Prescribing Information

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

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.

HOW SUPPLIED

NDC	SIZE
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