Since Safety is a Concern... Elliotts B® Solution

 
 
 
Elliotts B® Solution (buffered intrathecal electrolyte/dextrose injection)
Rx only

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, USP qs 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
WEIGH
T
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).

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

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.)

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 SUPPLIED

NDCSIZE
67871-007-10
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. 10/15

 

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.

The information in this website should not be used as a substitute for a consultation or visit with your physician or other healthcare professional.
Should you have any healthcare related questions, see your physician or other healthcare professional promptly. For further information about
indications and usage, contraindications, warnings, precautions, adverse reactions, and overdosage please see the doctor's prescribing information
or other referenses such as "Martinedale", "PDR", "BP" etc.