Dextrose
Dextrose Injections USP
FULL PRESCRIBING INFORMATION: CONTENTS*
- DEXTROSE DESCRIPTION
- CLINICAL PHARMACOLOGY
- DEXTROSE INDICATIONS AND USAGE
- DEXTROSE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DEXTROSE ADVERSE REACTIONS
- OVERDOSAGE
- DEXTROSE DOSAGE AND ADMINISTRATION
- Pediatric Use
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 500 mL Container Label
- PRINCIPAL DISPLAY PANEL - 150 mL Container Label
FULL PRESCRIBING INFORMATION
Package Insert
DEXTROSE DESCRIPTION
5% Dextrose Injection USP10% Dextrose Injection USP
The formula of the active ingredient is:
Ingredient | Molecular Formula | Molecular Weight |
---|---|---|
Hydrous Dextrose USP | 198.17 |
CLINICAL PHARMACOLOGY
Dextrose Injections USP provide calories and are a source of water for hydration. These solutions are capable of inducing diuresis depending on 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 loss by perspiration and urine production).
DEXTROSE INDICATIONS AND USAGE
These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.
DEXTROSE CONTRAINDICATIONS
Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
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 concentration.
WARNING: Dextrose Injection USP contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
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
These solutions 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.
Essential electrolytes, minerals, and vitamins should be supplied as needed.
Hypokalemia may develop during parenteral administration of hypertonic dextrose solutions. Sufficient amounts of potassium should be added to dextrose solutions administered to fasting patients with good renal function, especially those on digitalis therapy.
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.
If 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.
These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.
Use only if solution is clear and vacuum is present.
Dextrose Injection USP contains no more than 25 µg/L of aluminum.
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 these or alternative solutions.
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 Dextrose Injections 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 Dextrose Injections USP. It is also not known whether Dextrose Injections USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose Injections 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 Dextrose Injections USP are administered to nursing women.
Pediatric Use
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.
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
.
Geriatric Use
See WARNINGS .
DEXTROSE 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.
Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended. (See
DOSAGE AND ADMINISTRATION
.)
The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.
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.
OVERDOSAGE
In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition, and institute appropriate corrective treatment.
DEXTROSE DOSAGE AND ADMINISTRATION
These solutions are for intravenous use only.
Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.
When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.
Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Pediatric Use
There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. (See WARNINGS and PRECAUTIONS .)
HOW SUPPLIED
Container | ||||
NDC | Cat. No. | Size | Fill | |
5% Dextrose Injection USP | ||||
0264-1101-55 | S1101-SS | 500 mL | 500 mL | |
0264-1102-55 | S1102-15SS | 250 mL | 150 mL | |
10% Dextrose Injection USP | ||||
0264-1207-55 | S1200-50SS | 1000 mL | 500 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: March 2007
Made in USA
©2007 B. Braun Medical Inc.
Before use, perform the following checks:
- Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
- 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 the bottom and sides of the bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle.
- 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.
- Grasp and remove the metal disk, exercising caution not to touch the exposed sterile stopper surface.
Warning: Some additives may be incompatible. Consult with pharmacist. When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store.
- 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.
- 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.
- When adding medication to the container during administration, swab the triangular medication site, inject medication and mix thoroughly by gentle agitation.
- Spiking, additions, or transfers should be made immediately after exposing the sterile stopper surface. Check for vacuum at first puncture of stopper. Admixture by needle or syringe should be made through the triangular (
- If the first puncture of the stopper is the administration set spike, insert the spike fully into the outlet port of the stopper and promptly invert the bottle. Verify vacuum by observing rising air bubbles. Do not use the bottle if vacuum is not present.
- If admixture or set insertion is not performed immediately following removal of protective metal disk, swab stopper surface.
Caution: Large partial fill containers (one liter and larger) have high vacuum to facilitate large additions or transfers. This creates an implosion hazard and requires special care in use and handling.
Notice: Variation in color between different lots, and between units of the same lot, is normal for carbohydrate solutions, and electrolyte solutions containing sugars. These color differences have no effect on the therapeutic value of the solutions.
Distinction should be made between color (tint) and clarity (transparency). These solutions may be colored and are satisfactory for use if solution is clear and vacuum is present.
B. Braun Medical Inc.
Irvine, CA USA 92614-5895
Y36-002-600
PRINCIPAL DISPLAY PANEL - 500 mL Container Label
500 mL
NDC 0264-1101-55
S1101-SS
5% Dextrose
Injection USP
Each 100 mL contains:
Hydrous Dextrose USP 5 g
Water for Injection USP qs
pH 4.7 (3.5-6.5)
Calc. Osmolarity: 250 mOsmol/liter
B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Sterile, nonpyrogenic.
Single dose container.
Electrolyte-free dextrose solutions should not be given
conjointly with blood because agglomeration may occur.
For intravenous use only. Use only if solution is clear and
vacuum is present.
Recommended Storage:
Room temperature (25ºC).
Avoid excessive heat. Protect from freezing.
See package Insert.
Rx only
Made in USA
Y37-002-252 LD-284-1
PRINCIPAL DISPLAY PANEL - 150 mL Container Label
150 mL
NDC 0264-1102-55
S1102-15SS
5% Dextrose
Injection USP
Partial Fill Container
Each 100 mL contains:
Hydrous Dextrose USP 5 g
Water for Injection USP qs
pH 4.7 (3.5-6.5)
Calc. Osmolarity: 250 mOsmol/liter
B. Braun Medical Inc.
Irvine, CA USA 92614-5895
Sterile, nonpyrogenic.
Single dose container.
Electrolyte-free dextrose solutions should
not be given conjointly with blood because
agglomeration may occur.
For intravenous use only. Use only if
solution is clear and vacuum is present.
Recommended Storage:
Room temperature (25ºC).
Avoid excessive heat. Protect from freezing.
See package Insert.
Rx only
Y37-002-253
Made in USA
DextroseDEXTROSE INJECTION, SOLUTION
|
DextroseDEXTROSE INJECTION, SOLUTION
|
DextroseDEXTROSE INJECTION, SOLUTION
|