Bacteriostatic Water
FDA Drug Information • Also known as: Bacteriostatic Water
- Brand Names
- Bacteriostatic Water
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION The following preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) of benzyl alcohol added as a bacteriostatic preservative. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection. The pH is 5.7 (4.5 to 7.0). Water for Injection, USP is chemically designated H 2 O. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume.
What Is Bacteriostatic Water Used For?
INDICATIONS AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Dosage and Administration
DOSAGE AND ADMINISTRATION The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS .
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination. Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg infant or neonate is potentially capable of producing blood pressure changes.
Warnings and Precautions
WARNINGS Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be used. Intravenous administration of Bacteriostatic Water for Injection without a solute may result in hemolysis.
Contraindications
CONTRAINDICATIONS Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. Parenteral preparations with benzyl alcohol should not be used for fluid replacement. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures. Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use.
Overdosage
OVERDOSAGE Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .
How Supplied
HOW SUPPLIED Unit of Sale Benzyl Alcohol Preservative Concentration NDC 0409-3977-03 Tray of 25 Multiple-dose 30 mL plastic Fliptop vials 9 mg/mL NDC 0409-1093-04 Tray of 25 Multiple-dose 20 mL fill in 30 mL glass Fliptop vials 11 mg/mL Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0977-2.0 Revised: 08/2019 Hospira Logo
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.