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Sod Chloride 4meq/ml Inj, 25x30ml

Manufacturer FRESENIUS KABI USA 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 replacement, Fluid and electrolyte balance
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Pharmacologic Class
Electrolyte, Crystalloid solution
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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?

This medication is a very concentrated salt solution given directly into a vein (intravenously). It is used to quickly correct very low salt levels in the blood, or to add extra salt to other IV fluids. It is not a regular IV fluid and must be used with extreme care and monitoring.
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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 intravenous infusion over a period of time. Your doctor may instruct you on how to self-administer the medication. Before and after handling the medication, wash your hands thoroughly.

Important Administration Instructions

Do not use the medication if the solution appears cloudy, is leaking, or contains particles.
 Do not use the medication if the solution has changed color.
Dispose of needles and other sharp objects in a designated 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

  • Report any unusual symptoms immediately, such as excessive thirst, confusion, muscle weakness, or swelling.
  • Adhere to all monitoring appointments and blood tests as instructed by your healthcare provider.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized; typically administered as a calculated bolus or slow infusion to correct severe, symptomatic hyponatremia or as an additive to other IV fluids. Not for direct primary infusion.

Condition-Specific Dosing:

Severe Symptomatic Hyponatremia: Typically 100 mL of 3% NaCl (equivalent to 51.3 mEq NaCl) infused over 10-20 minutes, repeated once if symptoms persist. Goal is to raise serum sodium by 4-6 mEq/L in the first 1-2 hours. Subsequent correction rate should not exceed 8-12 mEq/L in 24 hours to prevent Osmotic Demyelination Syndrome (ODS). This 4 mEq/mL solution is approximately 23.4% NaCl, so 1 mL contains 4 mEq NaCl. Dosing must be precisely calculated based on patient's sodium deficit and desired correction rate.
Additive to IV Fluids: Added to parenteral nutrition or other IV solutions to meet daily sodium requirements or correct ongoing losses, based on patient's electrolyte status.
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Pediatric Dosing

Neonatal: Not established for routine use; highly individualized and used with extreme caution for severe, symptomatic hyponatremia under strict monitoring. Dosing is weight-based and calculated to avoid rapid sodium shifts.
Infant: Not established for routine use; highly individualized and used with extreme caution for severe, symptomatic hyponatremia under strict monitoring. Dosing is weight-based and calculated to avoid rapid sodium shifts.
Child: Not established for routine use; highly individualized and used with extreme caution for severe, symptomatic hyponatremia under strict monitoring. Dosing is weight-based and calculated to avoid rapid sodium shifts.
Adolescent: Similar to adult considerations, but with careful attention to weight and fluid status. Highly individualized for severe, symptomatic hyponatremia.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor serum electrolytes and fluid status closely.
Moderate: Use with extreme caution; significant dose reduction and frequent monitoring of serum sodium, fluid balance, and renal function are required due to impaired sodium excretion.
Severe: Contraindicated or used with extreme caution and continuous monitoring in patients with severe renal impairment or anuria due to high risk of hypernatremia and fluid overload. Dialysis may be required.
Dialysis: Sodium chloride administration should be carefully managed in dialysis patients to avoid fluid overload and electrolyte imbalances. Dosing should be guided by pre- and post-dialysis electrolyte levels and fluid status.

Hepatic Impairment:

Mild: No specific adjustment typically required, but monitor for fluid retention.
Moderate: Use with caution, especially if ascites or edema are present, due to potential for fluid overload.
Severe: Use with caution, particularly in patients with significant fluid retention (e.g., cirrhosis with ascites and edema), as it can exacerbate fluid overload. Monitor fluid balance and electrolytes closely.

Pharmacology

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Mechanism of Action

Sodium chloride is the principal extracellular cation and anion, respectively. Sodium plays a primary role in the regulation of osmotic pressure, fluid balance, and acid-base equilibrium. It is essential for nerve impulse transmission, muscle contraction, and maintenance of cell membrane potential. Chloride ions follow sodium ions to maintain electrical neutrality and are also involved in acid-base balance.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: Rapid (minutes) following intravenous administration.
FoodEffect: Not applicable (IV administration).

Distribution:

Vd: Approximately 0.2 L/kg (extracellular fluid volume)
ProteinBinding: Negligible
CnssPenetration: Yes (distributes into CSF, but slow equilibration across blood-brain barrier can lead to osmotic shifts if serum sodium changes too rapidly).

Elimination:

HalfLife: Not applicable for an ion; elimination depends on renal function and fluid balance.
Clearance: Primarily renal clearance, regulated by glomerular filtration and tubular reabsorption.
ExcretionRoute: Renal (urine), sweat, feces.
Unchanged: 100% (ions are not chemically altered).
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Pharmacodynamics

OnsetOfAction: Immediate (upon IV administration)
PeakEffect: Minutes (for changes in serum sodium concentration)
DurationOfAction: Variable, depends on renal function, fluid status, and ongoing losses/intake.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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

Reporting Side Effects

This is not a complete list of possible 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:

  • Excessive thirst
  • Confusion or altered mental status
  • Headache
  • Nausea or vomiting
  • Muscle weakness or cramps
  • Swelling in the hands, feet, or ankles
  • Difficulty breathing or shortness of breath
  • Seizures
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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 allergic reaction you experienced, including any symptoms that occurred.
 All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems you have, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is vital to:

 Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dose of any medication without first consulting your doctor. This will help prevent potential interactions or adverse effects.
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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 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 ensure safe management of your condition.

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

When administering this medication to newborns, exercise caution due to a potentially higher risk of side effects in this age group.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the benefits and risks of this medication with your doctor to make an informed decision about its use.
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Overdose Information

Overdose Symptoms:

  • Severe hypernatremia (very high blood sodium)
  • Fluid overload (pulmonary edema, peripheral edema, heart failure)
  • Metabolic acidosis
  • Central pontine myelinolysis (Osmotic Demyelination Syndrome - ODS), characterized by neurological symptoms like dysarthria, dysphagia, quadriparesis, and altered consciousness, typically developing days after rapid correction.

What to Do:

Immediate medical attention is required. Management involves discontinuing the infusion, administering hypotonic fluids (e.g., D5W) to lower serum sodium, and potentially diuretics to manage fluid overload. In severe cases, dialysis may be necessary. For suspected ODS, supportive care is provided. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Major Interactions

  • Corticosteroids (e.g., Prednisone, Dexamethasone): May increase sodium and fluid retention, exacerbating hypernatremia or fluid overload.
  • Lithium: Increased sodium intake can increase lithium excretion, potentially reducing lithium levels. Conversely, sodium depletion can increase lithium reabsorption and toxicity.
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Moderate Interactions

  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): Loop and thiazide diuretics can alter sodium and fluid balance, requiring careful monitoring when co-administering sodium chloride.
  • Drugs that cause sodium retention (e.g., NSAIDs): May increase risk of fluid overload or hypernatremia.

Monitoring

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Baseline Monitoring

Serum Electrolytes (Na, K, Cl)

Rationale: To establish baseline sodium level and identify other electrolyte imbalances.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

Rationale: To assess kidney's ability to excrete sodium and fluid.

Timing: Prior to initiation of therapy.

Fluid Status (Weight, I&O, Edema)

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

Timing: Prior to initiation of therapy.

Neurological Status

Rationale: For patients with symptomatic hyponatremia, to assess baseline neurological deficits.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Sodium

Frequency: Every 2-4 hours initially, then less frequently as stable (e.g., every 6-12 hours).

Target: Correction rate should not exceed 8-12 mEq/L in 24 hours (or 4-6 mEq/L in first few hours for severe symptoms).

Action Threshold: If sodium rises too rapidly (>12 mEq/L/24h or >8 mEq/L/day), stop infusion and consider administering D5W or desmopressin to lower sodium.

Serum Electrolytes (K, Cl, Bicarbonate)

Frequency: Every 6-12 hours or as clinically indicated.

Target: Normal ranges.

Action Threshold: Address any developing imbalances.

Fluid Balance (Intake & Output)

Frequency: Every 4-8 hours.

Target: Maintain appropriate fluid balance.

Action Threshold: Significant positive or negative balance may indicate need for adjustment.

Vital Signs (BP, HR, RR)

Frequency: Every 4-8 hours or as clinically indicated.

Target: Within normal limits for patient.

Action Threshold: Changes may indicate fluid overload or other complications.

Neurological Status

Frequency: Continuously for symptomatic patients, then every 4-8 hours.

Target: Improvement of hyponatremia symptoms without signs of ODS.

Action Threshold: New or worsening neurological symptoms (e.g., confusion, seizures, weakness) require immediate evaluation.

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Symptom Monitoring

  • Signs of hypernatremia (excessive thirst, dry mucous membranes, lethargy, confusion, seizures, muscle twitching, hyperreflexia)
  • Signs of fluid overload (peripheral edema, pulmonary edema, dyspnea, crackles, elevated blood pressure, jugular venous distension)
  • Signs of Osmotic Demyelination Syndrome (ODS) (dysarthria, dysphagia, quadriparesis, pseudobulbar palsy, locked-in syndrome - typically delayed onset 2-7 days after rapid correction)

Special Patient Groups

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Pregnancy

Sodium chloride is an essential electrolyte. When administered appropriately to correct severe hyponatremia or as an additive, it is generally considered safe during pregnancy. However, excessive administration can lead to fluid overload or electrolyte imbalances in both mother and fetus. Use only when clearly indicated and with careful monitoring.

Trimester-Specific Risks:

First Trimester: No specific increased risk identified beyond general risks of electrolyte imbalance.
Second Trimester: No specific increased risk identified beyond general risks of electrolyte imbalance.
Third Trimester: Increased risk of fluid overload due to physiological changes in pregnancy; monitor closely for edema and pulmonary congestion.
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Lactation

Sodium chloride is a natural component of breast milk. When administered appropriately to the mother, it is not expected to pose a significant risk to the breastfed infant. Maternal electrolyte balance should be maintained.

Infant Risk: L1 (Safest) - No adverse effects expected with appropriate maternal use.
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Pediatric Use

Pediatric patients, especially neonates and infants, have a higher risk of fluid and electrolyte imbalances due to immature renal function and higher body water content. Dosing must be precisely calculated based on weight and clinical status. Rapid correction of hyponatremia carries the same, if not higher, risk of Osmotic Demyelination Syndrome (ODS) as in adults. Close monitoring of serum sodium and neurological status is critical.

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Geriatric Use

Elderly patients are more susceptible to fluid overload, hypernatremia, and electrolyte imbalances due to age-related decline in renal function, decreased thirst sensation, and polypharmacy. They may also have comorbidities (e.g., heart failure, renal insufficiency) that increase risk. Dosing should be conservative, and monitoring should be frequent and meticulous.

Clinical Information

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Clinical Pearls

  • This 4 mEq/mL Sodium Chloride solution is highly concentrated (approximately 23.4% NaCl) and is NOT for direct primary infusion. It must be diluted or administered very slowly via a central venous line with an infusion pump.
  • Primarily used for rapid, controlled correction of severe, symptomatic hyponatremia to prevent cerebral edema, or as an additive to other IV fluids.
  • The most critical risk is Osmotic Demyelination Syndrome (ODS) if hyponatremia is corrected too rapidly. The rate of sodium correction should generally not exceed 8-12 mEq/L in 24 hours, and often less (4-6 mEq/L in 24 hours) in high-risk patients (e.g., chronic alcoholism, malnutrition, advanced liver disease).
  • Frequent monitoring of serum sodium (every 2-4 hours initially) is essential during correction of severe hyponatremia.
  • Consider stopping the infusion and administering D5W or desmopressin if serum sodium rises too quickly.
  • Always assess fluid status carefully to avoid fluid overload, especially in patients with cardiac or renal impairment.
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Alternative Therapies

  • Less concentrated sodium chloride solutions (e.g., 0.9% NaCl, 3% NaCl) for less severe hyponatremia or maintenance.
  • Oral sodium chloride supplements (for chronic, mild hyponatremia or sodium depletion).
  • Vaptans (e.g., Tolvaptan) for euvolemic or hypervolemic hyponatremia (not for acute, severe hyponatremia).
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Cost & Coverage

Average Cost: Low per 30ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. For guidance on the best disposal method, consult your pharmacist, who may also be aware of local drug take-back programs. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them 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 quantity, and the time of ingestion to ensure prompt and effective treatment.