Alcohol in Dextrose

Name: Alcohol in Dextrose

Indications and Usage for Alcohol in Dextrose

5% Alcohol in 5% Dextrose Injection, USP is indicated for parenteral replenishment of fluid and carbohydrate calories, especially to increase caloric intake in patients whose oral intake is restricted or inadequate to maintain nutritional requirements.

Warnings

Alcohol should be used cautiously, if at all, in patients with liver impairment, in the presence of shock, following cranial surgery, in actual or anticipated postpartum hemorrhage or in the presence of significant renal impairment.

Alcohol will decrease blood sugar in diabetic patients. In the untreated diabetic the rate of alcohol metabolism will be slowed.

As a nutrient, alcohol supplies only calories. Given alone, it may cause or potentiate vitamin deficiencies and disturbances of liver function.

Alcohol crosses the placenta rapidly and enters the fetal circulation. It may also be found in the milk of lactating women. The use of this preparation in pregnancy should be carefully deliberated.

The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Precautions

5% Alcohol in 5% Dextrose Injection, USP should be administered slowly, and the patient observed for restlessness or narcosis.

The half-lives of diphenylhydantoin, warfarin and tolbutamide may be shortened by 50 to 75% by concurrent administration of alcohol.

Alcohol increases serum uric acid and can precipitate acute gout.

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

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

Do not administer unless solution is clear and seal is intact. Discard unused portion.

Pregnancy Category C.

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

Pediatric Use

The safety and effectiveness of 5% Alcohol in 5% Dextrose Injection, USP have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Alcoholic intoxication may occur with too rapid infusion. Vertigo, flushing, disorientation (especially in elderly patients), or sedation may also occur. An alcoholic odor may be noted on the breath. Generally, these effects can be avoided by slowing the rate of infusion.

Too rapid infusion of hypertonic solutions may cause local pain and rarely, excessive vein irritation. Use of the largest available peripheral vein and a small bore needle is recommended.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Alcohol in Dextrose Dosage and Administration

5% Alcohol in 5% Dextrose Injection, USP should be administered by slow intravenous infusion. Administration of 200 mL per hour will produce a blood level of less than 0.08 g of alcohol per 100 mL of blood. A normal adult can metabolize 10 mL of alcohol per hour (equivalent to 200 mL of a 5% alcohol solution).

The adult dosage ranges from 1 to 2 liters/day (24 hours) as determined by the needs of the patient. The average adult daily fluid requirement of 3 liters/day should be provided by other suitable solutions to meet daily maintenance requirements for electrolytes.

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

How is Alcohol in Dextrose Supplied

5% Alcohol in 5% Dextrose Injection, USP is supplied in a single-dose 1000 mL glass container (List No. 1500).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

©Hospira 2004

EN-0146

Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Alcohol in Dextrose 
alcohol and dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-1500
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 hydrous (Dextrose) Dextrose 5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Packaging
# Item Code Package Description
1 NDC:0409-1500-05 6 BOTTLE, GLASS (6 BOTTLE) in 1 CASE
1 1000 mL (1000 MILLILITER) in 1 BOTTLE, GLASS
Labeler - HOSPIRA, INC.
Revised: 05/2006   HOSPIRA, INC.
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