Sodium Chloride 10% Neb Sol 60x4ml

Manufacturer NEPHRON PHARMACEUTICALS CORP. 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
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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 10% Nebulizer Solution is a strong salt water solution that you breathe in using a nebulizer. It helps to thin the thick mucus in your lungs, making it easier to cough up and clear your airways. This can help you breathe more easily, especially if you have conditions like cystic fibrosis or bronchiectasis.
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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 look into local drug take-back programs.

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

  • Ensure proper nebulizer technique as instructed by your healthcare provider.
  • Maintain good hydration by drinking plenty of fluids, as this can also help thin mucus.
  • Clean your nebulizer equipment regularly as per manufacturer instructions 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 2-4 times daily, or as directed by physician. May require pre-treatment with a bronchodilator.

Condition-Specific Dosing:

Cystic Fibrosis: 4 mL of 10% solution via nebulizer 2-4 times daily.
Bronchiectasis: 4 mL of 10% solution via nebulizer 2-4 times daily.
Sputum Induction: 4 mL of 10% solution via nebulizer as a single dose for sputum collection.
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Pediatric Dosing

Neonatal: Not established. Use with extreme caution and under specialist supervision due to high osmolality and potential for bronchospasm.
Infant: Not established. Use with extreme caution and under specialist supervision due to high osmolality and potential for bronchospasm.
Child: Dosing should be individualized based on patient tolerance and clinical response, typically starting with lower concentrations (e.g., 3% or 7%) and escalating if tolerated and needed. 4 mL of 10% solution via nebulizer 1-2 times daily, or as directed by physician for specific conditions (e.g., Cystic Fibrosis), often with bronchodilator pre-treatment.
Adolescent: 4 mL of 10% solution via nebulizer 2-4 times daily, or as directed by physician. May require pre-treatment with a bronchodilator.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required as systemic absorption is minimal.
Moderate: No specific dose adjustment required as systemic absorption is minimal.
Severe: No specific dose adjustment required as systemic absorption is minimal.
Dialysis: No specific dose adjustment required as systemic absorption is minimal.

Hepatic Impairment:

Mild: No specific dose adjustment required as systemic absorption is minimal.
Moderate: No specific dose adjustment required as systemic absorption is minimal.
Severe: No specific dose adjustment required as systemic absorption is minimal.

Pharmacology

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Mechanism of Action

Hypertonic saline (sodium chloride solution with a concentration greater than 0.9%) creates an osmotic gradient across the airway surface, drawing water from the submucosa and cells into the airway lumen. This rehydrates the airway surface liquid, thins the mucus, and improves mucociliary clearance. It may also induce a cough reflex, further aiding in sputum expectoration.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from nebulized administration; primarily local effect in the respiratory tract.
Tmax: Not applicable for systemic effect; local effect is rapid.
FoodEffect: Not applicable.

Distribution:

Vd: Not applicable; localized to respiratory tract.
ProteinBinding: Not applicable.
CnssPenetration: No

Elimination:

HalfLife: Not applicable; primarily cleared locally.
Clearance: Cleared via mucociliary transport, swallowing, or expectoration.
ExcretionRoute: Respiratory tract (expectoration/swallowing)
Unchanged: 100%
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Pharmacodynamics

OnsetOfAction: Rapid, within minutes of inhalation.
PeakEffect: Within 15-30 minutes.
DurationOfAction: Varies, typically 1-4 hours, depending on patient's condition and mucus burden.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
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 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

Other Possible Side Effects
All medications can cause side effects, but many people experience none or only mild effects. If you have 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, discuss them with your doctor.

Reporting Side Effects
To report side effects, you can:
- Call your doctor for medical advice
- Contact the FDA at 1-800-332-1088
- Submit a report online at https://www.fda.gov/medwatch
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Seek Immediate Medical Attention If You Experience:

  • Sudden increase in coughing or coughing fits
  • New or worsening wheezing
  • Feeling short of breath or difficulty breathing
  • Chest tightness or pain
  • Throat irritation or soreness that is severe or persistent
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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 conditions 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 drugs 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 pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Overdose from nebulized sodium chloride is highly unlikely due to minimal systemic absorption. However, excessive inhalation could theoretically worsen respiratory irritation or bronchospasm.

What to Do:

If severe respiratory distress occurs, discontinue use immediately and seek emergency medical attention. Call 911 or your local emergency number. For general concerns, contact Poison Control at 1-800-222-1222.

Drug Interactions

Monitoring

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Baseline Monitoring

Respiratory assessment (e.g., lung sounds, sputum characteristics, baseline spirometry if applicable)

Rationale: To establish baseline respiratory status and assess the need for and response to therapy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Respiratory status (e.g., cough, sputum production, ease of breathing)

Frequency: During and after each treatment, and regularly throughout therapy.

Target: Improved sputum clearance, reduced cough, improved breathing.

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

Patient tolerance and adverse effects (e.g., bronchospasm, throat irritation)

Frequency: During and after each treatment.

Target: Absence of significant adverse effects.

Action Threshold: Presence of significant adverse effects may require dose adjustment, pre-treatment, or discontinuation.

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Symptom Monitoring

  • Increased cough
  • Wheezing
  • Shortness of breath
  • Chest tightness
  • Sore throat
  • Hoarseness
  • Increased sputum production

Special Patient Groups

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Pregnancy

Sodium chloride nebulizer solution is generally considered safe for use during pregnancy due to minimal systemic absorption. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: No known specific risks.
Second Trimester: No known specific risks.
Third Trimester: No known specific risks.
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Lactation

Sodium chloride nebulizer solution is considered safe for use during lactation as it is not significantly absorbed systemically and is a natural component of breast milk. No adverse effects on the infant are expected.

Infant Risk: Low risk (L1)
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Pediatric Use

Use with caution, especially in very young children or those with reactive airways, as hypertonic saline can induce bronchospasm. Pre-treatment with a bronchodilator is often recommended. Start with lower concentrations (e.g., 3% or 7%) and gradually increase if tolerated and clinically indicated. Close monitoring for respiratory distress is essential.

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Geriatric Use

No specific dose adjustments are typically required. Use with general caution as with any respiratory therapy, monitoring for tolerance and adverse effects.

Clinical Information

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Clinical Pearls

  • Always consider pre-treating with a short-acting bronchodilator (e.g., albuterol) 10-15 minutes before administering 10% hypertonic saline to minimize the risk of bronchospasm, especially in patients with reactive airway disease.
  • Monitor patients closely during and after the first few treatments for signs of bronchospasm (e.g., increased cough, wheezing, shortness of breath).
  • Ensure proper nebulizer technique is taught and reinforced to patients for optimal drug delivery.
  • While 10% is a high concentration, it may be used in specific cases where lower concentrations (3% or 7%) are insufficient, particularly in adults with very tenacious secretions.
  • Not for intravenous or injectable use; strictly for nebulization.
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Alternative Therapies

  • Dornase alfa (Pulmozyme) - for cystic fibrosis
  • N-acetylcysteine (NAC) - mucolytic agent
  • Mannitol (inhaled dry powder) - osmotic agent
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Cost & Coverage

Average Cost: Low to moderate per 4ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.