Sterile Water For Injection
FDA Drug Information • Also known as: Sterile Water
- Brand Names
- Sterile Water
- Dosage Form
- INJECTION
- Product Type
- BULK INGREDIENT
Description
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. For intravenous injection, add sufficient solute to make an approximately isotonic solution. pH 5.0 to 7.0. Water for Injection, USP is chemically designated H2O. The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach our certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.
What Is Sterile Water For Injection 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. 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
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. 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.
Side Effects (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. To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc., at 1-630-682-4600 or www.medefilinc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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. To report SUSPECTED ADVERSE REACTIONS, contact Medefil, Inc., at 1-630-682-4600 or www.medefilinc.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings and Precautions
Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis
Drug Interactions
Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. 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 and seal intact. Do not reuse single-dose containers. Discard unused portion. Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. 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 and seal intact. Do not reuse single-dose containers. Discard unused portion.
Contraindications
Sterile Water for Injection, USP must be made approximately isotonic prior to use. Sterile Water for Injection, USP must be made approximately isotonic prior to use.
Pregnancy and Breastfeeding
Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Injection. It is also not known whether sterile water containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed.
Overdosage
Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or 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
Sterile Water for Injection, USP is supplied in the following: Product NDC Number Sterile Water for Injection, USP 1 mL, Single-dose pre-filled syriinge, carton of 10s 64523-020-41 Sterile Water for Injection, USP 2.5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-51 Sterile Water for Injection, USP 3 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-61 Sterile Water for Injection, USP* 5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-71 Sterile Water for Injection, USP** 5 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-81 Sterile Water for Injection, USP 10 mL, Single-dose pre-filled syringe, carton of 10s 64253-020-91 Sterile Water for Injection, USP 1 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-21 Sterile Water for Injection, USP 2.5 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-52 Sterile Water for Injection, USP 3 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-23 Sterile Water for Injection, USP* 5 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-25 Sterile Water for Injection, USP** 5 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-35 Sterile Water for Injection, USP 10 mL, Single-dose pre-filled syringe, carton of 60s 64253-020-30 *in 6 mL Syringe **in 12 mL Syringe Discard unused portion Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]. Protect from freezing
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.