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NA | Dextrose [Hospira, Inc.] | BioPortfolio

13:30 EST 27th January 2019 | BioPortfolio

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50% and 70% Dextrose Injection, USP Concentrated Dextrose in Water

NOTE: These solutions are hypertonic – see WARNINGS and PRECAUTIONS .

Flexible Plastic Containers                                                                                                                Rx only

Pharmacy Bulk Package — Not For Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.

50% and 70% Dextrose Injection, USP (concentrated dextrose in water) are sterile, nonpyrogenic, hypertonic solutions of Dextrose, USP in water for injection for intravenous administration after appropriate admixture or dilution.

The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program.

The content and physical characteristics of the solutions are as follows:

The solutions contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as a single-dose injection following admixture or dilution.

This Pharmacy Bulk Package is intended only for use in the preparation of sterile, intravenous nutrient admixtures using automated compounding devices. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. 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.

Dextrose Injection, USP is a parenteral fluid and nutrient replenisher.

Dextrose, USP is chemically designated D-glucose, monohydrate (CHO • HO), a hexose sugar freely soluble in water. It has the following structural formula:   

Water for Injection, USP is chemically designated HO.

Solution Characteristics 50% Dextrose Injection, USP 70% Dextrose Injection, USP
pH 4.0 4.0
pH range 3.2 - 6.5 3.2 - 6.5
Osmolarity (mOsmol/L) (calc.) 2523 3532
Specific Gravity 1.170 1.236
Grams Dextrose/100 mL 50 70
kcal/100 mLCaloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous. 170 238
Fill volume (mL) 2000 2000

When administered intravenously, solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein sparing action. Dextrose injection undergoes oxidation to carbon dioxide and water.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments, and sodium (NA) plays a major role in maintaining physiologic equilibrium.

50% and 70% Dextrose Injection, USP (concentrated dextrose in water) in Pharmacy Bulk Packages are indicated for use with automated compounding devices for preparing intravenous nutritional admixtures in the pharmacy.

A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present nor in the presence of delirium tremens if the patient is already dehydrated.

Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

Concentrated dextrose in water should be administered only after suitable dilution. Hypertonic dextrose solutions should be given slowly. Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

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.

FOR PERIPHERAL VEIN ADMINISTRATION

Hypertonic dextrose solutions (above 5% concentration) should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation.

FOR CENTRAL VENOUS ADMINISTRATION

Concentrated dextrose should be administered via central vein after appropriate admixture or dilution when required.

Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential, and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed.

To minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and if necessary, add insulin. When concentrated dextrose infusion is abruptly withdrawn, it is advisable to follow with the administration of 5% or 10% dextrose to avoid rebound hypoglycemia.

Aseptic technique is essential with the use of sterile preparations for compounding nutritional admixtures. Discard container within 4 hours of entering closure.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

Care should be exercised to insure that the needle (or catheter) is well within the lumen of the vein and that extravasation does not occur.

Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

Do not administer unless solution is clear and container is undamaged.

Pregnancy Category C: Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.

Pediatric Use

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Caution should be exercised with low birth weight premature neonates, who are receiving dextrose concentrations of 10% or greater, as they are most susceptible to glucose intolerance and hyperglycemia. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause hypovolemia, dehydration, mental confusion and/or loss of consciousness.

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.

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.

In the event of overhydration or solute overload during therapy, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS ).

Concentrated Dextrose in Water is administered by slow intravenous infusion (a) after admixture with amino acid solutions or (b) after dilution with other compatible IV fluids. Dosage should be adjusted to meet the requirements of each individual patient.

50% and 70% Dextrose Injection, USP in the 2000 mL flexible Pharmacy Bulk Package are designed for use with automated compounding devices for preparing intravenous nutritional admixtures. Dosages will be in accordance with the recommendation of the prescribing physician. 50% and 70% Dextrose Injection, USP are not intended for direct infusion. Admixtures should be made by, or under the direction of, a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration.

The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hr. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr.

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.

As reported in the literature, the dosage 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS .)

Drug Interactions

Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique, mix thoroughly and do not store.

Some opacity of the plastic due to moisture absorption during sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

Recommended Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique

50% and 70% Dextrose Injection, USP are supplied as follows:

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: June, 2010Printed in USA                                                 EN-2527                                                              Hospira, Inc., Lake Forest, IL 60045 USA

NDC No. Container Concentration Fill
0409-7119-07 Flexible Pharmacy Bulk Package 50% 2000 mL
0409-7120-07 Flexible Pharmacy Bulk Package 70% 2000 mL

2000 mLNDC 0409-7120-07

DEXTROSEINJECTION,USP70%

Pharmacy Bulk Package —Not For Direct Infusion.MUST BE DILUTED.

EACH 100 mL CONTAINS DEXTROSE, HYDROUS, USP70 g IN WATER FOR INJECTION.HYPERTONIC OSMOLARITY 3532 mOsmol/LITER (calc).pH 4.0 (3.2 to 6.5)SPECIFIC GRAVITY 1.236STERILE, NONPYROGENIC. DOSAGE AND ADMINISTRATION: SEE PACKAGEINSERT.CAUTION: DO NOT USE UNLESS SOLUTION ISCLEAR, CLOSURE IS INTACT, AND CONTAINERIS UNDAMAGED. CHECK FOR MINUTE LEAKS BYSQUEEZING FIRMLY. IF LEAKS ARE FOUND DISCARDCONTAINER AND CONTENTS AS STERILITY MAY BEIMPAIRED. WITHIN 4 HOURS AFTER INITIAL ENTRYDISCARD CONTAINER AND UNUSED CONTENTS.

DATE ENTERED:

TIME OF ENTRY:

STORE AT 20 TO 25°C (68 TO 77°F). [SEE USPCONTROLLED ROOM TEMPERATURE.] PROTECT FROMFREEZING.

THIS PRODUCT CONTAINS NO MORE THAN 25 mcg/LOF ALUMINUM.

RX ONLY

70%

3v CONTAINS DEHP

IM-1398 (11/06)

PRINTED IN USAHOSPIRA, INC., LAKE FOREST, IL 60045 USA Hospira

TO OPEN — TEAR AT NOTCH

The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap untilready for use. Visually inspect overwrap for tears or holes. Use unit promptly whenpouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled RoomTemperature.] Protect from freezing. See insert. After removing the overwrap, check forminute leaks by squeezing container firmly. If leaks are found, discard solution assterility may be impaired.

COLOR VARIATION IN THE DEXTROSE INJECTION FROM PALE YELLOW TO YELLOW ISNORMAL AND DOES NOT ALTER EFFICACY.

Rx only

WR-0337

Hospira, Inc., Lake Forest, IL 60045 USA Hospira

2000 mLNDC 0409-7119-07

50%DEXTROSEINJECTION,USP

Pharmacy Bulk Package —Not For Direct Infusion.MUST BE DILUTED.

EACH 100 mL CONTAINS DEXTROSE, HYDROUS, USP50 g IN WATER FOR INJECTION.HYPERTONIC OSMOLARITY 2523 mOsmol/LITER (calc).pH 4.0 (3.2 to 6.5)SPECIFIC GRAVITY 1.170STERILE, NONPYROGENIC.

DOSAGE AND ADMINISTRATION: SEE PACKAGEINSERT.

CAUTION: DO NOT USE UNLESS SOLUTION IS CLEAR, CLOSURE IS INTACT, AND CONTAINERIS UNDAMAGED. CHECK FOR MINUTE LEAKS BYSQUEEZING FIRMLY. IF LEAKS ARE FOUND DISCARDCONTAINER AND CONTENTS AS STERILITY MAY BEIMPAIRED. WITHIN 4 HOURS AFTER INITIAL ENTRYDISCARD CONTAINER AND UNUSED CONTENTS.

DATE ENTERED:

TIME OF ENTRY:

STORE AT 20 TO 25°C (68 TO 77°F). [SEE USPCONTROLLED ROOM TEMPERATURE.] PROTECT FROMFREEZING.

THIS PRODUCT CONTAINS NO MORE THAN 25 mcg/LOF ALUMINUM.

RX ONLY

50%

3v CONTAINS DEHP

IM-1347 (10/06)

PRINTED IN USAHOSPIRA, INC., LAKE FOREST, IL 60045 USA Hospira

TO OPEN — TEAR AT NOTCH

The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap untilready for use. Visually inspect overwrap for tears or holes. Use unit promptly whenpouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled RoomTemperature.] Protect from freezing. See insert. After removing the overwrap, check forminute leaks by squeezing container firmly. If leaks are found, discard solution assterility may be impaired.

COLOR VARIATION IN THE DEXTROSE INJECTION FROM PALE YELLOW TO YELLOW ISNORMAL AND DOES NOT ALTER EFFICACY.

Rx only

WR-0336

Hospira, Inc., Lake Forest, IL 60045 USA Hospira

Manufacturer

Hospira, Inc.

Active Ingredients

Source

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40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose

The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood glucose concentration and to reducing of pain before painful procedures on healthy term neonate ...

Changes in Cytokine Levels After Dextrose Injection in Stage IV Knee Osteoarthritis

Twenty participants with severe arthritis will be enrolled. For the first week participants will either be injected with dextrose or just have fluid withdrawn for testing. The remaining pa...

Ulnar Wrist Pain Treatment With Dextrose Prolotherapy

Participants with wrist pain on the little finger side of the wrist will received either usual care, consisting of ultrasound, specialized massage and stabilization exercises therapy for 6...

Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose

The posterior antebrachial cutaneous nerve (PACN) can be compressed between the deltoid and triceps, with resultant pain and dysfunction. The active treatment for this study will be injec...

Effects of Hypertonic Dextrose Water Injection for Supraspinatus Tendinosis Patients

Using hypertonic dextrose water for chronic supraspinatus tendonitis and using ultrasound as assessment tool to evaluate the effect of intervention.

PubMed Articles [34 Associated PubMed Articles listed on BioPortfolio]

Comparison of imaged capillary isoelectric focusing and cation exchange chromatography for monitoring dextrose-mediated glycation of monoclonal antibodies in infusion solutions.

Intravenous (IV) infusion of therapeutic proteins typically involves dilution of the formulated product into infusion media such as normal saline or dextrose, 5% m/v in water. We report results from a...

Effects of hypertonic dextrose and paraffin solution as non-antibiotic treatments of clinical endometritis on reproductive performance of high producing dairy cows.

The objective of this study is to compare the reproductive performance of cows affected by clinical endometritis (CE) following treatment with an intrauterine infusion of 50% dextrose solutions (DEX) ...

Hypertonic milk replacers increase gastrointestinal permeability in healthy dairy calves.

Hypertonic milk replacers are commonly used in animal production systems and their effect on the gastrointestinal system of young animals is insufficiently studied. Total lactose inclusion or its part...

Embolization of a Complex Facial Arteriovenous Malformation, Balloon-Assisted Flow Arrest, and Controlled n-BCA Injection with Dextrose Push Technique: 2-Dimensional Operative Video.

N-butyl cyanoacrylate glue (n-BCA, Cerenovus, Irvine, California) is commonly used to treat arteriovenous malformation (AVM). Even though Onyx (ethylene vinyl alcohol, Medtronic, Dublin, Ireland) pres...

Stability of mycophenolate mofetil in polypropylene 5% dextrose infusion bags and chemical compatibility associated with the use of the EQUASHIELD® closed-system transfer device.

Stability studies are necessary in healthcare settings as they facilitate fast, cost-effective and efficient work related to batch manufacturing and availability of supplies. We studied the stability ...

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