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Legal information concerning Stadol (Butorphanol) in the form of a nasal
spray: NewYork InjuryLawyers.com: "Stadol NS (butorphanol) is
synthetic opiate nasal spray that is used as a painkiller. Stadol was believed
by the manufacturer, Bristol-Myers Squibb to have a very low risk of addiction
as compared to other narcotics used to treat pain. Because of these claims of
an extremely low potential for abuse and addiction, the FDA allowed physicians
to widely prescribe Stadol with little or no safeguards. Unfortunately, Stadol
has been found to be extremely addictive and over the last few years the FDA
has reports of severe addictions and has linked Stadol to several deaths and
serious side effects. In fact, 2mg of butorphanol is equivalent to 10 mg of
morphine and has similar additive qualities."
http://www.newyork-injurylawyers.com/pages/stadol_nasal_spray.html
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Half-Life and Ceiling effect of Stadol (Butorphanol): PedsPain Professional
Version: "Stadol is metabolized primarily by the liver and is excreted in
the urine (70 to 80%), and feces (approx. 15%). Because of this metabolism,
Stadol should be used with caution in persons with reduced kidney function or
hepatic impairment. Studies have indicated that standard dose may be
appropriate, but interval between doses should be extended and based on patient
response. This is also true with those patients over the age of 65. Half-life
in the elderly is increased. Half-life: Generally 4.7 hrs. in younger patients,
6.6 hrs in elderly patients, may be increased to as much as 10.5 hours in
patients that are renally impaired. The major metabolite of Stadol is
hydroxybutorphanol and makes up 45% of the excreted drug. Norbutorphanol accounts
for 5% of the excreted drug. Preliminary studies have shown that
hydroxybutorphanol may have a longer half-life than the parent drug, and both
metabolites have some analgesic effects on their own. Ceiling effect: Stadol
has a ceiling effect which is 30 to 60 mcg/kg in the degree of respiratory
depression produced. This depression is reversible by Narcan."
http://coninfo.nursing.uiowa.edu/sites/pedspain/MixedAgo/stadolt.htm
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A collection of Articles concerning Stadol (Butorphanol) and it's
addictiveness: ABC News.com Nightline: "Nearly 25 million
Americans suffer from the debilitating pain of migraine headaches. It can be
excruciating, leaving sufferers desperate for relief. So when a painkiller
called Stadol became available in an easy-to-use nasal spray, it provided many
not only with relief, but with a sense of hope as well. "First squirt I
took," recalls Phillips, "my pain was completely gone. I thought,
man, what a savior. Stadol Nasal Spray, manufactured by Bristol-Myers
Squibb, hit the market in 1992. It's a powerful drug, five times as potent at
pain relief as morphine. At the time, the manufacturer told the U.S. Food and
Drug Administration that Stadol had little of the addictive qualities of other
narcotics. Stadol, said Bristol-Myers Squibb, was a different kind of narcotic,
"remarkably safe," with an "extremely low" potential for
abuse. Their claims were backed by the FDA, which decided to allow doctors to
prescribe Stadol without any government controls."
http://archive.abcnews.go.com/sections/newsuse/nl_stadol_opener/index.html
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Stadol (Butorphanol) Clinical trial information and general drug
characteristics: Rx List: "A total of 2446 patients were studied
in butorphanol clinical trials. Approximately half received STADOL Injection
with the remainder receiving STADOL NS. In nearly all cases the type and
incidence of side effects with butorphanol by any route were those commonly
observed with opioid analgesics. The adverse experiences described below are
based on data from short- and long-term clinical trials as well as
postmarketing experience in patients receiving butorphanol by any route. There
has been no attempt to correct for placebo effect or to subtract the
frequencies reported by placebo treated patients in controlled trials. The most
frequently reported adverse experiences across all clinical trials with STADOL
Injection and STADOL NS were somnolence (43%), dizziness (19%), nausea and or
vomiting (13%). In long-term trials with STADOL NS only, nasal congestion (13%)
and insomnia (11%) were frequently reported."
http://www.rxlist.com/cgi/generic2/butor_ad.htm
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Dosage, side effects and considerations for Stadol (Butorphanol): "Headache
Pain Free: "Adults: 1 to 4mg IM every 3 to 4 hours, PRN or around the
clock; or 0.5 to 2mg IV every 3-4 hrs PRN or around the clock. Not to exceed
4mg per dose. Alternatively, 1mg by nasal spray every 3-4 hours (1 spray in
each nostril); repeated in 60 to 90 minutes if pain relief is inadequate.
Elderly: Use one-half of the usual dose or twice the interval for IV use; for
nasal use, allow 1-2 hours to elapse before repeating dose. Adverse Reactions:
confusion, nervousness, lethargy, headache, somnolence, dizziness, insomnia,
anxiety, paresthesia, euphoria, hallucinations, flushing, increased
intracranial pressure, palpitations, vasodilation, hypotension, blurred vision,
nasal congestion (with nasal spray), tinnitus, unpleasant taste, nausea,
vomiting, constipation, anorexia, respiratory depression, rash, hives,
clamminess, excessive diaphoresis, sensation of heat. Interactions: Drug-Drug
CNS depressants: additive effects. Use together cautiously. Drug-Lifestyle Alcohol
use: additive effects. Avoid alcohol use."
http://members.tripod.com/~headachepainfree/stadol.html
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Stadol (Butorphanol) has to be used with caution: Iowa College of Nursing:
"Stadol has been used as a pre-operative medication (before surgery), and as an analgesic
(pain reliever) after certain operations. It also has been usedto help relieve labor pain. Stadol
NS (nasal spray) has also been used to treat the pain of migraine headaches when other
drugs are not working. Stadol and Stadol NS alter pain messages at certain sites in your
brain and spinal cord. Stadol can be given as a shot (IM), or in the vein (IV). Stadol NS is
given nasally (in the nose). Stadol NSŪ (butorphanol tartrate) is indicated for the
management of pain when the use of an opioid analgesic is appropriate. If your have heart,
kidney, liver, or respiratory problems your doctor will decide if this medicine is appropriate
for you to take. This drug MAY BE HABIT FORMING- take only the amount prescribed
by your doctor and do not take for a longer time than prescribed."
http://www.nursing.uiowa.edu/sites/Adultpain/MixedAge/stadolnt.htm
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Disease
contraindications while taking Stadol (Butorphanol): Med Line Plus
Health Information: "The presence of other medical problems may affect the
use of butorphanol. Make sure you tell your doctor if you have any other
medical problems, especially: CNS disease affecting breathing or Emphysema,
asthma, or other chronic lung disease or Head injury--Some of the side effects
of butorphanol can be dangerous if you have any of these conditions Drug
dependence, especially narcotic abuse, or history of, or Emotional
problems--The chance of side effects may be increased; also, withdrawal
symptoms may occur if a narcotic you are dependent on is replaced by
butorphanol, Heart disease or Kidney disease or Liver disease--The chance of
side effects may be increased"
http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601204.html
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Stadol (butorphanol) description and indications: Health Center: "Common prescription names
for Butorphanol: Stadol injection, Stadol NS (nasal spray). Butorphanol is commonly
given for pain relief to people who have undergone surgery or who have serious injuries.
Butorphanol acts in the brain to decrease the feeling of pain and to reduce emotional response to
pain. Butorphanol is a narcotic analgesic or a narcotic painkiller. Butorphanol is a synthetic
narcotic unrelated to morphine, but similar in effect. It has a mild antagonist effect. This means
it may cause withdrawal symptoms in individuals who have been taking other narcotic
analgesics. Even so, Butorphanol can be addicting.Always make sure you follow your
doctor's and pharmacist's directions if you are prescribed narcotic analgesics."
http://www3.health-center.com/db/PageReq?SessionID=687380292.1002771965090&
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