Dextrose

DEXTROSE- dextrose monohydrate injection, solution
B. Braun Medical Inc.

Partial Fill

DESCRIPTION

Each mL of 5% Dextrose Injection USP contains:
Hydrous Dextrose USP 50 mg; Water for Injection USP qs

pH: 4.5 (3.5–6.5)
Calculated Osmolarity: 250 mOsmol/literCalories per 100 mL: 17

This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration.

The formula of the active ingredient is:

IngredientMolecular FormulaMolecular Weight
Hydrous Dextrose USPChemical Structure 198.17

Not made with natural rubber latex, DEHP, or PVC.

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

The container/solution unit is a closed system and is not dependent upon entry of external air during administration. The container has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use of the container to properly identify the ports.

No vapor barrier is necessary.

CLINICAL PHARMACOLOGY

5% Dextrose Injection USP provides calories and is a source of water for hydration. It is capable of inducing diuresis depending on the volume administered and the clinical condition of the patient.

Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

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).

INDICATIONS AND USAGE

5% Dextrose Injection USP is indicated for use in adults and pediatric patients as sources of calories and water for hydration.

This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.

CONTRAINDICATIONS

Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Do not administer 5% Dextrose Injection USP simultaneously with blood through the same infusion set because hemolysis or pseudoagglutination may occur.

WARNINGS

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions.

Prolonged infusion of isotonic or hypotonic dextrose in water may increase the volume of extracellular fluid and cause water intoxication.

Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration.

Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia. Serum potassium levels should be maintained and potassium supplemented as required.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

PRECAUTIONS

General

This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

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.

Laboratory Tests

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. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or an alternative solution(s).

Drug Interactions

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with 5% Dextrose Injection USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy -

Teratogenic Effects -

Pregnancy Category C.

Animal reproduction studies have not been conducted with 5% Dextrose Injection USP. It is also not known whether 5% Dextrose Injection USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Dextrose Injection USP should be given to a pregnant woman only if clearly needed.

Labor and Delivery

As reported in the literature, dextrose solutions have been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

Nursing Mothers

Because many drugs are excreted in human milk, caution should be exercised when 5% Dextrose Injection USP is administered to a nursing woman.

Pediatric Use

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations.

In neonates or in very small infants even small volumes of fluid may affect fluid and electrolyte balance. Care must be exercised in treatment of neonates, especially pre-term neonates, whose renal function may be immature and whose ability to excrete fluid and solute loads may be limited. Fluid intake, urine output, and serum electrolytes should be monitored closely.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

Serum glucose concentrations should be frequently monitored when dextrose is prescribed to pediatric patients, particularly infants, neonates, and low birth weight infants. See WARNINGS and DOSAGE AND ADMINISTRATION.

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