FDA
Sterile Water for Injection
The FDA lists this product in 21 strengths and forms.
Indications
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.
Contraindications
Sterile Water for Injection, USP must be made approximately isotonic prior to use.
Warnings and precautions
Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
Interactions
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. Use aseptic technique for single or multiple entry and withdrawal from all containers. 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.
Pregnancy and breastfeeding
Pregnancy 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.
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.
At a glance
- Brand name
- Sterile Water for Injection
- Route
- N/a
- Dosage form
- Liquid
- Applicant
- Hikma
- Status
- Discontinued
- FDA approval
- 2 Sept 2015
- Application
- ANDA206369-002
- RxCUI
- 107129



