Alcohol and Dextrose

Name: Alcohol and Dextrose

Alcohol and Dextrose - Clinical Pharmacology

Alcohol and Dextrose Injections USP are an intravenous source of calories. In the average adult, pure ethyl alcohol is metabolized at a rate of 10 to 20 mL per hour. Sedative effects of alcohol occur if the rate of infusion exceeds the rate of metabolism. Dextrose (D-glucose) can be infused at a maximum rate of approximately 0.5 to 0.85 g/kg of body weight/hr without producing significant glycosuria. Thus, the maximum rate that alcohol can be infused without producing sedative effects is well below the maximum rate of utilization of dextrose.

Alcohol is metabolized, mostly in the liver, to acetaldehyde or acetate. The rate of oxidation is a linear function of time. Starvation lowers the rate of metabolism and insulin increases the rate.

Precautions

General

Alcohol and Dextrose Injections USP should be administered slowly, and the patient observed for restlessness or narcosis.

The half lives of phenytoin, warfarin and tolbutamide may be shortened 50% to 75% by concurrent administration of alcohol. Alcohol increases serum uric acid and can precipitate acute gout.

The vasodilating effect of alcohol may potentiate postural hypotension, particularly in association with some antihypertensive drugs.

If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Use only if solution is clear and vacuum is present.

Usage in Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Alcohol and Dextrose Injections USP. It is also not known whether Alcohol and Dextrose Injections USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Alcohol and Dextrose Injections USP should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in children have not been established.

How is Alcohol and Dextrose Supplied

These solutions are supplied sterile and nonpyrogenic in single dose glass containers packaged 6 per case.

Canada DIN NDC Cat. No. Size
10% Alcohol and 5% Dextrose Injection USP
0264-1978-00 S9780 1000 mL
5% Alcohol and 5% Dextrose Injection USP
01924230 0264-1981-00 S9810 1000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Rx only

Revised: June 1999

Directions for Use of B. Braun Glass Containers

Before use, perform the following checks:

  1. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Check the security of bail and band.
  2. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on bottom and sides of bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle.
  3. To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (See Figure 1). Use a circular pulling motion on the tab until it breaks away.
  4. Grasp and remove the metal disk, exercising caution not to touch the sterile latex disk underneath.
  5. With the sterile latex disk exposed, check for vacuum by confirming the presence of depressions in the latex disk, which should be held tightly over stopper (See Figure 2). If the latex disk is puffed or depressions cannot be seen, the vacuum has dissipated and the bottle should be rejected. The sterile latex disk provides a surface for aseptic medication addition prior to administration.

    Note: When vacuum is essential for the use of the product (medication addition or transfer, etc.) the latex disk should be left in place until all additions or transfers are completed.
    Medication addition or transfers should be made immediately after exposing the sterile latex disk. Identify three depressions in the latex disk prior to adding medication: a triangular medication site, one large round outlet port, and one small air-inletting port (See Figures 2 and 3).
  6. Before removing the latex disk, add medication through the triangular () medication site (See Figure 4). The vacuum in the container will automatically draw the contents of a syringe or spiked vial into the container. Each addition/transfer will reduce the vacuum remaining in the bottle.



    Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly.
    Do not store.


  7. Remove the latex disk prior to inserting administration set. To remove the latex disk, grasp the lip of the disk, lift and pull up and away (See Figure 5). As the disk is lifted, and if no additions have been made, vacuum can be confirmed by an audible hiss.
  8. Refer to Directions for Use of the set being used. Insert the set spike into the large round outlet port of the stopper and hang container.
  9. After admixture and during administration, reinspect the solution frequently. If any evidence of solution contamination or instability is found or if the patient exhibits any signs of fever, chills or other reactions not readily explainable, discontinue administration immediately and notify the physician.
  10. When adding medication to the container during administration, swab the triangular medication site, inject medication and mix thoroughly by gentle agitation.

B. Braun Medical Inc.
Irvine, CA USA 92614-5895

In Canada, distributed by:
B. Braun Medical Inc.
Scarborough, Ontario M1H 2W4

©1999 B. Braun Medical Inc.

Y36-002-423

Alcohol and Dextrose 
Alcohol and Dextrose monohydrate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0264-1981
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 5 mL  in 100 mL
Dextrose monohydrate (Dextrose) Dextrose 5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Packaging
# Item Code Package Description
1 NDC:0264-1981-00 6 CONTAINER (6 CONTAINER) in 1 CASE
1 1000 mL (1000 MILLILITER) in 1 CONTAINER
Alcohol and Dextrose 
Alcohol and Dextrose monohydrate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0264-1978
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 10 mL  in 100 mL
Dextrose monohydrate (Dextrose) Dextrose 5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Packaging
# Item Code Package Description
1 NDC:0264-1978-00 6 CONTAINER (6 CONTAINER) in 1 CASE
1 1000 mL (1000 MILLILITER) in 1 CONTAINER
Labeler - B. Braun Medical Inc.
Revised: 10/2006   B. Braun Medical Inc.

What is alcohol?

The term "alcohol" has been synonymous with "spirituous" liquids for the past 300 years. The history of alcohol consumption, along with codes limiting its consumption go back to 1700 B.C. There are four types of alcohol: methyl alcohol, ethyl alcohol, propyl alcohol and butyl alcohol. Ethyl Alcohol, or ethanol (C2H5OH), is the type used in the production of alcoholic beverages. The other three types, methyl, propyl and butyl alcohol, if consumed can result in blindness and death, even in relatively small doses.

Alcohol, or ethanol, is the intoxicating agent found in beer, wine and liquor. Alcohol is produced by fermentation of yeast, sugars, and starches.1 Fruits such as grapes, and grains like barley and wheat are most commonly used for wine, beer and liquors. Other plants, such as the cactus or sugar cane may be used in liquor production.

Fourteen grams or about 0.6 fluid ounces of pure alcohol equals one “drink”. Examples of this amount may include one twelve ounce beer (5 percent alcohol), eight to nine ounces of malt liquor (7 percent alcohol), 5 ounces of wine (12 percent alcohol) or 1.5 fluid ounce “shot” of 80 proof liquor (40 percent alcohol).

In the U.S., The Federal Uniform Drinking Age Act, signed into law in 1984 raised the minimum drinking age to 21 years. All states now prohibit the purchase of alcohol by youth under the age of 21 years since 1988. It is illegal to sell or buy alcohol for anyone under the age of 21. According to The Office of the Surgeon General, alcohol is used by more young people in the United States than tobacco or illicit drugs, resulting in a serious public health concern.2

Health Hazards Due to Alcohol Abuse

Long-term alcohol misuse is associated with liver and cardiovascular disease, cancer, and nervous system damage as well as psychiatric problems such as depression, anxiety, and antisocial personality disorder.4

Alcohol, and its consumption can cause a number of marked changes in behavior. Even low doses significantly impair judgment and coordination. In small amounts, it can induce feelings of relaxation and tranquillity, suppress anxiety, and in some, inspire feelings of confidence. However, as the dose is increased, normally beyond six ounces of 100 proof alcohol, the pleasant euphoric feelings begin to give way to feelings of depression. Intoxication occurs because the liver is unable to metabolize more than one ounce of alcohol every hour. Therefore, when a person consumes more alcohol than the body can metabolize, intoxication occurs. Intoxication can generally last anywhere from one to 12 hours, and the after-effects (“hang-over”) of intoxication can last 24 hours or more.

Repeated use of alcohol can lead to increased tolerance that in turn leads to greater amounts required to achieve its desired effects. Once the body develops a dependence to alcohol, a sudden cessation of its intake is likely to produce withdrawal symptoms. Withdrawal symptoms can be life-threatening and include severe anxiety, tremors, hallucinations, and convulsions.

Alcohol can be lethal if the amount of alcohol reaches a concentration above 460 milligrams of alcohol per 100 milliliters of blood (0.46 g/dL). Death from respiratory depression can occur with severe alcohol intoxication, and this can be hastened if alcohol is combined with CNS depressant medications.

Mixing alcohol with caffeine, either in premixed drinks or by adding liquor to energy drinks has become a common way for younger crowds to consumer alcohol. With this dangerous combination, drinkers may feel somewhat less intoxicated than if they had consumed alcohol alone. However, they are just as impaired and more likely to take risks. This drinking practice often takes place in and around college campuses.

Excessive use of alcohol can lead to alcoholism, or alcohol dependence. There are four cardinal symptoms in alcoholism: craving, loss of control, physical dependence, and tolerance. A clinician is able to diagnose alcoholism based upon a specific set of criteria published by the American Psychiatric Association and the World Health Organization.5

Drinking and driving results in numerous car accidents, injuries, and deaths each year. In 2009, there were over 10,800 crash fatalities with a driver BAC of 0.08 or higher, roughly 32 percent of total traffic fatalities for the year. Of these drivers, fifty-six percent had had a BAC of 0.15 or greater. However, since 1982, alcohol-related fatalities have dropped from 60 percent to 38 percent in 2009.6

Alcoholism is a treatable disease, but is considered a lifelong, chronic illness that requires counseling, support and often medication to control cravings. Relapses are a common problem for alcoholics. Risks for developing alcoholism include a genetic predisposition and lifestyle practices. Stress, ease of alcohol availability, and peer groups can increase the risk for alcoholism.

Treatment Options for Alcohol Abuse and Alcoholism

The treatment of alcoholism requires strong family, social and medical support. Treatment for alcohol dependence usually involves a wide array of interventions, including stepped therapy, group support, individual counseling, and medications.

Some patients may opt to join Alcoholic Anonymous (AA), a group support organization available for men and women since 1935. Over 2 million recovered alcoholics in the United States, Canada, and other countries belong to AA.13

Medical treatments for alcohol dependence include three approved oral medications - disulfiram (Antabuse), naltrexone (Depade, Revia) and acamprosate (Campral) - and an injectable long-acting form of naltrexone (Vivitrol). Use of these medical treatments may work to help reduce drinking, relapses, and lead to full recovery and abstinence from alcohol. According to one review, naltrexone and acamprosate have strong evidence and are recommended as treatment options for alcohol dependence in conjunction with behavioral therapy. Disulfiram has not been shown to increase abstinence rates or decrease relapse rates or cravings compared with placebo, and it is not recommended for routine use in primary care.14

Alcohol Identification

Substance Name

Alcohol

CAS Registry Number

64-17-5

Drug Class

Central Nervous System Depressants

(web3)