Sodium Chloride 7% Neb Sol 60x4ml

Manufacturer PHARMACARIBE 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, Respiratory agent
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Pharmacologic Class
Osmotic agent, Electrolyte
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Pregnancy Category
Category B
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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 7% Nebulizer Solution is a salty 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.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, 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 teach you how to use the nebulizer properly.

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. Dispose of unused or expired medications by throwing them away. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. 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

  • Use your nebulizer as prescribed by your doctor, typically 2 to 4 times a day.
  • Ensure proper nebulizer technique for effective delivery of the medication.
  • Clean your nebulizer equipment regularly as instructed to prevent infections.
  • If you experience increased coughing or wheezing, especially at the beginning of treatment, inform your doctor. They may recommend using a bronchodilator medication before your hypertonic saline treatment.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 4 mL of 7% solution via nebulizer, 2 to 4 times daily
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

cysticFibrosis: 4 mL of 7% solution via nebulizer, 2 to 4 times daily
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Pediatric Dosing

Neonatal: Not established
Infant: Dosing typically similar to older children/adults (e.g., 4 mL of 7% solution via nebulizer, 2 to 4 times daily), but individual assessment is crucial.
Child: 4 mL of 7% solution via nebulizer, 2 to 4 times daily
Adolescent: 4 mL of 7% solution via nebulizer, 2 to 4 times daily
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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 7% (hypertonic saline) is an osmotic agent that draws water into the airway lumen via osmosis. This rehydrates the airway surface liquid, thins tenacious mucus, and improves mucociliary clearance, facilitating expectoration of secretions.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption when administered via nebulization; primarily local effect in the airways.
Tmax: Not applicable for systemic effect; local effect onset within minutes.
FoodEffect: Not applicable.

Distribution:

Vd: Not applicable for systemic distribution; localized to the respiratory tract.
ProteinBinding: Not applicable for systemic protein binding.
CnssPenetration: No

Elimination:

HalfLife: Not applicable for systemic half-life; cleared locally from airways.
Clearance: Cleared via mucociliary transport, swallowing, or exhalation.
ExcretionRoute: Primarily local clearance from airways; minimal systemic excretion if absorbed.
Unchanged: Not applicable.
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Pharmacodynamics

OnsetOfAction: Within minutes (e.g., 5-10 minutes)
PeakEffect: Within 30-60 minutes
DurationOfAction: Approximately 2-6 hours, depending on individual mucociliary clearance rates.

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

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.

Reporting Side Effects

This list does not include all possible side effects. If you have questions or concerns about side effects, talk to 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 about side effects and help you manage them.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent coughing
  • Increased shortness of breath or difficulty breathing
  • New or worsening wheezing or chest tightness
  • Chest pain
  • Signs of an allergic reaction (rare, but possible): 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, including allergies to this medication, any of its components, or other substances, such as foods or 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 information will help your doctor assess potential interactions between this medication and other substances you are taking.
* Any health problems you have, as they may affect the safety and efficacy of this medication.

Please note that this is not an exhaustive list of all possible interactions or health problems that may be relevant to this medication. To ensure your safety, it is crucial to consult with your doctor and pharmacist about all your medications and health issues before taking this drug. Additionally, do not start, stop, or change the dose of any medication without first discussing it with your doctor to avoid any potential adverse effects.
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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 breastfeeding, notify your doctor immediately. You and your doctor will need 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:

  • Overdose with nebulized sodium chloride is highly unlikely due to minimal systemic absorption. Excessive local irritation might occur.

What to Do:

If accidental ingestion or excessive use occurs, contact a poison control center or emergency services. For local irritation, discontinue use and consult a healthcare professional. Call 1-800-222-1222 for Poison Control.

Drug Interactions

Monitoring

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Baseline Monitoring

Respiratory assessment (e.g., lung sounds, cough characteristics)

Rationale: To establish baseline respiratory status before initiating therapy.

Timing: Prior to first dose

Spirometry (FEV1)

Rationale: To assess baseline lung function, particularly in conditions like cystic fibrosis.

Timing: Prior to first dose (if applicable)

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Routine Monitoring

Respiratory symptoms (e.g., cough, sputum production, shortness of breath)

Frequency: Daily or as needed

Target: Improvement or stabilization of symptoms

Action Threshold: Worsening symptoms, increased cough, or bronchospasm may require intervention or discontinuation.

Tolerance to nebulization (e.g., presence of cough, chest tightness, wheezing)

Frequency: With each dose

Target: Minimal or no adverse effects

Action Threshold: Significant bronchospasm or discomfort may necessitate pre-treatment with a bronchodilator or discontinuation.

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Symptom Monitoring

  • Increased cough (especially productive cough)
  • Sputum characteristics (amount, color, consistency)
  • Shortness of breath
  • Chest tightness
  • Wheezing
  • Bronchospasm

Special Patient Groups

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Pregnancy

Sodium chloride 7% nebulizer solution is generally considered safe for use during pregnancy. Systemic absorption is minimal, limiting potential fetal exposure.

Trimester-Specific Risks:

First Trimester: Minimal risk expected due to negligible systemic absorption.
Second Trimester: Minimal risk expected due to negligible systemic absorption.
Third Trimester: Minimal risk expected due to negligible systemic absorption.
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Lactation

Sodium chloride 7% nebulizer solution is considered safe for use during lactation. Systemic absorption by the mother is minimal, and therefore, transfer into breast milk is negligible. It is not expected to cause adverse effects in a breastfed infant.

Infant Risk: Very low risk (L1 - Safest)
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Pediatric Use

Generally well-tolerated and effective in pediatric patients, including infants and children, for conditions like cystic fibrosis. Dosing is typically similar to adults (4 mL of 7% solution). Close monitoring for bronchospasm is important, especially in younger children.

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Geriatric Use

No specific dose adjustments are typically required for geriatric patients. The safety profile is similar to that in younger adults. Monitor for tolerance and potential for bronchospasm.

Clinical Information

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Clinical Pearls

  • Pre-treatment with a short-acting bronchodilator (e.g., albuterol) is often recommended 10-15 minutes before hypertonic saline nebulization to minimize the risk of bronchospasm and improve tolerance, especially in patients prone to airway hyperreactivity.
  • Patients should be instructed to cough effectively after treatment to clear loosened secretions.
  • Hypertonic saline can induce coughing and sputum production, which is an expected therapeutic effect, but excessive or painful coughing should be reported.
  • Ensure proper nebulizer device and technique are used for optimal drug delivery.
  • Regular cleaning of nebulizer equipment is crucial to prevent bacterial contamination.
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Alternative Therapies

  • Dornase alfa (Pulmozyme) - another mucolytic agent for cystic fibrosis.
  • N-acetylcysteine (NAC) - a mucolytic agent (though less commonly used for nebulization in CF compared to hypertonic saline or dornase alfa).
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Cost & Coverage

Average Cost: Low cost (typically $0.50 - $2.00 per 4mL vial) per 4mL vial
Generic Available: Yes
Insurance Coverage: Tier 1 (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 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.