Sterile Water
FDA Drug Information • Also known as: Sterile Diluent, Sterile Water
- Brand Names
- Sterile Diluent, Sterile Water
- Route
- IRRIGATION
- Dosage Form
- IRRIGANT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0). The osmolarity is 0. The flexible plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
What Is Sterile Water Used For?
INDICATIONS AND USAGE Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.
Dosage and Administration
DOSAGE AND ADMINISTRATION Following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying additive drug. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Injections in flexible plastic containers are intended for intravenous administration using sterile equipment. Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Do not store an unused portion of Sterile Water for Injection, USP. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS The administration of a suitable admixture of prescribed additives may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.
Warnings and Precautions
WARNINGS Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute. Hemolysis may occur following infusion of Sterile Water for Injection, USP. Hemoglobin induced renal failure has been reported following hemolysis.
Contraindications
CONTRAINDICATIONS Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without additives.
How Supplied
HOW SUPPLIED Sterile Water for Injection, USP is supplied in flexible plastic containers; 12 bags per carton as follows: Strength Package NDC Number 1000 mL Single Bag 0143-9339-01 12 Bags per carton 0143-9339-12 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; brief exposure up to 40°C does not adversely affect the product.
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.