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Sod Chloride 23.4% Inj, 100ml

Manufacturer FRESENIUS KABI Active Ingredient Intravenous (IV) Fluids(in truh VEE nuhs FLOO ids) Pronunciation SO-dee-um KLOR-ide
It is used to give fluids to the body when more fluids and electrolytes are needed.It is used as a way to give other drugs as a shot.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Electrolyte Replenisher; Fluid and Electrolyte Balance Agent
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Pharmacologic Class
Hypertonic Saline Solution; Sodium Salt
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Sodium Chloride 23.4% Injection is a very concentrated salt solution given directly into a vein. It is used in very specific, serious situations, such as when the body's salt level is dangerously low (severe hyponatremia) or to help reduce swelling in the brain. Because it is so strong, it must be given very carefully and slowly, and your salt levels will be checked frequently.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an infusion into a vein over a period of time. Your doctor may instruct you on how to self-administer this medication.

Before and after handling the medication, wash your hands thoroughly. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.

To dispose of used needles and other sharp objects, use a needle/sharp disposal box. Never reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.

Storage and Disposal

Typically, this medication is administered in a hospital or doctor's office. If you need to store it at home, follow the storage instructions provided by your doctor.

Missed Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • This medication is administered in a hospital or clinical setting and does not typically require specific lifestyle modifications from the patient, other than adherence to medical advice and monitoring.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized; not a standard 'dose' for routine use. Used for severe, symptomatic hyponatremia or as an osmotic agent. For severe symptomatic hyponatremia, a common approach is 30 mL of 23.4% NaCl (120 mEq Na) IV push over 5-10 minutes, or to prepare 3% NaCl solution for infusion (e.g., 12.8 mL of 23.4% NaCl diluted to 100 mL to yield 100 mL of 3% NaCl). Goal is to raise serum sodium by 4-6 mEq/L in the first 1-2 hours, with a maximum increase of 8-12 mEq/L in 24 hours to avoid osmotic demyelination syndrome.

Condition-Specific Dosing:

severe_symptomatic_hyponatremia: Initial bolus of 30 mL (120 mEq Na) of 23.4% NaCl IV over 5-10 minutes, or as a continuous infusion of 3% NaCl (prepared from 23.4% NaCl) at a rate to achieve desired sodium correction, typically 0.5-2 mEq/L/hour. Close monitoring of serum sodium is critical.
increased_intracranial_pressure: Used off-label as an osmotic agent, typically as 3% or 7.5% NaCl infusions, which can be prepared from 23.4% NaCl. Dosing is highly variable based on patient response and ICP monitoring.
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Pediatric Dosing

Neonatal: Not established for routine use. Use with extreme caution for severe symptomatic hyponatremia, highly individualized and under expert supervision. Risk of intracranial hemorrhage and osmotic demyelination syndrome is higher.
Infant: Not established for routine use. Use with extreme caution for severe symptomatic hyponatremia, highly individualized and under expert supervision. Risk of osmotic demyelination syndrome is higher.
Child: Highly individualized for severe symptomatic hyponatremia (e.g., 3% NaCl 2-4 mL/kg over 10-30 minutes, repeated as needed, or continuous infusion). 23.4% NaCl is used to prepare these solutions or for very small, rapid boluses in critical situations. Max rate of sodium correction is crucial.
Adolescent: Similar to adult considerations, but with careful attention to weight-based dosing and fluid status.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor fluid and electrolyte status closely.
Moderate: Use with extreme caution; increased risk of fluid overload and electrolyte imbalances. Frequent monitoring of serum sodium, fluid balance, and renal function is essential. Dosing may need to be reduced or administered more slowly.
Severe: Generally contraindicated or used with extreme caution in life-threatening situations only, due to high risk of fluid overload, hypernatremia, and pulmonary edema. Dialysis may be required to manage fluid and electrolyte balance.
Dialysis: Considerations: May be used to correct severe hyponatremia in dialysis patients, but requires very careful monitoring and coordination with dialysis schedule to prevent rapid shifts and complications. Fluid removal during dialysis can impact sodium levels.

Hepatic Impairment:

Mild: Use with caution; monitor fluid and electrolyte status.
Moderate: Use with caution, especially in patients with ascites or edema, due to increased risk of fluid retention and electrolyte disturbances. Monitor fluid balance and serum sodium closely.
Severe: Use with extreme caution, particularly in patients with cirrhosis and ascites, due to high risk of fluid overload, pulmonary edema, and worsening portal hypertension. May exacerbate hyponatremia in some cases if not managed carefully.

Pharmacology

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Mechanism of Action

Sodium chloride is the principal extracellular cation and anion, respectively, and plays a vital role in maintaining fluid and electrolyte balance, osmotic pressure, and acid-base balance. Hypertonic sodium chloride (23.4%) increases serum sodium concentration and serum osmolality. This creates an osmotic gradient that draws water from the intracellular compartment (including brain cells) into the extracellular compartment, thereby reducing cellular swelling and cerebral edema. It also helps to correct severe hyponatremia.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (intravenous administration)
Tmax: Minutes (rapid distribution after IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.2 L/kg (distributes primarily in the extracellular fluid space)
ProteinBinding: Not protein-bound
CnssPenetration: Limited (does not readily cross the blood-brain barrier, but its osmotic effect influences brain water content)

Elimination:

HalfLife: Regulated by renal excretion and homeostatic mechanisms; not a fixed half-life like other drugs.
Clearance: Primarily renal excretion; influenced by glomerular filtration rate, tubular reabsorption, and hormonal regulation (e.g., aldosterone, ADH).
ExcretionRoute: Renal (urine)
Unchanged: 100% (as ions)
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of administration)
PeakEffect: Depends on rate of administration and patient's physiological response; typically within 30-60 minutes for osmotic effects.
DurationOfAction: Variable, depends on renal function, fluid status, and ongoing electrolyte losses/gains; typically hours.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst
+ Seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or change in the amount of urine produced
+ Dry mouth
+ Dry eyes
+ Severe upset stomach or vomiting
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
 Swelling, warmth, numbness, change of color, or pain in a leg or arm
Chest pain or pressure
 Fever
Shortness of breath
 Sudden weight gain
Swelling in the arms or legs

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you experience any of the following:

 Irritation or swelling at the injection site
* Pain at the injection site

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of too much salt (hypernatremia): extreme thirst, confusion, weakness, muscle twitching, seizures.
  • Signs of too much fluid (fluid overload): shortness of breath, swelling in legs/ankles, rapid weight gain.
  • New or worsening neurological symptoms (e.g., difficulty speaking, swallowing, weakness, balance problems) which could indicate a serious complication if salt levels are corrected too quickly.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
 Potential interactions with other medications or health conditions. To ensure safe use, disclose all your medications, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
* Any existing health problems, as they may affect the safety or efficacy of this medication.

To avoid potential interactions or complications, do not start, stop, or modify the dosage of any medication without first consulting your doctor. Your doctor and pharmacist will work together to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If your medication contains potassium, consult with your doctor before using any salt substitutes or products that also contain potassium.

If your medication contains dextrose and you have diabetes (high blood sugar), discuss this with your doctor to determine the best course of action.

Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to follow your doctor's instructions and discuss any concerns or questions you may have.

When administering this medication to newborns, exercise caution, as they may be at a higher risk of experiencing side effects.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe hypernatremia (serum sodium >160 mEq/L)
  • Fluid overload (pulmonary edema, peripheral edema, congestive heart failure)
  • Metabolic acidosis
  • Central pontine myelinolysis (osmotic demyelination syndrome) if hyponatremia is corrected too rapidly
  • Seizures, coma, death

What to Do:

Immediate discontinuation of the infusion. Management is supportive and may include administration of hypotonic fluids (e.g., D5W) to lower serum sodium, diuretics to promote sodium excretion, and in severe cases, dialysis. Close monitoring of fluid and electrolyte balance is essential. Call 911 or poison control (1-800-222-1222) immediately.

Drug Interactions

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Contraindicated Interactions

  • Hypernatremia
  • Fluid overload (e.g., severe congestive heart failure, pulmonary edema)
  • Severe renal impairment (anuria, oliguria) without dialysis
  • Conditions where sodium retention is detrimental (e.g., severe edema, hypertension)
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Major Interactions

  • Corticosteroids (e.g., prednisone, hydrocortisone): May increase sodium and fluid retention, exacerbating risk of hypernatremia and fluid overload.
  • Lithium: Sodium levels can affect lithium excretion. Increased sodium intake or rapid correction of hyponatremia can lead to decreased lithium levels and loss of therapeutic effect. Conversely, sodium depletion can increase lithium levels and toxicity.
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Moderate Interactions

  • Diuretics (especially loop diuretics like furosemide): While sometimes used to manage fluid overload, concurrent use with hypertonic saline requires careful monitoring to avoid excessive electrolyte shifts or volume depletion/overload.
  • Drugs causing sodium retention (e.g., NSAIDs): May increase risk of fluid overload and hypernatremia.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Sodium, Potassium, Chloride)

Rationale: To establish baseline electrolyte status and guide initial dosing for hyponatremia correction.

Timing: Prior to administration

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete sodium and water, influencing dosing and risk of complications.

Timing: Prior to administration

Fluid Status (Weight, I&O, Vital Signs, Physical Exam)

Rationale: To assess baseline hydration status and risk of fluid overload.

Timing: Prior to administration

Neurological Status (GCS, mental status)

Rationale: Crucial for patients with symptomatic hyponatremia or cerebral edema to track improvement or worsening.

Timing: Prior to administration

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Routine Monitoring

Serum Sodium

Frequency: Every 1-2 hours initially during rapid correction, then every 4-6 hours once stable, or as clinically indicated.

Target: Individualized, aiming for a controlled increase (e.g., 4-6 mEq/L in first 1-2 hours, max 8-12 mEq/L in 24 hours).

Action Threshold: If sodium rises too rapidly (>12 mEq/L in 24h or >18 mEq/L in 48h), or if target sodium is reached, stop or reduce infusion rate and consider administering D5W or desmopressin to prevent overcorrection.

Serum Osmolality

Frequency: Every 4-6 hours or as clinically indicated.

Target: Individualized, typically aiming for a gradual increase.

Action Threshold: Rapid increase may indicate risk of osmotic demyelination syndrome.

Fluid Balance (Intake and Output)

Frequency: Every 1-4 hours, depending on clinical stability.

Target: Maintain appropriate balance, avoiding significant positive or negative balance unless clinically desired.

Action Threshold: Significant fluid retention or excessive diuresis may require adjustment of fluid therapy.

Neurological Status

Frequency: Continuous or every 1-2 hours during acute phase, then every 4 hours.

Target: Improvement in symptoms (e.g., seizures, coma, confusion).

Action Threshold: Worsening neurological symptoms or new onset of symptoms (e.g., weakness, dysphagia, ataxia) may indicate overcorrection or other complications.

Vital Signs (BP, HR, RR, SpO2)

Frequency: Every 1-4 hours.

Target: Within normal limits for patient.

Action Threshold: Changes may indicate fluid overload, hypovolemia, or other adverse effects.

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Symptom Monitoring

  • Signs of hypernatremia (thirst, lethargy, irritability, seizures, coma)
  • Signs of fluid overload (dyspnea, crackles, peripheral edema, elevated JVP, rapid weight gain)
  • Neurological changes (worsening confusion, weakness, dysphagia, ataxia, seizures - suggestive of osmotic demyelination syndrome if overcorrected)
  • Headache, nausea, vomiting

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. While sodium chloride is a natural component of the body, hypertonic solutions can cause significant fluid and electrolyte shifts in both mother and fetus. Careful monitoring is essential.

Trimester-Specific Risks:

First Trimester: Potential for electrolyte imbalance and fluid shifts, though direct teratogenicity is not expected.
Second Trimester: Potential for electrolyte imbalance and fluid shifts.
Third Trimester: Potential for electrolyte imbalance and fluid shifts, risk of fluid overload in mother.
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Lactation

L3 (Moderately Safe). Sodium and chloride are normal components of breast milk. However, administration of hypertonic saline to the mother can alter maternal fluid and electrolyte balance, which could theoretically affect milk composition or volume. Monitor the infant for any signs of electrolyte imbalance or adverse effects, though significant risk is generally low with appropriate maternal monitoring and dosing.

Infant Risk: Low to moderate; monitor for signs of electrolyte imbalance or dehydration/overhydration.
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Pediatric Use

Use with extreme caution. Pediatric patients, especially neonates and infants, are more vulnerable to rapid fluid and electrolyte shifts and have a higher risk of developing osmotic demyelination syndrome (ODS) if hyponatremia is corrected too rapidly. Dosing must be highly individualized based on weight, clinical status, and frequent serum sodium monitoring. Expert consultation is recommended.

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Geriatric Use

Use with caution. Elderly patients may have age-related decreases in renal function, pre-existing cardiovascular disease, and altered fluid regulation, increasing their susceptibility to fluid overload, hypernatremia, and other electrolyte imbalances. Lower doses or slower infusion rates may be necessary, and frequent monitoring of fluid status, renal function, and electrolytes is crucial.

Clinical Information

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Clinical Pearls

  • 23.4% Sodium Chloride is a highly concentrated solution (4 mEq Na/mL) and is NOT for routine intravenous hydration. It is primarily used as an additive or for acute, life-threatening conditions like severe symptomatic hyponatremia or cerebral edema.
  • The most critical risk associated with hypertonic saline for hyponatremia is Osmotic Demyelination Syndrome (ODS) due to overly rapid correction of chronic hyponatremia. Strict adherence to correction rate guidelines (e.g., max 8-12 mEq/L in 24 hours) is paramount.
  • Frequent (e.g., hourly or every 2 hours) monitoring of serum sodium is mandatory during administration, especially during the initial phase of correction.
  • Consider using a central venous line for administration of highly concentrated solutions to minimize vein irritation and extravasation risk.
  • Always verify calculations for dilution if preparing lower concentration hypertonic saline (e.g., 3% NaCl) from 23.4% NaCl.
  • In patients with severe hyponatremia, consider co-administration of desmopressin (DDAVP) to prevent overcorrection, especially if the patient is at high risk for ODS or if sodium is rising too quickly.
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Alternative Therapies

  • For severe hyponatremia: Fluid restriction (for euvolemic/hypervolemic hyponatremia), vasopressin receptor antagonists (e.g., tolvaptan, conivaptan - for euvolemic/hypervolemic hyponatremia), loop diuretics (with saline for hypervolemic hyponatremia).
  • For cerebral edema: Mannitol, hyperventilation, surgical decompression.
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Cost & Coverage

Average Cost: Not available (varies widely by supplier and contract) per 100ml vial
Generic Available: Yes
Insurance Coverage: Typically covered by most insurance plans as a necessary medical supply/medication when administered in a healthcare setting.
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet. If you have questions or concerns about your medication, it is best to consult with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in prompt and effective treatment.