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Elliotts B Solution Prescribing Information

Package insert / product label
Generic name: sodium chloride, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride and sodium phosphate
Dosage form: intrathecal injection
Drug class: Intravenous nutritional products
J Code (medical billing code): J9175 (1 mL)

Medically reviewed by Drugs.com. Last updated on Jun 15, 2023.

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, USP73 mg
Sodium Bicarbonate, USP19 mg
Dextrose, USP8 mg
Magnesium Sulfate • 7H2O, USP3 mg
Potassium Chloride, USP3 mg
Calcium Chloride • 2H2O, USP2 mg
Sodium Phosphate, dibasic • 7H2O, USP2 mg
Water for Injection, USPqs 10 mL


Concentration of Electrolytes:

Sodium149 mEq/literBicarbonate22.6 mEq/liter
Potassium4.0 mEq/literChloride132 mEq/liter
Calcium2.7 mEq/literSulfate2.4 mEq/liter
Magnesium2.4 mEq/literPhosphate1.5 mEq/liter

The formulae and molecular weights of the ingredients are:

INGREDIENTMOLECULAR
FORMULA
MOLECULAR
WEIGHT
Sodium ChlorideNaCl58.44
Sodium BicarbonateNaHCO384.01
DextroseC6H12O6180.16
Magnesium Sulfate • 7H2OMg2SO4 • 7H2O246.48
Potassium ChlorideKCl74.55
Calcium Chloride • 2H2OCaCl2 • 2H2O147.01
Sodium Phosphate, dibasic • 7H2ONa2HPO4 • 7H2O268.07



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

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

Adverse Reactions/Side Effects

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

NDCSIZE
55792-007-1010 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. 10/2015

PACKAGING

Ampule labeling:

Ampule Labeling

Box labeling:

Box Labeling

ELLIOTTS B
sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55792-007
Route of AdministrationINTRATHECAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium chloride (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37, chloride ion - UNII:Q32ZN48698) sodium chloride73 mg in 10 mL
sodium bicarbonate (UNII: 8MDF5V39QO) (bicarbonate ion - UNII:HN1ZRA3Q20) sodium bicarbonate19 mg in 10 mL
anhydrous dextrose (UNII: 5SL0G7R0OK) (anhydrous dextrose - UNII:5SL0G7R0OK) anhydrous dextrose8 mg in 10 mL
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED3 mg in 10 mL
potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152) potassium chloride3 mg in 10 mL
calcium chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB) calcium chloride2 mg in 10 mL
sodium phosphate (UNII: SE337SVY37) (phosphate ion - UNII:NK08V8K8HR) sodium phosphate2 mg in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R) 10 mL in 10 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55792-007-1010 in 1 BOX06/04/2013
1NDC:55792-007-0110 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02057706/04/2013
Labeler - Lukare Medical, LLC (062862393)
Registrant - Lukare Medical, LLC (062862393)