Elliotts B Solution

Generic Name: sodium chloride, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride and sodium phosphate
Dosage Form: injection

ELLIOTTS B® SOLUTION (buffered intrathecal electrolyte/dextrose injection)
Rx Only

Elliotts B Solution Description

Elliotts B® Solution is a sterile, nonpyrogenic, isotonic solution containing no bacteriostatic preservatives. Elliotts B Solution is a diluent for intrathecal administration of methotrexate sodium and cytarabine.

Each 10 mL of Elliotts B Solution contains:

Sodium Chloride, USP 73 mg
Sodium Bicarbonate, USP 19 mg
Dextrose, USP 8 mg
Magnesium Sulfate • 7H2O, USP 3 mg
Potassium Chloride, USP 3 mg
Calcium Chloride • 2H2O, USP 2 mg
Sodium Phosphate, dibasic • 7H2O, USP 2 mg
Water for Injection, USP qs 10 mL


Concentration of Electrolytes:

Sodium 149 mEq/liter Bicarbonate 22.6 mEq/liter
Potassium 4.0 mEq/liter Chloride 132 mEq/liter
Calcium 2.7 mEq/liter Sulfate 2.4 mEq/liter
Magnesium 2.4 mEq/liter Phosphate 1.5 mEq/liter

The formulae and molecular weights of the ingredients are:

INGREDIENT MOLECULAR
FORMULA
MOLECULAR
WEIGHT
Sodium Chloride NaCl 58.44
Sodium Bicarbonate NaHCO3 84.01
Dextrose C6H12O6 180.16
Magnesium Sulfate • 7H2O Mg2SO4 • 7H2O 246.48
Potassium Chloride KCl 74.55
Calcium Chloride • 2H2O CaCl2 • 2H2O 147.01
Sodium Phosphate, dibasic • 7H2O Na2HPO4 • 7H2O 268.07



The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).

Elliotts B Solution - Clinical Pharmacology

Elliotts B Solution provides a buffered salt solution for use as a diluent for the intrathecal administration of methotrexate sodium and cytarabine. It has been demonstrated that Elliotts B Solution is comparable to cere­brospinal fluid in pH, electrolyte composition, glucose content, and osmolarity:


Comparison of Electrolyte Composition, pH and Nonelectrolytic Constituents of Elliotts B Solution and CSF

Solution

Na+
mEq/L

K+
mEq/L

Ca++
mEq/L

Mg++
mEq/L

HCO3-
mEq/L

Cl-
mEq/L

pH

Phosphorus
mg/dL

Glucose
mg/dL

Cerebrospinal Fluid

117-137

2.3-4.6

2.2

2.2

22.9

113-127

7.31

1.2-2.1

45-80

Elliotts B Solution

149

4.0

2.7

2.4

22.6

132

6.0-7.5

2.3

80

The approximate buffer capacity of Elliotts B Solution is 1.1 X 10-2 equivalents when the challenge solution is 0.01 N HCl and 7.8 X 10-3 equivalents when the challenge solution is 0.01 N NaOH.1


Compatibility studies with methotrexate sodium and cytarabine indicate these drugs are physically compati­ble with Elliotts B Solution.


Indications and Usage for Elliotts B Solution

Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.

Contraindications

None known.

Warnings

Intrathecal administration of drugs such as methotrexate sodium and cytarabine should be performed by per­sonnel skilled in the technique of lumbar puncture under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. The labeling for methotrexate sodium and cytarabine should be consulted.

Precautions


General

Particular attention should be taken to assure the maintenance of sterile technique throughout the procedure. (See DOSAGE AND ADMINISTRATION.)

Carcinogenesis, Mutagenesis, Impairment of Fertility

No standard mutagenicity or carcinogenicity studies have been conducted with Elliotts B Solution.

Usage in Pregnancy

Pregnancy Category C



All components of Elliotts B Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts B Solution.

Adverse Reactions

Adverse reactions may occur with any given intrathecal injection due to the chemotherapy or the technique of intrathecal administration.  (See product labeling for methotrexate sodium and cytarabine.)


Preservative-free methotrexate sodium and cytarabine should be used to minimize adverse reactions due to preservatives.


If an adverse reaction does occur, discontinue the administration, evaluate the patient, institute appropriate therapeutic countermeasures and, if possible, save the remainder of the unused solution(s) for examination.

Drug Abuse and Dependence

There is no potential for drug abuse or drug dependence.

Overdosage

Elliotts B Solution is a diluent. In the event of a drug, fluid or solute overload following administration, evalu­ate the patient's condition, and institute appropriate corrective treatment. (See product labeling for methotrexate sodium and cytarabine.)

Elliotts B Solution Dosage and Administration

See product labeling for methotrexate sodium and cytarabine.


Elliotts B Solution is intended for intrathecal administration only.  Elliotts B Solution does not contain antibac­terial preservatives and introduction of contaminated solutions into the cerebrospinal fluid may have extremely serious consequences. Therefore, administration of intrathecal solutions should be accomplished as soon as possible after preparation.


A sterile filter-needle should be used to withdraw the contents of the ampule.


Intrathecal drug products should be inspected visually for particulate matter and discoloration prior to admin­istration.

Preparation and Administration Precautions

Elliotts B Solution is a diluent for the cytotoxic anticancer agents, methotrexate sodium and cytarabine. Care should be exercised in the handling and preparation of infusion solutions with these products. (See product labeling for methotrexate sodium and cytarabine.)

How is Elliotts B Solution Supplied

NDC SIZE
55792-007-10 10 mL ampule

Elliotts B Solution is available in single-use clear glass ampules, packaged 10 ampules per box.

Store at controlled room temperature, 20º-25ºC (68º-77ºF) [See USP].

Preservative Free.  Discard unused portion.  Use only if solution is clear and ampule is intact.

Distributed by:
Lukare Medical, LLC
Scotch Plains, NJ 07076
1-855-752-9317
www.elliottsbsolution.com

REFERENCES:

1. Cradock JC, et al. Evaluation of some pharmaceutical aspects of intrathecal methotrexate sodium, cytara­bine and hydrocortisone sodium succinate.  American Journal of Hospital Pharmacy (1978); 35:402.

Rev. 13/05

PACKAGING

Ampule labeling:


Box labeling:

ELLIOTTS B 
sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55792-007
Route of Administration INTRATHECAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium chloride (sodium cation and chloride ion) sodium chloride 73 mg  in 10 mL
sodium bicarbonate (bicarbonate ion) sodium bicarbonate 19 mg  in 10 mL
anhydrous dextrose (anhydrous dextrose) anhydrous dextrose 8 mg  in 10 mL
magnesium sulfate (magnesium cation) magnesium sulfate 3 mg  in 10 mL
potassium chloride (potassium cation) potassium chloride 3 mg  in 10 mL
calcium chloride (calcium cation) calcium chloride 2 mg  in 10 mL
sodium phosphate (phosphate ion) sodium phosphate 2 mg  in 10 mL
Inactive Ingredients
Ingredient Name Strength
Water 10 mL  in 10 mL
Packaging
# Item Code Package Description
1 NDC:55792-007-10 10 AMPULE (AMPULE) in 1 BOX
1 NDC:55792-007-01 10 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020577 06/04/2013
Labeler - Lukare Medical, LLC (062862393)
Registrant - Lukare Medical, LLC (062862393)
Revised: 06/2013
 
Lukare Medical, LLC
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