ELLIOTTS B- sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate injection

Elliotts B by

Drug Labeling and Warnings

Elliotts B by is a Prescription medication manufactured, distributed, or labeled by Lukare Medical, LLC, Neopharm Labs Inc., Nelson Laboratories, LLC, LabAnalysis s.r.l., SGS Canada Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

DRUG ABUSE AND DEPENDENCE

There is no potential for drug abuse or drug dependence.

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
• 55792-007-10: 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.

Distributed by:
Lukare Medical, LLC
Scotch Plains, NJ 07076
1-855-752-9317
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. 10/2015

PACKAGING

Ampule labeling:

Box labeling:

INGREDIENTS AND APPEARANCE

ELLIOTTS B 
sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55792-007
Route of Administration	INTRATHECAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
sodium chloride (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37, chloride ion - UNII:Q32ZN48698)	sodium chloride	73 mg  in 10 mL
sodium bicarbonate (UNII: 8MDF5V39QO) (bicarbonate ion - UNII:HN1ZRA3Q20)	sodium bicarbonate	19 mg  in 10 mL
anhydrous dextrose (UNII: 5SL0G7R0OK) (anhydrous dextrose - UNII:5SL0G7R0OK)	anhydrous dextrose	8 mg  in 10 mL
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED	3 mg  in 10 mL
potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152)	potassium chloride	3 mg  in 10 mL
calcium chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB)	calcium chloride	2 mg  in 10 mL
sodium phosphate (UNII: SE337SVY37) (phosphate ion - UNII:NK08V8K8HR)	sodium phosphate	2 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)	10 mL  in 10 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55792-007-10	10 in 1 BOX	06/04/2013
1	NDC: 55792-007-01	10 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020577	06/04/2013

Labeler - Lukare Medical, LLC (062862393)

Registrant - Lukare Medical, LLC (062862393)