dextrose 5 % in 1000 ML Injection
Generic Name: DEXTROSE
Brand Name: DEXTROSE
- Substance Name(s):
- DEXTROSE
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.
DRUG INTERACTIONS
Drug Interactions Some additives may be incompatible.
Consult with pharmacist.
When introducing additives, use aseptic techniques.
Mix thoroughly.
Do not store.
OVERDOSAGE
In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient’s condition and institute appropriate corrective treatment.
DESCRIPTION
Each 100 mL of 5% Dextrose Injection USP contains: Hydrous Dextrose USP 5 g; Water for Injection USP qs pH: 4.4 (3.5–6.5); Calculated Osmolarity: 250 mOsmol/liter Calories per liter: 170 Each 100 mL of 10% Dextrose Injection USP contains: Hydrous Dextrose USP 10 g; Water for Injection USP qs pH: 4.4 (3.5–6.5); Calculated Osmolarity: 505 mOsmol/liter, hypertonic Calories per liter: 340 Dextrose Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents.
These products are intended for intravenous administration.
The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multilayered film specifically developed for parenteral drugs.
It contains no plasticizers and exhibits virtually no leachables.
The solution contact layer is a rubberized copolymer of ethylene and propylene.
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 is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
Addition of medication should be accomplished using complete aseptic technique.
The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site.
Refer to the Directions for Use of the container.
Chemical Structure
HOW SUPPLIED
Dextrose Injections USP are supplied sterile and nonpyrogenic in EXCEL ® Containers.
The 1000 mL containers are packaged 12 per case, the 500 mL and 250 mL containers are packaged 24 per case.
NDC REF Size 5% Dextrose Injection USP (Canada DIN 01924281) 0264-7510-00 L5100 1000 mL 0264-7510-10 L5101 500 mL 0264-7510-20 L5102 250 mL 10% Dextrose Injection USP (Canada DIN 01924427) 0264-7520-00 L5200 1000 mL 0264-7520-10 L5201 500 mL 0264-7520-20 L5202 250 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.
GERIATRIC USE
Geriatric Use An evaluation of current literature revealed no clinical experience identifying differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
These drugs are known to be substantially excreted by the kidney, and the risk of toxic reactions to these drugs may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
See WARNINGS .
INDICATIONS AND USAGE
These intravenous solutions are indicated for use in adults and pediatric patients as sources of calories and water for hydration.
PEDIATRIC USE
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 .
PREGNANCY
Pregnancy Teratogenic Effects 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.
NUSRING MOTHERS
Nursing Mothers Because many drugs are excreted in human milk, caution should be exercised when Dextrose Injections USP are administered to a nursing woman.
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.