Sterile Water
Generic Name: sterile water
Brand Names:
Sterile Water
This 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. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection, which contains no bacteriostat, antimicrobial agent or added buffer, and is supplied only in single-dose containers to dilute or dissolve drugs for injection.
Overview
This 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. Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection, which contains no bacteriostat, antimicrobial agent or added buffer, and is supplied only in single-dose containers to dilute or dissolve drugs for injection.
Uses
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
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. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Please refer to INSTRUCTIONS FOR USE for administration instructions.
Side Effects
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.
Interactions
Some drugs for injection may be incompatible in a given vehicle, when combined in the same vehicle, or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for withdrawal from the container. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear. Do not reuse single-dose containers. Discard unused portion.
Warnings
Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. Sterile Water for Injection must be made approximately isotonic prior to use.
Pregnancy
Animal reproduction studies have not been conducted with Sterile Water for Injection. It is not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.
Storage
Sterile Water for Injection, USP is supplied in 5 mL vials, packaged in cartons as follows: NDC 0487-6105-01, 30 individual 5 mL single-dose luer-lock vials. Discard unused portion. Each vial is made from a polypropylene (PP) resin. Store at 2°C to 25°C (36°F to 77°F).
Frequently Asked Questions
What is Sterile Water used for?▼
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.
What are the side effects of Sterile Water?▼
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.
Can I take Sterile Water during pregnancy?▼
Animal reproduction studies have not been conducted with Sterile Water for Injection. It is not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.
What are the important warnings for Sterile Water?▼
Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. Sterile Water for Injection must be made approximately isotonic prior to use.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.