TERATOGENIC EFFECTS SECTION.

Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with 70% Dextrose Injection, USP. It is also not known whether 70% Dextrose Injection, USP can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. 70% Dextrose Injection, USP should be given to pregnant woman only if clearly needed.

ADVERSE REACTIONS SECTION.

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 solution may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and small bore needle is recommended. (See DOSAGE AND ADMINISTRATION.)Dextrose may be administered at rate of 0.5 g/kg/hour without producing glycosuria. Hyperglycemia and glycosuria may be function of rate of administration or metabolic insufficiency. Appropriate therapy may include slowing of the infusion rate and administration of insulin.Too rapid administration of hypertonic dextrose solution may result in hyperosmolar syndrome with signs of mental confusion and/or loss of consciousness. If undetected and untreated, this can lead to osmotic dehydration, hyperosmolar coma and death.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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies with Hypertonic Dextrose Injections, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. 70% Dextrose Injection, USP provides calories and is source of water for hydration. This solution is 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.70% dextrose solution provides maximum source of calories in minimal fluid volume.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.Administration of solutions containing hypertonic dextrose is contraindicated in patients with intracranial or intraspinal hemorrhage, diabetic coma or delirium tremens, especially if such patients are already dehydrated.

DESCRIPTION SECTION.

DESCRIPTION. Each 100 mL of 70% Dextrose Injection, USP contains:Hydrous Dextrose USP 70 g; Water for Injection USP qspH: 4.6 (3.2-6.5); Calculated Osmolarity: 3530 mOsmol/literCalories per liter: 2380; Calculated Specific Gravity 1.2370% Dextrose Injection, USP is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents.The formula of the active ingredient is:IngredientMolecular FormulaMolecular Weight Hydrous Dextrose USP 198.17. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. This solution is for intravenous use only. Hypertonic, administer only after dilution via central venous catheter. Dosage is to be directed by 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.Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.Dextrose may be administered to normal individuals at rate of 0.5 g/kg/hour without producing glycosuria. At the maximum infusion rate of 0.8 g/kg/hour, approximately 95% of the dextrose is retained.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.

DRUG INTERACTIONS SECTION.

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

GENERAL PRECAUTIONS SECTION.

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.Prolonged administration of solutions containing hypertonic dextrose may adversely affect the production of insulin in some patients. To avoid this potential danger, and to minimize hyperglycemia and consequent glycosuria, it may be necessary to add insulin to the infusion. Periodically measure blood and urinary glucose.Essential electrolytes, minerals, and vitamins should be supplied as needed.When infusions of concentrated dextrose are discontinued, it is advisable to substitute solution of 5% or 10% dextrose to prevent rebound hypoglycemia. 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 pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.Do not use unless solution is clear, closure is intact and vacuum is present. This drug product contains no more than 25 ug/L of aluminum.

GERIATRIC USE SECTION.

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.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. 70% Dextrose Injection, USP is supplied sterile and nonpyrogenic in 1000 mL glass containers, packaged per case. NDC REF Size 70% Dextrose Injection, USP 0264-1290-55 S1290-SS 1000 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 (25C/77F); however, brief exposure up to 40C/104F does not adversely affect the product.. Rx onlyRevised: January 2014.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. This intravenous solution is indicated for use in adults and pediatric patients as source of calories and water for hydration.

LABOR & DELIVERY SECTION.

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.

LABORATORY TESTS SECTION.

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 alternative solutions.

NURSING MOTHERS SECTION.

Nursing Mothers. Because many drugs are excreted in human milk, caution should be exercised when Hypertonic Dextrose Injection, USP is administered to nursing women.

OVERDOSAGE SECTION.

OVERDOSAGE. In the event of fluid or solute overload during parenteral therapy, reevaluate the patients condition and institute appropriate corrective treatment.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 1000 mL Container Label. 1000 mLNDC 0264-1290-55 S1290-SSDEXTROSE INJECTION, USP 70%NOT FOR DIRECT INFUSION MUST BE DILUTEDEach 100 mL contains: Hydrous Dextrose USP 70 Water for Injection USP qspH: 4.6 (3.2-6.5), Hypertonic Calc. Osmolarity: 3530 mOsmol/liter Calc. Specific Gravity: 1.23B. Braun Medical Inc.Bethlehem, PA 18018-3524 USAMade in USASterile, nonpyrogenic.Single dose container.Dosage and Administration: See Package Insert.Caution: Do not use unless solution is clear, closure is intact and vacuum is present.Recommended Storage:Room temperature (25C/77F). Avoid excessive heat.Protect from freezing.Rx onlyHK-22603Y37-002-475 LD-287-2. S1290-SS 1000 mL Container Label.

PEDIATRIC USE SECTION.

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.

PRECAUTIONS SECTION.

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.Prolonged administration of solutions containing hypertonic dextrose may adversely affect the production of insulin in some patients. To avoid this potential danger, and to minimize hyperglycemia and consequent glycosuria, it may be necessary to add insulin to the infusion. Periodically measure blood and urinary glucose.Essential electrolytes, minerals, and vitamins should be supplied as needed.When infusions of concentrated dextrose are discontinued, it is advisable to substitute solution of 5% or 10% dextrose to prevent rebound hypoglycemia. 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 pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.Do not use unless solution is clear, closure is intact and vacuum is present. This drug product contains no more than 25 ug/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 this 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 Hypertonic 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 70% Dextrose Injection, USP. It is also not known whether 70% Dextrose Injection, USP can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. 70% Dextrose Injection, USP should be given to 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 Hypertonic Dextrose Injection, USP is 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. 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.This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug 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.

PREGNANCY SECTION.

Pregnancy. Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with 70% Dextrose Injection, USP. It is also not known whether 70% Dextrose Injection, USP can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. 70% Dextrose Injection, USP should be given to pregnant woman only if clearly needed.

SPL PATIENT PACKAGE INSERT SECTION.

Directions for Use of B. Braun Glass Containers with Solid Stoppers. Designed for use with vented set. Use 18 to 22 gauge needle size for admixing or withdrawing solutions from the glass bottle.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 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. When adding medication to the container prior to administration, swab the target area of the rubber stopper, inject medication and mix thoroughly by gentle agitation. Refer to Directions for Use of the set being used. Insert the set spike into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before administration begins. Hang the container. After admixture and during administration, re-inspect 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. 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 target area of the rubber stopper; contents should be drawn by vacuum into the bottle. Admixture by spiked vial should also be through the target area of the rubber stopper (see Figure 2). If contents of initial addition are not drawn into the bottle, vacuum is not present and the unit should be discarded. Each addition/transfer will reduce the vacuum remaining in the bottle. If the first puncture of the stopper is the administration set spike, insert the spike fully into the target area of the rubber 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.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). This solution may be colored and is satisfactory for use if solution is clear and vacuum is present.. 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. 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 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. When adding medication to the container prior to administration, swab the target area of the rubber stopper, inject medication and mix thoroughly by gentle agitation. Refer to Directions for Use of the set being used. Insert the set spike into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before administration begins. Hang the container. After admixture and during administration, re-inspect 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. 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 target area of the rubber stopper; contents should be drawn by vacuum into the bottle. Admixture by spiked vial should also be through the target area of the rubber stopper (see Figure 2). If contents of initial addition are not drawn into the bottle, vacuum is not present and the unit should be discarded. Each addition/transfer will reduce the vacuum remaining in the bottle. If the first puncture of the stopper is the administration set spike, insert the spike fully into the target area of the rubber 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.. Figure 1. Figure Illustration.

SPL UNCLASSIFIED SECTION.

Package InsertAdminister only after dilution via central venous catheter.

STORAGE AND HANDLING SECTION.

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 (25C/77F); however, brief exposure up to 40C/104F does not adversely affect the product.

WARNINGS SECTION.

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: 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 to 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.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.Hypertonic dextrose solutions (above approximately 600 mOsmol/liter) may cause thrombosis if infused via peripheral vein. It is, therefore, advisable to administer such solutions via an intravenous catheter placed in large central vein, preferably the superior vena cava. Concentrations of Dextrose Injection, USP 20% and greater should be administered exclusively by this route.Rapid administration of solutions containing hypertonic dextrose may produce significant hyperglycemia and hyperosmolar syndrome. Patients should be observed for signs of mental confusion and loss of consciousness, especially in patients with chronic uremia or carbohydrate intolerance. If undetected and untreated, this can lead to osmotic dehydration, hyperosmolar coma and death.In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.