Sodium Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate

FDA Drug Information • Also known as: Elliotts B

Brand Names: Elliotts B
Route: INTRATHECAL
Dosage Form: INJECTION
Product Type: HUMAN PRESCRIPTION DRUG

Description

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

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).

What Is Sodium Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate Used For?

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.

Dosage and Administration

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.)

Side Effects (Adverse Reactions)

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.

Warnings and 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

CONTRAINDICATIONS None known.

Pregnancy and Breastfeeding

Usage in Pregnancy All components of Elliotts B Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts B Solution.

Overdosage

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.)

How Supplied

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

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.