Hypersal 3.5% Nebulizer Sol 60x4ml

Manufacturer PARI 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 tract fluid
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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?

Hypersal 3.5% is a salt 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 it 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. 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 medications, 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 exactly as prescribed by your doctor.
  • Do not mix with other medications in the nebulizer unless directed by your doctor or pharmacist.
  • Clean your nebulizer equipment thoroughly after each use as directed by the manufacturer to prevent infection.
  • If you experience increased coughing, wheezing, or difficulty breathing during or after treatment, stop the treatment and contact your doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 4 mL of 3.5% solution, 2 to 4 times daily via nebulizer
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

Cystic Fibrosis: 4 mL of 3.5% solution, 2 to 4 times daily via nebulizer
Bronchiolitis (off-label): 4 mL of 3.5% solution, 2 to 4 times daily via nebulizer
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Pediatric Dosing

Neonatal: Not established
Infant: 4 mL of 3.5% solution, 2 to 4 times daily via nebulizer (often off-label for bronchiolitis, with bronchodilator pre-treatment)
Child: 4 mL of 3.5% solution, 2 to 4 times daily via nebulizer
Adolescent: 4 mL of 3.5% solution, 2 to 4 times daily via nebulizer
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific considerations as systemic absorption is minimal

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Hypertonic saline (3.5% sodium chloride) creates an osmotic gradient across airway surfaces, drawing water from the submucosa and cells into the airway lumen. This rehydrates airway secretions, thins mucus, and improves mucociliary clearance. It may also induce cough, further aiding in mucus expectoration.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (primarily local action)
Tmax: Not applicable (primarily local action)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (primarily local action)
ProteinBinding: Not applicable (inorganic salt, local action)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (primarily local action)
Clearance: Not applicable (primarily local action)
ExcretionRoute: Primarily cleared from the lungs via mucociliary clearance and expectoration. Minimal systemic absorption, if any, would be renally excreted.
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes of inhalation)
PeakEffect: Approximately 30-60 minutes post-inhalation
DurationOfAction: Varies, generally short-acting, requiring multiple doses daily

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, or 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 minor ones, it's essential to discuss any concerns with your doctor. 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, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent coughing
  • New or worsening wheezing
  • Increased shortness of breath or difficulty breathing
  • Chest tightness or discomfort
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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 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.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to evaluate potential interactions and determine the best course of treatment for you.
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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, 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:

  • Unlikely with nebulized administration due to minimal systemic absorption.
  • Excessive local irritation, increased cough, or bronchospasm could occur.

What to Do:

Discontinue use and seek medical attention if severe symptoms occur. For general overdose concerns, call a poison control center (e.g., 1-800-222-1222 in the US).

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 before initiating therapy and assess for potential bronchospasm.

Timing: Prior to first dose

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Routine Monitoring

Symptoms of bronchospasm (e.g., wheezing, increased cough, shortness of breath)

Frequency: During and immediately after nebulization

Target: Absence of symptoms or mild, tolerable symptoms

Action Threshold: Significant wheezing, severe cough, or respiratory distress; consider bronchodilator pre-treatment or discontinuation.

Effectiveness of therapy (e.g., ease of mucus expectoration, improved breathing)

Frequency: Daily or as clinically indicated

Target: Improved airway clearance and respiratory comfort

Action Threshold: Lack of improvement or worsening symptoms; re-evaluate treatment plan.

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Symptom Monitoring

  • Cough (especially productive cough)
  • Wheezing
  • Shortness of breath
  • Chest tightness
  • Sputum production and characteristics

Special Patient Groups

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Pregnancy

Sodium chloride is a naturally occurring substance. Nebulized hypertonic saline is generally considered safe during pregnancy as systemic absorption is minimal. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Low risk, minimal systemic exposure.
Second Trimester: Low risk, minimal systemic exposure.
Third Trimester: Low risk, minimal systemic exposure.
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Lactation

Sodium chloride is a natural component of breast milk. Nebulized hypertonic saline is considered safe during lactation due to minimal systemic absorption by the mother and no expected adverse effects on the infant.

Infant Risk: Low risk (L1)
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Pediatric Use

Commonly used in pediatric populations, particularly for conditions like cystic fibrosis and bronchiolitis. Bronchodilator pre-treatment may be recommended, especially in younger children or those prone to bronchospasm.

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Geriatric Use

Generally safe for use in geriatric patients. No specific dose adjustments are typically required. Monitor for potential bronchospasm, as older adults may have underlying respiratory conditions.

Clinical Information

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Clinical Pearls

  • Hypertonic saline can induce cough and bronchospasm, especially in sensitive individuals. Pre-treatment with a short-acting bronchodilator (e.g., albuterol) 10-15 minutes prior to hypertonic saline nebulization is often recommended to mitigate this effect.
  • The primary goal of hypertonic saline nebulization is to improve mucociliary clearance and facilitate expectoration of thick, tenacious secretions.
  • Patients should be instructed on proper nebulizer technique and cleaning to ensure efficacy and prevent contamination.
  • While generally safe, monitor patients for signs of respiratory distress or worsening symptoms during and after administration.
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Alternative Therapies

  • Isotonic saline (0.9% sodium chloride) nebulization (less effective for mucolysis)
  • Dornase alfa (Pulmozyme) - for cystic fibrosis patients to reduce sputum viscosity
  • N-acetylcysteine (Mucomyst) - mucolytic agent (less commonly used via nebulization due to odor and potential for bronchospasm)
  • Airway clearance techniques (e.g., chest physiotherapy, high-frequency chest wall oscillation)
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Cost & Coverage

Average Cost: Varies, generally low per 60x4ml box
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often covered by most insurance plans)
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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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.