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Name:Elliotts B
Manufacturer:Qol Medical Llc
Category:Prescription Marketed Drugs


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

ELLIOTTS B  - sodium chloride, sodium bicarbonate, dextrose, magnesium sulfate, unspecified, potassium chloride, calcium chloride and sodium phosphate injection, solution 
QOL Medical LLC

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

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).

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

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.)

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 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:

Ampule Labeling

Box labeling:

Box Labeling


ELLIOTTS B 
buffered intrathecal electrolyte/dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC:67871-007-10 10 AMPULE ( AMPULE) in 1 BOX contains a AMPULE (67871-007-01)
1 NDC: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: 03/2011 QOL Medical LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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