Dextrose 70 g/100mL Solution — NDC 0264-7387-50 (Billing 00264-7387-50)

WARNINGS This injection is 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. Use of 70% Dextrose Injection USP to prepare parenteral nutritional admixtures may be incompatible with other components, especially calcium and phosphate salts and lipid emulsions. Incompatibility of admixed components can produce precipitates which may cause particulate emboli.

Use 70% Dextrose Injection USP only to prepare formulations that are known to be stable: refer to standard texts for further information. 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: 70% 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.

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. Incompatibility of admixed components can produce precipitates which may cause particulate emboli. Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause hypovolemia, dehydration, mental confusion and/or loss of consciousness.

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 .) Hypersensitivity reactions, including anaphylaxis and chills. 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.

Drug Interactions Caution must be exercised in the administration of 70% Dextrose Injection USP to patients receiving corticosteroids or corticotropin. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Dispose of any unused product. See WARNINGS .

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. 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.

See WARNINGS . Do not use plastic container in series connection. If administration of 70% Dextrose Injection USP after admixture or dilution is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. This solution is intended for intravenous administration after admixture or dilution using sterile equipment.

When using an automated compounding device replace all disposable components as recommended by manufacturer and at least every 24 hours. Aseptic technique is essential with the use of sterile preparations for compounding nutritional admixtures. Discard container within 4 hours of entering closure.

Administration of hypertonic dextrose and amino acid solutions via central venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure. This includes attention to solution preparation, administration and patient monitoring. It is essential that a carefully prepared protocol, based upon current medical practice, be followed, preferably by an experienced team .

The package insert of the protein (nitrogen) source should be consulted for dosage and all precautionary information. Use only if solution is clear and container and seals are intact. 70% Dextrose Injection USP contains no more than 25 mcg/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 Caution must be exercised in the administration of 70% Dextrose Injection USP to patients receiving corticosteroids or corticotropin.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques.

Mix thoroughly. Do not store. Dispose of any unused product.

See WARNINGS . 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 There are no adequate and well controlled studies with Dextrose Injections, USP in pregnant women and animal reproduction studies have not been conducted with this drug.

Therefore, it is not known whether Dextrose Injections USP can cause fetal harm when administered to a pregnant woman. Dextrose Injections USP should be given during pregnancy only if the potential benefit justifies the potential risk to the fetus. Labor and Delivery I… [Excerpted — this section continues on DailyMed.]