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Side Effects & Adverse Reactions
These injections are for compounding only, not for direct infusion.
Dilute before use to a concentration which will, when administered with an amino acid (nitrogen) source, result in an appropriate calorie to gram of nitrogen ratio and which has an osmolarity consistent with the route of administration.
Unless appropriately diluted, the infusion of hypertonic dextrose injection into a peripheral vein may result in vein irritation, vein damage, and thrombosis. Strongly hypertonic nutrient solutions should only be administered through an indwelling intravenous catheter with the tip located in a large central vein such as the superior vena cava.
In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.
WARNING: This product 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.
Administration by central venous catheter should be used only by those familiar with this technique and its complications.
Monitor changes in fluid balance, electrolyte concentration, and acid base balance during prolonged parenteral therapy or whenever the conditions of the patient warrants such evaluation.
Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Dextrose Injection, USP are indicated as a caloric component in a parenteral nutrition regimen. They are used with an appropriate protein (nitrogen) source in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.
History
There is currently no drug history available for this drug.
Other Information
Dextrose Injections, USP are sterile, nonpyrogenic hypertonic solutions for fluid replenishment and caloric supply in Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. They contain no antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown below.
Composition |
Osmolarity |
Caloric Content |
How Supplied |
||
Dextrose Hydrous, USP (g/L) |
(mOsmol/L) (calc.) |
pH |
(kcal/L) |
Size, code, NDC |
|
2000 mL unit |
|||||
70% Dextrose Injection, USP |
700 |
3530 |
4.0 (3.2 to 6.5) |
2390 |
2B0296 NDC 0338-0719-06 |
The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly.
Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as tissue culture toxicity studies.
Sources
Golfers Skin Broad Spectrum Spf 30 Plus Sunscreen Manufacturers
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Skin Alive, Ltd.
Golfers Skin Broad Spectrum Spf 30 Plus Sunscreen | Baxter Healthcare Corporation
Following suitable admixture of prescribed drugs, the dosage is usually dependent upon age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying drugs.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not administer unless solution is clear and seal is intact.
Use of a final filter is recommended during administration of all parenteral solutions where possible.
The dosage selection and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient, concomitant therapy and should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.
70% Dextrose Injection, USP in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of the 70% Dextrose Injection, USP.
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