ALCOHOL AND DEXTROSE monohydrate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)

Available from:

B. Braun Medical Inc.

INN (International Name):

Alcohol

Composition:

5 mL in 100 mL

Prescription type:

PRESCRIPTION DRUG

Summary of Product characteristics

ALCOHOL AND DEXTROSE- ALCOHOL AND DEXTROSE MONOHYDRATE INJECTION
B. BRAUN MEDICAL INC.
----------
ALCOHOL AND DEXTROSE
INJECTIONS USP
HYPERTONIC
DESCRIPTION
Each 100 mL of 5% ALCOHOL AND 5% DEXTROSE INJECTION USP contains:
Alcohol USP 5 mL; Hydrous Dextrose USP 5 g
Water for Injection USP qs
pH: 5.0 (3.5–6.5); Calories per liter: 450
Calculated Osmolarity: 1125 mOsmol/liter, hypertonic
Each 100 mL of 10% ALCOHOL AND 5% DEXTROSE INJECTION USP contains:
Alcohol USP 10 mL;
Hydrous Dextrose USP 5 g
Water for Injection USP qs
pH: 4.6 (3.5–6.5); Calories per liter: 720
Calculated Osmolarity: 1995 mOsmol/liter, strongly hypertonic
These intravenous solutions are sterile, nonpyrogenic, hypertonic and
contain no bacteriostatic or
antimicrobial agents.
The formulas of the active ingredients are:
INGREDIENTS
MOLECULAR FORMULA
MOLECULAR WEIGHT
Alcohol USP
CH CH OH
46.07
Hydrous Dextrose USP
198.17
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.
INDICATIONS AND USAGE
Alcohol and Dextrose Injections USP are indicated for increasing
caloric intake.
3
2
CONTRAINDICATIONS
Alcohol should not be used in patients with epilepsy, urinary tract
infection, or diabetic coma.
Alcohol is contraindicated in patients who have been addicted to it.
Do not give subcutaneously and avoid extravasation during intravenous
administration.