Dehydrated Alcohol

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Dehydrated Alcohol Recall

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Side Effects & Adverse Reactions

Alcohol is a flammable liquid and should be kept cool and away from any heat source. Alcohol injections should be made with care to avoid unwanted tissue necrosis. Proper positioning of the patient is essential to control localization of injections of dehydrated alcohol (which is hypobaric) into the subarachnoid space.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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.

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History

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Other Information

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:

Sources

Dehydrated Alcohol Manufacturers

American Regent, Inc.

Dehydrated Alcohol | American Regent, Inc.

The dosage of Dehydrated Alcohol Injection for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to insure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites. Since Dehydrated Alcohol Injection is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.

When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.

The LD50 oral dose in rats is 13.7 g/kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
Akorn, Inc.

Dehydrated Alcohol | Akorn, Inc.

The dosage of Dehydrated Alcohol Injection, USP for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to insure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites. Since Dehydrated Alcohol Injection, USP is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.

When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.

The LD50 oral dose in rats is 13.7 g/kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
Akorn, Inc.

Dehydrated Alcohol | Akorn, Inc.

The dosage of Dehydrated Alcohol Injection, USP for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to insure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites. Since Dehydrated Alcohol Injection, USP is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.

When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.

The LD50 oral dose in rats is 13.7 g/kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
General Injectables & Vaccines, Inc

Dehydrated Alcohol | General Injectables & Vaccines, Inc

The dosage of Dehydrated Alcohol Injection, USP for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to ensure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites. Since Dehydrated Alcohol Injection, USP is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.

When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.

The LD50 oral dose in rats is 13.7 g/kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED: Dehydrated Alcohol Injection, USP

NDC 17478-503-05 5 mL Vial Packages of 10

Storage: Store in a cool dry place away from any heat source.

Akorn

Manufactured by: Akorn, Inc.

Lake Forest, IL 60045

DA00N Rev. 09/11

No Recall
Valesco Pharmaceuticals

Dehydrated Alcohol | Valesco Pharmaceuticals

The dosage of Dehydrated Alcohol Injection for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to insure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites. Since Dehydrated Alcohol Injection is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.

When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.

The LD50 oral dose in rats is 13.7 g/kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
Major Pharmaceuticals

Dehydrated Alcohol | Major Pharmaceuticals

The dosage of Dehydrated Alcohol Injection for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to insure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites. Since Dehydrated Alcohol Injection is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.

When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.

The LD50 oral dose in rats is 13.7 g/kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall
Raw Materials International Overseas Llc

Dehydrated Alcohol | Raw Materials International Overseas Llc

The dosage of Dehydrated Alcohol Injection, USP for therapeutic nerve or ganglion block varies from as little as 0.05 to 0.5 mL in trigeminal neuralgia to 0.5 to 1.0 mL per interspace for subarachnoid injections. Doses larger than 1.5 mL are seldom required. All injections should be made slowly and only after all steps have been taken to insure precise placement of the alcohol. A 1.0 mL tuberculin syringe is desirable to facilitate accurate measurement of the dose. Separate needles should be used for injection of successive interspaces or other sites. Since Dehydrated Alcohol Injection, USP is hypobaric as compared to spinal fluid, proper positioning of the patient is essential to control localization of injections into the subarachnoid space.

When lesser concentrations of alcohol are used, larger volumes are usually injected. A dose of 2 mL of 45% alcohol has been used for injecting individual motor nerves, or from 1.5 to 4.0 mL for epidural injection in children with spastic cerebral palsy; 50 mL of 50% alcohol has been used for celiac plexus blockade.

The LD50 oral dose in rats is 13.7 g/kg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

No Recall