Sodium Chloride 2.5meq/ml Inj, 20ml

Manufacturer FRESENIUS KABI USA Active Ingredient Sodium Chloride Injection Solution(SOW dee um KLOR ide) Pronunciation SOW dee um KLOR ide
It is used to treat low sodium levels. It is used to treat fluid loss.It is used to mix with a drug that is given 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 agent
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Pharmacologic Class
Electrolyte solution, Hypertonic solution
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Pregnancy Category
Category A
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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 is a type of salt solution given directly into your vein (intravenously). This specific solution is very concentrated and is used in serious situations to quickly raise your body's salt (sodium) levels if they are dangerously low, or to add salt to other IV fluids. It helps balance the water and salt in your body.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered as an intravenous infusion, which means it is slowly injected into a vein over a specified period of time.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • No specific lifestyle modifications are required for the administration of this medication, as it is given in a hospital or clinical setting for acute conditions.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Highly individualized based on sodium deficit and clinical condition. For severe symptomatic hyponatremia, typically administered as 3% NaCl (which is ~0.5 meq/ml) at rates to increase serum sodium by 4-6 mEq/L over the first 1-2 hours, not exceeding 8-12 mEq/L in 24 hours. This 2.5 meq/ml (14.6%) concentration is significantly more concentrated and often used for compounding or specific, calculated boluses/infusions.

Condition-Specific Dosing:

severeSymptomaticHyponatremia: Calculated based on sodium deficit and desired rate of correction. Often diluted or administered via central line with extreme caution. Example: 1-2 mL/kg of 3% NaCl (equivalent to 0.5 meq/ml) over 10-20 minutes for acute, severe symptoms, then reassess. This 14.6% solution would be used in much smaller, calculated volumes.
electrolyteAdditive: As per specific formulation or physician order for parenteral nutrition or other IV solutions.
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Pediatric Dosing

Neonatal: Not established as standard dosing; highly individualized and requires expert consultation due to high risk of complications.
Infant: Not established as standard dosing; highly individualized and requires expert consultation due to high risk of complications.
Child: Not established as standard dosing; highly individualized based on weight, sodium deficit, and clinical condition. Correction rates are similar to adults but volumes are much smaller and require precise calculation.
Adolescent: Similar considerations to adult dosing, but individualized based on weight and clinical status.
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Dose Adjustments

Renal Impairment:

Mild: Monitor serum sodium and fluid status closely.
Moderate: Use with extreme caution; monitor serum sodium and fluid status frequently. Increased risk of fluid overload and hypernatremia.
Severe: Contraindicated or use with extreme caution and continuous monitoring (e.g., in ICU setting) due to high risk of fluid overload, hypernatremia, and other electrolyte disturbances. Dialysis may be required to manage fluid and electrolyte balance.
Dialysis: Sodium chloride administration should be carefully considered and managed in conjunction with dialysis to prevent rapid shifts in fluid and electrolytes.

Hepatic Impairment:

Mild: Monitor fluid status and electrolytes.
Moderate: Monitor fluid status and electrolytes closely, as hepatic impairment can affect fluid balance and contribute to hyponatremia (e.g., in cirrhosis).
Severe: Monitor fluid status and electrolytes closely. Use with caution, as patients with severe hepatic impairment (e.g., cirrhosis) may have altered fluid balance and be prone to fluid overload or persistent hyponatremia.

Pharmacology

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Mechanism of Action

Sodium is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride is the major extracellular anion. Sodium chloride injection provides a source of sodium and chloride to maintain isotonicity, distribute water, and maintain electrolyte balance. This highly concentrated solution (14.6% NaCl) is used to rapidly increase serum sodium concentration and plasma osmolality, primarily in severe symptomatic hyponatremia, by drawing water from the intracellular to the extracellular compartment.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 0.2 L/kg (extracellular fluid volume)
ProteinBinding: Not applicable (ions)
CnssPenetration: Yes, but regulated by the blood-brain barrier. Rapid changes in serum osmolality can lead to osmotic shifts across the blood-brain barrier.

Elimination:

HalfLife: Not a typical drug half-life; serum levels are regulated by renal excretion and fluid balance.
Clearance: Primarily renal clearance, regulated by glomerular filtration and tubular reabsorption.
ExcretionRoute: Renal
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Immediate (upon intravenous administration)
PeakEffect: Minutes to hours, depending on infusion rate and patient's physiological response.
DurationOfAction: Variable, depends on renal function, fluid status, and ongoing electrolyte balance. Effects persist as long as the administered sodium is retained in the extracellular fluid.

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 immediate medical attention:

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 electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Change in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Shortness of breath
Sudden weight gain or swelling in the arms or legs
Severe dizziness or fainting
Fever or chills
Shakiness
Chest pain or pressure, or a rapid heartbeat
Flushing
Burning, stinging, or redness at the injection site
* Pain and irritation at the injection site

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, talk to your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and answering any questions you may have.
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Seek Immediate Medical Attention If You Experience:

  • Increased thirst
  • Feeling very tired or confused
  • Muscle weakness or twitching
  • Seizures
  • Swelling in your hands, ankles, or feet
  • Difficulty breathing
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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.
If you have high sodium levels or swelling.

This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all 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 you are following a low-salt or salt-free diet, consult with your doctor to discuss any potential interactions. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition.

This medication may contain aluminum, which can increase the risk of aluminum toxicity with long-term use. This risk is particularly higher if you have pre-existing kidney problems or if you are a premature infant. It is crucial to discuss this potential risk with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, you must consult with your doctor to weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypernatremia (very high sodium levels)
  • Fluid overload (excess fluid in the body, leading to swelling, difficulty breathing, high blood pressure)
  • Cerebral edema (swelling of the brain, if sodium levels drop too quickly after correction)
  • Osmotic Demyelination Syndrome (severe, irreversible brain damage due to rapid sodium correction, leading to neurological symptoms like paralysis, difficulty speaking, or coma)

What to Do:

Overdose is a medical emergency. Immediate medical attention is required. Treatment involves discontinuing the infusion, administering diuretics to promote sodium excretion, and potentially administering hypotonic fluids (e.g., D5W) to lower serum sodium. In severe cases, dialysis may be necessary. Call 911 or your local emergency number immediately.

Drug Interactions

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Major Interactions

  • Corticosteroids (e.g., prednisone, hydrocortisone): May cause increased sodium and fluid retention, leading to hypernatremia and edema.
  • Lithium: Sodium intake affects lithium excretion. Increased sodium intake can lead to increased lithium excretion and decreased lithium levels, potentially reducing therapeutic effect. Decreased sodium intake can lead to decreased lithium excretion and increased lithium levels, potentially leading to toxicity.
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Moderate Interactions

  • Drugs causing sodium retention (e.g., NSAIDs, some antihypertensives like ACE inhibitors or ARBs in specific contexts): May exacerbate fluid retention or hypernatremia.
  • Diuretics (especially loop diuretics): While often used to manage fluid overload, concurrent use with hypertonic saline requires careful monitoring to avoid electrolyte imbalances.

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 initiation of therapy.

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation of therapy.

Fluid Status (Volume status, vital signs)

Rationale: To assess for signs of hypovolemia, euvolemia, or hypervolemia, which guides fluid management.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Sodium

Frequency: Every 2-4 hours initially, then every 4-6 hours or as clinically indicated, especially during rapid correction of hyponatremia.

Target: Gradual increase, typically not exceeding 8-12 mEq/L in 24 hours for chronic hyponatremia.

Action Threshold: If serum sodium rises too rapidly (>12 mEq/L in 24 hours or >18 mEq/L in 48 hours), consider stopping hypertonic saline and administering D5W or desmopressin to re-lower sodium.

Fluid Balance (Intake and Output)

Frequency: Every 4-8 hours.

Target: Maintain appropriate fluid balance to avoid overload or dehydration.

Action Threshold: Significant positive or negative fluid balance may require adjustment of fluid therapy.

Neurological Status

Frequency: Continuously or every 1-2 hours during rapid correction.

Target: Stable or improving neurological function.

Action Threshold: Worsening neurological symptoms (e.g., lethargy, seizures, confusion) may indicate over-correction or other complications.

Vital Signs (BP, HR, RR)

Frequency: Every 2-4 hours or as clinically indicated.

Target: Within normal limits for the patient.

Action Threshold: Significant changes may indicate fluid overload or other adverse effects.

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Symptom Monitoring

  • Excessive thirst
  • Lethargy
  • Confusion
  • Weakness
  • Irritability
  • Muscle twitching or cramps
  • Seizures
  • Coma (signs of severe hypernatremia or osmotic demyelination syndrome)
  • Peripheral edema (swelling in extremities)
  • Dyspnea (shortness of breath)
  • Crackles on lung auscultation (signs of fluid overload)

Special Patient Groups

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Pregnancy

Sodium chloride is an essential electrolyte and is generally considered safe for use during pregnancy when clinically indicated to correct electrolyte imbalances. It is classified as Pregnancy Category A.

Trimester-Specific Risks:

First Trimester: No known specific risks associated with appropriate use.
Second Trimester: No known specific risks associated with appropriate use.
Third Trimester: No known specific risks associated with appropriate use. Monitor fluid status closely to avoid fluid overload, especially in pre-eclampsia.
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Lactation

Sodium chloride is compatible with breastfeeding. It is an endogenous substance and is not expected to cause adverse effects in a breastfed infant.

Infant Risk: Minimal to none.
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Pediatric Use

Dosing must be extremely precise in pediatric patients due to their smaller fluid volumes and higher susceptibility to rapid shifts in fluid and electrolytes. The risk of osmotic demyelination syndrome is present, and correction rates must be carefully controlled. Requires expert consultation and frequent monitoring.

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Geriatric Use

Elderly patients may be more susceptible to fluid overload, hypernatremia, and other electrolyte imbalances due to age-related changes in renal function, fluid regulation, and comorbidities. Close monitoring of fluid status, electrolytes, and neurological function is essential.

Clinical Information

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Clinical Pearls

  • This 2.5 meq/ml (14.6%) Sodium Chloride solution is highly concentrated and is NOT for routine fluid replacement. It is primarily used for severe, symptomatic hyponatremia or as an additive to other IV fluids requiring precise sodium supplementation.
  • When correcting chronic hyponatremia, the rate of serum sodium increase must be slow and controlled (typically not exceeding 8-12 mEq/L in 24 hours) to prevent the devastating complication of Osmotic Demyelination Syndrome (ODS).
  • Frequent (e.g., every 2-4 hours) serum sodium monitoring is critical during administration of hypertonic saline.
  • Administration of hypertonic saline should ideally be via a central venous catheter due to its high osmolality, which can cause peripheral vein irritation and phlebitis.
  • Consider concurrent administration of desmopressin (DDAVP) in patients at high risk for overcorrection of hyponatremia (e.g., those with conditions causing transient ADH secretion).
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Alternative Therapies

  • For hyponatremia: Fluid restriction (for euvolemic/hypervolemic hyponatremia), vasopressin receptor antagonists (e.g., tolvaptan, conivaptan for euvolemic/hypervolemic hyponatremia), loop diuretics (for hypervolemic hyponatremia), urea.
  • For general electrolyte replacement: Oral electrolyte supplements, other intravenous electrolyte preparations (e.g., potassium chloride, magnesium sulfate).
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Cost & Coverage

Average Cost: $5 - $20 per 20ml vial (approximate)
Generic Available: Yes
Insurance Coverage: Generally covered by most health insurance plans as a generic injectable.
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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 to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call 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 providing appropriate care.