Sodium Chloride 10% Neb Soln, 15ml

Manufacturer MYLAN Active Ingredient Sodium Chloride Nebulizer Solution(SOW dee um KLOR ide) Pronunciation SOW dee um KLOR ide
It is used to thin mucus so it can be taken from the body by coughing.It is used to mix with other drugs for use in a special machine (nebulizer).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Mucolytic agent
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Pharmacologic Class
Osmotic agent; Electrolyte 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?

Sodium Chloride 10% Nebulizer Solution is a strong salt water solution that you breathe in using a nebulizer. It works by drawing water into your airways, which helps to thin the thick mucus in your lungs, making it easier to cough up and clear your breathing passages.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication properly, follow your doctor's instructions and read all the information provided. You will inhale this medication through your mouth using a special machine called a nebulizer. Your doctor will show you how to use the nebulizer correctly.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, away from bathrooms and heat sources. Keep all medications in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.

Missing a Dose

If you take this medication regularly, use a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at the same time or take extra doses. If you use this medication as needed, do not use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Always use your nebulizer as directed by your healthcare provider.
  • Ensure proper nebulizer technique for effective delivery of the medication.
  • If you are prescribed a bronchodilator, use it before inhaling the sodium chloride solution as directed by your doctor to help prevent airway irritation or narrowing.
  • Maintain good hydration by drinking plenty of fluids, as this also helps to thin mucus.
  • Clean your nebulizer equipment regularly as instructed to prevent infections.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 4 mL of 10% solution via nebulizer, 2 to 4 times daily
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

Cystic Fibrosis: 4 mL of 10% solution via nebulizer, 2 to 4 times daily, often preceded by a bronchodilator.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution and under specialist guidance)
Infant: Not established (use with extreme caution and under specialist guidance)
Child: For Cystic Fibrosis: 4 mL of 10% solution via nebulizer, 2 to 4 times daily, often preceded by a bronchodilator. Dosing may vary based on age and tolerance, often starting with lower concentrations (e.g., 3% or 7%).
Adolescent: For Cystic Fibrosis: 4 mL of 10% solution via nebulizer, 2 to 4 times daily, often preceded by a bronchodilator.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for nebulized use due to minimal systemic absorption.
Moderate: No specific adjustment needed for nebulized use due to minimal systemic absorption.
Severe: No specific adjustment needed for nebulized use due to minimal systemic absorption. Monitor for fluid and electrolyte balance if significant systemic absorption is suspected (unlikely).
Dialysis: No specific adjustment needed for nebulized use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Hypertonic saline (e.g., 10% Sodium Chloride) creates an osmotic gradient across the airway surface, drawing water from the submucosa and epithelial cells into the airway lumen. This rehydrates the airway surface liquid, thins thickened mucus, and improves mucociliary clearance, facilitating the expectoration of secretions.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption when administered via nebulization; primarily local action in the airways.
Tmax: Not applicable (local action)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (local action)
ProteinBinding: Not applicable (local action)
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not applicable (local action; endogenous ions are homeostatically regulated)
Clearance: Not applicable (local action)
ExcretionRoute: Primarily cleared from airways via mucociliary clearance and expectoration; any minimally absorbed systemic ions are renally excreted.
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of inhalation)
PeakEffect: Within 15-30 minutes of inhalation
DurationOfAction: Variable, typically lasts for several hours (e.g., 4-6 hours), depending on individual patient response and underlying condition.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. 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, or swelling of the mouth, face, lips, tongue, or throat.

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 side effects that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, discuss them with your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing side effects.
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Seek Immediate Medical Attention If You Experience:

  • Worsening cough or new onset of severe coughing spells
  • Increased wheezing or whistling sound when breathing
  • Difficulty breathing or shortness of breath that gets worse
  • Chest tightness or pain
  • Signs of an allergic reaction (rare): rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble 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 to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to disclose all your medications and health issues to your doctor and pharmacist.
Any health problems you have, as they may interact with this medication. Your doctor and pharmacist need to be aware of your complete medical profile to ensure safe treatment.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor. 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 of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, you must discuss this with your doctor. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Overdose with nebulized sodium chloride is highly unlikely due to minimal systemic absorption.
  • If ingested or given intravenously in excessive amounts, symptoms could include hypernatremia (high sodium levels): thirst, confusion, lethargy, irritability, seizures, coma.
  • Excessive inhalation could theoretically lead to severe bronchospasm.

What to Do:

If accidental ingestion or severe symptoms occur, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the US). Management would be supportive, focusing on airway management and addressing any severe bronchospasm.

Drug Interactions

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Moderate Interactions

  • Other inhaled medications (administer sequentially with appropriate spacing to avoid dilution or altered deposition)

Monitoring

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Baseline Monitoring

Respiratory assessment (lung sounds, respiratory rate, effort)

Rationale: To establish baseline respiratory status and identify any pre-existing bronchospasm.

Timing: Prior to initiation of therapy.

Sputum characteristics (volume, viscosity, color)

Rationale: To assess baseline mucus burden and monitor treatment effectiveness.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Respiratory status (cough, wheezing, dyspnea)

Frequency: Before and after each nebulization, then regularly as clinically indicated.

Target: Improvement in cough effectiveness, reduced sputum viscosity, decreased wheezing/dyspnea.

Action Threshold: Worsening cough, increased wheezing, new onset dyspnea, or chest tightness may indicate bronchospasm and require intervention (e.g., bronchodilator, discontinuation).

Sputum production and ease of expectoration

Frequency: Daily or as clinically indicated.

Target: Increased sputum volume, thinner consistency, easier to clear.

Action Threshold: No change or worsening sputum characteristics may indicate inadequate response or need for re-evaluation.

Oxygen saturation (SpO2)

Frequency: As clinically indicated, especially in patients with underlying respiratory compromise.

Target: Maintain baseline or improved SpO2.

Action Threshold: Significant drop in SpO2 may indicate bronchospasm or respiratory distress.

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Symptom Monitoring

  • Increased coughing (especially immediately after inhalation)
  • Wheezing
  • Shortness of breath
  • Chest tightness
  • Bronchospasm
  • Sore throat or irritation

Special Patient Groups

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Pregnancy

Sodium chloride is an endogenous substance. While specific studies on 10% hypertonic saline in pregnancy are limited, the systemic absorption from nebulized administration is minimal. Generally considered low risk, but use only if clearly needed and potential benefits outweigh risks. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Sodium chloride is an endogenous substance and is not expected to be excreted in breast milk in clinically significant amounts following nebulized administration due to minimal systemic absorption. Considered compatible with breastfeeding (L1).

Infant Risk: Low risk.
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Pediatric Use

Can be used in pediatric patients, particularly those with cystic fibrosis, but often lower concentrations (e.g., 3% or 7%) are initiated first, and careful monitoring for bronchospasm is essential. Pre-treatment with a bronchodilator is often recommended. Use in neonates and infants should be under strict medical supervision due to potential for airway reactivity.

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Geriatric Use

Generally safe for use in geriatric patients. No specific dose adjustments are typically required due to minimal systemic absorption. Monitor for tolerance and potential for airway irritation or bronchospasm, as older adults may have more sensitive airways.

Clinical Information

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Clinical Pearls

  • Always pre-treat with a short-acting bronchodilator (e.g., albuterol) 10-15 minutes before inhaling hypertonic saline, especially with higher concentrations like 10%, to minimize the risk of bronchospasm.
  • Patients should be instructed on proper nebulizer technique to ensure optimal drug delivery.
  • Monitor patients closely for signs of bronchospasm (e.g., increased wheezing, coughing, shortness of breath) during and after administration.
  • Hypertonic saline is often used as part of a comprehensive airway clearance regimen, not as a standalone therapy.
  • The 10% concentration is potent and typically reserved for patients who do not respond adequately to lower concentrations (e.g., 3% or 7%) or for specific indications like severe cystic fibrosis lung disease.
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Alternative Therapies

  • Lower concentrations of hypertonic saline (e.g., 3%, 7%)
  • Isotonic saline (0.9% Sodium Chloride) for nebulization (less effective for mucolysis)
  • Dornase alfa (Pulmozyme) - a mucolytic enzyme for cystic fibrosis
  • N-acetylcysteine (NAC) - another mucolytic agent (less commonly used for inhalation due to side effects)
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Cost & Coverage

Average Cost: Low cost per 15ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic) or Tier 2 (Non-Preferred Generic) for most insurance plans.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them 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. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.