Drug Facts
Composition & Profile
Identifiers & Packaging
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, 20ºC-25ºC (68ºF-77ºF) [See USP]. Preservative Free. Discard unused portion. Use only if solution is clear and ampule is intact. Distributed by: Lukare Medical, LLC Ponte Vedra Beach, FL 32082 1-855-752-9317 www.elliottsbsolution.com; PACKAGING Ampule labeling: Box labeling: Elliotts B Solution Ampule Label Elliotts B Solution Carton Label
- 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, 20ºC-25ºC (68ºF-77ºF) [See USP]. Preservative Free. Discard unused portion. Use only if solution is clear and ampule is intact. Distributed by: Lukare Medical, LLC Ponte Vedra Beach, FL 32082 1-855-752-9317 www.elliottsbsolution.com
- PACKAGING Ampule labeling: Box labeling: Elliotts B Solution Ampule Label Elliotts B Solution Carton Label
Overview
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 • 7H 2 O, USP 3 mg Potassium Chloride, USP 3 mg Calcium Chloride • 2H 2 O, USP 2 mg Sodium Phosphate, dibasic • 7H 2 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 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 NaHCO 3 84.01 Dextrose C 6 H 12 O 6 180.16 Magnesium Sulfate • 7H 2 O Mg 2 SO 4 • 7H 2 O 246.48 Potassium Chloride KCl 74.55 Calcium Chloride • 2H 2 O CaCl 2 • 2H 2 O 147.01 Sodium Phosphate, dibasic • 7H 2 O Na 2 HPO 4 • 7H 2 O 268.07 The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).
Indications & 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.
Dosage & 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.)
Warnings & Precautions
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.
Contraindications
None known.
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.