Water for Injection

Water for Injection (WFI)

Generic Name

Water for Injection (WFI)

Mechanism

  • Physical solvent: WFI provides a medium for the dissolution or suspension of active drug substances, ensuring uniform concentration and bioavailability.
  • Dilution for parenteral routes: By diluting medications, it reduces local irritation and facilitates accurate dosing.
  • No ion or osmolar contribution: Its isotonicity (≈273 mOsm/kg) is a characteristic of pure water, avoiding osmotic shifts when used in small volumes.

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Pharmacokinetics

  • Absorption/Distribution: Not applicable—WFI acts locally at the injection site or as an IV fluid, where it rapidly distributes into the extracellular fluid compartment.
  • Metabolism/Elimination: Water is eliminated primarily through renal excretion and insensible loss. When infused, the added water volume is integrated into total body water and cleared by the kidneys.

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Indications

  • Diluent for injectable drugs (e.g., formulation of vaccines, antibiotics, chemotherapeutics).
  • Reconstitution medium for lyophilized drugs requiring an aqueous environment.
  • IV hydration adjunct in protocols that necessitate sterile water, though usually only in very small volumes.
  • Preparation of oral solutions from liquid tablets or extemporaneous compounding.

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Contraindications

  • Absolute contraindication in high‑volume IV therapy for patients with decompensated heart failure, cirrhosis, or severe renal impairment; large volumes of WFI can precipitate water intoxication and hyponatremia.
  • Avoid in patients with hypersensitivity to residual phenols or endotoxins—WFI must be USP compliant.
  • Do not use as a standalone IV fluid for hydration; preferrably isotonic saline or balanced solutions.

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Dosing

  • Reconstitution: Follow the manufacturer’s instructions; typically 1–10 mL of WFI per 0.5–5 mg of drug.
  • IV Use (rare): ≤ 5 mL/kg (≈ 250 mL for a 50 kg adult) when necessary; monitor serum sodium and volume status.
  • Intramuscular/SC: Use small volumes (≤ 0.5 mL/dose) unless the drug formulation specifically requires larger volumes.
RouteTypical VolumeNotes
IV1–5 mL (reconstitution)Not for routine hydration
IM/SC≤ 0.5 mL/doseDilits local irritation
Oral0.5–5 mL (for compounding)May be used as excipient

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Adverse Effects

  • Local: Mild irritation or phlebitis when injected rapidly or in large volumes.
  • Systemic (rare):
  • Water intoxication (hyponatremia, cerebral edema) when volumes exceed the kidneys' excretory capacity.
  • Allergic reaction: Anaphylaxis extremely rare; monitor at first exposure.

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Monitoring

  • Serum electrolytes (Na⁺, K⁺) if IV volumes > 250 mL or in high-risk patients.
  • Vital signs (BP, pulse) during rapid IV administration.
  • Urine output for patients on large-volume hydration.
  • Signs of local irritation (pain, erythema).

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Clinical Pearls

  • Always confirm USP sterility before using WFI, especially for pediatric or immunocompromised populations.
  • Do not mix WFI with medications containing electrolytes (e.g., multi‑component antibiotic solutions) unless the formulation specifies such compatibility.
  • Use “water for injection” over distilled water for parenteral preparations; distilled water may contain trace organic contaminants.
  • When reconstituting high‑potency drugs (e.g., monoclonal antibodies), use the smallest volume of WFI necessary to avoid unnecessary dilution and potential inadvertent loss of drug.
  • In emergency IV fluid resuscitation, request an isotonic saline or balanced crystalloid; reserve WFI for when a sterile solvent is truly required for drug reconstitution.

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References

1. USP Good Manufacturing Practice for sterile preparations.

2. AAPS Journal: “Water for Injection: Quality, Safety, and Clinical Use”.

3. SmPCs of commonly reconstituted injectable drugs.

*This drug card is intended for educational purposes. Always consult product labeling and institutional protocols before use.*

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Medical Disclaimer: Medical definitions are provided for educational purposes and should not replace professional medical advice, diagnosis, or treatment.

AI Content Disclaimer: Some definitions may be AI-generated and may contain inaccuracies. Always verify with authoritative medical references.

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