DEHYDRATED ALCOHOL- dehydrated alcohol injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Tilgængelig fra:

American Regent, Inc.

INN (International Name):

ALCOHOL

Sammensætning:

ALCOHOL 0.98 mL in 1 mL

Indgivelsesvej:

INTRASPINAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Dehydrated Alcohol Injection is indicated for therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (ticdouloureux), in patients for whom neurosurgical procedures are contraindicated. Relief of trigeminal neuralgia usually is only temporary. Other conditions for which injection of alcohol has been reported include glossopharyngeal neuralgia, angina pectoris and severe claudication due to peripheral vascular insufficiency. Alcohol concentrations of 40 to 50% (prepared by appropriate dilution of dehydrated alcohol) have been used for epidural or individual motor nerve injections to control certain manifestations of cerebral palsy and spastic paraplegia. Similar concentrations also have been injected for celiac plexus block to relieve pain of inoperable upper abdominal cancer, and have been injected intra-and subcutaneously for relief of intractable pruritus ani. Subarachnoid injection of dehydrated alcohol is contr

Produkt oversigt:

Dehydrated Alcohol Injection, USP NDC 0517-8571-10     1 mL Ampule     Packages of 10 NDC 0517-8575-10     5 mL Ampule     Packages of 10 Store in a cool place away from any heat source. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN8571 Rev. 01/09

Autorisation status:

unapproved drug other

Produktets egenskaber

DEHYDRATED ALCOHOL- DEHYDRATED ALCOHOL INJECTION, SOLUTION
AMERICAN REGENT, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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DEHYDRATED ALCOHOL INJECTION, USP
RX ONLY
FOR THERAPEUTIC NEUROLYSIS
DESCRIPTION
Dehydrated Alcohol Injection, USP consists of not less than 98% by
volume of ethanol (ethyl alcohol).
Dehydrated alcohol is hypobaric in relation to the cerebrospinal
fluid. It is injected proximate to nerve
tissues and into spinal subarachnoid spaces to produce degeneration of
nerve function (neurolysis) for
control of chronic pain.
The product contains no bacteriostat or antimicrobial agent (other
than ethanol) and no added buffer.
Dehydrated alcohol is a clear, colorless liquid miscible with water
and has the following structural
formula:
CLINICAL PHARMACOLOGY
Alcohol produces injury to tissue cells by dehydration and
precipitation of protoplasm. When alcohol is
injected in close proximity to nerve tissues, it produces neuritis and
nerve degeneration (neurolysis).
Deliberate injury to selected spinal nerves, peripheral nerves, or
ganglia by injection of alcohol results
in more or less enduring block of sensory, motor and autonomic
function.
The injection of alcohol used for therapeutic neurolysis involves
amounts too small to produce
significant systemic effects of ethanol.
Ninety to 98% of ethyl alcohol that enters the body is completely
oxidized.
INDICATIONS AND USAGE
Dehydrated Alcohol Injection is indicated for therapeutic neurolysis
of nerves or ganglia for the relief
of intractable chronic pain in such conditions as inoperable cancer
and trigeminal neuralgia
(ticdouloureux), in patients for whom neurosurgical procedures are
contraindicated. Relief of
trigeminal neuralgia usually is only temporary. Other conditions for
which injection of alcohol has been
reported include glossopharyngeal neuralgia, angina pectoris and
severe claudication due to peripher