CATEGORIES: FDA Approval Pre 1982Pregnancy Category C

FDS Drug Classes: Electrolyte replacementsNutritionals, enteral/parenteralVitamins/minerals

DESCRIPTION

For the Excel Container Only

Dextrose; sodium chloride injections are sterile, nonpyrogenic, and contain no bacteriostatic or antimicrobial agents.

The formulas of the active ingredients are shown in TABLE 1.

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 Excel container.

For the Viaflex Container Only

Dextrose; sodium chloride injections are sterile, nonpyrogenic solutions for fluid and electrolyte replenishment and caloric suply in single dose containers for intravenous administration. They contain no antimicrobial agents.

Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions may cause vein damage.

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 tests for plastic containers as well as by tissue culture toxicity studies.

For the Generic Flexible Plastic Container

Dextrose; sodium chloride injection solutions are sterile and nonpyrogenic. They are large volume perenteral solutions containing various concentrations and combinations of these drugs in water for injection intended for intravenous administration.

See TABLE 2A and TABLE 2B for summary of content and characteristics of these solutions.

The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.

The solutions are parenteral fluid, nutrient, and electrolyte replenishers.

Dextrose is chemically designated D-glucose monohydrate (C6H1206.H2O), a hexose sugar freely soluble in water.

Sodium chloride is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for injection is chemically designated H2O.

The flexible plastic container is fabricated from a specifically formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

Quanitative Information for All Container Types

CLINICAL PHARMACOLOGY

For Viaflex and Excel Containers Only:

For the Excel Container Only

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.

For the Generic Flexible Plastic Container

When administered intravenously, these solutions provide a source of water, carbohydrate, and electrolytes.

Solutions which provide combinations of hypotonic or isotonic concentrations of dextrose and of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requiements with minimal carbohydrate calories.

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 portein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. Sodium (Na+) is the principal caton of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl-) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl-) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from 2 to 3 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.

INDICATIONS AND USAGE

Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

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.

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.

Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia. Serum potassium levels should be maintained and potassium supplemented as required.

For the Excel Container Only:

Solutions containing dextrose and 0.20%, 0.30%, or 0.33% sodium chloride should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration.

For the Viaflex Container Only:

PRECAUTIONS

General

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.

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 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.

Do not use plastic container 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.

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.

Pregnancy Category C

Animal reproduction studies have not been conducted with dextrose; sodium chloride injections. It is also not known whether dextrose; sodium chloride injections can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose; sodium chloride injections 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.

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 adminstration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

DRUG INTERACTIONS

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

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.

OVERDOSAGE

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment. (See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.)

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. (See PRECAUTIONS.)

For Pediatric Patients:

Directions for Use of EXCEL Container (10-90)

Caution:

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

NOTE-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. Any container which is suspect should not be used.

Use only if solution is clear and container and seals are intact.

Preparation for Administration

1.

Remove plastic protector from sterile set port at bottom of container.

2.

Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning:

To Add Medication Before Solution Administration:

1.

Prepare medication site.

2.

Using syringe with 18-22 gauge needle, puncture medication port and inner diaphragm and inject.

3.

Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration:

1.

Close clamp on the set.

2.

Prepare medication site.

3.

Using syringe with 18-22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.

4.

Remove container from IV pole and/or turn to an upright position.

5.

Evacuate both ports by tapping and squeezing them while container is in the upright position.

6.

Mix solution and medication thoroughly.

7.

Return container to in use position and continue administration.

Directions for Use of Viaflex Plastic Container

WARNING:

To Open:

Preparation for Administration:

1.

Suspend container from eyelet support.

2.

Remove plastic protector from outlet port at bottom of container.

3.

Attach administration set. Refer to complete directions accompanying set.

To Add Medication

WARNING:

To Add Medication Before Solution Administration:

1.

Prepare medication site.

2.

Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

3.

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:

1.

Close clamp on the set.

2.

Prepare medication site.

3.

Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

4.

Remove container from IV pole and/or turn to an upright position.

5.

Evacuate both ports by squeezing them while container is in the upright postion.

6.

Mix solution and medication thoroughly.

7.

Return container to in use position and continue administration.

Directions for Use of Generic Flexible Plastic Container

To Open:

To Add Medication:

1.

Prepare additive port.

2.

Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.

3.

The additive port may be protected by covering with an additive cap.

4.

Mix container contents thoroughly.

Preparation for Administration (Use aseptic technique):

1.

Close flow control clamp of administration set.

2.

Remove cover from outlet port at bottom of container.

3.

Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: When using a vented administration set, replace bacterial retentive air filter with piercing pin cover. Insert piercing pin with twisting motion until shoulder of air filter housing rests against the outlet port flange.

4.

Suspend container from hanger.

5.

Squeeze and release drip chamber to establish proper fluid level in chamber.

6.

Attach venipuncture device to set.

7.

Open clamp to expel air from set and venipuncture device. Close clamp.

8.

Perform venipuncture.

9.

Regulate rate of administration with flow control clamp.

WARNING:

HOW SUPPLIED

Storage: