DEXTROSE description, usages, side effects, indications, overdosage, supplying and lots more!

DEXTROSE

Baxter Healthcare Corporation

Dextrose Injection, USP in VIAFLEX Plastic Container

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION

Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown in Table 1.

Table 1
Size
(mL)
* Dextrose
Hydrous,
USP (g/L)
Osmolarity
(mOsmol/L)
(calc.)
pH Caloric
Content
(kcal/L)
5% Dextrose
Injection, USP
25 50 252 4.0
(3.2 to 6.5)
170
Quad pack
50
Single pack
Quad pack
Multi pack
100
Single pack
Quad pack
Multi pack
150
250
500
1000
10% Dextrose
Injection, USP
250
500
1000
100 505 4.0
(3.2 to 6.5)
340
DESCRIPTION

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). 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 test for plastic containers as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

Dextrose Injection, USP has value as a source of water and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

INDICATIONS AND USAGE

Dextrose Injection, USP is indicated as a source of water and calories.

CONTRAINDICATIONS

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

WARNINGS

Dextrose Injection, USP should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis.

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. The risk of dilutive states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

Excessive administration of dextrose injections may result in significant hypokalemia.

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

PRECAUTIONS

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

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.

Dextrose Injection, USP should be used with caution in patients with overt or subclinical diabetes mellitus.

Pregnancy:

Teratogenic Effects

Pregnancy Category C.

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

Pediatric Use

Dextrose is safe and effective for the stated indications in pediatric patients (see Indications and Usage).

Newborns – especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death.

Geriatric Use

Clinical studies of Dextrose Injection, 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 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.

Do not administer unless solution is clear and seal is intact.

ADVERSE REACTIONS

Hypersensitivity reactions, including anaphylaxis and chills.

Reactions which may occur because of the injection 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.

DOSAGE AND ADMINISTRATION

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

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

All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.

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.

Additives may be incompatible. Complete information is not available.

Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

HOW SUPPLIED

Dextrose Injection, USP in VIAFLEX plastic container is available as follows:

Code Size
(mL)
NDC Product Name
  25    
2B0080 Quad pack 0338-0017-10 5% Dextrose Injection, USP
  50    
2B0086 Single pack 0338-0017-41 5% Dextrose Injection, USP
2B0081 Quad pack 0338-0017-11
2B0088 Multi pack 0338-0017-31
  100    
2B0087 Single pack 0338-0017-48 5% Dextrose Injection, USP
2B0082 Quad pack 0338-0017-18
2B0089 Multi pack 0338-0017-38
2B0061 150 0338-0017-01
2B0062 250 0338-0017-02
2B0063 500 0338-0017-03
2B0064 1000 0338-0017-04
2B0162 250 0338-0023-02 10% Dextrose Injection, USP
2B0163 500 0338-0023-03
2B0164 1000 0338-0023-04

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER

For Information on Risk of Air Embolism - see Precautions

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow “To Add Medication” directions below.

Preparation for Administration

  • Suspend container from eyelet support.
  • Remove protector from outlet port at bottom of container.
  • Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Additives may be incompatible.

To add medication before solution administration

  • Prepare medication site.
  • Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  • Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

  • Close clamp on the set.
  • Prepare medication site.
  • Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  • Remove container from IV pole and/or turn to an upright position.
  • Evacuate both ports by squeezing them while container is in the upright position.
  • Mix solution and medication thoroughly.
  • Return container to in-use position and continue administration.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

07-19-69-268

Rev. November 2013

Baxter, PL 146, and Viaflex are trademarks of Baxter International Inc.

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL
Container Label LOTEXP 5% DextroseInjection USP 2B0061NDC 0038-0017-01 150 mL Each 100 mL contains5 g DextroseHydrousUSP pH 4.0 (3.2 to 6.5)Osmolarity 252 mOsmol/L (calc)SterileNonpyrogenic Single dose container Read package insert for fullinformation Additives may beincompatible Dosage Intravenously asdirected by a physician CautionsSqueeze and inspect inner bag whichmaintains product sterility Discard ifleaks are found Must not be used inseries connections Do not administersimultaneously with blood Do notuseunless solution is clear Rx OnlyStore unit in moisture barrier overwrapat room temperature(25°C/77°F) untilready to use Avoid excessive heat SeeinsertViaflex container PL146 plasticBAXTER VIAFLEX and PL 146 aretrademarks of Baxter International IncFor product information 1-800-933-0303 Baxter Baxter Healthcare Corporation Deerfield, IL 60015 USAMade in USA Carton Label 2B006136-150 MLVIAFLEX(R) CONTAINER5% DEXTROSE INJECTION, USPSECONDARY BAR CODE(17) YYMMOO (10) XXXXXPRIMARY BAR CODE(01) 5030338017015EXPXXXXXLOTXXXXX Container Label LOTEXP 2B0063NDC 0038-0023-03DIN 00060364 10% DextroseInjection USP 500 mL Each 100 mL contain 10 g Dextrose Hydrous USP pH 4.0 (3.2 to 6.5) Hypertonic Osmolarity 505 mOsmol/L (calc) Sterile Nonpyrogenic Single dose container Additives may be incompatible Consult withpharmacist if available When introducing additives use aseptic technique Mix thorouhly Do not store Dosage Intravenously as directed by a physician See cirections Cautions Squeeze and inspect inner bag which maintains product sterility Discard if leaks are found Must not be used in series connections Do not administer simultaneously with blood Do not use unless solution is clear Rx Only Store unit in moisture barrier overwrap at room temperature (25°C/77°F) until ready to use Avoid excessive heat See insertViaflex container PL 146 plasticBAXTER VIAFLEX and PL 146 are trademarks of Baxter International IncFor product information 1-800-933-0303 Baxter logo Baxter Healthcare Corporation Deerfield, IL 60015 USAMade in USADistribute in Canada By Baxter Corporation Toronto Ontario Canada Carton Label

2B0063Q

24-500 ML

VIAFLEX(R) CONTAINER

10% DEXTROSE INJECTION, USP

SECONDARY BAR CODE
(17) YYMMOO (10) XXXXX

PRIMARY BAR CODE
(01) 50303380023030

EXP
XXXXX

LOT
XXXXX

DEXTROSE

DEXTROSE MONOHYDRATE INJECTION, SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0338-0017
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dextrose monohydrate ANHYDROUS DEXTROSE 50 g

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 BAG
2 50 in 1 BAG
3 50 in 1 BAG
4 50 in 1 BAG
5 100 in 1 BAG
6 100 in 1 BAG
7 100 in 1 BAG
8 NDC:0338-0017-01 150 in 1 BAG
9 NDC:0338-0017-02 250 in 1 BAG
10 NDC:0338-0017-03 500 in 1 BAG
11 NDC:0338-0017-04 1000 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA016673 1971-03-04


DEXTROSE

DEXTROSE MONOHYDRATE INJECTION, SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0338-0023
Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dextrose monohydrate ANHYDROUS DEXTROSE 100 g

Inactive Ingredients

Ingredient Name Strength
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0338-0023-02 250 in 1 BAG
2 NDC:0338-0023-03 500 in 1 BAG
3 NDC:0338-0023-04 1000 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA016694 1971-01-25


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