. In: Wall PD, Melzack R, editors. Textbook of pain. 3rd ed.
New York:
Churchill Livingstone; 1994. p. 1437-67. 2 Most of the data were derived from single-dose, acute pain studies and should be considered an approximation for selection of doses when treating chronic […]