Stadol


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butorphanol tartrate

APO-Butorphanol (CA), PMS-Butorphanol (CA), Stadol

Pharmacologic class: Opioid agonist-antagonist

Therapeutic class: Opioid analgesic

Controlled substance schedule IV Pregnancy risk category C

Action

Alters perception of and emotional response to pain by binding with opioid receptors in brain, causing CNS depression. Also exerts antagonistic activity at opioid receptors, which reduces risk of toxicity, drug dependence, and respiratory depression.

Availability

Injection: 1 mg/ml, 2 mg/ml

Nasal spray: 10 mg/ml

Indications and dosages

Moderate to severe pain

Adults: 1 to 4 mg I.M. q 3 to 4 hours as needed, not to exceed 4 mg/dose. Or 0.5 to 2 mg I.V. q 3 to 4 hours as needed. With nasal spray, 1 mg (one spray in one nostril) q 3 to 4 hours, repeated in 60 to 90 minutes if needed.

Labor pains

Adults: 1 to 2 mg I.V. or I.M., repeated after 4 hours as needed

Preoperative anesthesia

Adults: 2 mg I.M. 60 to 90 minutes before surgery

Balanced anesthesia

Adults: 2 mg I.V. shortly before anesthesia induction, or 0.5 to 1 mg I.V. in increments during anesthesia

Dosage adjustment

• Renal or hepatic impairment

• Elderly patients

Off-label uses

• Headache

• Symptomatic relief of ureteral colic

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:

• head injury, ventricular dysfunction, coronary insufficiency, respiratory disease, renal or hepatic dysfunction

• history of drug abuse.

Administration

• Make sure solution is clear and free of particulates before giving.

• When using nasal spray, insert tip of the sprayer about ¼″ into nostril, point tip backwards, and administer one spray.

• Be aware that I.V. route is preferred for severe pain.

Know that drug may cause infant respiratory distress in neonate of pregnant patient, especially if given within 2 hours of delivery.

Adverse reactions

CNS: drowsiness, sedation, dizziness, tremor, irritability, syncope, stimulation

CV: hypertension, hypotension, palpitations, bradycardia, tachycardia, extrasystole, arrhythmias

EENT: blurred vision, nasal congestion or dryness, dry or sore throat

GI: nausea, vomiting, constipation, epigastric distress, dry mouth, GI obstruction

GU: urinary retention or hesitancy, dysuria, early menses, decreased libido, erectile dysfunction

Hematologic: hemolytic anemia, hypoplastic anemia, thrombocytopenia, agranulocytosis, leukopenia, pancytopenia

Respiratory: thickened bronchial secretions, chest tightness, wheezing

Skin: urticaria, rash, diaphoresis

Other: increased or decreased appetite, weight gain, local stinging, anaphylactic shock, hypersensitivity reaction (with I.V. use)

Interactions

Drug-drug. CNS depressants: additive CNS effects

Drugs-herbs. Kava, St. John's wort, valerian: increased CNS depression

Drug-behaviors. Alcohol use: additive CNS effects

Patient monitoring

• Monitor respiratory status closely, especially after I.V. administration.

• Watch for signs and symptoms of withdrawal in long-term use and in opioid-dependent patients.

• Assess elderly patient closely for sensitivity to drug.

Patient teaching

• Teach patient how to use nasal spray properly.

• Emphasize importance of using drug exactly as prescribed.

• Caution patient that drug may be habit-forming.

• Advise patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.

c

butorphanol

(byoo-tor-fa-nole) ,

Stadol

(trade name)

Classification

Therapeutic: opioid analgesics
Pharmacologic: opioid agonists antagonists
Pregnancy Category: C

Indications

Management of moderate to severe pain.Analgesia during labor.Sedation before surgery.Supplement in balanced anesthesia.

Action

Binds to opiate receptors in the CNS.
Alters the perception of and response to painful stimuli while producing generalized CNS depression.
Has partial antagonist properties that may result in opioid withdrawal in physically dependent patients.

Therapeutic effects

Decreased severity of pain.

Pharmacokinetics

Absorption: Well absorbed from IM sites and nasal mucosa.
Distribution: Crosses the placenta and enters breast milk.
Metabolism and Excretion: Mostly metabolized by the liver; 11–14% excreted in the feces. Minimal renal excretion.
Half-life: 3–4 hr.

Time/action profile (analgesia)

ROUTEONSETPEAKDURATION
IMwithin 15 min30–60 min3–4 hr
IVwithin mins4–5 min2–4 hr
Intranasalwithin 15 min1–2 hr4–5 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Patients physically dependent on opioids (may precipitate withdrawal).
Use Cautiously in: Head trauma;↑ intracranial pressure;Severe renal, hepatic, or pulmonary disease (↑ interval to q 6–8 hr initially in hepatic/renal impairment);Hypothyroidism;Adrenal insufficiency;Alcoholism;Undiagnosed abdominal pain;Prostatic hyperplasia; Obstetric / Lactation / Pediatric: Safety not established but has been used during labor (may cause respiratory depression in the newborn); Geriatric: ↓ usual dose by 50%; give at twice the usual interval initially.

Adverse Reactions/Side Effects

Central nervous system

  • confusion (most frequent)
  • dysphoria (most frequent)
  • hallucinations (most frequent)
  • sedation (most frequent)
  • euphoria
  • floating feeling
  • headache
  • unusual dreams

Ear, Eye, Nose, Throat

  • blurred vision
  • diplopia
  • miosis (high doses)

Respiratory

  • respiratory depression

Cardiovascular

  • hypertension
  • hypotension
  • palpitations

Gastrointestinal

  • nausea (most frequent)
  • constipation
  • dry mouth
  • ileus
  • vomiting

Genitourinary

  • urinary retention

Dermatologic

  • sweating (most frequent)
  • clammy feeling

Miscellaneous

  • physical dependence
  • psychological dependence
  • tolerance

Interactions

Drug-Drug interaction

Use with extreme caution in patients receiving MAO inhibitors (may produce severe, potentially fatal reactions—reduce initial dose of butorphanol to 25% of usual dose).Additive CNS depression with alcohol, antidepressants, antihistamines, and sedative/hypnotics.May precipitate withdrawal in patients who are physically dependent on opioids and have not been detoxified.May ↓ effects of concurrently administered opioids.Concomitant use of kava-kava, valerian, chamomile, or hops can ↑ CNS depression.

Route/Dosage

Intramuscular (Adults) 2 mg q 3–4 hr as needed (range 1–4 mg).
Intravenous (Adults) 1 mg q 3–4 hr as needed (range 0.5–2 mg).
Intramuscular Intravenous (Geriatric Patients) 1 mg q 4–6 hr, ↑ as necessary.
Intranasal (Adults) 1 mg (1 spray in 1 nostril) initially. An additional dose may be given 60–90 min later. This sequence may be repeated in 3–4 hr. If pain is severe, an initial dose of 2 mg (1 spray in each nostril) may be given. May be repeated in 3–4 hr.
Intranasal (Geriatric Patients) 1 mg (1 spray in 1 nostril) initially. An additional dose may be given 90–120 min later. This sequence may be repeated in 3–4 hr.

Availability (generic available)

Injection: 1 mg/mL, 2 mg/mL
Intranasal solution: 10 mg/mL, in 2.5-mL metered-dose spray pump (14–15 doses; 1 mg/spray)

Nursing implications

Nursing assessment

  • Assess type, location, and intensity of pain before and 30–60 min after IM, 5 min after IV, and 60–90 min after intranasal administration. When titrating opioid doses, increases of 25–50% should be administered until there is either a 50% reduction in the patient’s pain rating on a numerical or visual analogue scale or the patient reports satisfactory pain relief. A repeat dose can be safely administered at the time of the peak if previous dose is ineffective and side effects are minimal. Patients requiring doses higher than 4 mg should be converted to an opioid agonist. Butorphanol is not recommended for prolonged use or as first-line therapy for acute or cancer pain.
  • An equianalgesic chart (see ) should be used when changing routes or when changing from one opioid to another.
  • Assess BP, pulse, and respirations before and periodically during administration. If respiratory rate is <10/min, assess level of sedation. Dose may need to be decreased by 25–50%. Respiratory depression does not increase in severity, only in duration, with increased dosage.
  • Assess previous analgesic history. Antagonistic properties may induce withdrawal symptoms (vomiting, restlessness, abdominal cramps, increased BP and temperature) in patients who are physically dependent on opioid agonists.
  • Butorphanol has a lower potential for dependence than other opioids; however, prolonged use may lead to physical and psychological dependence and tolerance. This should not prevent the patient from receiving adequate analgesia. Most patients receiving butorphanol for pain do not develop psychological dependence. If tolerance develops, changing to an opioid agonist may be required to relieve pain.
  • Lab Test Considerations: May cause ↑ serum amylase and lipase levels.
  • If an opioid antagonist is required to reverse respiratory depression or coma, naloxone (Narcan) is the antidote. Dilute the 0.4-mg ampule of naloxone in 10 mL of 0.9% NaCl and administer 0.5 mL (0.02 mg) by direct IV push every 2 min. For children and patients weighing <40 kg, dilute 0.1 mg of naloxone in 10 mL of 0.9% NaCl for a concentration of 10 mcg/mL and administer 0.5 mcg/kg every 1–2 min. Titrate dose to avoid withdrawal, seizures, and severe pain.

Potential Nursing Diagnoses

Acute pain (Indications)
Risk for injury (Side Effects)
Disturbed sensory perception(visual, auditory) (Side Effects)

Implementation

  • high alert: Accidental overdosage of opioid analgesics has resulted in fatalities. Before administering, clarify all ambiguous orders; have second practitioner independently check original order, dose calculations, route of administration, and infusion pump programming.
  • Explain therapeutic value of medication before administration to enhance the analgesic effect.
    • Regularly administered doses may be more effective than prn administration. Analgesic is more effective if given before pain becomes severe.
    • Coadministration with nonopioid analgesics may have additive analgesic effects and permit lower opioid doses.
  • Intramuscular: Administer IM injections deep into well-developed muscle. Rotate sites of injections.
  • Intravenous Administration
  • pH: 3.0–5.5.
  • Diluent: May give IV undiluted.
  • Concentration: 1–2 mg/mL.
  • Rate: Administer over 3–5 min. high alert: Rapid administration may cause respiratory depression, hypotension, and cardiac arrest.
  • Y-Site Compatibility: acyclovir, alemtuzumab, allopurinol, amifostine, amikacin, aminocaproic acid, aminophylline, amphotericin B lipid complex, amphotericin B liposome, anidulafungin, argatroban, ascorbic acid, atracurium, atropine, aztreonam, benztropine, bivalirudin, bleomycin, bumetanide, buprenorphine, calcium chloride, calcium gluconate, carboplatin, carmustine, caspofungin, cefazolin, cefepime, cefoperazone, cefotaxime, cefotetan, ceftazidime, ceftriaxone, cefuroxime, chlorpromazine, cisatracurium, cladribine, clindamycin, cyanocobalamin, cyclophosphamide, cyclosporine, cytarabine, dexamethasone, dexmedetomidine, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dopamine, doxacurium, doxorubicin hydrochloride, doxorubicin liposome, doxycycline, enalaprilat, ephedrine, epinephrine, epirubicin, epotein alfa, eptifibatide, ertapenem, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, filgrastim, fluconazole, fludarabine, fluorouracil, gemcitabine, gentamicin, glycopyrrolate, granisetron, heparin, hydrocortisone, idarubicin, ifosfamide, imipenem/cilastatin, irinotecan, isoproterenol, ketorolac, labetalol, levofloxacin, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, mechlorethamine, melphalan, meperidine, metaraminol, methotrexate, methoxamine, methyldopate, methylprednisolone, metoclorpramide, metoprolol, metronidazole, milrinone, mitoxantrone, morphine, multivitamins, mycophenolate, nafcillin, nalbuphine, naloxone, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxacillin, oxaliplatin, oxytocin, paclitaxel, palonosetron, pamidronate, pancruonium, papaverine, pemetrexed, penicillin G, pentazocine, phenobarbital, phentolamine, phenylephrine, phytonadione, piperacillin/tazobactam, potassium acetate, potassium chloride, procainamide, prochlorperazine, promethazine, propofol, propranolol, protamine, pyridoxime, quinupristin/dalfopristin, ranitidine, remifentanil, rituximab, rocuronium, sargramostim, sodium acetate, streptokinase, succinylcholine, sufentanil, tacrolimus, teniposide, theophylline, thiamine, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, tobramycin, tolazoline, trastuzumab, trimethphan, vancomycin, vasopressin, vecuronium, verapamil, vincristine, vinorelbine, voriconazole, zoledronic acid
  • Y-Site Incompatibility: amphotericin B cholesteryl, amphotericin B colloidal, azathioprine, chloramphenicol, dantrolene, diazepam, diazoxide, furosemide, genciclovir, indomethacin, insulin, pantoprazole, pentamidine, pentobarbital, phenytoin, sodium bicarbonate, trimethoprim/sulfamethoxazole
  • Intranasal: Administer 1 spray in 1 nostril.

Patient/Family Teaching

  • Instruct patient on how and when to ask for pain medication.
  • Medication may cause drowsiness or dizziness. Advise patient to call for assistance when ambulating and to avoid driving or other activities requiring alertness until response to the medication is known.
  • Encourage patients on bedrest to turn, cough, and deep-breathe every 2 hr to prevent atelectasis.
  • Instruct patient to change positions slowly to minimize orthostatic hypotension.
  • Caution patient to avoid concurrent use of alcohol or other CNS depressants with this medication.
  • Advise patient that good oral hygiene, frequent mouth rinses, and sugarless gum or candy may decrease dry mouth.
  • Intranasal: Instruct patient on proper use of nasal spray. See package insert for detailed instructions. Instruct patient to replace protective clip and clear cover after use and to store the unit in the child resistant container. Caution patient that medication should not be used by anyone other than the person for whom it was prescribed. Excess medication should be disposed of as soon as it is no longer needed. To dispose of, unscrew cap, rinse bottle and pump with water, and dispose of in waste can.
    • If 2-mg dose is prescribed, administer additional spray in other nostril. May cause dizziness and dysphoria. Patient should remain recumbent after administration of 2-mg dose until response to medication is known.

Evaluation/Desired Outcomes

  • Decrease in severity of pain without a significant alteration in level of consciousness or respiratory status.

Stadol

(stä′dôl′, -dŏl′)
A trademark for the drug butorphanol tartrate.

Stadol

a trademark for an opioid analgesic (butorphanol tartrate).
References in periodicals archive ?
Corbitt recommended that she participate in drug rehabilitation because of her Stadol consumption; (2) the nurse's admission that she lied to several physicians in 1994 and early 1995 in order to obtain "multiple prescriptions of Stadol;" (3) the nurse's termination from her employment as a nurse-practitioner in early 1995; (4) testimony by Nurse Uhiren's supervisor that she did not contest his statement to her that the investigation by the Department of Health dealt with her alleged drug abuse; and (5) the fact that the nurse filled prescriptions for 336 bottles of Stadol in 1994.
The latest tactic is to litigate over drugs that are still on the market, such as Stadol (butorphanol).
This resulted in an epidural, stadol, electronic fetal monitoring, and a second-degree perineal tear from a supine birthing position.
Look for strong sales of Taxol and Paraplatin, anticancer drugs, and Pravachol, a cholesterol-lowering agent, as well as of such new entries as Stadol NS, an analgesic, and Glucophage, a diabetes medication.
The prescription products are atenolol, Fungizone, K-Lyte, K-Lyte/CL Klotrix, Naldecon, Naturetin, Prolixin, Pronestyl, Quibron, Quibron-T, Raudixin, Rauzide, Saluron, Salutensin, Stadol and Vasodilan.