Hospira bacteriostatic water for injection
Understanding This Medication Diluent
In clinical practice, bacteriostatic water is a fundamental tool for preparing injections safely and effectively. It is not a drug itself but a sterile solvent designed to reconstitute or dilute medications that will later be administered parenterally. The defining feature is its preservative content, which allows healthcare professionals to withdraw multiple doses from the same vial without compromising sterility.
Hospira, a recognized manufacturer of injectable solutions, has supplied bacteriostatic water in multiple-dose vials for decades. The formulation is aligned with United States Pharmacopeia (USP) standards, making it suitable for medical settings where precision and safety are non-negotiable. This solution, though seemingly simple, plays an essential role in drug preparation workflows across hospitals, clinics, and pharmacies.
Key Components and Properties
The composition is straightforward yet highly functional. Each milliliter contains sterile water for injection combined with a small amount of benzyl alcohol, typically at 0.9%. This preservative inhibits microbial growth, which is what enables repeated entry into the vial without immediate contamination.
Key features include:
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Sterile formulation: Ensures safety when preparing injectable drugs.
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Benzyl alcohol preservative: Provides bacteriostatic protection against contamination.
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Multi-dose vial design: Available in 30 mL containers, sealed to maintain integrity.
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USP compliance: Meets pharmaceutical quality benchmarks for injection solutions.
Because of these properties, clinicians often prefer this type of diluent when medications require multiple withdrawals over several hours or days.
Benefits of Using Preservative-Containing Water
The inclusion of a preservative delivers several advantages over preservative-free sterile water.
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Extended usability: Instead of discarding a vial after one use, clinicians can withdraw multiple doses. This reduces waste and improves efficiency.
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Cost savings: Multi-use design lowers overall expenses by minimizing the need for single-dose vials.
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Reduced contamination risk: Benzyl alcohol prevents microbial growth between withdrawals, adding a layer of safety.
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Convenience: Especially in hospital wards or outpatient settings, where multiple doses of reconstituted drugs are prepared throughout the day.
These benefits explain why bacteriostatic water remains widely used for certain medications and procedures.
Safety Warnings and Contraindications
Despite its utility, caution is essential. The presence of benzyl alcohol makes this solution unsuitable for some patient populations, particularly neonates.
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Neonatal toxicity: Benzyl alcohol has been linked to “gasping syndrome,” a potentially fatal condition in newborns. For this reason, the product is contraindicated in neonates.
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Not for direct intravenous infusion: Bacteriostatic water should never be injected alone. It must always be used to dilute or reconstitute another medication. Injecting it directly can cause hemolysis.
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Epidural contraindication: The solution should not be used in epidural procedures due to risks associated with preservatives near the central nervous system.
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Allergic reactions: Though uncommon, hypersensitivity to benzyl alcohol can occur. Patients with known allergies require preservative-free alternatives.
Healthcare professionals must carefully consider these warnings before selecting the diluent for patient care.
Usage Guidelines and Best Practices
For safe application, clinicians must follow strict guidelines.
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Drug reconstitution: Use the solution to reconstitute powdered medications, following manufacturer instructions for concentration.
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Visual inspection: Always check for discoloration or particulate matter before use.
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Aseptic withdrawal: Clean vial stoppers with alcohol and use sterile needles and syringes for each entry.
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Dosage limits: Avoid exceeding recommended withdrawal volumes; once contamination is suspected, discard the vial.
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Time constraints: Although bacteriostatic water extends usability, it should still be discarded within 28 days of initial entry unless labeling states otherwise.
These best practices help maintain both drug integrity and patient safety.
Real-World Considerations and Supply Status
Over the years, production and supply of bacteriostatic water have occasionally faced shortages. Factors such as increased demand, manufacturing delays, and regulatory inspections can disrupt availability. Clinicians may need to source alternatives or adjust protocols when shortages occur.
Storage requirements are straightforward: keep vials at controlled room temperature and protect them from contamination. Once punctured, labeling guidelines should dictate whether the solution remains suitable for repeated use.
Recalls have occasionally been issued in the past by manufacturers when sterility or labeling issues were suspected, reminding healthcare systems of the importance of monitoring batch information and lot numbers.
Final Considerations for Clinical Use
From a clinical standpoint, bacteriostatic water remains a practical, cost-effective solution for reconstituting injectable medications in multi-dose scenarios. Its preservative content adds convenience but also introduces risks that must not be ignored. For neonatal and sensitive patient populations, preservative-free sterile water is a safer alternative. For most other uses, adherence to USP guidelines and institutional protocols ensures safe, effective handling.
Healthcare professionals should continue evaluating whether the benefits of preserved multi-dose diluents outweigh the risks for their specific patient populations.
FAQs
1. What is the main purpose of bacteriostatic water?
It is a sterile solvent used to reconstitute or dilute injectable medications.
2. Why does it contain benzyl alcohol?
Benzyl alcohol acts as a preservative, allowing multi-dose usage by inhibiting bacterial growth.
3. Can it be injected directly into a vein?
No, it must always be mixed with another medication. Injecting it alone can cause hemolysis.
4. Is it safe for newborns?
No, it is contraindicated in neonates due to the risk of benzyl alcohol toxicity.
5. How long can a vial be used after opening?
Typically up to 28 days, provided aseptic technique is followed, though labeling may specify otherwise.
6. What size vials are available?
Hospira generally supplies 30 mL multi-dose vials, but availability may vary.
7. Is there a preservative-free alternative?
Yes, preservative-free sterile water for injection is available and preferred for neonates or patients with sensitivities.
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