STADOL (butorphanol tartrate) Injection and STADOL NS (butorphanol tartrate) Nasal Spray are indicated for the management of pain when the use of an opioid analgesic is appropriate.

STADOL Injection is also indicated as a preoperative or preanesthetic medication, as a supplement to balanced anesthesia, and for the relief of pain during labor.

Factors to be considered in determining the dose are age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and surgical procedure involved. Use in the elderly, in patients with hepatic or renal disease, or in labor requires extra caution (see PRECAUTIONS and CLINICAL PHARMACOLOGY: Individualization of Dosage). The following doses are for patients who do not have impaired hepatic or renal function and who are not on CNS active agents.

Use for Pain

STADOL Injection

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 2 mg repeated every 3 to 4 hours.

Intramuscular: The usual recommended single dose for IM administration is 2 mg 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 4 mg repeated every 3 to 4 hours. There are insufficient clinical data to recommend single doses above 4 mg.

STADOL NS

The usual recommended dose for initial nasal administration is 1 mg (1 spray in one nostril). Adherence to this dose reduces the incidence of drowsiness and dizziness. If adequate pain relief is not achieved within 60–90 minutes, an additional 1-mg dose may be given.

The initial dose sequence outlined above may be repeated in 3–4 hours as required after the second dose of the sequence.

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 occurs. In such patients single additional 2-mg doses should not be given for 3–4 hours.

Use as Preoperative/Preanesthetic Medication

The preoperative medication dosage of STADOL Injection should be individualized (see CLINICAL PHARMACOLOGY: Individualization of Dosage). 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 of STADOL Injection is 2 mg IV shortly before induction and/or 0.5 to 1.0 mg IV in increments during anesthesia. The increment may be higher, up to 0.06 mg/kg (4 mg/70 kg), depending on previous sedative, analgesic, and hypnotic drugs administered. The total dose of STADOL Injection will vary; however, patients seldom require less than 4 mg or more than 12.5 mg (approximately 0.06 to 0.18 mg/kg).

The use of STADOL NS is not recommended because it has not been studied in induction or maintenance of anesthesia.

Labor

In patients at full term in early labor a 1–2 mg dose of STADOL Injection 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.

If concomitant use of STADOL with drugs that may potentiate its effects is deemed necessary (see PRECAUTIONS: DRUG INTERACTIONS), the lowest effective dose should be employed.

The use of STADOL NS is not recommended as it has not been studied in labor.

Safety and Handling

STADOL Injection is supplied in sealed delivery 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. Following skin contact, rinsing with cool water is recommended.

STADOL NS is an open delivery system with increased risk of exposure to health care workers.

In the priming process, a certain amount of butorphanol may be aerosolized; therefore, the pump sprayer should be aimed away from the patient or other people or animals.

The disposal of Schedule IV controlled substances must be consistent with State and Federal Regulations. The unit should be disposed of by unscrewing the cap, rinsing the bottle, and placing the parts in a waste container.

STADOL ® (butorphanol tartrate) Injection, USP, for IM or IV use is available as follows:

NDC 0015-5644-20—2 mg per mL, 2–mL vial
NDC 0015-5645-20—1 mg per mL, 1–mL vial
NDC 0015-5646-20—2 mg per mL, 1–mL vial
NDC 0015-5648-20—2 mg per mL, 10–mL multi-dose vial

STADOL NS ® (butorphanol tartrate) Nasal Spray

STADOL NS is supplied in a child-resistant prescription vial containing a metered-dose spray pump with protective clip and dust cover, a bottle of nasal spray solution, and a patient instruction leaflet. On average, one bottle will deliver 14–15 doses if no repriming is necessary.

NDC 0087-5650-41—10 mg per mL, 2.5–mL bottle.

PHARMACIST ASSEMBLY INSTRUCTIONS FOR STADOL NS NASAL SPRAY

The pharmacist will assemble STADOL NS prior to dispensing to the patient, according to the following instructions:

1. Open the child-resistant prescription vial and remove the spray pump and solution bottle.
2. Assemble STADOL NS by first unscrewing the white cap from the solution bottle and screwing the pump unit tightly onto the bottle. Make sure the clear cover is on the pump unit.
3. Return the STADOL NS bottle to the child-resistant prescription vial for dispensing to the patient.

Storage Conditions

Store at 25º C (77º F) controlled room temperature. See USP. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

STADOL NS also promoted by: Distributed by Geneva Pharmaceuticals, Inc. Dayton, NJ 08810 USA. FDA Rev date: 11/5/2001

Bookmark this page: