Isolyte S in Dextrose

B. Braun Medical Inc.

Isolyte S in 5% Dextrose(Multi-Electrolyte Injection)

FULL PRESCRIBING INFORMATION: CONTENTS*

• ISOLYTE S IN DEXTROSE DESCRIPTION
• CLINICAL PHARMACOLOGY
• ISOLYTE S IN DEXTROSE INDICATIONS AND USAGE
• ISOLYTE S IN DEXTROSE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Laboratory Tests
  • Drug Interactions
  • Carcinogenesis, mutagenesis, impairment of fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use
• ISOLYTE S IN DEXTROSE ADVERSE REACTIONS
• OVERDOSAGE
• ISOLYTE S IN DEXTROSE DOSAGE AND ADMINISTRATION
  • Directions for Use of EXCEL Container
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

FULL PRESCRIBING INFORMATION

ISOLYTE S IN DEXTROSE DESCRIPTION

Each 100 mL of Isolyte^® S (Multi-Electrolyte Injection) in 5% Dextrose contains:
Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.53 g
Sodium Gluconate USP 0.5 g; Sodium Acetate Trihydrate USP 0.37 g
Potassium Chloride USP 0.037 g
Magnesium Chloride Hexahydrate USP 0.03 g
Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.0 (4.0–6.0)    Calories per liter: 170
Calculated Osmolarity: 550 mOsmol/liter, hypertonic
Concentration of Electrolytes (mEq/liter): Sodium 140; Chloride 106
Acetate (CH₃COO⁻) 27; Gluconate (HOCH₂(CHOH)₄COO⁻) 23
Potassium 5; Magnesium 3

Isolyte^® S in 5% Dextrose is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents or added buffers. This product is intended for intravenous administration in a single dose container.

The formulas of the active ingredients are:

Ingredients	Molecular Formula	Molecular Weight
Sodium Acetate Trihydrate USP	CH3COONa•3H2O	136.08
Sodium Chloride USP	NaCl	58.44
Potassium Chloride USP	KCl	74.55
Magnesium Chloride Hexahydrate USP	MgCl2•6H2O	203.30
Hydrous Dextrose USP	198.17  Sodium Gluconate USP	218.14

The EXCEL^® Container is Latex-free, PVC-free, and DEHP-free.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a rubberized copolymer of ethylene and propylene. 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. 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. 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.

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 site. Refer to the Directions for Use of the container.

CLINICAL PHARMACOLOGY

Isolyte^® S in 5% Dextrose provides electrolytes and calories, and is a source of water for hydration. It is 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.

Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

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.

Magnesium, a principal cation of soft tissue, is primarily involved in enzyme activity associated with the metabolism of carbohydrates and protein. Magnesium is also involved in neuromuscular irritability.

Gluconate and acetate are organic ions which are hydrogen ion acceptors and contribute bicarbonate during the metabolism to carbon dioxide and water, and in sufficient quantities may serve as alkalinizing agents.

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.

ISOLYTE S IN DEXTROSE INDICATIONS AND USAGE

This solution is indicated for use in adults as a source of electrolytes, calories and water for hydration, and as an alkalinizing agent.

ISOLYTE S IN DEXTROSE CONTRAINDICATIONS

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.

Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate or gluconate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.

PRECAUTIONS

General

This solution 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.

Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels.

Solutions containing potassium or magnesium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease.

Solutions containing acetate or gluconate should be used with caution. Excess administration may result in metabolic alkalosis.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

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. 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.

This solution is intended for intravenous administration using sterile equipment.

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 this or an alternative solution.

Drug Interactions

Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients.

Administration of barbiturates, narcotics, hypnotics, or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect.

Parenteral magnesium should be administered with extreme caution to patients receiving digitalis preparations.

Carcinogenesis, mutagenesis, impairment of fertility

Studies with Isolyte^® S (Multi-Electrolyte Injection) in 5% Dextrose 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 Isolyte^® S in 5% Dextrose. It is also not known whether Isolyte^® S in 5% Dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isolyte^® S in 5% Dextrose should be given to a pregnant woman only if clearly needed.

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 Isolyte^® S (Multi-Electrolyte Injection) in 5% Dextrose is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Isolyte^® S (Multi-Electrolyte Injection) in 5% Dextrose in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte and dextrose solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

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

Geriatric Use

Clinical studies of Isolyte^® S (Multi-Electrolyte Injection) in 5% Dextrose 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 drug therapy.

ISOLYTE S IN DEXTROSE 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.

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.

Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

Abnormally high plasma levels of magnesium can result in flushing, sweating, hypotension, circulatory collapse, and depression of cardiac and central nervous system function. Respiratory depression is the most immediate threat to life.

Magnesium deficits can result in tachycardia, hypertension, hyperirritability and psychotic behavior.

The physician should also be alert to the possibility of adverse reactions to drug additives. 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.

ISOLYTE S IN DEXTROSE DOSAGE AND ADMINISTRATION

This solution is 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.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

The presence of magnesium ions in this solution should be considered when phosphate is present in the additive solution, in order to avoid precipitation.

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.

Directions for Use of EXCEL Container

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.

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

• Remove plastic protector from sterile set port at bottom of container.
• Attach administration set. Refer to complete directions accompanying set.

To Add Medication Before Solution Administration

• Prepare medication site.
• Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
• Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration

• Close clamp on the set.
• Prepare medication site.
• Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
• Remove container from IV pole and/or turn to an upright position.
• Evacuate both ports by tapping and squeezing them while container is in the upright position.
• Mix solution and medication thoroughly.
• Return container to in use position and continue administration.

HOW SUPPLIED

Isolyte^® S (Multi-Electrolyte Injection) in 5% Dextrose is supplied sterile and nonpyrogenic in 1000 mL EXCEL^® Containers packaged 12 per case.

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).

Rx only

Revised: December 2009

EXCEL and Isolyte are registered trademarks of B. Braun Medical Inc.

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

In Canada, distributed by:
B. Braun Medical Inc.
Scarborough, Ontario M1H 2W4

Y36-002-718

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

 Isolyte® S in 5% Dextrose
(Multi-Electrolyte Injection)

REF L7040
NDC 0264-7704-00
DIN 01935992

1000 mL
EXCEL® CONTAINER

Electrolytes (mEq/liter):
Na⁺ . . . . . 140      Mg⁺⁺ . . . . 3       Acetate  . . . . .  27
K⁺ . . . . .    5         Cl^- . . . . 106      Gluconate . . .  23
Each 100 mL contains:
Hydrous Dextrose USP 5 g
Sodium Chloride USP 0.53 g
Sodium Gluconate USP 0.5 g
Sodium Acetate•3H₂O USP 0.37 g
Potassium Chloride USP 0.037 g
Magnesium Chloride•6H₂O USP 0.03 g
Water for Injection USP qs
pH adjusted with HCl NF

pH: 5.0 (4.0-6.0)
Calc. Osmolarity: 550 mOsmol/liter, hypertonic

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

Recommended Storage:
Room temperature (25ºC). Avoid excessive heat. Protect from
freezing. See Package Insert.