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

05:49 EDT 27th August 2014 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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:

The formulae and molecular weights of the ingredients are:

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
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
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

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

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

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

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.

None known.

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.

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

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

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 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.

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.)

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.

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.)

NDC SIZE
67871-007-10
10 mL ampule

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. 09/06Part No. 210

Ampule labeling:

Box labeling:

Manufacturer

QOL Medical LLC

Active Ingredients

Source

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