Elliotts B

ELLIOTTS B- sodium chloride, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride and sodium phosphate injection
Lukare Medical, LLC

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, 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:

INGREDIENT MOLECULARFORMULA MOLECULARWEIGHT
Sodium Chloride NaCl 58.44
Sodium Bicarbonate NaHCO3 84.01
Dextrose C6 H12 O6 180.16
Magnesium Sulfate • 7H2 O Mg2 SO4 • 7H2 O 246.48
Potassium Chloride KCl 74.55
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).

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

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.

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