ELLIOTTS B — sodium chloride, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride and sodium phosphate injection
QOL Medical, LLC
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 • 7H2 O, USP||3 mg|
|Potassium Chloride, USP||3 mg|
|Calcium Chloride • 2H2 O, USP||2 mg|
|Sodium Phosphate, dibasic • 7H2 O, 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:
|Dextrose||C6 H12 O6||180.16|
|Magnesium Sulfate • 7H2 O||Mg2 SO4 • 7H2 O||246.48|
|Calcium Chloride • 2H2 O||CaCl2 • 2H2 O||147.01|
|Sodium Phosphate, dibasic • 7H2 O||Na2 HPO4 • 7H2 O||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 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
HCO3 - mEq/L
Elliotts B Solution
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
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.
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.)
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 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.
There is no potential for drug abuse or drug dependence.
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