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Sodium Chloride 3% Inj, 500ml

Manufacturer BRAUN MCGAW 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, Fluid and Electrolyte Replenisher
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Pharmacologic Class
Hypertonic Saline Solution, Osmotic Agent
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Pregnancy 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 strong salt solution given directly into your vein (intravenously). It is used in emergency situations to quickly raise very low levels of sodium (salt) in your blood, especially when these low levels are causing serious problems like brain swelling or seizures. It helps to pull extra water out of your brain cells to reduce swelling.
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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 to you. 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 medication if the solution 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 setting under close medical supervision.
  • Fluid and dietary restrictions may be necessary depending on the cause of your low sodium levels.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized and titrated based on serum sodium levels and clinical response. For severe, symptomatic hyponatremia: 100 mL bolus over 10-20 minutes, repeated up to 2-3 times if symptoms persist, or continuous infusion at 0.5-2 mL/kg/hr. Target correction rate typically 4-6 mEq/L in the first 24 hours, and not more than 8-10 mEq/L in 24 hours to prevent osmotic demyelination syndrome (ODS).

Condition-Specific Dosing:

severe_symptomatic_hyponatremia: Initial bolus: 100 mL over 10-20 minutes, may repeat up to 2-3 times. Continuous infusion: 0.5-2 mL/kg/hr, titrated to achieve target sodium correction.
cerebral_edema: Dosing is similar to severe hyponatremia, aimed at reducing intracranial pressure.
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Pediatric Dosing

Neonatal: Not established, use with extreme caution and expert consultation. Dosing is highly individualized and weight-based, typically 0.5-1 mL/kg/hr, with strict monitoring.
Infant: Not established, use with extreme caution and expert consultation. Dosing is highly individualized and weight-based, typically 0.5-1 mL/kg/hr, with strict monitoring.
Child: For severe symptomatic hyponatremia: 2-4 mL/kg bolus over 10-20 minutes, may repeat. Continuous infusion: 0.5-1 mL/kg/hr, titrated to achieve target sodium correction (e.g., 4-8 mEq/L in 24 hours).
Adolescent: Dosing similar to adult recommendations, but with careful consideration of weight and fluid status.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor fluid balance and electrolytes closely.
Moderate: Use with extreme caution; increased risk of fluid overload and electrolyte imbalance. Frequent monitoring of serum sodium, fluid status, and renal function is essential.
Severe: Contraindicated or use with extreme caution and expert consultation; high risk of fluid overload, pulmonary edema, and worsening electrolyte imbalances. May require concomitant diuretic therapy or dialysis.
Dialysis: Not typically used during dialysis. If needed for severe hyponatremia in dialysis patients, requires expert consultation and careful titration to avoid rapid fluid shifts and electrolyte disturbances.

Hepatic Impairment:

Mild: Use with caution; monitor fluid balance and electrolytes.
Moderate: Use with caution, especially in patients with cirrhosis and ascites, due to increased risk of fluid retention and electrolyte disturbances. Monitor closely.
Severe: Use with extreme caution; increased risk of fluid overload, pulmonary edema, and worsening ascites. May require concomitant diuretic therapy.

Pharmacology

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Mechanism of Action

Sodium Chloride 3% solution is a hypertonic saline solution. Its primary mechanism of action involves increasing the serum sodium concentration, which in turn increases serum osmolality. This creates an osmotic gradient that draws water from the intracellular compartment (including brain cells) into the extracellular space, thereby reducing cellular swelling and cerebral edema. It directly replaces sodium deficits in severe hyponatremia.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (intravenous)
Tmax: Rapid (minutes)
FoodEffect: Not applicable

Distribution:

Vd: Approximately 0.2 L/kg (distributes primarily in the extracellular fluid space)
ProteinBinding: Not applicable (ions)
CnssPenetration: Yes (affects brain osmolality and fluid shifts)

Elimination:

HalfLife: Not a typical drug half-life; depends on fluid balance, renal function, and underlying condition.
Clearance: Primarily renal excretion; influenced by glomerular filtration rate and tubular reabsorption.
ExcretionRoute: Renal
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of administration)
PeakEffect: Rapid (within minutes to an hour, depending on infusion rate)
DurationOfAction: Variable; depends on the rate of administration, patient's fluid status, renal function, and ongoing fluid/electrolyte losses or gains.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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. Many people experience no side effects or only 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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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:

  • New or worsening headache
  • Nausea or vomiting
  • Confusion or changes in mental status
  • Seizures
  • Shortness of breath or difficulty breathing
  • Swelling in your ankles, feet, or hands
  • New weakness or difficulty speaking/swallowing (these could be signs of a serious complication called osmotic demyelination syndrome, which can occur if sodium 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.
 All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 a salt substitute or any product that also contains 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 discuss any concerns or questions you have with your doctor.

When administering this medication to a newborn, it is crucial to exercise caution, as the risk of side effects may be increased in this age group.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary 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:

  • Hypernatremia (too much sodium in the blood)
  • Fluid overload (excess fluid in the body, leading to swelling, pulmonary edema, heart failure)
  • Pulmonary edema (fluid in the lungs, causing severe shortness of breath)
  • Congestive heart failure
  • Osmotic Demyelination Syndrome (ODS) / Central Pontine Myelinolysis (CPM) - a severe neurological disorder caused by rapid correction of chronic hyponatremia, leading to symptoms like dysarthria, dysphagia, quadriparesis, and locked-in syndrome, often with delayed onset.

What to Do:

Immediate discontinuation of the infusion. Management of hypernatremia may involve administration of free water (e.g., D5W) or diuretics. Management of fluid overload may involve diuretics. For ODS, supportive care is crucial, and re-lowering sodium levels may be considered in some cases. Call 911 or your local emergency number immediately.

Drug Interactions

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Contraindicated Interactions

  • Hypernatremia
  • Severe fluid overload
  • Congestive heart failure (severe, uncontrolled)
  • Renal failure (anuric, without dialysis capability)
  • Conditions where sodium retention is detrimental (e.g., severe edema, hypertension)
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Major Interactions

  • Corticosteroids (may enhance sodium and fluid retention, increasing risk of fluid overload and hypertension)
  • Drugs causing sodium retention (e.g., NSAIDs, some antihypertensives)
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Moderate Interactions

  • Lithium (sodium levels can affect lithium excretion; changes in sodium intake or administration of hypertonic saline can alter lithium levels, requiring close monitoring)
  • Diuretics (especially loop diuretics, if used concomitantly to manage fluid overload, require careful monitoring of electrolyte balance)
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Minor Interactions

  • Not many specific drug-drug interactions beyond those affecting fluid and electrolyte balance.

Monitoring

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Baseline Monitoring

Serum Sodium (Na+)

Rationale: To establish baseline hyponatremia severity and guide initial dosing.

Timing: Prior to initiation of therapy.

Serum Osmolality

Rationale: To assess overall solute concentration and confirm hypotonic hyponatremia.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation of therapy.

Fluid Status (I&O, weight, vital signs, physical exam)

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

Timing: Prior to initiation of therapy.

Neurological Status (GCS, mental status, seizure activity)

Rationale: To assess severity of symptoms related to hyponatremia and monitor response to therapy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Sodium (Na+)

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

Target: Correction rate of 4-6 mEq/L in the first 24 hours, and not more than 8-10 mEq/L in 24 hours.

Action Threshold: If sodium correction exceeds target rate, or if symptoms worsen, stop infusion and re-evaluate. If overcorrection occurs, consider free water administration or desmopressin.

Serum Osmolality

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

Target: Gradual increase towards normal range.

Action Threshold: Rapid increase may indicate overcorrection risk.

Fluid Balance (Intake & Output, daily weight)

Frequency: Every 4-8 hours for I&O, daily for weight.

Target: Appropriate fluid balance to avoid overload or dehydration.

Action Threshold: Positive fluid balance or significant weight gain may indicate fluid overload; negative balance may indicate dehydration.

Vital Signs (BP, HR, RR, SpO2)

Frequency: Every 1-4 hours or as clinically indicated.

Target: Within normal limits for patient.

Action Threshold: Changes may indicate fluid overload (e.g., hypertension, tachycardia, tachypnea) or other complications.

Neurological Status

Frequency: Continuous or every 1-2 hours initially, then every 4 hours.

Target: Improvement in symptoms (e.g., resolution of seizures, improved mental status).

Action Threshold: Worsening neurological symptoms or new symptoms (e.g., dysarthria, dysphagia, quadriparesis) may indicate osmotic demyelination syndrome (ODS).

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Symptom Monitoring

  • Headache
  • Nausea
  • Vomiting
  • Confusion
  • Lethargy
  • Seizures
  • Coma
  • Shortness of breath
  • Peripheral edema
  • Signs of osmotic demyelination syndrome (e.g., dysarthria, dysphagia, quadriparesis, locked-in syndrome - typically delayed onset after overcorrection)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Severe hyponatremia is a life-threatening condition, and treatment with hypertonic saline may be necessary. Close monitoring of maternal fluid and electrolyte status is essential.

Trimester-Specific Risks:

First Trimester: Potential for fluid and electrolyte shifts; use only if clearly indicated for life-threatening maternal condition.
Second Trimester: Potential for fluid and electrolyte shifts; use only if clearly indicated.
Third Trimester: Potential for fluid and electrolyte shifts, risk of fluid overload; use only if clearly indicated.
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Lactation

Lactation Risk L3 (Moderately safe). Sodium and chloride are natural components of breast milk. However, administration of hypertonic saline can significantly alter maternal fluid and electrolyte balance. Use with caution, and monitor the infant for any signs of electrolyte imbalance or adverse effects.

Infant Risk: Low to moderate risk; potential for electrolyte imbalance in infant if maternal levels are significantly altered or if large volumes are administered. Monitor infant for signs of dehydration or fluid overload.
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Pediatric Use

Use with extreme caution. Pediatric patients, especially neonates and infants, are at higher risk for fluid and electrolyte imbalances and osmotic demyelination syndrome (ODS) due to their smaller fluid compartments and developing blood-brain barrier. Dosing must be meticulously calculated based on weight and titrated with very frequent serum sodium monitoring.

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Geriatric Use

Use with caution. Elderly patients may have decreased renal function, pre-existing cardiovascular disease, and altered fluid regulation, increasing their risk for fluid overload, pulmonary edema, and heart failure. They may also be more susceptible to osmotic demyelination syndrome (ODS). Close monitoring of fluid status, renal function, and electrolytes is crucial.

Clinical Information

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Clinical Pearls

  • Sodium Chloride 3% is a high-risk medication due to the potential for severe adverse effects, particularly osmotic demyelination syndrome (ODS) if hyponatremia is corrected too rapidly.
  • It is primarily reserved for severe, symptomatic hyponatremia (e.g., serum Na < 120 mEq/L with seizures, coma, or severe neurological symptoms) or for cerebral edema with elevated intracranial pressure.
  • Correction rate is paramount: aim for a rise of 4-6 mEq/L in the first 24 hours, and generally no more than 8-10 mEq/L in any 24-hour period. For high-risk patients (e.g., chronic hyponatremia, alcoholism, malnutrition, liver disease), the correction target should be even lower (e.g., < 4-6 mEq/L in 24 hours).
  • Frequent (e.g., every 1-2 hours) serum sodium monitoring is mandatory during administration.
  • Consider concomitant administration of a loop diuretic (e.g., furosemide) to prevent fluid overload, especially in patients with impaired renal or cardiac function.
  • If overcorrection occurs (sodium rises too quickly), consider administering free water (e.g., D5W) and/or desmopressin to re-lower serum sodium and prevent ODS.
  • Often administered via a central venous catheter due to its hypertonicity, which can cause phlebitis and tissue damage if extravasated from a peripheral line.
  • Address the underlying cause of hyponatremia once the acute crisis is managed.
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Alternative Therapies

  • Normal Saline (0.9% Sodium Chloride) for less severe or asymptomatic hyponatremia.
  • Fluid restriction (for euvolemic or hypervolemic hyponatremia).
  • Vasopressin receptor antagonists (e.g., tolvaptan, conivaptan) for euvolemic or hypervolemic hyponatremia (e.g., SIADH, heart failure).
  • Demeclocycline (for chronic SIADH).
  • Urea (oral, for chronic hyponatremia).
  • Loop diuretics (to induce aquaresis in hypervolemic hyponatremia).
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Cost & Coverage

Average Cost: $10 - $50 per 500mL bag
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 promptly. 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 a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist, as they can provide guidance or inform you about potential drug take-back programs in your area. Additionally, some medications may come with a separate patient information leaflet, which your pharmacist can provide upon request. If you have any questions or concerns about your medication, it is crucial to 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 detailed information about the overdose, including the medication taken, the quantity, and the time it occurred, to facilitate prompt and effective treatment.