ALCOHOL IN DEXTROSE
dextrose hydrous injection, solution HOSPIRA, INC.
5% ALCOHOL IN 5% DEXTROSE INJECTION, USP
5% Alcohol in 5% Dextrose Injection, USP is a sterile, nonpyrogenic,
hypertonic solution of ethyl alcohol and dextrose in water for injection,
intended for intravenous administration.
Each 100 mL
contains dehydrated alcohol 5 mL and dextrose, hydrous 5 g in water for injection;
osmolar concentration 1104 mOsmol/liter (calc.); pH 4.5 (3.5 to 6.5). The
solution provides a total of 450 calories/liter (alcohol 280; dextrose 170).*
solution contains no bacteriostat, antimicrobial agent or added buffer and
is intended only for use as a single-dose injection. When smaller doses are
required the unused portion should be discarded.
Alcohol in 5% Dextrose is a parenteral fluid and nutrient replenisher.
Alcohol, USP is chemically designated as ethanol or ethyl alcohol (CH3CH2OH),
a clear, colorless, mobile, volatile liquid miscible with water.
USP is chemically designated D-glucose monohydrate (C6H12O6•
H2O), a hexose sugar freely soluble in water. It has the following
Water for Injection, USP is chemically
Intravenously administered 5% Alcohol in 5% Dextrose Injection,
USP provides a source of water and carbohydrate calories. In the average adult,
pure ethyl alcohol is metabolized at a rate of approximately 10 to 20 mL per
hour, depending on body weight and tolerance of the individual. (This is equivalent
to an intravenous rate of infusion of 200 to 400 mL per hour of a 5% alcohol
solution). Sedative effects of alcohol occur if the rate of infusion exceeds
the rate of metabolism. Dextrose can be infused at a maximum rate of 0.5 g/kg
of body weight/hr without producing glycosuria (equivalent to 700 mL of a
5% dextrose solution for a 70 kg adult). Thus, the maximum rate that alcohol
can be infused without producing sedative effects is well below the maximum
rate of utilization of dextrose.
carbohydrate in the form of dextrose restore blood glucose levels and provide
calories. Carbohydrate in the form of dextrose may aid in minimizing liver
glycogen depletion and exerts a protein-sparing action.
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.
Dextrose injected parenterally
undergoes oxidation to carbon dioxide and water.
value based on 5.6 calories/mL of alcohol and 3.4 calories/g of dextrose (International
Critical Tables, V, p. 166, 1929).
Water is an essential
constituent of all body tissues and accounts for approximately 70% of total
body weight. Average normal adult daily requirements range from two to three
liters (1.0 to 1.5 liters each for insensible water loss by perspiration
and urine production).
Water balance is maintained by
various regulatory mechanisms. Water distribution depends primarily on the
concentration of electrolytes in the body compartments and sodium ion (Na+)
plays a major role in maintaining physiologic equilibrium.
INDICATIONS AND USAGE
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.
Alcohol should not be used in patients with epilepsy or urinary
tract infection. 5% Alcohol in 5% Dextrose Injection, USP is contraindicated
in diabetic coma.
Alcohol is contraindicated in patients
who have been addicted to it.
Do not give subcutaneously
and avoid extravasation during intravenous administration.
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
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
5% Alcohol in 5% Dextrose Injection, USP should be administered
slowly, and the patient observed for restlessness or narcosis.
half-lives of diphenylhydantoin, warfarin and tolbutamide may be shortened
by 50 to 75% by concurrent administration of alcohol.
increases serum uric acid and can precipitate acute gout.
vasodilating effect may potentiate postural hypotension, particularly in association
with some antihypertensive drugs.
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
Solutions containing dextrose should be
used with caution in patients with known subclinical or overt diabetes mellitus.
not administer unless solution is clear and seal is intact. Discard unused
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.
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.
Additives may be incompatible. Consult with pharmacist, if
available. When introducing additives, use aseptic technique, mix thoroughly
and do not store.
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.
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.
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.
DRUG ABUSE AND DEPENDENCE
Abuse of ingested alcohol is well known, including alcohol
dependence due to addiction. Abuse of parenterally administered alcohol is
not known or considered to pose a potential problem of dependence or addiction.
In the event of alcoholic intoxication or sedation, the infusion
should be slowed or temporarily discontinued. If overhydration or solute overload
occurs, re-evaluate the patient and institute appropriate corrective measures.
See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.
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.
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. See PRECAUTIONS.
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