Each ampoule (1 mL) contains: Butorphanol tartrate 2 mg.
Butorphanol is used to relief moderate to severe pain, for pre-operative or pre-anesthetic medication as a supplement to balanced anesthesia, for relief of pain during labor.
Pain: Intravenous: The usual recommended single dose for IV administration is 1 mg repeated every 3 to 4 hours as necessary. The effective dosage range, depending on the severity of pain, is 0.5 to 2mg repeated every 3 to 4 hours.
Intramuscular: The usual recommended single dose for IM administration is 2mg in patients who will be able to remain recumbent, in the event drowsiness or dizziness occurs. This may be repeated every 3 to 4 hours, as necessary. The effective dosage range depending on the severity of pain is 1 to 4mg repeated every 3 to 4 hours. There are insufficient clinical data to recommend single doses above 4 mg.
Both expected efficacy and adverse reaction should be considered in dosage adjustment. The dose of this drug recommended for elderly patients, patients with hepatic or renal impairment should generally be half the recommended adult dose (0.5 mg IV and 1.0 mg IM). Repeat doses should be determined by the patient's response rather than at fixed intervals, but will generally be no less than 6 hours apart.
Use as Preoperative/Pre-anesthetic/Post-operative Medication: The preoperative medication dosage should be individualized. The usual adult dose is 2 mg IM, administered 60-90 minutes before surgery. This is approximately equivalent in sedative effect to 10 mg morphine or 80 mg meperidine.
Use in Balanced Anesthesia: The usual dose is 2 mg IV shortly before induction and/or 0.5 to 1.0 mg IV in increments during anesthesia. The increments may be higher, up to 0.6 mg/kg (4 mg/70 kg), depending on previous sedative, analgesic, and hypnotic drugs administered. The total dose of this drug will vary; however, patients seldom require less than 4 mg or more than 12.5 mg (approximately 0.06 to 0.18 mg/kg). Opioid, including this drug, may not produce appropriate analgesic effect for every patient or every state during surgery. Analgesic fail during induction anesthesia can be judged to be general sympathetic nerve negative, intensive inhalation anesthesia or another IV should be considered.
Labor: In patients at full term or without fetal distress in early labor a 1-2 mg dose IV or IM may be administered and repeated after 4 hours. Alternative analgesia should be used for pain associated with delivery or if delivery is expected to occur within 4 hours. Other analgesics should be used when delivery is expected within 4 hours. Dosage titration should be based on concurrent analgesics, sedatives, expected time of delivery and response of the first administration. If concomitant use of this drug with drugs that may potentiate its effects is deemed necessary, the lowest effective dose should be employed.
The clinical manifestations of butorphanol overdose are those of opioid drugs in general. The most serious symptoms are hypoventilation, cardiovascular insufficiency, coma, and death.
The management of suspected butorphanol overdosage includes maintenance of adequate ventilation, peripheral perfusion, normal body temperature, and protection of the airway. Patients should be under continuous observation with adequate serial measures of mental state, responsiveness, and vital signs. Oxygen and ventilatory assistance should be available with continual monitoring by pulse oximetry if indicated. In the presence of coma, placement of an artificial airway may be required. An adequate intravenous portal should be maintained to facilitate treatment of hypotension associated with vasodilation.
The use of a specific opioid antagonist such as naloxone should be considered. As the duration of butorphanol action usually exceeds the duration of action of naloxone, repeated dosing with naloxone may be required.
In managing cases of suspected butorphanol overdosage, the possibility of multiple drug ingestion should always be considered.
Use in Pregnancy: Reproduction studies in mice, rats, and rabbits during organogenesis did not reveal any teratogenic potential to butorphanol. However, pregnant rats treated subcutaneously with butorphanol at 1 mg/kg (5.9 mg/m2) had a higher frequency of stillbirths than controls. Butorphanol at 30 mg/kg/oral (360 mg/m2) and 60 mg/kg/oral (720 mg/m2) also showed higher incidences of post-implantation loss in rabbits. There are no adequate and well-controlled studies of this drug in pregnant women before 37 weeks of gestation. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the infant.
Labor and Delivery: There have been rare reports of infant respiratory distress/apnea following the administration of this drug during labor. The reports of respiratory distress/apnea have been associated with administration of a dose within 2 hours of delivery, use of multiple doses, use with additional analgesic or sedative drugs, or use in preterm pregnancies.
In a study of 119 patients, the IV administration of 1 mg of this drug during labor was associated with transient sinusoidal fetal heart rate patterns, but was not associated with adverse neonatal outcomes. In the presence of an abnormal fetal heart rate pattern, this drug should be used with caution.
Use in Lactation: Butorphanol has been detected in milk following administration of this drug to nursing mothers. The amount an infant would receive is probably clinically insignificant (estimated 4 μg/L of milk in a mother receiving 2 mg IM four times a day).
Store at temperatures not exceeding 30°C.
N02AF01 - butorphanol ; Belongs to the class of morphinan derivative opioids. Used to relieve pain.
Ziphanol soln for inj 2 mg/mL
1 mL x 10 × 1's
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