Dextrose And Sodium Chloride

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 .) Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic container. 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.

CONTRAINDICATIONS These solutions are contraindicated where the administration of sodium or chloride could be clinically detrimental. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

DESCRIPTION (See chart below for quantitative information.) Dextrose and Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Sodium Chloride USP NaCl 58.44 Hydrous Dextrose USP 198.17 Composition – Each 100 mL contains: Concentration of Electrolytes (mEq/liter) Hydrous Dextrose USP Sodium Chloride USP Calories per liter Calculated Osmolarity mOsmol/liter pH Solution Sodium Chloride Water for Injection USP qs 3.3% Dextrose and 0.30% Sodium Chloride Injection USP 3.3 g 0.3 g 51 51 110 270 4.5 (3.5–6.5) 5% Dextrose and 0.9% Sodium Chloride Injection USP 5 g 0.9 g 154 154 170 560 4.4 (3.5–6.5) 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 77 77 170 405 4.4 (3.5–6.5) 5% Dextrose and 0.33% Sodium Chloride Injection USP 5 g 0.33 g 56 56 170 365 4.4 (3.5–6.5) 5% Dextrose and 0.20% Sodium Chloride Injection USP 5 g 0.2 g 34 34 170 320 4.4 (3.5–6.5) 10% Dextrose and 0.45% Sodium Chloride Injection USP 10 g 0.45 g 77 77 340 660 4.3 (3.5–6.5) 10% Dextrose and 0.20% Sodium Chloride Injection USP 10 g 0.2 g 34 34 340 575 4.3 (3.5–6.5) 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

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. In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of fluid containing 0.9% sodium chloride (154 mEq each of sodium and chloride). 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. See WARNINGS and PRECAUTIONS .

INDICATIONS AND USAGE These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories and water for hydration.

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. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient's circulatory system status as a guide. Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia. Serum potassium levels should be maintained and potassium supplemented as required. Solutions containing dextrose and low electrolyte concentrations should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination or hemolysis.

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

CLINICAL PHARMACOLOGY Dextrose and Sodium Chloride Injections USP provide electrolytes and calories and are a source of water for hydration. All are capable of inducing diuresis depending on the clinical condition of the patient. Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration. Dextrose provides a source of calories. 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.

20220919

14

Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE DEXTROSE DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE DEXTROSE DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE DEXTROSE DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE DEXTROSE DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE DEXTROSE DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE DEXTROSE DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE DEXTROSE DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE DEXTROSE DEXTROSE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER

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

NDA019631

Dextrose And Sodium Chloride

DEXTROSE and SODIUM CHLORIDE

0264-7610

HUMAN PRESCRIPTION DRUG

INTRAVENOUS

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.

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label 3.3% Dextrose and 0.30% Sodium Chloride Injection USP REF L6080-00 NDC 0264-7608-00 DIN 01927981 1000 mL EXCEL® CONTAINER Each 100 mL contains: Hydrous Dextrose USP 3.3 g; Sodium Chloride USP 0.3 g; Water for Injection USP qs pH: 4.5 (3.5-6.5); Calc. Osmolarity: 270 mOsmol/liter Electrolytes (mEq/liter): Na + 51; Cl – 51 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Do Not Administer Simultaneously With Blood. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-252 LD-183-3 EXP LOT Other 1000 mL Container Label L6080-00

Rx only Revised: November 2018 EXCEL is a registered trademark of B. Braun Medical Inc.

Geriatric Use Clinical studies of Dextrose and Sodium Chloride Injections USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between 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 .

Labor and Delivery The effects of Dextrose and Sodium Chloride Injections USP on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and on the later growth, development, and functional maturation of the child are unknown. As reported in the literature, sodium and dextrose containing 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 It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dextrose and Sodium Chloride Injections USP are administered to a nursing woman.

Pediatric Use Safety and effectiveness of Dextrose and Sodium Chloride Injections USP in pediatric patients have not been established by adequate and well-controlled studies. Dextrose is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND USAGE ). As reported in the literature, 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. 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. See WARNINGS and DOSAGE AND ADMINISTRATION .

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injections USP. It is also not known whether Dextrose and Sodium Chloride Injections USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose and Sodium Chloride Injections USP should be given to a pregnant woman only if clearly needed.

Teratogenic Effects Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injections USP. It is also not known whether Dextrose and Sodium Chloride Injections USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose and Sodium Chloride Injections USP should be given to a pregnant woman only if clearly needed.

HOW SUPPLIED Dextrose and Sodium Chloride 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. Canada DIN NDC REF Size 3.3% Dextrose and 0.30% Sodium Chloride Injection USP 01927981 0264-7608-00 L6080-00 1000 mL 0264-7608-10 L6081-00 500 mL 5% Dextrose and 0.9% Sodium Chloride Injection USP 01924435 0264-7610-00 L6100 1000 mL 0264-7610-10 L6101 500 mL 5% Dextrose and 0.45% Sodium Chloride Injection USP 01927531 0264-7612-00 L6120 1000 mL 0264-7612-10 L6121 500 mL 0264-7612-20 L6122 250 mL 5% Dextrose and 0.33% Sodium Chloride Injection USP 0264-7614-00 L6140 1000 mL 0264-7614-10 L6141 500 mL 5% Dextrose and 0.20% Sodium Chloride Injection USP 01927558 0264-7616-00 L6160 1000 mL 0264-7616-10 L6161 500 mL 0264-7616-20 L6162 250 mL 10% Dextrose and 0.45% Sodium Chloride Injection USP 0264-7622-00 L6220 1000 mL 10% Dextrose and 0.20% Sodium Chloride Injection USP 0264-7623-20 L6232 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.

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.

General These solutions should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals and vitamins should be supplied as needed. Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. Infusion of more than one liter of isotonic (0.9%) sodium chloride per day may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. 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 any of these solutions 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. Do not use plastic containers in series connection. 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. 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. 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 container and seals are intact.

PRECAUTIONS General These solutions should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation. Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. Additional essential electrolytes, minerals and vitamins should be supplied as needed. Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. Infusion of more than one liter of isotonic (0.9%) sodium chloride per day may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. 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 any of these solutions 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. Do not use plastic containers in series connection. 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. 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. 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 container and seals are intact. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Dextrose and Sodium Chloride Injections USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Dextrose and Sodium Chloride Injections USP. It is also not known whether Dextrose and Sodium Chloride Injections USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose and Sodium Chloride Injections USP should be given to a pregnant woman only if clearly needed. Labor and Delivery The effects of Dextrose and Sodium Chloride Injections USP on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and on the later growth, development, and functional maturation of the child are unknown. As reported in the literature, sodium and dextrose containing 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 It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dextrose and Sodium Chloride Injections USP are administered to a nursing woman. Pediatric Use Safety and effectiveness of Dextrose and Sodium Chloride Injections USP in pediatric patients have not been established by adequate and well-controlled studies. Dextrose is safe and effective for the stated indications in pediatric patients (see INDICATIONS AND USAGE ). As reported in the literature, 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. 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. See WARNINGS and DOSAGE AND ADMINISTRATION . Geriatric Use Clinical studies of Dextrose and Sodium Chloride Injections USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between 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 .