Elliotts B Solution

Dosage Form: injection, solution
ELLIOTTS B® SOLUTION (buffered intrathecal electrolyte/dextrose injection)

Rx Only

Elliotts B Solution 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 • 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

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	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

The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).

Elliotts B Solution - 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 for Elliotts B Solution

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.

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.)

Elliotts B Solution 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 is Elliotts B Solution 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.


Manufactured by:  Ben Venue Laboratories, Inc.

                            Bedford, Ohio  44146


Distributed by:    QOL Medical LLC

                         Kirkland, WA  98033

                         1-866-528-4750

                         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. 09/06

Part No. 210

PACKAGING

Ampule labeling:

Box labeling:

ELLIOTTS B  buffered intrathecal electrolyte/dextrose  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67871-007 Route of Administration INTRATHECAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium chloride (sodium cation and chloride ion) sodium chloride 73 mg  in 10 mL sodium bicarbonate (sodium cation and bicarbonate ion) sodium bicarbonate 19 mg  in 10 mL dextrose (dextrose) dextrose 8 mg  in 10 mL magnesium sulfate, unspecified (magnesium cation and sulfate ion) magnesium sulfate, unspecified 3 mg  in 10 mL potassium chloride (potassium cation and chloride ion) potassium chloride 3 mg  in 10 mL calcium chloride (calcium cation and chloride ion) calcium chloride 2 mg  in 10 mL sodium phosphate (sodium cation and phosphate ion) sodium phosphate 2 mg  in 10 mL

Inactive Ingredients Ingredient Name Strength Water 10 mL  in 10 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67871-007-10 10 AMPULE In 1 BOX contains a AMPULE (67871-007-01) 1 67871-007-01 10 mL In 1 AMPULE This package is contained within the BOX (67871-007-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020577	09/01/2006

Labeler - QOL Medical LLC (140026258)

Revised: 03/2011QOL Medical LLC