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Sterile isotonic saline solution
Sterile isotonic saline solution provides fluid and electrolyte replacement by delivering sodium chloride and water in osmotically balanced proportions to maintain cellular hydration and electrolyte homeostasis.
Sterile isotonic saline solution provides fluid and electrolyte replacement by delivering sodium chloride and water in osmotically balanced proportions to maintain cellular hydration and electrolyte homeostasis. Used for Fluid and electrolyte replacement in dehydration, Maintenance of intravascular volume during surgery or critical illness, Vehicle for intravenous medication administration.
At a glance
| Generic name | Sterile isotonic saline solution |
|---|---|
| Sponsor | Hospital Italiano de Buenos Aires |
| Drug class | Crystalloid fluid / Electrolyte replacement solution |
| Modality | Small molecule |
| Therapeutic area | Fluid and Electrolyte Management |
| Phase | FDA-approved |
Mechanism of action
Isotonic saline (0.9% NaCl) is a crystalloid solution with osmolality matching plasma (~308 mOsm/L), allowing it to distribute between intravascular and interstitial compartments without causing cell lysis or crenation. It serves as a physiologic replacement for lost fluids and electrolytes, restoring circulating volume and maintaining proper ion balance essential for cellular function and hemodynamic stability.
Approved indications
- Fluid and electrolyte replacement in dehydration
- Maintenance of intravascular volume during surgery or critical illness
- Vehicle for intravenous medication administration
- Treatment of hypovolemic shock
Common side effects
- Hyperchloremic acidosis (with large volume infusion)
- Fluid overload / pulmonary edema (in susceptible patients)
- Hypernatremia (with excessive administration)
- Phlebitis at infusion site
Key clinical trials
- Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
- Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease (NA)
- The Development of New Functions of Esculin and Digitalis Glycosides Eye Drops: A Study on the Treatment of Presbyopia (PHASE4)
- Volume Reduction for Open Fracture Irrigation (PHASE4)
- Angiotensin II in Liver Transplantation (PHASE2, PHASE3)
- Stem Cells for Erectile Dysfunction Post RALP (PHASE1, PHASE2)
- Erector Spinae Plane Block for Acute Low Back Pain (NA)
- Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sterile isotonic saline solution CI brief — competitive landscape report
- Sterile isotonic saline solution updates RSS · CI watch RSS
- Hospital Italiano de Buenos Aires portfolio CI