Sodium Chloride 3% Neb Sol 60x4ml

Manufacturer RITEDOSE PHARMACEUTICALS 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; Respiratory 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 3% nebulizer solution is a salty water solution that you breathe in using a nebulizer. It helps to thin the mucus in your lungs, making it easier to cough up and clear your airways, which can help you breathe better.
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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 medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs in your area.

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

  • Maintain good hydration by drinking plenty of fluids, as this can also help thin mucus.
  • Follow your healthcare provider's instructions for nebulizer use and cleaning.
  • If you experience increased coughing or wheezing during treatment, stop and inform your doctor.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 4 mL of 3% Sodium Chloride Nebulizer Solution via nebulizer 2 to 4 times daily
Dose Range: 4 - 4 mg

Condition-Specific Dosing:

cysticFibrosis: 4 mL of 3% or 7% Sodium Chloride Nebulizer Solution via nebulizer 2 to 4 times daily
bronchiolitis: 4 mL of 3% Sodium Chloride Nebulizer Solution via nebulizer every 4-6 hours as needed
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Pediatric Dosing

Neonatal: Not established for routine use; use with caution and under medical supervision for specific conditions.
Infant: 4 mL of 3% Sodium Chloride Nebulizer Solution via nebulizer every 4-6 hours as needed for bronchiolitis (typically for infants > 6 weeks of age).
Child: 4 mL of 3% Sodium Chloride Nebulizer Solution via nebulizer 2 to 4 times daily for cystic fibrosis or as needed for other conditions.
Adolescent: 4 mL of 3% Sodium Chloride Nebulizer Solution via nebulizer 2 to 4 times daily for cystic fibrosis or as needed for other conditions.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.
Dialysis: No specific considerations for nebulized use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Sodium chloride 3% nebulizer solution is a hypertonic saline solution. When inhaled, its hyperosmolar nature 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 tenacious 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 for systemic effects; local effect is immediate upon inhalation.
FoodEffect: Not applicable.

Distribution:

Vd: Not applicable for systemic distribution; primarily distributed locally in the respiratory tract.
ProteinBinding: Not applicable for systemic protein binding.
CnssPenetration: No

Elimination:

HalfLife: Not applicable for systemic elimination; local effects dissipate as solution is cleared from airways.
Clearance: Not applicable for systemic clearance.
ExcretionRoute: Not applicable for systemic excretion; cleared from airways via mucociliary escalator and expectoration.
Unchanged: Not applicable.
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of inhalation)
PeakEffect: During and immediately after administration
DurationOfAction: Short (effects may last for a few hours, depending on individual mucus production and clearance)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:

* 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to monitor your body's response. If you have any side effects that bother you or persist, contact your doctor for guidance.

Reporting Side Effects
If you have questions or concerns about side effects, don't hesitate to reach out to your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Remember, not all possible side effects are listed here, so it's crucial to stay informed and consult your doctor if you have any concerns.
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Seek Immediate Medical Attention If You Experience:

  • Increased shortness of breath or difficulty breathing immediately after treatment
  • Severe or persistent coughing
  • New or worsening wheezing or chest tightness
  • Signs of an allergic reaction (rare, but possible: rash, itching, swelling, 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 any 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 discuss all your medications and health conditions with your doctor.
* Any health problems you have, as they may interact with this medication.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist need to be aware of all your medications and health problems to provide the best possible care.
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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. Your doctor will need to weigh the benefits and risks of this medication for both you and your baby to determine the best course of action.
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Overdose Information

Overdose Symptoms:

  • Excessive coughing
  • Bronchospasm (wheezing, chest tightness)
  • Airway irritation

What to Do:

Discontinue use. If symptoms are severe or persistent, seek immediate medical attention. For severe bronchospasm, a bronchodilator may be administered. Systemic overdose (hypernatremia) is highly unlikely with nebulized administration.

Drug Interactions

Monitoring

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Baseline Monitoring

Respiratory assessment (e.g., lung sounds, respiratory rate, oxygen saturation)

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

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: Improvement in cough effectiveness, reduction in sputum viscosity, improved breathing.

Action Threshold: Worsening cough, increased wheezing, shortness of breath, or signs of bronchospasm; discontinue treatment and assess patient.

Signs of bronchospasm (e.g., wheezing, chest tightness, increased work of breathing)

Frequency: During and immediately after each treatment.

Target: Absence of bronchospasm.

Action Threshold: Presence of bronchospasm; administer bronchodilator if indicated, discontinue hypertonic saline if severe.

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Symptom Monitoring

  • Cough effectiveness
  • Sputum quantity and consistency
  • Ease of breathing
  • Presence of wheezing or chest tightness
  • Signs of respiratory distress

Special Patient Groups

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Pregnancy

Sodium chloride 3% nebulizer solution is generally considered safe for use during pregnancy due to minimal systemic absorption. However, use should be based on clinical need and under medical supervision.

Trimester-Specific Risks:

First Trimester: Minimal risk due to local action and negligible systemic absorption.
Second Trimester: Minimal risk due to local action and negligible systemic absorption.
Third Trimester: Minimal risk due to local action and negligible systemic absorption.
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Lactation

Sodium chloride 3% nebulizer solution is considered compatible with breastfeeding. Systemic absorption is minimal, making transfer into breast milk unlikely to be clinically significant.

Infant Risk: Low risk to infant.
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Pediatric Use

Commonly used in pediatric populations, particularly for conditions like bronchiolitis and cystic fibrosis. Dosing may be adjusted based on age and condition. Close monitoring for bronchospasm is important, especially in infants.

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Geriatric Use

Generally safe for use in geriatric patients. No specific dose adjustments are typically required. Monitor for tolerance and potential for increased cough or bronchospasm.

Clinical Information

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Clinical Pearls

  • Hypertonic saline can induce cough and bronchospasm in some patients. Pre-treatment with a short-acting bronchodilator (e.g., albuterol) 10-15 minutes before hypertonic saline nebulization is often recommended, especially for patients with reactive airways.
  • The 3% concentration is generally well-tolerated, but higher concentrations (e.g., 7%) are also available and may be used in specific conditions like cystic fibrosis.
  • Ensure proper nebulizer technique and maintenance for optimal delivery and hygiene.
  • Not for intravenous use. For inhalation only.
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Alternative Therapies

  • Isotonic saline (0.9% sodium chloride) nebulizer solution (less effective for mucus clearance)
  • Dornase alfa (Pulmozyme) - for cystic fibrosis patients to reduce mucus viscosity
  • N-acetylcysteine (Mucomyst) - another mucolytic agent, though less commonly used via nebulization for chronic conditions due to side effects and odor.
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Cost & Coverage

Average Cost: $10 - $50 per 60 x 4mL vials
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 medication taken, the amount, and the time it happened.