DEHYDRATED ALCOHOL- alcohol injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Seton Pharmaceuticals, LLC

Administration route:

INTRASPINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dehydrated Alcohol Injection, USP 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 (tic douloureux), 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

Product summary:

Dehydrated Alcohol Injection, USP NDC 13925-177-10 5mL Vial, Packages of 10 Storage : Store in a cool place away from any heat source.

Authorization status:

unapproved drug other

Summary of Product characteristics

DEHYDRATED ALCOHOL- ALCOHOL INJECTION, SOLUTION
SETON PHARMACEUTICALS, LLC
_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
For Therapeutic Neurolysis
Rx only
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 USP is a clear, colorless liquid miscible with
water and has the following
structural formula:
CLINICAL PHARMACOLOGY:
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, USP 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 (tic
douloureux), 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 approp